BEGIN:VCALENDAR VERSION:2.0 PRODID:-//The Center for Research on Complex Generics (CRCG) - ECPv6.17.4//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:The Center for Research on Complex Generics (CRCG) X-ORIGINAL-URL:https://www.complexgenerics.org X-WR-CALDESC:Events for The Center for Research on Complex Generics (CRCG) REFRESH-INTERVAL;VALUE=DURATION:PT1H X-Robots-Tag:noindex X-PUBLISHED-TTL:PT1H BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD TZOFFSETFROM:+0000 TZOFFSETTO:+0000 TZNAME:UTC DTSTART:20250101T000000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=UTC:20260923T080000 DTEND;TZID=UTC:20260924T170000 DTSTAMP:20260910T193821Z CREATED:20250918T215130Z LAST-MODIFIED:20260910T193821Z UID:38345-1790150400-1790269200@www.complexgenerics.org SUMMARY:Navigating the GLP-1 Generic Drug Pathway DESCRIPTION:Navigating the GLP-1 Generic Drug Pathway\n \n \n HomeEducation and Training\n \n \n \n \n \n Explore This Section\n \n \n Upcoming Events\n \n \n Event Summary\n \n \n \n \n\n\n\n\n\n\n\n\n\n\nCo-hosts: FDA and the Center for Research on Complex Generics (CRCG) \n\n\n\nIn person (at The Universities at Shady Grove; Rockville\, MD) and virtual workshop \n\n\n\n \n \n \n \n \n Registration Now Open\n \n \n \n \n \n \n \n Register Here \n \n \n \n \n \n Download the Agenda \n \n \n \n \n \n Small Group Discussion Topics (In-Person Only) \n \n \n \n \n\n\n\nAboutEvent OutlineSpeaker BiosTravel & AccomodationsOrdering Lunch\n \n This two-day workshop will address some of the key product development and regulatory assessment considerations for generic glucagon-like peptide-1 (GLP-1) agonist products. The goal of this workshop is to provide clarity and foster discussions on evidence-based approaches to establish the acceptable critical quality attributes of recombinant and synthetic peptide products\, address manufacturing quality considerations\, and tackle the unique challenges associated with drug-device combination products\, where applicable. \nKey areas of focus include: \n\nRegulatory and Scientific Foundations: Current FDA scientific thinking on generic GLP-1 product development\, Product-Specific Guidance (PSG) development\, and in vivo BE studies for GLP-1 oral products\nActive Pharmaceutical Ingredient (API) Characterization and Manufacturing: Comprehensive approaches to demonstrating API sameness\, analytical characterization strategies\, impurity profiling\, and sameness assessment for peptide products\nRecombinant Peptide Production: Best practices for controlling host cell impurities\, regulatory expectations\, and risk assessment strategies\nOral GLP-1 Formulation Development: Formulation and delivery innovations\, bioequivalence study design for highly variable products\, absorption enhancement technologies\, and drug product quality expectations\nDevice User Interface and Human Factors: Comparative analyses (CA) of device user interfaces\, Comparative Use Human Factors (CUHF) study design and case examples\, alternative approaches\, and device platform strategies\nDevice Quality and Integration: Quality considerations for generic injectors\, drug-device interface and compatibility\, manufacturing quality control\, and submission coordination strategies\n\nJoin us for an immersive two-day experience featuring presentations from leading experts in regulatory agencies\, pharmaceutical industry\, and academia. All attendees will benefit from insights shared by a diverse group of speakers\, including FDA officials\, industry leaders\, and renowned academics. This workshop offers a unique opportunity to: \n\nUnderstand the latest regulatory thinking on generic GLP-1 product development\nLearn about cutting-edge analytical and formulation approaches for peptide products\nGain insights into device design\, human factors\, and combination product development\nNetwork with peers and experts in the field\nExplore real-world case examples and best practices\nParticipate in collaborative discussions on emerging challenges\n\nJoin us to be part of the conversation shaping the future of generic GLP-1 product development. \nChoose your experience: \nVirtual Attendees will have free access to all sessions of the workshop except the small group (in-person only) working sessions. Virtual attendees will be able to: \n\nAttend all presentations and panel discussions\nParticipate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists\nEnjoy free access to workshop recordings of presentations and panel discussion (not including the small group working sessions)\n\nIn-person Attendees will enjoy all of the benefits of virtual attendance as well as interactive experiences featuring: \n\nSmall group working sessions at the end of each day will facilitate collaborative problem-solving and discussion of complex technical and regulatory issues impacting GLP-1 generics. During these working sessions\, attendees will help identify actionable next steps to address challenges with generic product development and regulatory assessment.\nCollaborative interactions with experts from industry\, consulting groups\, academia and FDA for clarifying regulatory expectations and exploring insights into regulatory standards\nNetworking opportunities designed to foster collaboration and contribute to moving the field forward.\n\nWorkshop Topics\n\nRegulatory Pathways and Clinical Context\nAPI Characterization and Peptide Manufacturing\nOral Formulation Development and Bioequivalence\nDevice Design and Human Factors\nDrug-Device Integration and Quality\n\nAudience\nThis workshop is designed for professionals involved in the development\, manufacturing\, and regulation of generic GLP-1 products. The target audience includes pharmaceutical scientists (formulation and product development scientists\, analytical chemists\, quality assurance and control experts)\, regulatory affairs professionals\, device engineers\, human factors specialists\, clinical development professionals\, and manufacturing experts. Additionally\, the workshop will be valuable for academic researchers in pharmaceutical sciences\, representatives from contract research organizations (CROs) and contract manufacturing organizations (CMOs)\, regulatory agency staff\, and healthcare professionals interested in generic complex drug products. The content is tailored to accommodate participants with varying levels of expertise in peptide products and drug-device combination products\, from those seeking to understand the fundamentals to advanced practitioners looking to stay abreast of the latest regulatory considerations and development strategies. \n\nVirtual Attendance is optimal for an audience who would like to have access to workshop content from anywhere\, eliminate travel time and expenses\, and who would like to have the flexibility to attend dynamic sessions/presentations at preferred times.\nIn-Person Attendance is optimal for an audience that is interested in collaborative discussions and real-time engagement\, immersive learning\, interactive sessions and group activities.\n\nRegistration Fees: \n\nThis workshop is FREE for virtual attendees.\n\n\nThe combined cost for both days of in-person attendance and activities is:\n\n$350\, in-person attendees – general\n$150\, in-person attendees – government (must have an email ending in “.gov” in order to register at this rate)\n\n\n\nFor faculty and students from the University of Maryland\, Baltimore\, The Universities at Shady Grove\, and University of Michigan\, please contact CRCG (info@complexgenerics.org) regarding registration. \nContinuing education (CE) credits will not be provided for attending this workshop.  A certificate of attendance will only be provided to individuals attending in-person\, when requested. \nFor in-person attendees\, beverages and food for breaks will be provided; Lunch will not be provided. Please see the Ordering Lunch tab regarding pre-ordering lunch instructions. Links are provided. Orders must be placed by September 14 (5 PM ET). Also there is an onsite cafe for purchasing food or you are welcome to bring your own lunch. \n\n\n\n\n\n\n\n\n \n Introduction to the Workshop \nThis two-day hybrid (virtual and in-person) workshop focuses on exploring the scientific\, regulatory\, and technical considerations for developing generic GLP-1 products throughout development. The workshop will include comprehensive sessions examining regulatory pathways and clinical context\, API characterization and manufacturing\, oral formulation development\, device design and human factors\, and drug-device integration strategies. The program features expert presentations from regulatory scientists across multiple FDA offices\, industry leaders from both innovator and generic companies\, device manufacturers\, and academic researchers\, complemented by interactive Q&A panels and small working group discussions for in-person attendees at the end of each day. This collaborative forum aims to advance understanding of the unique challenges in generic GLP-1 development and foster dialogue on best practices\, emerging approaches\, and regulatory expectations for these complex products. \nDAY 1\nSession 1: Opening Remarks and Regulatory Foundations \nFormat: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees) \n\nThis opening session establishes the regulatory and clinical framework for generic GLP-1 product development. The session provides an overview of the currently available GLP-1 products for generic products to reference. It will also explore the economics and patent landscape of GLP-1 products\, providing essential background for understanding the market dynamics and development considerations.\n\nSession 2: API Characterization and Sameness Demonstration \nFormat: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees) \n\nThis session establishes regulatory expectations and scientific approaches for demonstrating API sameness in generic GLP-1 peptide products. Topics include structural and functional equivalence demonstration\, comprehensive analytical characterization strategies (including higher-order structure analysis and mass spectrometry)\, peptide-specific stability challenges and shelf-life determinations\, impurity profiling and characterization\, and an update on peptide impurity qualification. The session will address common deficiencies and provide practical guidance on analytical methods and data requirements.\n\nSession 3: Recombinant Peptide Production and Host Cell Impurities \nFormat: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees) \n\nThis session examines best practices for controlling host cell impurities in recombinant peptide production\, drawing on regulatory expectations and experience from 505(b)(2) applications and biologics (including insulins). Attendees will learn about manufacturing considerations for recombinant peptides\, analytical approaches for host cell protein detection and quantification and regulatory expectations for impurity control and cleanup processes.\n\nSession 4: Small Group Working Sessions \nFormat: Interactive Working Sessions Around a Roundtable (In-Person Only) \n\nIn this interactive and collaborative session\, in-person attendees will participate in focused discussions on key topics from Day 1\, including API characterization challenges\, analytical method development\, stability strategies\, and manufacturing considerations. Guided by experienced moderators\, participants will engage in immersive round-table deliberations on selected high-impact topics\, and work together to identify new approaches to facilitate the development and assessment of GLP-1 generic products. Potential topics may include API characterization and demonstrations of sameness\, as well as recombinant peptide production and host cell impurities.\n\nDAY 2\nSession 5: Device Design\, User Interface\, Human Factors\, and Quality \nFormat: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees) \n\nThis session examines how device user interface differences in GLP-1 products affect substitutability\, bioequivalence\, and FDA expectations for Comparative analyses (CA) and Comparative Use Human Factors (CUHF) studies\, and addresses device engineering and drug-device compatibility considerations that impact performance\, bioequivalence\, and ANDA review for GLP-1 generic combination products. Topics include the landscape of GLP-1 drug-device combination products in the US market\, regulatory framing of “acceptable” UI differences\, current CUHF study guidance and design fundamentals\, case examples for pen injectors and autoinjectors\, alternative CUHF approaches\, device platform-based approaches for CA and HF data sharing\, engineering considerations for generic GLP-1 injectors and drug-device interfaces\, and CMC considerations for device evaluation. The session provides practical insights into study design\, recruitment challenges\, and regulatory expectations for developing robust GLP-1 generic combination products.\n\nSession 6: Oral Semaglutide: Bioequivalence\, Regulatory Considerations\, and Oral Peptide Delivery \nFormat: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees) \n\nThis session addresses the regulatory and scientific challenges of developing generic oral semaglutide tablets\, drawing on FDA’s experience with PSG development and generic application review. Topics include PSG development and bioequivalence study design\, strategies for managing high intrasubject pharmacokinetic variability\, FDA perspectives on drug product specifications and quality expectations\, clinical considerations for oral peptide formulation approaches\, and permeation enhancer selection for oral peptide delivery. Together\, these presentations provide practical insights into the unique challenges of developing generic oral semaglutide products and the evolving landscape of oral peptide delivery technologies.\n\nSession 7: Small Group Working Sessions – Day 2 \nFormat: Interactive Working Sessions Around a Roundtable (In-Person Only) \n\nIn this interactive and collaborative session\, in-person attendees will participate in focused discussions on key topics from Day 2\, including oral formulation challenges\, device design considerations\, human factors study approaches\, and combination product development strategies. Guided by experienced moderators\, participants will engage in immersive round-table deliberations on selected high-impact topics\, and work together to identify new approaches to facilitate the development and assessment of GLP-1 generic products. Potential topics may include CUHF study challenges\, subgroup analysis and extrapolation\, device platform approaches\, and submission coordination strategies.\n\nThe workshop will conclude with a summary of key takeaways and future directions for generic GLP-1 product development. \n\n\n\n\n\n\n \n \n \n Aktham Aburub\, Ph.D. \n \n \n \n \nVice President-Research\, Synthetic Molecule Design and Development\, Eli Lilly and Company \nDr. Aktham Aburub is Vice President\, Research—Synthetic Molecule Design and Development at Eli Lilly and Company. He brings extensive pharmaceutical industry experience spanning the full development continuum\, from discovery through commercialization. He has led and contributed to the development\, regulatory submission\, and commercialization of multiple products across diverse modalities\, and he has served as the CMC leader for Lilly’s oral peptide delivery program. Aktham is a recipient of the ACS Heroes of Chemistry Award and has authored more than 80 journal articles\, book chapters\, patents/applications\, and conference proceedings. He is also an adjunct professor at the University of Minnesota. Aktham earned a Ph.D. in Pharmaceutical Sciences from the University of Iowa and a B.Sc. in Pharmacy from Jordan University of Science and Technology.   \n\n \n \n \n \n \n Linda Assatourians\, M.D. \n \n \n \n \nPhysician\, DCR\, OSCE\, OGD\, CDER\, FDA \nDr. Linda Assatourians is a clinical reviewer in the Division of Clinical Review within the Office of Safety and Clinical Evaluation\, where she began her career at the FDA in 2023. Dr. Assatourians provides clinical input related to the development of generic drug products. This work includes assessment of comparative analyses in Abbreviated New Drug Applications\, evaluation of controlled correspondences and suitability petitions from generic product developers\, and collaboration with various FDA divisions on clinical issues encountered in the review of generic drug applications. Prior to joining the FDA\, Dr. Assatourians\, who is board certified in Internal Medicine\, practiced for over 15 years as an outpatient internal medicine physician in Washington\, DC. Dr. Assatourians obtained her medical degree and completed her training in Internal Medicine at the George Washington University School of Medicine. \n\n \n \n \n \n \n Heather Boyce\, Ph.D.\n \n \n \n \nLead Pharmacokineticist\, DTP II\, ORS\, OGD\, CDER\, FDA \nDr. Heather Boyce serves as a Lead Pharmacokineticist for the Modified Release Oral Drug Products Team in the Division of Therapeutic Performance II (DTP II)\, Office of Research and Standards (ORS)\, Office of Generic Drugs\, Center for Drug Evaluation and Research at the Food and Drug Administration in White Oak\, MD.   \nDr. Boyce brings 15 years of experience in the pharmaceutical industry with expertise in good manufacturing processes (GMP)\, pharmaceutical manufacturing and product development\, clinical trial design and analysis\, and clinical pharmacology.  \nDr. Boyce received her Ph.D. in Pharmaceutical Sciences at the University of Maryland\, Baltimore\, School of Pharmacy where her research focused on excipient properties and formulation design of pharmaceutical drug products. She received her Bachelor of Science degree in chemistry with a minor in mathematics from Temple University of Philadelphia\, PA.   \n\n \n \n \n \n \n Kang Chen\, Ph.D.​​ \n \n \n \n \nResearch Chemist\, OPQ\, OPQR\, CDER\, FDA \nDr. Kang Chen received his Ph.D. in Physical Chemistry from New York University and previously worked at the NIH\, where he developed NMR methods to study viral protein structure and dynamics. At the FDA Center for Drug Evaluation and Research (CDER)\, he develops and applies NMR\, DLS\, and chemometric approaches to characterize complex drug chemical and higher-order structures. He has coauthored more than 60 publications with collaborators and has conducted consultative reviews for over 200 ANDA\, DMF\, and BLA applications\, contributing to the approval of more than 10 first generic and biologic drug products.  \n\n \n \n \n \n \n Michael Davis\, M.D.\, Ph.D.\n \n \n \n \nDirector of the Center for Drug Evaluation and Research (CDER)\, FDA \nDr. Michael Davis is the Director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER)\, where he helps lead the Center’s work to ensure that safe\, effective\, and high-quality drugs are available to the public. He previously served as CDER Deputy Center Director and\, earlier\, as a Clinical Team Leader in CDER’s Office of New Drugs\, Division of Psychiatry\, where he led multidisciplinary review teams and contributed to regulatory science and policy development in psychiatric drug development. His FDA work has included national and international engagement on regulatory issues in psychedelic drug development\, estimands\, and digital health technologies.  \nDr. Davis is a board-certified psychiatrist and physician-scientist. He completed an M.D./Ph.D. in pharmacology at Case Western Reserve University\, psychiatry residency training at UCLA’s Semel Institute for Neuroscience and Human Behavior\, and a clinical research fellowship at the West Los Angeles VA Mental Illness Research\, Education\, and Clinical Center\, with research interests focused on novel therapeutics for schizophrenia. Before returning to FDA in 2025\, he served as Chief Medical Officer at Usona Institute\, a nonprofit medical research organization developing psychedelic drugs for major depressive disorder and post-traumatic stress disorder; earlier in his career\, he was a staff psychiatrist at the Michael E. DeBakey VA Medical Center and an Assistant Professor at Baylor College of Medicine.  \n\n \n \n \n \n \n Ashish Dwivedi\, M.Pharm. \n \n \n \n \nAssistant General Manager\, Advanced Characterization Lab\, Peptides & Complex Injectables\, R&D\, Alembic Pharmaceuticals\, Vadodara Gujrat\, India​​  \nMr. Ashish Dwivedi heads end to end characterization & CMC (analytical) functions for large therapeutic peptides with core focus on GLP-1/GIP agonists\, NBCDs\, and Novel drug delivery systems. He has more than 15 years of experience in characterization of peptides and some advanced drug delivery systems i.e.\, dual agonist peptides\, liposomes and albumin drug conjugates.   \nHis core educational background lies in pharmaceutical sciences. He completed his Masters in Pharmaceutical Sciences (M.Pharm.) from the University of Pune in 2013.  \nMr. Dwivedi is listed as an inventor in five patents related to peptides and complex injectables.  He has been instrumental in designing & submitting crucial characterization studies with a key focus on peptide related impurities\, aggregates (including soluble & covalently bonded) and higher order structures for GLP-1/GIP peptides.   \nOver the years\, he has worked closely with FDA & EMA to resolve complex CMC questions related to peptides aggregates\, and immunogenicity related concerns\, thereby ensuring safe\, efficacious\, and quality medicine for patients worldwide.  \n\n \n \n \n \n \n William B. Feldman\, M.D.\, D.Phil.\, MPH​​ \n \n \n \n \nAssociate Professor of Medicine and Director of the Pharmaceutical Policy & Outcomes Lab\, UCLA \nDr. William B. Feldman is a physician-scientist who writes about topics at the intersection of medicine\, health policy\, and law. He received his undergraduate degree in philosophy from Duke University\, his medical degree from UCSF\, his doctoral degree in politics from the University of Oxford\, and his master’s degree in public health from the Harvard TH Chan School of Public Health. He was a Fulbright Scholar at the University of Haifa and a Zuckerman Fellow at the Center for Public Leadership at the Harvard Kennedy School. He completed his residency in internal medicine and fellowship in pulmonary and critical care medicine at Brigham and Women’s Hospital and Harvard Medical School. Prior to joining the faculty at UCLA\, he was an Assistant Professor of Medicine at Harvard Medical School at Brigham and Women’s Hospital.  Dr. Feldman’s research focuses on FDA regulation\, pharmaceutical pricing and policy\, intellectual property\, and pharmacoepidemiology. His work has been funded by the National Institutes of Health\, the Food and Drug Administration\, the Commonwealth Fund\, and Arnold Ventures and has appeared in the New England Journal of Medicine\, JAMA\, BMJ\, and other top medical and health policy journals. He has mentored trainees at all levels\, from undergraduate and medical students to residents\, post-doctoral fellows\, and junior faculty\, and he has advised policymakers and testified before Congress. He is an Associate Editor at Health Affairs Scholar and serves on the Editorial Board of the Journal of Law\, Medicine\, and Ethics.  \n\n \n \n \n \n \n Jack Giacomini\, M.S. \n \n \n \n Principal Human Factors Consultant\, Core Human Factors\, A Rimkus Company \nMr. Jack Giacomini is a Principal Human Factors Consultant at Core Human Factors\, A Rimkus Company\, based in Philadelphia\, PA. He holds a M.S. in Mathematics\, Learning\, and Teaching from Drexel University\, as well as a B.S. in Mechanical Engineering from the Rensselaer Polytechnic Institute.  \n Jack specializes in human factors research for medical devices and combination products. He has conducted human factors research for over five years and has experience managing\, teaching\, designing\, conducting\, and analyzing the results of human factors studies for a wide variety of medical devices and combination products. He works on products spanning a wide variety of indications\, user populations\, and device types. Jack has a particular interest in comparative use human factors (CUHF) studies and other tools to support bringing complex generic products to the market. Jack recently collaborated with FDA on a CUHF study that led to the publication Comparative Use Human Factors Study of a Manual vs. A Partially Automated Pen Injector for GLP-1 Receptor Agonist Delivery (Natarajan et al.\, 2026).  \n\n \n \n \n \n \n Yuqing Gong\, Ph.D. \n \n \n \n \nLead Pharmacologist\, DQMM\, ORS\, OGD\, CDER\, FDA  \nDr. Yuqing Gong is currently the Team Lead at the Quantitative Clinical Pharmacology Team in the Division of Quantitative Methods and Modeling (DQMM)\, Office of Research and Standards (ORS)\, Office of Generic Drugs (OGD)\, Center for Drug Evaluation and Research (CDER)/FDA. She has led critical research priorities utilizing quantitative clinical pharmacology approaches and model-integrated evidence (MIE) to develop innovative study designs and methods supporting bioequivalence (BE) demonstrations for generics with complex in vivo study considerations. Dr. Gong received her Ph.D. degree in Pharmaceutical Sciences at the University of Tennessee Health Science Center (Memphis\, TN\, US) in 2020. Her Ph.D. thesis work was to develop a nanoformulation for antiretroviral drugs to suppress the viral load in the central nervous system across the blood-brain barrier. \n\n \n \n \n \n \n Rong Guo Ph.D.\n \n \n \n \nSenior Reviewer\, Injection Devices Team\, DHT3C:  Division of Drug Delivery and General Hospital Devices and Human Factors\, OHT3: Office of Reproductive\, Gastro‐Renal\, Urological\, General Hospital Device & Human Factors\, OPEQ\, CDRH\, FDA \nDr. Rong Guo is a senior reviewer focusing on device constituents in combination products and standalone injection/infusion devices at CDRH/FDA. She is an US expert on several ISO standards committees including syringes\, needles\, and needle-based injection systems. Prior to joining CDRH\, she is FDA/NCI Interagency Oncology Taskforce Fellowship recipient and worked as a CMC reviewer at CDER/FDA. She received her Ph.D. from University of Maryland College Park in molecular virology.  \n\n \n \n \n \n \n Suresh Gupta\, Ph.D. (Cantab)​​ \n \n \n \n \nSVP\, Head of Human Factors and Usability Engineering\, Global Healthcare\, Cambridge Consultants \nDr. Suresh Gupta is a recognised leader in Human Factors and Usability Engineering within the MedTech and Pharmaceutical sectors. With over 20 years of experience\, he has led and supported the design and development of numerous successful medical devices and combination products across a wide range of therapeutic areas\, including diabetes\, obesity\, asthma\, COPD\, cystic fibrosis\, osteoporosis\, rheumatoid arthritis\, multiple sclerosis\, hepatitis C\, haemophilia\, oncology\, growth disorders\, and age-related macular degeneration. He brings deep expertise in integrating Human Factors into product development and regulatory strategy\, supporting submissions across the US\, Europe\, the UK\, and global markets\, including Generics\, Biosimilars and Interchangeable Biosimilars.  \nSuresh holds a Ph.D. from the University of Cambridge\, specialising in the Human Factors of medical products. He is also an author of multiple publications and has developed novel methodologies in Human Factors and Risk Management that continue to shape industry best practice. \n\n \n \n \n \n \n Suzanne Keating M.Sc.\n \n \n \n \nSenior Director Regulatory Affairs\, Injectables\, Regulatory Affairs\, Viatris Inc. \nMs. Suzanne Keating leads a team of regulatory professionals responsible for injectable products including complex generics\, combination products and GLP-1’s at Viatris. In this role Suzanne leads global regulatory strategy\, submissions and lifecycle maintenance of GLP-1s adapting to and navigating changes in the ever-evolving regulatory landscape impacting these products to minimize review cycles and secure expedient approvals. Suzanne joined the company in 2008 and has 30+ years in the pharmaceutical industry with 23 years in regulatory affairs. Prior experience includes medical device regulatory affairs at Abbott and product development of dry powder inhalers at GlaxoSmithKline. Suzanne holds a B.Sc. in Chemistry from National University of Ireland Galway and an M.Sc. in Pharmaceutical Science from Kings College\, London. \n\n \n \n \n \n \n Myong Jin Kim\, Pharm.D.\, FCP\n \n \n \n \nDirector\, DTP II\, ORS\, OGD\, CDER\, FDA \nDr. Myong Jin Kim serves as Director of the Division of Therapeutic Performance II within the Office of Research and Standards\, Office of Generic Drugs at CDER/FDA. Since joining the FDA in 2001\, she has held several key positions\, including Deputy Director of the Division of Quantitative Methods and Modeling and Team Leader in the Office of Clinical Pharmacology.  Dr. Kim earned her Bachelor of Science degree in Chemistry from the Georgia Institute of Technology. She went on to receive her Doctor of Pharmacy\ndegree from Temple University School of Pharmacy and completed a two-year postdoctoral fellowship in clinical pharmacology at Bassett Healthcare\, a major teaching affiliate of Columbia University College of Physicians and Surgeons\, in New York. \n\n \n \n \n \n \n Shinae Kim\, Ph.D.\, M.S.\n \n \n \n \nPharmacokineticist\, DTP I\, ORS\, OGD\, CDER\, FDA  \nDr. Shinae Kim serves as a Pharmacokineticist on the Device\, Injectable\, and Peptide Team within the Division of Therapeutic Performance I (DTP I) at the U.S. Food and Drug Administration’s Office of Generic Drugs (OGD). In this role\, she reviews complex drug-device combination products\, facilitates pre-ANDA interactions with industry on drug-device combination product issues\, and leads GDUFA research activities to advance the development of generic drug-device combination products. She also contributes to the development of product-specific guidances that support the regulatory pathway for generic combination product approval.   \n Prior to joining the FDA\, Dr. Kim served as a Lead Researcher at the American Dental Association Science and Research Institute\, where her work centered on the development of medical diagnostic devices and innovative technologies for real-time health monitoring and diagnostics. She earned both her M.S. and Ph.D. in Electrical Engineering and Computer Science from Seoul National University\, Republic of Korea\, and completed postdoctoral training in Chemical and Biomedical Engineering at the Georgia Institute of Technology.  \n\n \n \n \n \n \n John D. Kirsch\, R.Ph.\, Ph.D.\, MBA\n \n \n \n \nHead of CMC R&D\, Viatris \nDr. John Kirsch is Head of CMC R&D for Viatris\, whose group is focused on the development of formulation/process and analytical methods for the manufacture and control of solid oral dosage forms. Over the past 24+ years\, he and his team have developed\, gained regulatory approval\, and successfully launched well over 100 products distributed in markets around the globe\, primarily as generic equivalents to branded products. Prior to joining Viatris\, John worked in Formulation Design of Merck Research Laboratories at the West Point\, PA site\, where he led a group conducting early-stage formulation and process development for tablet and capsule products. He began his career at Merck as a Technical Services Scientist. John is a registered pharmacist\, having graduated with a  B.S. Pharmacy from Duquesne University\, where he also completed M.S. Pharmaceutics\, MBA\, and Ph.D. (Pharmaceutics) degrees. \n\n \n \n \n \n \n Renee Kleris\, M.D.\, MPH\n \n \n \n \nPhysician\, DCR\, OSCE\, OGD\, CDER\, FDA  \nDr. Renee Kleris is a physician at the U. S. Food and Drug Administration (FDA). She began her FDA career in 2018 within the Office of New Drugs (OND)\, serving as a medical officer reviewing applications for the Division of Pulmonary\, Allergy\, and Critical Care (DPACC). She received a CDER Honor Award for outstanding review of COVID-19 applications to successfully protect public health and advance potential therapeutics. In 2022\, Dr. Kleris transitioned to the Office of Generic Drugs (OGD). In her current role within the Division of Clinical Review (DCR)\, she conducts comparative analyses assessments\, consults\, and serves on multiple working groups. \nDr. Kleris completed her pediatrics residency at Brown University in Providence\, Rhode Island and her fellowship in Allergy/Immunology at Duke University Medical Center in Durham\, North Carolina. She also holds a Master of Public Health from the UNC Gillings School of Global Public Health. Board-certified in both pediatrics and allergy/immunology\, Dr. Kleris continues to treat patients at Children’s National Hospital and remains active in clinical teaching. \n\n \n \n \n \n \n Vasiliy Korotchenko\, Ph.D.\n \n \n \n \nChemist\, OPQA I\, OPQ\, CDER\, FDA  \nDr. Vasiliy Korotchenko received his Ph.D. in Organic Chemistry from Lomonosov Moscow State University\, Moscow\, Russia. He joined the FDA in 2017 as a drug product quality reviewer. He is currently a secondary assessor and Application Technical Lead (ATL) in the Office of Pharmaceutical Quality (OPQ) at the FDA. In his role\, Dr. Korotchenko leads an interdisciplinary review team in the assessment of a variety of drug products\, including peptides. Prior to joining the FDA\, he worked as a medicinal and organic chemist in academia (University of North Carolina at Chapel Hill; University of Pittsburgh) and government service (Walter Reed Army Institute of Research).  \n\n \n \n \n \n \n Darby Kozak\, Ph.D.\n \n \n \n \nDeputy Director\, OGD\, CDER\, FDA \nDr. Darby Kozak is the Deputy Director for the Office of Generic Drugs (OGD) where he serves as a senior agency advisor in the development and implementation of FDA policies and long-range objectives for generic drug scientific programs and activities\, including the development of a strategic plan for the Generic Drug Program. Dr. Kozak started his FDA career in April 2015 in OGD’s Office and Research and Standards where he helped develop new analytical methods and equivalence evaluation methodologies for complex generic drug substances and parenteral\, ophthalmic\, otic\, and inhalation formulations. Prior to joining the FDA\, Dr. Kozak was Chief Scientist for Izon Science and Research Fellow at The University of Queensland’s Australian Institute for Bioengineering and Nanotechnology. Dr. Kozak has a B.Sc. in Chemical Engineering from the University of Washington (Seattle\, WA) and Ph.D. in Chemistry from the University of Bristol (United Kingdom).  \n\n \n \n \n \n \n Kai Kwok\, Ph.D.\n \n \n \n \nSenior Pharmaceutical Quality Assessor\, DPQA I\, OPQA I\, OPQ\, CDER\, FDA \nDr. Kai Kwok\, is a Senior Pharmaceutical Quality Assessor (SPQA) in the Division of Product Quality Assessment I\, Office of Product Quality Assessment I\, Office of Pharmaceutical Quality\, CDER at FDA. In this role\, he serves as the application technical lead for integrated quality assessment of generic parenteral\, ophthalmic\, topical\, nasal\, and oral solid/solution drug products. Over the past 10 years\, he has reviewed ANDA\, Bio-IND\, IND\, and Pre-ANDA meeting packages involving complex drug products\, such as drug-device peptide products. He has also served as an FDA liaison to the USP Packaging and Distribution Expert Committee\, contributing to the development of USP packaging chapters and standards\, and as a member supporting FDA guidance development for drug delivery performance of drug-device combination products. Prior to joining FDA\, Dr. Kwok spent over 10 years as a formulation scientist in pharmaceutical companies focused on drug product and process development. He received his Ph.D. in Pharmaceutical Sciences from the University of Michigan.  \n\n \n \n \n \n \n Karen Li\, Pharm.D.\n \n \n \n \nPharmacologist\, DTP II\, ORS\, OGD\, CDER\, FDA  \nDr. Karen Li is a Pharmacologist on the Clinical Safety and Human Subject Research Team within the Division of Therapeutic Performance II\, Office of Research and Standards. Her work primarily focuses on the protection of human subjects in bioequivalence studies by providing guidance and addressing safety inquiries related to product-specific guidance development and pre-application support. Dr. Li has served as the project lead on published work related to swallowability of solid oral dosage forms and pharmacogenetic approaches in generic drug development. She received her Doctor of Pharmacy degree from the University of Maryland School of Pharmacy.  \n\n \n \n \n \n \n Li Li\, Ph.D.\n \n \n \n \nSenior Pharmacologist\, OB\, OGD\, CDER\, FDA \nSince joining the FDA in 2014\, Dr. Li Li has been working on bioequivalence assessments of generic drug products in the Office of Bioequivalence (OB) within Office of Generic Drugs (OGD). Dr. Li has expertise in evaluating bioequivalence studies for a diverse range of complex drug products\, including locally acting drugs\, long-acting drug suspensions\, topical drug products\, and pharmaceutical products with specialized formulations. Dr. Li completed her postdoctoral training at the University of Minnesota. She received her Ph.D. in Pharmaceutical Sciences from the University of South Carolina\, and a Bachelor’s in Pharmaceutical Analysis from the China Pharmaceutical University. \n\n \n \n \n \n \n Robert Lionberger\, Ph.D.\n \n \n \n \nDirector\, ORS\, OGD\, CDER\, FDA \nDr. Robert Lionberger serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD).  Dr. Lionberger leads OGD’s implementation of the Generic Drug User Fee Amendments (GDUFA) science and research commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. ORS also provides pre-submission advice on complex generics through pre-Abbreviated New Drug Application (ANDA) meetings\, product-specific guidance\, and correspondence responses.     \nHe received his undergraduate degree from Stanford University in Chemical Engineering\, and a Ph.D. from Princeton University in Chemical Engineering. After his Ph.D.\, he conducted post-doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the FDA 18 years ago\, Dr. Lionberger was an Assistant Professor of Chemical Engineering at the University of Michigan. \n  \n\n \n \n \n \n \n Markham C. Luke\, M.D.\, Ph.D.\, FAAD\n \n \n \n \nDirector\, DTP I\, ORS\, OGD\, CDER\, FDA \nDr. Markham C. Luke serves as FDA Supervisory Physician (Dermatology) and Director of the Division of Therapeutic Performance 1 (DTP I) in the Office of Research and Standards\, Office of Generic Drugs at FDA. DTP I is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Markham has an M.D. and a Ph.D. in Pharmacology from Johns Hopkins University and completed his dermatology residency and fellowship at Washington University\, St. Louis\, MO and the  National Institutes of Health\, Bethesda\, MD. He is an Associate Professor at the Uniformed Services University of the Health Sciences\, Bethesda\, MD with research interests in dermatopharmacology\, clinical pharmacology\, clinical study design and endpoints assessment (including patient-reported outcomes) for medical\, surgical\, and aesthetic products.  Markham has been at FDA since 1998 serving various roles\, including as the Lead Medical Officer for dermatology drugs\, Chief Medical Officer and Deputy Director for the Office of Device Evaluation in the Center for Devices and Radiologic Health\, and as Acting Director for Cosmetics in the Center for Food Safety and Applied Nutrition.   \n\n \n \n \n \n \n Utpal Kumar Mondal\, Ph.D.\n \n \n \n \nPharmaceutical Quality Assessor\, DPQA IV\, OPQA I\, OPQ\, CDER\, FDA \nDr. Utpal Kumar Mondal is a Pharmaceutical Quality Assessor in the Division of Product Quality Assessment IV\, Office of Pharmaceutical Quality (OPQA I)\, at the U.S. Food and Drug Administration (FDA). He earned his Ph.D. in Pharmaceutical Sciences from Temple University School of Pharmacy in Philadelphia\, Pennsylvania\, where his doctoral research focused on carbonic anhydrase modulators for the detection and treatment of human diseases. He also holds a Master of Pharmacy from the University of Dhaka\, Bangladesh.  \nPrior to his current role\, Dr. Mondal completed postdoctoral training at the National Cancer Institute’s Chemical Biology Laboratory\, where he designed\, synthesized\, and evaluated novel tumor-associated carbohydrate antigen-coated nanoparticles as cancer therapeutics. He subsequently joined the FDA as an ORISE Fellow in the Division of Therapeutic Performance I\, Office of Research and Standards\, where he served as a primary reviewer for controlled correspondences\, product specific guidances\, and pre-ANDA product development meetings related to complex and non-complex parenteral drug products. In his current Staff Fellow role within the Division of Product Quality Assessment IV\, Dr. Mondal serves as a primary quality assessor for a broad range of regulatory submissions\, including Abbreviated New Drug Applications (ANDAs)\, New Drug Applications (NDAs)\, Investigational New Drug applications (INDs)\, supplemental ANDAs (sANDAs)\, and supplemental NDAs (sNDAs)\, as well as controlled correspondences. Dr. Mondal has authored and co-authored numerous peer-reviewed publications\, book chapters\, and conference presentations\, with research spanning drug conjugate synthesis\, gold nanoparticle-based drug delivery\, and carbonic anhydrase pharmacology expertise that directly informs his regulatory work on complex drug products at the FDA. \n\n \n \n \n \n \n Sami Nazzal\, Ph.D.\n \n \n \n \nSenior Pharmacologist\, ORS\, OGD\, CDER\, FDA \nDr. Sami Nazzal is a Senior Pharmacologist in the Office of Research and Standards within the Office of Generic Drugs at the U.S. Food and Drug Administration\, where he contributes to the development of product-specific guidances\, delivers expert regulatory consultation through controlled correspondences and pre-ANDA meetings\, and advances international harmonization initiatives. Before joining the FDA in 2024\, Dr. Nazzal served as Professor of Pharmaceutical Sciences at Texas Tech University Health Sciences Center and the University of Louisiana at Monroe\, where he directed an extramurally funded research laboratory and trained a generation of pharmaceutical scientists. He also brings industry experience from his tenure as Senior Scientist at Cardinal Health\, specializing in lipid-based drug delivery systems. Dr. Nazzal is the author of over 98 peer-reviewed publications and earned his Ph.D. in Pharmaceutical Sciences from Texas Tech University Health Sciences Center. \n\n \n \n \n \n \n CDR Oluwamurewa (Murewa) Oguntimein\, Ph.D.\, MHS\n \n \n \n \nHuman Factors Team Leader\, DMEPA I\, OMEPRM\, OSE\, CDER\, FDA \nCDR Oguntimein is a United States Public Health Officer who serves as a human factors team lead in the Division of Medication Error Prevention and Analysis I (DMEPA I). Her team reviews all human factors related submissions for New Drug Applications (NDA) Biological Drug Applications (BLAs) and Abbreviated New Drug Applications (ANDAs). Prior to working in DMEPA I\, CDR Oguntimein worked in various offices at FDA. For six years\, she worked in the Therapeutic Performance (DTP)\, Office of Research and Standards (ORS) in OGD\, where reviewed controlled correspondences and Pre-Abbreviated New Drug Application (ANDA) meeting requests for generic drug-device combination products development and served as a subject matter expert and single point contact for device substitutability and human factor study research for all DTP initiatives. She also worked in Division of Medical Policy Programs (DMPP)\, Office of Medical Policy Initiatives (OMPI)\, CDER from 2011-2014. While at OMP\, she was the project lead for the research that informed the development patient medication leaflet for all prescription drugs. From 2009-2011\, CDR Oguntimein served as the social scientist reviewing consumer studies (label comprehension\, self-selection and actual-use) study protocols and results submitted for prescription-to-over-the counter applications in the Division of Nonprescription Clinical Evaluation (DNCE)\, Center for Drug Evaluation and Research (CDER).  \nCDR Oguntimein has a Doctor of Philosophy in Behavioral and Community Health from University of Maryland College Park School of Public Health (UMSPH) and a certificate in global health from UMSPH. She also has a masters in health science from the Johns Hopkins Bloomberg School of Public Health (JHSPH)\, and certificates in Health Communication and Health Financial Management. She is also certified in public health and is a certified masters health education specialist. \n\n \n \n \n \n \n Eric Pang\, Ph.D.\n \n \n \n \nActing Team Lead\, Senior Pharmacokineticist\, DTP I\, ORS\, OGD\, CDER\, FDA \nDr. Eric Pang is currently serving as acting Team Lead for the Device\, Injectable and Peptide Team in the Division of Therapeutic Performance I\, Office of Research and Standards\, Office of Generic Drugs\, within FDA’s Center for Drug Evaluation and Research. Dr. Pang specializes in the analysis and regulatory assessment of peptide and large-molecule drugs\, with an expertise in generic peptide products\, complex active ingredients\, immunogenicity\, and policy development. In his current role\, he and his team develop product-specific guidances for complex generics\, respond to controlled correspondence and pre-ANDA meeting requests\, supports Agency responses to citizen petitions\, and manages regulatory science projects related to generic complex combination products.  \nDr. Pang has more than 15 years of experience at FDA\, including roles as a researcher\, reviewer\, policy lead. He has been serving as subject matter expert on immunogenicity risk assessment for generic peptide products and comparative analysis for device combination products. Dr. Pang received his Ph.D. in Biochemistry from UCLA and undergraduate degrees in Molecular Cell Biology and Legal Studies from the University of California\, Berkeley.  \n\n \n \n \n \n \n Justin Penzenstadler\, Pharm.D.\n \n \n \n \nAssociate Director\, OCHEN\, OND\, CDER\, FDA \nDr. Justin Penzenstadler is an acting Associate Director in the Office of Cardiology\, Hematology\, Endocrinology\, and Nephrology (OCHEN) at the U.S. Food and Drug Administration (FDA). He holds a Doctor of Pharmacy (Pharm.D.) and a Master of Science in Pharmacometrics from the University of Maryland\, and completed a fellowship in Clinical Pharmacology.  His clinical and regulatory expertise centers on the evaluation of therapies for chronic disease.  In his current role\, Dr. Penzenstadler focuses on the application of quantitative methodologies to inform and strengthen regulatory decision-making.  Prior to his current position\, Dr. Penzenstadler managed FDA reviews as a Cross-Discipline Team Leader (CDTL) in the Division of Diabetes\, Lipid Disorders\, and Obesity (DDLO) within OCHEN.   \n\n \n \n \n \n \n James Polli\, Ph.D.\n \n \n \n \nRalph F. Shangraw/Noxell Endowed Professor\, Industrial Pharmacy and Pharmaceutics\, University of Maryland; co-Director\, CRCG \nDr. James Polli is Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption\, involving laboratory and clinical research. He has served as the advisor to 26 Ph.D. graduates. He is co-Director of the Center for Research on Complex Generics (CRCG). He is Director of the online M.S. in Regulatory Science program. He is a fellow of the American Association for Pharmaceutical Scientists (AAPS) and served as an editor of Pharmaceutical Research for 12 years. He is the 14th recipient of the American Pharmacists Association Takeru Higuchi Research Prize. He was the recipient of the 2024 American Association of Colleges of Pharmacy Volwiler Research Achievement Award\, the 2022 AAPS Global Leadership Award\, and the 2021 TOPRA Education Award. He is a member of the University of Maryland General Clinical Research Center Advisory Committee and the University of Maryland institutional review board (IRB). \n\n \n \n \n \n \n Mateja Prunk\, Ph.D.\n \n \n \n \nGroup Head Analytics\, Sandoz Global Development\, Sandoz  \nDr. Mateja Prunk joined Sandoz in 2021 at the Sandoz Development Center in Ljubljana\, Slovenia. She holds a Ph.D. in Biomedicine from the University of Ljubljana. Before joining Sandoz\, she was a Postdoctoral Researcher in the Department of Biotechnology at the Jožef Stefan Institute\, where she gained extensive experience in cell culture\, cell-based assays\, and bioanalytical method development\, and published in the fields of oncology and immunology. At Sandoz\, she has specialized in the development of injectable products and is particularly passionate about development of complex generics\, especially those with complex active ingredients. She is currently a Group Head in Analytical Development\, focusing on analytical strategies for API and drug product characterization\, impurity profiling\, specification setting\, and stability evaluation across complex and standard generics.  \n\n \n \n \n \n \n Sam Raney\, Ph.D.\n \n \n \n \nAssociate Director for Science & Chief Scientific Advisor\, ORS\, OGD\, CDER\, FDA \nDr. Sam Raney is the Associate Director for Science and Chief Scientific Advisor in the FDA’s Office of Research and Standards and Office of Generic Drugs\, where he oversees the research portfolio of FDA’s generic drug research program. He has over 30 years of experience in pharmaceutical drug development\, specializing in topical and transdermal products\, and producing numerous research manuscripts\, review articles\, book chapters and patents. He has been a researcher and adjunct professor within academia\, was the longest serving Chair of the AAPS Topical and Transdermal Community\, has been a principal or sub investigator on over 400 pharmaceutical product studies\, has held senior management roles in industry\, serves on multiple expert committees and panels for the U.S. Pharmacopeia\, and is frequently invited to speak at scientific meetings around the world. Dr. Raney holds a Bachelor’s Degree in Molecular Biophysics & Biochemistry from Yale University\, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada.  \n\n \n \n \n \n \n Sylvine Raverdy-Wilson\, Ph.D.​​ \n \n \n \n Medical Affairs Manager\, BioPharma Systems\, Becton Dickinson  \nDr. Sylvine Raverdy-Wilson is a Medical Affairs Manager for BioPharma Systems. Sylvine works at the intersection of human factors\, clinical insight\, science and customer collaboration to help shape innovative drug delivery solutions that are grounded in real patients and user needs. She is passionate about bringing the patient and healthcare provider perspective into development efforts and partnering across teams to translate insights into meaningful\, practical innovation.  \nDr Raverdy-Wilson holds an engineering degree in Biotechnology from the ESBS (Strasbourg\, France) and a Ph.D. in Molecular and Cellular Biology from the University of Strasbourg (France). Before joining BD in 2012\, she focused on identifying and characterizing drug targets for bacterial and parasitic diseases at Harvard Medical School (MA\, US) and New England Biolabs (MA\, US).   \n  \n\n \n \n \n \n \n Joshua Shipman\, Ph.D.​​ \n \n \n \n \nChemist\, DPQR II\, OPQR\, OPQ\, CDER\, FDA \nDr. Josh Shipman received his PhD in chemistry from the University of Kansas\, he joined the FDA as an ORISE post-doctoral fellow in 2019 and converted to a full-time chemist position in 2021. At FDA/CDER he has developed methods to characterize biologically sourced drug products including glycans\, peptides\, proteins and synthetic biopolymers. He serves as a subject matter expert for mass spectrometry-based characterization of biopharmaceutical products and has been consulted on over 30 regulatory applications for peptide products.  Other research interests include developing methods and data analysis strategies to characterize complex\, biologically derived drug products and the application of novel technologies\, such as IM-MS and CZE-MS\, to drug product characterization. He has published six first author manuscripts including two highly collaborative comparative studies conducted at the FDA. \n\n \n \n \n \n \n Anjali Shukla\, Ph.D.\n \n \n \n \nSupervisory Pharmaceutical Scientist\, OPQ\, CDER\, FDA  \nDr. Anjali Shukla is a supervisory pharmaceutical scientist in the Office of Pharmaceutical Quality\, CDER\, FDA\, and a member of the CDER Emerging Technology Team (ETT). She performs and supervises assessment of the chemistry\, manufacturing and control (CMC) programs of biotechnology products at all stages of drug development and product lifecycle\, as well as conducts FDA pre-license inspections of biologic drug manufacturing facilities. Anjali serves as a CMC subject matter expert for insulin products. As part of the ETT\, she engages with internal and external stakeholders in the development of novel manufacturing technologies. She has previously served as a product quality team lead and assessor for the CMC assessment of biotechnology products at the FDA. Prior to joining the FDA\, Anjali was a staff scientist at the National Cancer Institute\, NIH\, where her research elucidated novel mechanisms of skin carcinogenesis and breast cancer metastasis.   \n\n \n \n \n \n \n Houri Simonian Ph.D​​.\n \n \n \n \nVice President\, Global Analytical Operations\, Apotex Inc.  \nDr. Houri Simonian is Vice President\, Global Analytical Operations at Apotex\, with responsibility for providing strategic and scientific leadership for analytical operations across R&D and commercial quality laboratory functions. In this capacity\, she oversees global analytical teams supporting method development\, validation\, lifecycle management\, regulatory submissions\, across multiple dosage forms and product platforms.  \nHouri has more than 25 years of experience in the pharmaceutical industry\, with expertise spanning analytical sciences\, pharmaceutical product development\, regulatory strategy\, and quality operations. She began her career in medicinal chemistry before transitioning into product development. She holds a Ph.D. in Organic Chemistry from the University of Nottingham\, United Kingdom.  \n\n \n \n \n \n \n Cameron Smith\, Ph.D.\n \n \n \n \nSupervisory Pharmaceutical Scientist\, DPQA IV\, OPQA I\, OPQ\, CDER\, FDA \nDr. Cameron Smith is a Supervisory Pharmaceutical Scientist in the Division of Product Quality Assessment IV (DPQA IV) within the Office of Product Quality Assessment I (OPQA I)/Office of Pharmaceutical Quality (OPQ). Dr. Smith started his FDA career in October 2014 as a drug product quality assessor.  In his current role he manages and mentors a team of drug product quality assessors engaged in the assessment of pre- and post-market applications.  Prior to his Agency tenure\, he worked in the pharmaceutical industry for 15 years as a medicinal chemist\, primarily at Merck Research Laboratories in Rahway\, NJ and before that at OSI Pharmaceuticals in Durham\, NC.  Cameron completed his Ph.D. studies in organic chemistry at the University of Cambridge in Cambridge\, UK and followed this up with postdoctoral studies at the University of Utah in Salt Lake City\, UT.  He obtained his undergraduate degree at Monash University in Melbourne\, Australia.  \n  \n\n \n \n \n \n \n Kumara Subramanian\, Ph.D.\n \n \n \n \nSenior Pharmaceutical Quality Assessor\, DPQA IV\, OPQA I\, OPQ\, CDER\, FDA  \nDr. Kumara Subramanian received his Ph.D. in Organic Chemistry from the Indian Institute of Chemical Technology\, Hyderabad\, India. He is currently a Senior Pharmaceutical Quality Assessor and Application Technical Lead (ATL) in the Office of Pharmaceutical Quality (OPQ) at the U.S. Food and Drug Administration (FDA)\, where he leads interdisciplinary review teams in the assessment various complex drug products.  \nDr. Subramanian has more than 25 years of combined research and regulatory experience in pharmaceutical sciences\, medicinal chemistry\, drug discovery\, and product quality assessment. Prior to joining the FDA\, he served as Principal Research Scientist and Research Assistant Professor at Northeastern University’s Center for Drug Discovery\, leading medicinal chemistry and drug design programs focused on enzyme inhibitors and cannabinoid pharmacology. He also held research positions in France and the Netherlands\, contributing to synthetic chemistry and anti-infective drug development. At the FDA\, he serves as a Subject Matter Expert in multiple regulatory and scientific working groups and as a Government Liaison to the USP Expert Committee on Biologics Monographs 1 – Peptides\, Oligonucleotides\, and Complex Carbohydrates.  \n\n \n \n \n \n \n Samantha Sye\, M.S.\n \n \n \n \nHuman Factors Practice Leader\, Core Human Factors\, A Rimkus Company  \nMs. Samantha (Sam) Sye is a Human Factors Practice Leader at Core Human Factors Inc.\, A Rimkus Company (Core)\, based in Philadelphia\, PA. She holds a M.S. in Computer Science\, as well as a B.A. History and B.S. Behavioral Economics from the University of Pennsylvania.  \nSam specializes in human factors (HF) research for medical devices and combination products. She has extensive experience managing\, teaching\, designing\, conducting and analyzing HF research for products in the healthcare domain. She works on devices spanning a wide variety of indications\, user populations and device types. Sam has a particular interest in comparative use HF (CUHF) studies and other tools to support bringing complex generics to market. Core recently collaborated with the FDA on a CUHF study\, Comparative Use Human Factors Study of a Manual vs. A Partially Automated Pen Injector for GLP-1 Receptor Agonist Delivery (Natarajan et al.\, 2026). \n\n \n \n \n \n \n Tony Tran\, Pharm.D.\n \n \n \n \nPharmacokineticist\, DTP II\, ORS\, OGD\, CDER\, FDA \nDr. Tony Tran received his B.S. from University of Maryland\, College Park\, in chemistry and his Pharm.D. from University of Maryland\, Baltimore. He joined the FDA in 2023 as an Oak Ridge Institute for Science and Education (ORISE) Fellow with the Clinical Safety and Human Subject Research Team in the Division of Therapeutic Performance II (DTP II)\, Office of Research and Standards (ORS)\, under the Office of Generic Drugs (OGD) and is currently working as a contractor for the same team. His work focuses on developing product-specific guidances along with addressing controlled correspondences\, clinical safety consults\, and pre-ANDA meeting requests. \n\n \n \n \n \n \n Kamal Kumar Upadhyay\, M.Pharm.\, Ph.D. \n \n \n \n \nHead of R&D\, BE Biosol Ltd. (A Biological E. Ltd. Group Company)  \nDr. Kamal Kumar Upadhyay is the Head of R&D at BE Biosol Ltd.\, a Biological E. Ltd. group company\, where he leads the development of drug substances (DS) and drug products (DP) for complex injectables and biotherapeutics\, including peptides\, biologics\, and drug-device combination products. With over 20 years of experience in pharmaceutical research and development\, his expertise spans biologic and peptide formulations\, advanced drug delivery systems\, and complex injectable products. He played a key role in the development of one of the first approved generic GLP-1 injectable products and has more than six years of specialized experience in GLP-1 therapies.  \nPrior to joining BE Biosol Ltd.\, Kamal held leadership roles at Biocon Ltd.\, Intas Pharmaceuticals\, Piramal Pharma\, and Dr. Reddy’s Laboratories\, where he contributed to the development and commercialization of innovative and generic injectable and biotherapeutic products.  \nHe holds a Master’s degree in Pharmacy from Dr. Hari Singh Gour University\, India\, and a Ph.D. from The Maharaja Sayajirao University of Baroda\, India\, completed in collaboration with the University of Bordeaux\, France.  \n\n \n \n \n \n \n Brandon Wood\, B.Sc.\n \n \n \n \nSr. Director\, Regulatory Affairs\, Complex Gx\, Teva Pharmaceuticals USA\, Inc. \nMr. Brandon Wood is an accomplished regulatory affairs leader with 15+ years of experience in the pharmaceutical industry\, specializing in complex generic drug development. As Senior Director of Regulatory Affairs at Teva Pharmaceuticals USA\, Inc.\, he leads regulatory strategy\, submissions\, and lifecycle management for complex generics spanning complex APIs\, long acting injectables\, respiratory therapies\, combination products\, and non sterile complex products. Brandon has played a pivotal role in advancing and securing approvals for complex generic submissions\, including GLP 1–based therapies\, navigating scientific\, CMC\, and regulatory challenges to enable first to market or highly differentiated generic outcomes. Since joining Teva in 2018\, he has driven regulatory strategies for some of the company’s most technically demanding programs\, building on prior experience in regulatory affairs\, quality assurance\, and R&D at CorePharma and Impax Laboratories\, and an early technical foundation as a chemist at West Ward Pharmaceuticals. He holds a B.S. in Chemistry with a concentration in Organic Chemistry from Monmouth University. \n  \n\n \n \n \n \n \n Li Xia\, Ph.D.\n \n \n \n \nLead Pharmacologist\, DB III\, OB\, OGD\, CDER\, FDA  \nDr. Li Xia is a Lead Pharmacologist in the Division of Bioequivalence III\, Office of Bioequivalence\, within FDA’s Office of Generic Drugs. In this role\, she leads a bioequivalence assessment team\, conducting critical evaluations of in vivo & in vitro bioequivalence (BE) studies\, including abbreviated new drug applications (ANDAs)\, BE study protocols\, Bio-INDs\, controlled correspondences (CCs) and other regulatory submissions for generic drug products. Over her career at the FDA\, she has resolved many complex scientific and regulatory issues related to BE assessment. Dr. Xia earned her Ph.D. in Biological Sciences from Bowling Green State University. She completed postdoctoral fellowships in the Department of Chemistry at the University of Michigan and the Department of Pharmaceutics at the University of Washington prior to joining the Agency in 2008.  \n\n \n \n \n \n \n Derrick Zhang\, M.S.\, MBA\n \n \n \n \nSenior Scientist II\, Pipeline Development\, Global Biologics\, USP \nMr. Derrick Zhang is a Senior Scientist II in Global Biologics at the United States Pharmacopeia (USP) in Gaithersburg\, MD\, where he leads the development of biologics reference standards and shapes pipeline strategy through scientific partnerships with industry stakeholders. He holds a B.S. in Biochemistry from Virginia Tech\, a M.S. in Biotechnology from Johns Hopkins University\, and a MBA from the University of Maryland’s Robert H. Smith School of Business. Prior to USP\, he held analytical and process development roles at Adaptive Phage Therapeutics\, United Therapeutics\, and MesoScale Diagnostics\, where his work included included development\, qualification and validation of process specific ELISA for the approved anti-GD2 monoclonal antibody dinutuximab (Unituxin). \nDerrick’s current work centers on the analytical characterization and quantitation of host cell proteins by LC-MS/MS and on building the reference standards and best practices that support process-related impurity analysis across the industry. He leads USP’s HCP reference standard portfolio—including CHO-derived antigens and stable-isotope-labeled (SIL) peptide standards for difficult-to-clear\, high-risk impurities such as PLBL2\, clusterin\, and lipoprotein lipase—and developed the USP HCP Normalization Control to support both targeted (MRM/PRM) and untargeted (DIA) proteomic workflows under USP General Chapter <1132.1>. He recently presented “From Discovery to Quantitation: USP Standards and Best Practices for LC-MS/MS-Based Host Cell Protein Analysis” at BEBPA 2026 and has a peer-reviewed publication on HCP quantitation in the Journal of Pharmaceutical and Biomedical Analysis. His research connects directly to this workshop’s focus\, as the shift toward yeast (S. cerevisiae) and E. coli expression systems—particularly for GLP-1 receptor agonists—raises new immunogenicity and impurity-clearance questions that orthogonal LC-MS characterization is uniquely positioned to address \n\n \n \n \n \n \n Hongling Zhang\, Ph.D.\n \n \n \n \nDivision Director\, DB II\, OB\, OGD\, CDER\, FDA \nDr. Hongling Zhang is the director of the Division of Bioequivalence II in the Office of Bioequivalence of OGD\, FDA. Since joining OGD in 2008\, she has been involved in developing bioequivalence (BE) recommendations and evaluating BE studies in ANDAs for many complex drug products. She is an expert in resolving complex scientific and/or regulatory issues related to BE. In her current role\, she provides scientific advice on BE standards through guidances\, meetings and controlled correspondences. Dr. Zhang received her Ph.D. degree in Pharmacology from the University of South Florida and completed a post-doctoral training at the Moffitt Cancer Institute.  \n\n \n \n \n \n \n Jinhui Zhang\, Ph.D.\n \n \n \n \nSenior Pharmaceutical Scientist\, OPQR\, OPQ\, CDER\, FDA \nDr. Jinhui Zhang is a Senior Pharmaceutical Scientist at the FDA/CDER. His research at FDA focuses on using advanced mass spectrometry and automation platforms for the characterization of biotherapeutics\, complex drug products\, and bioanalysis in support of clinical pharmacology and bioequivalence.  \nDr. Zhang has given 60 invited podium presentations and published 50 peer reviewed publications on implementing ICH M10\, Q14\, Q2(R2) and Q12 guidelines\, advanced characterization of complex modalities\, and bioanalytical methods.  \nDr. Zhang is an associate director advisory committee member of CASSS; and an editorial advisory board member of Bioanalysis.  \n\n \n \n \n \n \n Tianyi Zhang\, Ph.D.\n \n \n \n \nHuman Factors Reviewer\, DMEPA I\, OMEPRM\, OSE\, CDER\, FDA \nDr. Tianyi Zhang is a Human Factors Reviewer in the Division of Medication Error Prevention and Analysis I (DMEPA I) in the Office of Surveillance and Epidemiology at the FDA\, where he applies his extensive human factors knowledge in medication error prevention across multiple therapeutic areas to increase the safe and effective use of drugs\, biologics\, and combination products by minimizing use errors related to the naming\, labeling\, packaging\, or product design. Beyond his review responsibilities\, he serves in multiple working groups as the DMEPA I representative\, contributing to the development and updating of FDA policy documents and human factors research collaborations with the Office of Generic Drugs. He holds a Bachelor of Science and Master of Science in Industrial and Systems Engineering from the University of Wisconsin-Madison\, and a doctorate in Systems and Industrial Engineering from the University of Arizona.  \n\n \n \n \n \n \n Zhen Zhang\, Ph.D.\n \n \n \n \nMaster Pharmacologist\, DB I\, OB\, OGD\, CDER\, FDA  \nDr. Zhen Zhang is a Master Pharmacologist in the Division of Bioequivalence I\, Office of Bioequivalence\, within the FDA’s Office of Generic Drugs (OGD). His extensive expertise includes data analysis\, modeling and simulation\, dissolution studies\, and topical product evaluations. Dr. Zhang leads efforts to modernize data analysis tools within the Office of Bioequivalence\, significantly enhancing the efficiency of bioequivalence reviews. He also co-leads OGD’s Oral PBPK Expert Committee. Over the course of his career\, Dr. Zhang has addressed numerous complex bioequivalence challenges and played a key role in the development of several FDA general guidances. Dr. Zhang earned his Ph.D. in Pharmacology from the University of Wisconsin-Madison. \n\n \n \n \n \n \n Maotang Zhou\, Ph.D.\n \n \n \n \nDivision Director\, OPQA III\, OPQ\, CDER\, FDA \nDr. Maotang Zhou serves as a Division Director in the Office of Pharmaceutical Quality Assessment III (OPQA III) within the Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research (CDER)\, FDA. In this role\, he leads a team of scientists in assessing drug substance information for INDs\, NDAs\, BLAs\, and ANDAs. OPQA III is responsible for the quality of all active ingredients and substances in CDER\, from OTC drugs to complex biological products. He received his bachelor’s degree from Sichuan University\, his master’s degree from the Chinese Academy of Sciences\, and his Ph.D. from the State University of New York at Albany. Prior to his FDA career\, Dr. Zhou spent 12 years in the pharmaceutical industry\, gaining comprehensive experience at major companies such as Bristol Myers Squibb (BMS) and Wyeth\, as well as specialty companies including Chiral Quest and Cambrex. Dr. Zhou joined the FDA in 2008 with the former Office of New Drug Quality Assessment (ONDQA). Since then\, he has developed extensive expertise in quality assessment and policy development across multiple OPQ suboffices\, including OPMA\, OPPQ\, and OPQA III. Throughout his tenure\, Dr. Zhou has made significant contributions to the development of guidances\, policies\, and Manuals for Policies and Procedures (MaPPs) through his service on various CDER working groups and technical committees. \n\n \n \n\n\n\n\n\n \n \n \n Location\n \n \n \n The workshop will be held at the Universities at Shady Grove (USG). \nAddress: Building II\, Ballroom (please follow signs)\, 9630 Gudelsky Drive\, Rockville\, MD 20850 \n\n \n \n \n \n \n Directions and Transportation\n \n \n \n \nTravel from local airports to Rockville\, MD (The Universities at Shady Grove (USG)) will require an Uber or Lyft\, which is by far the best way to obtain car service.\nAs there is road traffic in the region\, the fastest way to the Shady Grove campus is the DCA airport\, then taking the Metro subway from the airport to Shady Grove\, then taking Uber or Lyft. Alternatively\, fly into any WAS airport and take Uber or Lyft. If flying into BWI airport\, we suggest taking Uber or Lyft to USG.\nThe Metro subway serves DCA and IAD airports\, which connects with the Shady Grove stop on the red line. If flying into IAD\, taking the Metro will save some cost\, but will probably take extra time\, even if traffic is heavy.\n\nMore links and information: \n\nDirections and transportation options to USG\nPublic transportation\nCampus map\n\n\n \n \n \n \n \n Parking\n \n \n \n \nThe Traville-Gateway Garage is the closest parking garage to the venue (parking map). Attendees may also park in Lot 2 and Shady Grove Garage but will need to allow more walking time to reach the event.\nVisitor Parking: Levels 2-6 of Traville Gateway Garage. PLEASE NOTE: The ground floor of Traville Gateway Garage requires a USG employee permit at all times.\nGuests are responsible for the cost of parking; parking will not be validated. Parking is $16 for all day.\n\nClick for parking information from the USG website. \n\n \n \n \n \n \n Airports\n \n \n \n Please click on the following “all transportation options” links to find transportation from the airport via subway\, bus\, taxi\, car\, and town car. \n\nReagan National Airport (DCA): 21.1 miles from Rockville\, MD (all transportation options from DCA) (train options from DCA)\nDulles International Airport (IAD): 27.8 miles from Rockville\, MD (all transportation options from IAD) (train options from IAD)\nBaltimore/Washington International Thurgood Marshall Airport (BWI): 37.5 miles from Rockville\, MD (all transportation options from BWI) (train options from BWI)\n\n\n \n \n \n \n \n Train\n \n \n \n Train tickets (Omio) \n\nWashington\, DC to Baltimore: Approximately 35 minutes\nPenn Station Marc SB (Baltimore): Approximately 41 miles from campus\n\n\n \n \n \n \n \n Taxi and Car Service\n \n \n \n Empire Sedan & Limo Services (empiresedan12@gmail.com):  240-988-1796 \nWashington Flyer Taxi:  703-572-TAXI or 706-853-6094\n(Syed Z Shah\, Cab #381\, 571-243-0020\, can book ride\, requires one day notice) \nRegency Taxi:  301-984-1900 \nBob’s Limo Service (Email): 301-525-2525 \nB&B Executive Sedan (Email): 240-533-6262 \nEast Coast Limousine (Email): 301-527-0413 or 240-793-8196 \n  \n\n \n \n \n \n \n Uber\n \n \n \n Uber: Baltimore\, BWI Airport\, Washington\, DC\, Dulles (IAD) Airport \nIf using Uber\, plese see the Uber Map for the designated spot for drop off and pick up for the workshop.  Do not request to be picked up/dropped off at the Traville-Gateway parking garage. \nAddress for Uber:\nUniversiites at Shady Grove\nLot 5\n9631 Gudelsky Drive\nRockville\, MD 20850 \n\n \n \n \n \n \n Hotels/Lodging\n \n \n \n Guests should mention they are attending a conference at Universities of Shady Grove; most hotels offer discounts. \nThere are many hotels within a short driving distance to the USG campus including: \n\nHilton Garden Inn Rockville-Gaithersburg (Book your room (CRCG rate) by Sept. 1\, 2026)\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1800\nHomewood Suites by Hilton Rockville-Gaithersburg\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1900\nCourtyard by Marriott Rockville\n2500 Research Boulevard\, Rockville\, MD 20850 (0.9 miles from USG)\n301-670-6700\nSleep Inn Rockville\n2 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-507-8000\nThe Rockville Hotel\, a Ramada by Wyndham\n3 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-202-1098\nSpring Hill Suites by Marriott Gaithersburg\n9715 Washingtonian Blvd\, Gaithersburg\, MD 20878 (1.4 miles from USG)\n301-987-0900\nSheraton Rockville Hotel\n920 King Farm Blvd\, Rockville\, MD 20850 (1.4 miles from USG)\n240-912-8200\nCourtyard by Marriott Gaithersburg Washingtonian Center\n204 Boardwalk Place\, Gaithersburg\, MD 20878 (1.6 miles from USG)\n301-527-9000\nComfort Inn Shady Grove-Gaithersburg-Rockville\n16216 Frederick Rd.\, Gaithersburg\, MD 20877 (2.2 miles from USG)\n301-330-0023\nEVEN by IHG Hotel Rockville\n1775 Rockville Pike\, Rockville\, MD 20852 (5.5 miles from USG)\n855-879-3836\n\n\n \n \n\n\n\n\n \n For the September 23-24 workshop\, you will need to pre-order your lunch for each day; lunch is not provided.  Lunch will be delivered to the main building where the workshop will be held (Building II\, Ballroom) and labeled with your name.  You will pick up your ordered food at the registration desk\, each day. (Note:  please disregard the confirmation message that states food will be available for pick up the next day; all food will be delivered to the Ballroom for each day of the workshop) \nYou can go to Dawson’s Market as well\, located in Building III\, first floor.  Hours are 9 AM-5 PM ET.  The cafe has additional food and beverage options there.  You are welcome to bring your lunch\, as well. \nLink for Wednesday\, September 23:  https://square.link/u/v9xMwlxI \nLink for Thursday\, September 24:  https://square.link/u/tRQgNkZk \nMake your selection and Add to Order.  Once you have made your selection\, you will then click on the shopping cart icon to check out.  If you want to purchase more than one meal for the same day\, you will need to place two separate orders.  You will Continue to Payment\, where you can pay with Google Pay\, Credit Card\, or Cash App Pay.  Then hit Place Order. \nDuring checkout\, there is a spot for Note to Seller\, to use when placing your order\, if needed for modifications to your order. \nThe deadline for ordering lunch is Monday\, September 14th by 5 PM ET. \nCoffee\, hot tea\, water\, and soft drinks will be available throughout each day in the conference room (Ballroom).  \nFood will be provided in the morning\, and AM and PM breaks each day. \nUSG Lunch (Dawson’s Market) \nChicken Caesar Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nTurkey & Swiss Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nTuna Salad Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nGrilled Vegetables & Hummus Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nEggless Egg Salad Wrap (VEGAN) $14.99 Includes chips\, cookie\, and choice of beverage \nYou will have the option to remove tomatoes and/or cheese\, if needed \nGreek Salad $14.99 Includes romaine lettuce\, tomatoes\, onion\, kalamata olives\, bell peppers\, feta cheese\, pepperoncini peppers served with Dijon vinaigrette. Includes chips\, cookie\, and choice of beverage \nGrilled Salmon Caesar Salad $15.99 Includes chopped romaine\, house made croutons\, shredded parmesan & Caesar dressing. Includes chips\, cookie\, and choice of beverage \nGoat & Greens $14.99 Includes spinach\, cranberries\, pecans\, tomatoes\, goat cheese served with balsamic vinaigrette. Includes chips\, cookie\, and choice of beverage \nHot Items \nTomato Bisque Soup  $6.99 \nTaco Bowl  $15.99 Your choice of [fajita chicken\, ground beef\, or vegetables] on a bed of rice with mixed greens\, fajita vegetables\, black beans\, shredded cheese\, and toppings on the side (guacamole\, sour cream\, and salsa) \nBeverage Choice \nCoke \nDiet Coke \nSprite \nWater \nJust Tea-Mango White (additional $1.00) \nJust Tea-Original Green (additional $1.00) \nJust Tea-Half & Half (additional $1.00) \nDr. Browns-Cream \nDr. Browns-Black Cherry \nDr. Browns-Root Beer \nOlipop-Grape (additional $1.50) \nOlipop-Ginger Lemon (additional $1.50) \nOlipop-Cherry Cola (additional $1.50) URL:https://www.complexgenerics.org/education-training/navigating-the-glp-1-generic-drug-pathway/ ATTACH;FMTTYPE=image/jpeg:https://www.complexgenerics.org/wp-content/uploads/2026/05/GLP-1-Conference-image.jpg END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20261014T080000 DTEND;TZID=UTC:20261015T173000 DTSTAMP:20260910T193626Z CREATED:20250918T215559Z LAST-MODIFIED:20260910T193626Z UID:38348-1791964800-1792085400@www.complexgenerics.org SUMMARY:Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro\, In Vivo\, and In Silico Methods DESCRIPTION:Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro\, In Vivo\, and In Silico Methods\n \n \n HomeEducation and Training\n \n \n \n \n \n Explore This Section\n \n \n Upcoming Events\n \n \n Event Summary\n \n \n \n \n\n\n\n\n\n\n\n\n\n\nCo-hosts: FDA and the Center for Research on Complex Generics (CRCG) \n\n\n\nIn person (at The Universities at Shady Grove; Rockville\, MD) and virtual workshop. \n\n\n\n \n \n \n \n \n Registration Now Open\n \n \n \n \n \n \n \n Register here \n \n \n \n \n \n Download the Agenda \n \n \n \n \n \n\n\n\nAboutEvent OutlineSpeaker BiosTravel & AccommodationsOrdering Lunch\n \n Advances in analytical methods and bioequivalence assessment science have driven the evolution of bioequivalence recommendations for locally acting inhalation products toward option-based bioequivalence frameworks\, incorporating innovative in vitro\, in vivo\, and in silico methods as viable alternatives to comparative clinical endpoint studies. These developments represent meaningful opportunities to modernize and strengthen the development and approval of generic inhalation products. As with any emerging methodology\, their novelty may give rise to questions where additional clarity could further support their implementation. This workshop will explore these opportunities with the goal of building shared understanding\, refining best practices\, reducing redundancies\, and streamlining evaluations that will ultimately support more efficient generic development programs and timely approvals. \nAttendees will gain valuable insights into the current understanding\, regulatory expectations\, and industry experiences with developing\, validating\, and using in vitro and in vivo methods included as part of bioequivalence recommendations for metered dose inhalers (MDIs) and dry powder inhalers (DPIs) without significant formulation differences with their reference standard (RS). The final session of the workshop will explore the potential for using innovative in vitro and in vivo methods in these option-based frameworks with products containing significant formulation differences with their RS. In addition to a series of expert-led presentations and panel discussions\, in-person attendees will interact directly with experts from industry\, academia and regulatory agencies to better understand the current practices and considerations with conducting these studies. \nThe two-day workshop is designed to discuss in vitro methods for particle size distribution\, dissolution and particle morphology; the current expectations and potential alternatives to charcoal block in vivo pharmacokinetic studies; a look forward at opportunities to expand use of these bioequivalence approaches and areas for products with significant formulation differences from their RS. \nChoose your experience: \nVIRTUAL ATTENDANCE: \nAll attendees will enjoy a series of expert-led presentations and panel discussions that provide valuable insights into the current understanding\, regulatory expectations\, and industry experiences with developing\, validating\, and using in vitro and in vivo methods recommended to support demonstration of bioequivalence for MDIs and DPIs without significant formulation differences from their RS. The final session of the workshop will explore the potential for using innovative in vitro and in vivo methods in these option-based frameworks with products containing significant formulation differences from their RS. Virtual attendees will be able to: \n\nAttend all presentations and panel discussions\nParticipate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists\nEnjoy free access to workshop recordings of presentations and panel discussions (not including the in-person-only sessions)\n\nIN-PERSON ATTENDANCE: \nIn-person attendees will enjoy all the benefits of virtual attendance and\, additionally\, interact directly with experts from FDA\, academia\, industry\, consulting groups\, and others to deepen their understanding of current practices and considerations\, regulatory expectations\, and emerging trends. These high-engagement scientific interactions will be facilitated through two in-person-only sessions: \n\nA session dedicated to interactive discussions and candid dialogue with FDA\, Industry\, Academic\, and other subject matter experts about scientific and regulatory challenges for complex inhalation generic products.\nA guided session for small groups of in-person attendees to elucidate and work through specific challenging issues for inhalation generic product development and assessment\, including key topics related to generic MDI and DPI drug products\, such as proper study development\, method complications and potential remedies. Participants will also have the opportunity to contribute to a publicly available workshop report summarizing key discussion points\, consensus findings\, and recommendations emerging from the workshop.\n\nWorkshop Topics\n\nCurrent Bioequivalence Approaches for Inhalation Drug Products\, discussing the option-based framework\, current challenges and areas for clarity\, and future directions for research initiatives and additional guidance.\nRevisiting Realistic Particle Size Distribution Study Designs and Analyses for inhalation products\, including considerations and challenges associated with method development and analyses of realistic aerodynamic particle size distribution (rAPSD) studies.\nExpectations for Designing Sensitive Dissolution Methods\, including regulatory expectations and reasoning around study development and design\, considerations around method development and sample collection\, and applicability of biopredictive and/or biorelevant approaches.\nExpectations and Opportunities with Particle Morphology Testing\, exploring the purpose and utility of conventional and alternative methods for morphological characterization\, along with considerations for multi-component formulations.\nWaivers for In Vitro and In Vivo PK Studies – Challenges and Opportunities\, focusing on the applicability for partial AUC metrics in lieu of charcoal block PK studies\, challenges and opportunities for additional strength(s) waivers\, expectations and other considerations around in silico approaches.\nMoving Beyond Formulation Sameness – Expanding BE Options for Non-Q1 and/or Non-Q2 OIDPs\, discussing the relevance of formulation sameness across inhalation products\, challenges with meeting Agency recommendations\, and potential approaches and/or opportunities to address uncertainties with non-Q1 and/or non-Q2 formulations.\n\nAudience\nThe workshop is designed for professionals interested in advancing their understanding of regulatory science and bioequivalence strategies that can support product development\, along with the performance and quality assessment of complex MDI and DPI drug products. This includes formulation scientists\, analytical scientists\, regulatory affairs specialists\, quality control experts\, and R&D professionals from industry\, academia\, and government. \n\nVirtual Attendance is ideal for those who wish to access expert presentations and panel discussions remotely\, eliminate travel requirements\, and have the flexibility to engage with content in real time or on demand.\nIn-Person Attendance is best for participants seeking high-level engagement through collaborative small group working sessions\, direct interaction with experts from FDA\, Academia\, Industry\, and others\, with opportunities for immersive learning focused on real-world challenges and problem-solving.\n\nRegistration Fees: \n This workshop is FREE for virtual attendees. \n\nThe combined cost for the two-day workshop in-person attendance and activities is:\n\n$350\, in-person attendees – general\n$150\, in-person attendees – government (must have an email ending in “.gov” to register at this rate)\n\n\n\nFor faculty and students from the University of Maryland\, Baltimore\, The Universities at Shady Grove\, and University of Michigan\, please contact CRCG (info@complexgenerics.org) regarding registration. \nContinuing education (CE) credits will not be provided for attending this workshop.  A certificate of attendance will only be provided to individuals attending in person\, when requested. \nFor in-person attendees\, beverages and food for breaks will be provided; Lunch will not be provided. Please visit the CRCG website regarding pre-ordering lunch instructions. Links will be provided once they are available. Orders must be placed by October 4 (5 PM ET). Also there is an onsite cafe for purchasing food or you are welcome to bring your own lunch. \n\n\n\n\n\n\n\n\n \n Introduction to the Workshop \nThis 2-day hybrid workshop will explore the regulatory expectations and industry experiences as well as challenges with conducting in vitro and in vivo bioequivalence studies recommended as part of newly included options in PSGs for MDIs and DPIs. Designed as a collaborative platform\, the workshop brings together FDA scientists\, industry leaders\, and academic experts to share knowledge\, discuss expectations and real-world experiences\, understand implications from additional formulation complexity\, and identify potential pathways forward for achieving adequate study methods that can help streamline complex generic inhalation product development and ANDA review. \nDAY 1\nSession 1: Current Bioequivalence Approaches for Inhalation Drug Products \nFormat: Presentations (Virtual and In-Person Attendees) \n\nThis session details the Agency’s latest advancements in bioequivalence strategies recommended for inhalation products\, their associated challenges\, and opportunities for clarity and efficiency. Topics include the current option-based framework\, recommended BE studies\, method considerations\, industry experiences and challenges\, and future directions for research initiatives and additional guidance.\n\nSession 2: Revisiting Realistic Particle Size Distribution Study Designs and Analyses \nFormat: Presentations and Panel Discussion (Virtual and In-Person Attendees) \n\nThis session examines the FDA expectations and industry experience with conducting conventional and realistic APSD studies. Speakers will cover topics such as selection and use of anatomical mouth-throat models and breathing profiles\, approaches for statistical analyses\, study size\, capturing clinically relevant variability\, bracketing approaches\, and potential opportunities for addressing common challenges.\n\nSession 3: Expectations for Designing Sensitive Dissolution Methods \nFormat: Presentations and Panel Discussion (Virtual and In-Person Attendees) \n\nThis session examines the FDA expectations and industry experience with dissolution studies. Speakers will cover topics on the rationale and utility of dissolution for inhalation products\, method development and sample collection\, validation\, demonstrating sensitivity\, approaches for statistical analysis\, and applicability of biopredictive and/or biorelevant approaches.\n\nSession 4: Expectations and Opportunities with Particle Morphology Testing \nFormat: Presentations and Panel Discussion (Virtual and In-Person Attendees) \n\nThis session examines the FDA expectations and industry experience with particle morphology characterization studies. Speakers will cover topics on purpose of utility of particle morphology characterization across inhalation products\, current and alternative methods for morphology characterization\, and considerations and challenges with multi-component formulations.\n\nSession 5: Open Exchange \nFormat: Interactive Discussions on Focused Product Development and Assessment Areas (In-Person Attendees Only) \n\nThis session is dedicated to interactive discussions and candid dialogue with FDA\, Industry\, Academic\, and other subject matter experts about scientific and regulatory challenges for complex inhalation generic products.\n\nDAY 2\nSession 6: Waivers for In Vitro and In Vivo PK Studies– Challenges and Opportunities \nFormat: Presentations and Panel Discussion (Virtual and In-Person Attendees) \n\nThis session explores the considerations and challenges with the recommended in vivo PK BE studies\, including more complex designs like charcoal-block studies. Speakers will cover topics related to the rationales for current recommendations\, implications and experiences from industry\, and where alternative methods like in silico modeling may have potential for improving efficiency.\n\nSession 7: Small Group Working Session \nFormat: Interactive Working Session (In-Person Attendees Only) \n\nIn this collaborative session\, participants will join small-group discussion tables facilitated by FDA\, industry\, and academic experts. In-person attendees will engage in guided discussions and exercises related to Sessions 2-4\, building consensus\, and reporting of actionable research or recommendations. The outcome of this session will be a meeting report summarizing key discussion points\, consensus findings\, and emerging recommendations\, which will be shared publicly after the workshop.\n\n\n\n\nSession 8: Moving Beyond Formulation Sameness – Expanding BE Options for Non-Q1 and/or Non-Q2 Inhalation Products \nFormat: Presentations and Panel Discussion (Virtual and In-Person Attendees) \n\nThe final hybrid session focuses on the implications of formulation sameness recommendations for inhalation products. Speakers will cover topics on the role of formulation sameness with inhalation products based on current scientific understanding\, along with potential opportunities for moving beyond these recommendations through improved understanding of the critical factors governing product performance.\n\n\n\n\n\n\n\n \n \n \n Andrew Babiskin\, Ph.D.\n \n \n \n \nDeputy Division Director\, DQMM\, ORS\, OGD\, CDER\, FDA \nDr. Andrew Babiskin is the Deputy Division Director of the Division of Quantitative Methods and Modeling (DQMM)\, Office of Research and Standards (ORS)\, Office of Generic Drugs\, CDER. He previously led the Locally-acting Physiologically Based Pharmacokinetic Modeling Team and the Quantitative Clinical Pharmacology Team in DQMM. Dr. Babiskin’s expertise lies in modernization of bioequivalence evaluation practices through model-integrated evidence. Dr. Babiskin received his B.S. degree from the University of Maryland (College Park) in Chemical Engineering and his M.S. and Ph.D. degrees from the California Institute of Technology in Chemical Engineering. He joined the FDA in 2012 as an ORISE postdoctoral fellow in the OGD Science Staff (now ORS) and became an employee within DQMM in 2014. \n\n \n \n \n \n \n Mark Berry\, M.Sc.\n \n \n \n \nDirector\, CMC/Nonclinical Statistics\, Respiratory R&D\, Viatris \nMr. Mark Berry holds a M.Sc\, in Statistics from The University of Georgia\, USA.  His current role is Director\, Nonclinical Statistician\, Viatris R&D\, with primary focus on support to respiratory product development. He has broad statistics experience across a number of industries (including aerospace and hi-tech)\, and specific relevance gained from providing statistical support to in vitro bioequivalence studies during development of Viatris’ approved generic DPI and MDI products. He was a contributing author to a peer-reviewed publication evaluating the performance characteristics of the population bioequivalence test applied to in vitro BE studies \n\n \n \n \n \n \n Jonas Biehler\, Ph.D.\n \n \n \n \nCo-Founder and CTO\, Ebenbuild GmbH \nDr. Jonas Biehler is co-founder and CTO of the Munich-based startup Ebenbuild.  He is responsible for the company’s product development and R&D. Ebenbuild develops a technology platform for precise\, patient-specific simulation models of the human lung\, so-called digital twins. Its digital toolset is based on physics-based simulation\, AI\, and data science and is designed to support decision-makers in healthcare and life sciences for instance through in silico trials for pulmonary drug delivery that enable subject-specific prediction of local aerosol deposition throughout the entire respiratory system. \nJonas studied Mechanical Engineering at the Technical University of Munich (TUM) and the University of Canterbury in Christchurch. Holding a Ph.D. in computational mechanics from TUM\, he has extensive experience in transdisciplinary research projects and entrepreneurial endeavors at the intersection of physics\, machine learning\, and medicine. Both his research and his entrepreneurial work have been awarded nationally and internationally. \n\n \n \n \n \n \n Elizabeth Bielski\, Ph.D. \n \n \n \n \nSenior Pharmacologist\, DTP I\, ORS\, OGD\, CDER\, FDA \nDr. Elizabeth Bielski is a Senior Pharmacologist working at Division of Therapeutic Performance I (DTP I)\, Office of Research and Standards (ORS)\, Office of Generic Drugs (OGD)\, Center of Drug Evaluation and Research (CDER) at the FDA since October 2022. Prior to her role as a Senior Pharmacologist\, she served as a Pharmacologist from October 2020 to October 2022 and as a Chemist from January 2020 to October 2020 within DTPI. Her areas of expertise involve orally inhaled and nasal drug products (OINDPs). She is actively involved in developing general and product-specific guidances\, addressing controlled correspondences\, pre-ANDA meeting requests\, citizen petitions\, internal consults\, and collaborating on current research projects to promote generic drug development of OINDPs. Prior to joining the FDA\, she served as an ORISE Fellow at FDA within DTP from August 2018-December 2019. Elizabeth completed her Ph.D. in Chemical Engineering from Wayne State University (Detroit\, MI\, USA) in July 2018 encompassing work also conducted at Department of Chemistry at the University of São Paulo (São Paulo\, Brazil) and Department of Pharmaceutics at Virginia Commonwealth University (Richmond\, VA\, USA) related to novel drug delivery strategies for treatment of lung cancer and lung metastases. Prior to receiving her doctorate\, she received her Bachelor of Science in Biomedical Physics Honors with University Honors in 2011\, and her Master of Science in Biomedical Engineering in 2012 from Wayne State University. \n\n \n \n \n \n \n Susan Boc\, Ph.D.\n \n \n \n \nPharmacokineticist\, DTP I\, ORS\, OGD\, CDER\, FDA \nDr. Susan Boc is a Pharmacokineticist in the Office of Generic Drugs’ Division of Therapeutic Performance I in the Office of Research and Standards. Specializing in inhalation and nasal drug products\, Susan is responsible for the development of product-specific guidances to support generic drug development\, reviewing and responding to controlled correspondences\, pre-Abbreviated New Drug Application (ANDA) meeting requests\, and internal consults. She also manages research projects focused on understanding and developing analytical methods and in vitro characterization tools for inhalation and nasal drug products to promote generic drug development. Prior to joining FDA\, Susan was a Research Associate both at Novartis Pharmaceuticals and Nektar Therapeutics working in the development of inhalation drug products. She received her Ph.D. in Pharmaceutical Sciences from Virginia Commonwealth University in 2018. \n\n \n \n \n \n \n Loy Britto\, Ph.D.\n \n \n \n \nCEO\, Healthy Airways LLC \nDr. Loy Britto earned his Ph.D. in Materials Engineering from the Massachusetts Institute of Technology (MIT). He has more than 44 years of industrial experience spanning materials science\, chemical engineering\, advanced manufacturing\, and pharmaceutical product development. Prior to joining the pharmaceutical industry\, he held engineering positions at ARCO and IBM\, where he worked on process modeling\, product development\, and manufacturing technologies. \nDr. Britto spent over 30 years at GlaxoSmithKline (GSK)\, where he held roles of increasing responsibility in the development and commercialization of orally inhaled and nasal drug products. His work encompassed formulations\, device components\, manufacturing processes\, analytical methods\, and technology transfer. He contributed to nearly 40 global regulatory submissions\, including INDs\, NDAs\, and Marketing Authorization Applications(MAAs)\, and served as the Global Product Owner for GSK’s Metered Dose Inhaler (MDI) portfolio within the Manufacturing Sciences and Technology organization. He also served as a subject matter expert during the early development of a low-global-warming-potential (low-GWP) propellant version of Ventolin. \nFollowing his retirement from GSK\, Dr. Britto founded Healthy Airways LLC and now serves as an independent consultant to pharmaceutical companies and device manufacturers. He is an inventor or co-inventor on more than a dozen U.S. patents and continues to focus on the development\, scale-up\, and commercial manufacture of inhaled products and their device components using Quality by Design (QbD) principles. \n\n \n \n \n \n \n Steven Chopski\, Ph.D.\n \n \n \n \nChemical Engineer\, DQMM\, ORS\, OGD\, CDER\, FDA \nDr. Steven Chopski is a chemical engineer in the Division of Quantitative Methods and Modeling (DQMM)\, Office of Research and Standards\, Office of Generic Drugs\, Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). He received his Ph.D. in Mechanical Engineering and a B.S. degree in Biomedical Engineering from Virginia Commonwealth University in Richmond\, Virginia. He joined the FDA in 2018 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. His research interests include physiologically-based pharmacokinetic (PBPK) modeling and computational fluid dynamics (CFD) modeling of both nasal and orally-inhaled drug products. He has 10+ years of experience with in silico modeling and simulation of medical devices. He is engaged in regulatory science research initiatives related to generic drug-device combination products. \n\n \n \n \n \n \n Jamie Clayton\, B.Eng.\n \n \n \n \nChief Executive Officer\, Copley Scientific Ltd. \nMr. Jamie Clayton is Chief Executive Officer of Copley Scientific\, the global leader in inhaler testing equipment\, where he is responsible for driving innovation\, strengthening customer relationships\, and guiding the company’s continued growth. With almost 20 years’ experience in powder testing\, material characterisation\, and life sciences\, Jamie brings a strong understanding of the analytical and practical challenges involved in developing reliable\, high-quality pharmaceutical products\, including orally inhaled and nasal drug products \nHe holds a B\,Eng. in Control Engineering from the University of Sheffield and combines his engineering background with deep sector experience to support the development of practical\, user-focused testing solutions. Alongside his leadership responsibilities\, Jamie has contributed to the scientific community through peer-reviewed publications\, conference papers\, posters\, and technical articles spanning material characterisation\, inhaler testing\, and pharmaceutical product development. \nJamie is committed to fostering collaborations that help scientists\, manufacturers\, and regulators advance robust testing approaches and deliver safer\, more effective treatments worldwide. \n\n \n \n \n \n \n Agnes Colombani\, Ph.D.\n \n \n \n \nDirector of Formulation Development\, Respiratory\, Nasals\, Semi Solid & Liquids (RNSSL) R&D; Hikma Pharmaceuticals \nDr. Agnes Colombani received her Ph.D. in Chemical Engineering and Analytical Sciences from the University of Manchester\, UK. She has over 20 years of experience in the development of orally inhaled and nasal drug products. She recently joined Hikma Pharmaceuticals in Ohio to lead formulation and process development within the RNSSL R&D unit. \n\n \n \n \n \n \n Andrew Cooper\, Ph.D.\n \n \n \n \nSenior Director\, Respiratory Bioequivalence Strategy Lead\, Respiratory R&D\, Viatris \nDr. Andrew Cooper holds a Ph.D. in Pharmaceutical Analysis from University of Bath\, UK. He has broad industrial experience of analytical chemistry supporting complex dosage form development\, focused for around 20 years on respiratory product development. \nHe has long held interests at the CMC – clinical interface\, particularly on the relevance of in-vitro quality tests to in-vivo performance and on the value of clinical studies to inform product development. He is committed to industry-regulatory engagement supporting the development of science-based bioequivalence strategies for respiratory products which facilitate patient access to high-quality medicines. \n\n \n \n \n \n \n Dino J. Farina\, M.S.\, EME\n \n \n \n \nFounder and CEO\, Proveris Scientific \nMr. Dino Farina founded Proveris in 1995 to help its customers deliver quality orally inhaled and nasal drug products (OINDPs) to patients that need them. He chose the company name to explain our philosophy\, Proveris from Latin Probare (Test\, Approve\, Demonstrate)\, And Veritas (Truth). He completed two graduate degree programs at Stanford University in mechanical engineering. He was awarded the prestigious NASA Student Fellowship grant to study advanced fluid dynamics at the NASA-Ames Research Center in Mountain View\, California and was a co-author on two groundbreaking journal articles related to his work with temperature and shear-stress sensitive liquid crystal coatings while a student. \nDino has been actively involved in the development of advanced measurement systems for OINDPs for nearly his entire professional career (31 years).  His experience in the OINDP area includes extensive time spent with the company’s global customers that include generic and brand pharmaceutical companies\, device makers\, CDMO/CROs\, and regulatory agencies around the world\, including those in China.  He is a named inventor on over 40 global patents related to spray and aerosol measurements and systems\, has co-authored numerous peer-reviewed journal articles\, and has advised FDA on numerous occasions on topics related to OINDPs\, including receiving a Faculty Recognition Award for Academic Year 2002-2003 \n\n \n \n \n \n \n Markus Fridén\, Ph.D.\n \n \n \n \nSenior Director\, Biopharmaceutics\, Global Product Development\, AstraZeneca \nDr. Markus Fridén earned his Ph.D. from Uppsala University in 2010\, with a thesis on experimental and computational approaches to quantify drug exposure in the brain. He joined AstraZeneca and worked in Drug Metabolism and Pharmacokinetics\, focusing on inhaled drug exposure in the lung\, mathematical modelling\, and translational PKPD. He has held a range of scientific and leadership roles and has extensive experience in inhalation-related research and development. \nSince 2020\, Markus has led the Biopharmaceutics team within Inhalation Product Development in Gothenburg\, Sweden. In his current role as Senior Director\, Biopharmaceutics in Global Product Development\, he works across delivery routes and leads biopharmaceutics activities in product development. He also serves as a co-opted Associate Professor at Uppsala University. \n\n \n \n \n \n \n Massimiliano Germani\, Ph.D.\n \n \n \n \nHead of Pharmacometrics\, Chiesi \nDr. Massimiliano Germani is Head of Pharmacometrics at Chiesi\, a role he has held since 2024\, where he leads the integration of model-informed drug development strategies across therapeutic areas. He has over 20 years of experience in the pharmaceutical industry\, having held senior clinical pharmacology\, pharmacometrics and modeling roles at GSK (2022-2024)\, UCB (2016-2022)\, and Ablynx (2013-2016)\, following his early career at Accelera former Pfizer and Pharmacia (2001-2013). \nDr. Germani holds a Ph.D\, in Bioengineering and Bioinformatics from the University of Pavia and an M.Sc. in Biomedical Engineering. His work focuses on the application of population PK/PD\, PBPK\, and advanced quantitative methods to support clinical development\, regulatory decision-making\, and lifecycle management. He has extensive experience interacting with regulatory agencies\, contributing to evidence-based and model-informed strategies from early development through post-marketing. \n\n \n \n \n \n \n Dipesh Gohil\, M.S.\n \n \n \n \nDirector\, Analytical R&D\, Amneal Pharmaceuticals \nMr. Dipesh Gohil is a Director of Analytical Research & Development at Amneal Pharmaceuticals. He holds a Master’s degree in Pharmaceutical Chemistry from Fairleigh Dickinson University\, New Jersey. Mr. Gohil has been with Amneal Pharmaceuticals since 2011. He has experience of working with a broad range of dosage forms\, including oral solids\, liquids (suspensions\, solutions) topical products\, otic\, and ophthalmic products\, as well as complex inhalation and other drug-device combination products. \nDipesh has extensive expertise in analytical method development and validation\, product characterization\, stability assessment\, and in vitro bioequivalence strategies across multiple dosage forms. His current work is focused on complex inhalation products\, including metered-dose inhalers (MDIs)\, dry powder inhalers (DPIs)\, and inhalation spray products\, with particular emphasis on delivered dose uniformity\, aerodynamic particle size distribution\, particle size characterization\, dissolution\, and other critical performance attributes. Mr. Gohil’s work is centered on advancing robust\, scientifically justified approaches for demonstrating product quality\, performance\, and equivalence for complex generic and drug-device combination products. \n\n \n \n \n \n \n Abhishek Gupta\, Ph.D.\, PMP\n \n \n \n \nChief Scientific Officer (CSO)\, Transpire Bio \nDr. Abhishek Gupta\, ‘Abhi’\, is Transpire Bio’s Chief Scientific Officer (CSO). Dr. Gupta is responsible for the scientific direction of Transpire Bio. As a member of the leadership team\, Dr. Gupta is responsible for providing the strategic and operational leadership to develop and implement the company’s scientific strategy\, overall product portfolio\, and conceptualization and introduction of new product opportunities. Dr. Gupta is also responsible for the evaluation of new product opportunities and M&A to expand existing business and create new business. \nDr. Gupta is a seasoned and accomplished bio-pharmaceutical executive with over 27 years of product development experience across dosage forms\, with over 20 years focused primarily on inhalation drug-device combination products. Dr. Gupta’s time in industry has included leadership positions at Novartis Pharmaceuticals\, Nektar Therapeutics (formerly Inhale)\, Cardinal Health\, Lupin\, and his most recent position at Cipla as the SVP & Head of R&D\, North America. Dr. Gupta has successfully led the product development and approval of several branded and generic dosage forms\, including small molecules\, polypeptides\, proteins\, and biologics for registration in the US and EU. \nDr. Gupta is a graduate of Harvard Business School’s business analytics program. Dr. Gupta has a Ph.D. in Pharmaceutical Sciences from the University of Arizona\, US\, with a focus on Pharmaceutics\, Analytical\, and Material Sciences. He is a certified project management professional (PMP) through the Project Management Institute (PMI) of America and has a Bachelor’s in Pharmacy (B. Pharm.) from India. Dr. Gupta has over 50 peer-reviewed publications and numerous granted and filed patents. \n\n \n \n \n \n \n Jayne E. Hastedt\, Ph.D.\n \n \n \n \nManaging Director\, JDP Pharma Consulting\, LLC \nDr. Jayne Hastedt is the Managing Director of JDP Pharma Consulting\, LLC\, which she founded in 2008. The consulting firm provides CMC support to the pharmaceutical and biotech industries\, with a primary focus on orally inhaled and nasal drug product development. She has extensive experience in the development of complex drug products and has held scientific and leadership roles at Boehringer Ingelheim\, Glaxo/Glaxo Wellcome (GSK)\, Inhale Therapeutic Systems (Novartis/Mylan)\, and ALZA Corporation (J&J). \nThroughout her career\, her research has explored the relationship between drug physicochemical and biopharmaceutical properties and their effects on drug delivery\, product performance\, and drug disposition. Dr. Hastedt developed an inhalation-based biopharmaceutics classification system (iBCS) for inhaled medicines\, a practical framework to guide candidate selection\, inform testing strategy\, and reduce CMC product development risk. She has co-authored five papers and delivered numerous presentations on this topic. Her current interests include the evaluation and development of biorelevant in vitro test methods for solubility\, dissolution\, lung dose\, and permeability suitable to classify inhaled medicines based on the framework of the iBCS. She received her M.S. and Ph.D. in Pharmaceutics from the University of Wisconsin–Madison School of Pharmacy\, which recognized her contributions to the field with a Citation of Merit in 2021. \n\n \n \n \n \n \n Mark Banaszak Holl\, Ph.D.\n \n \n \n \nProfessor and Associate Dean for Research\, Department of Mechanical and Materials Engineering\, Division of Pulmonology\, Allergy\, and Critical Care Medicine\, Lung Health Center\, University of Alabama at Birmingham \nDr. Mark Banaszak Holl is Professor and Associate Dean for Research in the School of Engineering at the University of Alabama at Birmingham. He also has an appointment in the Division of Pulmonology\, Allergy\, and Critical Care Medicine in the Heersink School of Medicine and is a member of the Lung Health Center\, the Center for the Study of Community Health\, the Gregory Fleming James Cystic Fibrosis Research Center\, and the Civitan International Research Center. He has more than 20 years of experience in synthesis and characterization of polymer and aerosol vectors for drug and gene delivery. His academic path includes 20 years at the University of Michigan\, including serving as Director of the Macromolecular Science and Engineering program\, and 4 years as the Head of Chemical and Biological Engineering at Monash University. He received his B.S. from the University of Chicago and Ph.D. from Cornell University. \n\n \n \n \n \n \n Tilen Huzjak\, M.Pharm.\n \n \n \n \nLeading Scientist\, IVIVC Group\, Pharmaceutical Research\, Sandoz\, Development Center \nMr. Tilen Huzjak is a Leading Scientist in the IVIVC group\, Sandoz Development Center\, specializing in the development of advanced\, mechanistically relevant dissolution and permeation methodologies for complex generic drug products. His expertise encompasses both solid and liquid dosage forms\, with particular emphasis on orally inhaled and nasal drug products (OINDP/OIDP). He has extensive experience working with compendial dissolution systems (USP Apparatus 1–4) as well as non-compendial\, product-specific approaches\, including modified in vitro setups designed to better reflect in vivo processes. He is particularly focused on two-compartment dissolution–permeation systems (e.g.\, Microflux™ and Macroflux™)\, enabling simultaneous assessment of drug release and membrane transport. His work supports the development of in vitro methods with enhanced biorelevance\, aiming to improve product understanding\, discriminate critical quality attributes\, and strengthen in vitro–in vivo linkages for complex generics. \nHe has contributed to multiple successful regulatory submissions by developing and justifying advanced in vitro methodologies in close collaboration with cross-functional technical and regulatory teams. His background includes extensive experience in solid-state and particle characterization using advanced analytical techniques such as SEM-EDS\, DSC\, DLS\, Raman microscopy\, MRI\, XPS\, and ToF-SIMS\, supporting reverse engineering and preformulation strategies. Tilen currently coordinates the preformulation–IVIVC platform and is actively engaged in collaborations with leading academic and research institutions. He holds a master’s degree in pharmacy from Faculty of Pharmacy\, University of Ljubljana and is completing his Ph.D. on advanced approaches for assessing drug release from hot-melt extruded amorphous solid dispersions\, with a focus on supersaturation behavior\, microstructure–dissolution relationships\, and their impact on drug absorption. \n\n \n \n \n \n \n James Jamieson\, B.Eng\, B.Comp.Sc.\n \n \n \n \nSenior Design Engineer\, Product Development\, Prior PLM Medical \nMr. James Jamieson is currently a Senior Design Engineer with Prior PLM Medical based in the Northwest of Ireland. His original qualifications were bachelor’s degrees in mechanical engineering and computer science and has spent the last 25 years developing new products for the automotive\, consumer appliance and medical device sectors. \nCurrently his main research focus has been developing CFD-DEM models (CFD coupled with Discrete Element Modelling of particles)\, that better reflect the reality of Dry Powder Inhaler device testing. This has led to the development of new test equipment to help better control air flow as seen by an Inhalation device under routine testing. \n\n \n \n \n \n \n Darby Kozak\, Ph.D.\n \n \n \n \nDeputy Director\, OGD\, CDER\, FDA \nDr. Darby Kozak is the Deputy Director for the Office of Generic Drugs (OGD) where he serves as a senior agency advisor in the development and implementation of FDA policies and long-range objectives for generic drug scientific programs and activities\, including the development of a strategic plan for the Generic Drug Program. Dr. Kozak started his FDA career in April 2015 in OGD’s Office and Research and Standards where he helped develop new analytical methods and equivalence evaluation methodologies for complex generic drug substances and parenteral\, ophthalmic\, otic\, and inhalation formulations. Prior to joining the FDA\, Dr. Kozak was Chief Scientist for Izon Science and Research Fellow at The University of Queensland’s Australian Institute for Bioengineering and Nanotechnology. Dr. Kozak has a B.Sc. in Chemical Engineering from the University of Washington (Seattle\, WA) and Ph.D. in Chemistry from the University of Bristol (United Kingdom). \n\n \n \n \n \n \n Mark Lepore\, M.D.\n \n \n \n \nChief Medical Officer\, Transpire Bio \nDr. Mark Lepore is the Chief Medical Officer of Transpire Bio\, where he leads Clinical Development\, Preclinical Development\, and Medical Affairs strategy for the company’s portfolio of inhaled novel investigational products targeting rare and serious lung diseases\, including idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases (ILDs)\, as well as the company’s inhaled bioequivalence programs. He oversees the advancement of the company’s pipeline from early preclinical research through late-stage clinical development\, including programs repurposing approved oral therapies for inhaled delivery as well as novel chemical entities. He earned his Doctor of Medicine (M.D.) from Jefferson Medical College at Thomas Jefferson University in Philadelphia\, followed by residency training in Pediatrics at The University of Maryland Medical System in Baltimore. He completed fellowship training in Allergy and Clinical Immunology at Children’s Hospital Medical Center in Cincinnati. Prior to joining Transpire Bio\, he held leadership roles at Aquestive Therapeutics\, Lupin\, and Teva\, where he was responsible for clinical development and medical affairs activities. He began his career as a practicing physician\, caring for patients with asthma and allergic diseases. His current focus is on addressing areas of significant unmet medical need by harnessing the advantages of inhalation drug delivery. \n\n \n \n \n \n \n Bing V. Li\, Ph.D.\n \n \n \n \nExpert Pharmacologist\, Associate Director for Science\, OB\, OGD\, CDER\, FDA          \nDr. Bing V. Li is the Associate Director for Science in the Office of Bioequivalence within the Office of Generic Drugs at the U.S. Food and Drug Administration (FDA). In this role\, she provides scientific leadership and expertise in the assessment of bioequivalence (BE) studies submitted through Abbreviated New Drug Applications (ANDAs) and oversees the scientific initiatives within the Office of Bioequivalence. Dr. Li is an Expert Pharmacologist at the FDA\, specializing in the bioequivalence of aerosolized drug products. Before joining the FDA in 2004\, Dr. Li was a Research Investigator at Bristol-Myers Squibb. She earned her Ph.D. in Pharmaceutical Sciences from the University of Wisconsin–Madison in 2001\, and her bachelor’s degree in Medicinal Chemistry from Peking University\, China\, in 1990. \n\n \n \n \n \n \n Markham C. Luke\, M.D.\, Ph.D.\, FAAD\n \n \n \n \nDirector\, DTP I\, ORS\, OGD\, CDER\, FDA  \nDr. Markham C. Luke serves as FDA Supervisory Physician (Dermatology) and Director of the Division of Therapeutic Performance 1 (DTP1) in the Office of Research and Standards\, Office of Generic Drugs at FDA. DTP1 is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Markham has an M.D. and a Ph.D. in Pharmacology from Johns Hopkins University and completed his dermatology residency and fellowship at Washington University\, St. Louis\, MO and the National Institutes of Health\, Bethesda\, MD. He is an Associate Professor at the Uniformed Services University of the Health Sciences\, Bethesda\, MD with research interests in dermatopharmacology\, clinical pharmacology\, clinical study design and endpoints assessment (including patient-reported outcomes) for medical\, surgical\, and aesthetic products.  Markham has been at FDA since 1998 serving various roles\, including as the Lead Medical Officer for dermatology drugs\, Chief Medical Officer and Deputy Director for the Office of Device Evaluation in the Center for Devices and Radiologic Health\, and as Acting Director for Cosmetics in the Center for Food Safety and Applied Nutrition. \n  \n\n \n \n \n \n \n Tian Ma\, Ph.D.\n \n \n \n \nLead Pharmacologist\, DB I\, OB\, OGD\, CDER\, FDA \nDr. Tian Ma is a Lead Pharmacologist within the Division of Bioequivalence I (DB I)\, Office of Bioequivalence (OB)\, Office of Generic Drugs (OGD). She has 12 years of experience in bioequivalence assessment of generic drug related submissions\, such as ANDA submissions\, pre-ANDA meetings\, controlled correspondences\, and bio-INDs\, including those for inhalation products\, Prior to joining the FDA\, Dr. Ma obtained her B.Sc. in Pharmacology from the University of Toronto\, and her Ph.D. in Pharmacology from Dartmouth College. \n\n \n \n \n \n \n Mridul Majumder\, Ph.D.\, FRSC\, FAPS\n \n \n \n \nFounder and Director\, M2M Pharmaceuticals Limited \nDr. Mridul Majumder is the founder and director of M2M Pharmaceuticals Ltd\, which is an award-winning Contract Research Organisation (CRO) specialising in material science\, advanced solid-state characterisation\, and pharmaceutical product development with a special emphasis on inhaled drug delivery. The company has received The King’s Award for Enterprise in International Trade in 2024 which is the highest accolade in the UK. Prior to M2M Pharma\, Dr. Majumder worked for a CRO and led its physical properties team which was eventually acquired by larger CDMO. \nWith over twenty-five years of experience in pharmaceutical R&D\, Dr. Majumder has developed a deep expertise in understanding inhaled APIs\, solid-state sciences\, amorphous materials\, and advanced analytical methodologies. These have significantly contributed to improving particle deposition in the deep lung for Dry Powder Inhaled (DPI) products. The work conducted by Dr. Majumder and the team he led for two decades has developed highly- sensitive analytical methods to quantify small level (<1%w/w) of amorphous content in crystalline bulk and overall solid-state properties. These have been submitted for regulatory approval to the FDA\, MHRA and the EMA. Dr. Majumder has also developed a “Green Chemistry” solution calorimetry method which is now commercially available as a service offering. The current research at M2M Pharma include state-of-the-art analytical techniques with orthogonal capabilities that include MDRS\, chemical imaging by Raman spectroscopy\, solution calorimetry\, gas perfusion microcalorimetry\, DVS\, iGC etc. \nAlongside business leadership\, Dr. Majumder remained committed to scientific advancement\, mentoring and education. He currently holds an Honorary Associate Professor position at UCL School of Pharmacy\, London. Dr. Majumder is a Fellow of Royal Society of Chemistry and Academy of Pharmaceutical Sciences in the UK. He is an internationally recognised speaker and has presented at RDD\, DDL\, AAPS\, APS\, CRS etc. Additionally\, he has published research in various publications in solid-state\, novel co-crystals in solid-state and their crystal structures. \n\n \n \n \n \n \n Bryan Newman\, Ph.D.\n \n \n \n \nLead Pharmacologist\, Team Lead\, Inhalation/Nasal Drug Products\, DTP I\, ORS\, OGD\, CDER\, FDA \nDr. Bryan Newman is a lead pharmacologist and team lead for inhalation and nasal drug products in the Division of Therapeutic Performance I (DTP I)\, Office of Research and Standards (ORS)\, within the Office of Generic Drugs (OGD). \nDr. Newman received his Bachelor of Science degree from Louisiana State University in Biochemistry and his Masters and Ph.D. degrees from the University of Michigan in Pharmaceutical Science. \nHis work focuses on developing product-specific guidances along with addressing controlled correspondences\, citizen petitions\, consults\, and pre-ANDA meeting requests. He also serves as a project officer and contracting officer’s representative for regulatory science research initiatives related to inhalation and nasal drug products. \n\n \n \n \n \n \n Mark Parry\, M.S.\n \n \n \n \nSenior Scientific Director\, Intertek \nMr. Mark Parry has worked with Intertek for over 24 years after graduating from Cambridge University and currently works as the Senior Scientific Director supporting the wide range of analytical\, formulation\, product development\, and research activities across the company. \nMark has worked in a range of pharmaceutical analysis and formulation development areas with a focus on inhaled and nasal drug products. Mostly working in the pre-approval stages\, Mark’s background includes extensive experience with product and formulation development\, as well as method development and validation\, IVBE studies\, and pharmaceutical development activities for a wide range of clients across the pharmaceutical industry. \nMark is one of DDL Scientific Advisors\, a member and chair of several EPAG and IPAC-RS working groups\, as well as the JPAG organising committee. Mark is also an elected member of the RSC Inclusion and Diversity Committee. He routinely presents at conferences as well as contributing to articles\, research papers\, and posters on a range of respiratory topics. \n\n \n \n \n \n \n David Pole\, Ph.D.\n \n \n \n \nSenior Director\, Respiratory Drug Product Development\, Respiratory R&D\, Sandwich\, UK\, Viatris \nDr. David Pole’s current role is Senior Director\, Respiratory Drug Product Development lead\, Viatris R&D\, with overall responsibility for pharmaceutical development strategies across the current Viatris R&D portfolio and experience gained from leading the development of Viatris’ approved generic DPI and MDI products. He has particular interest in the application of Quality by Design principles to product optimization for bioequivalence. \n\n \n \n \n \n \n James Polli\, Ph.D.\n \n \n \n \nRalph F. Shangraw/Noxell Endowed Professor\, Industrial Pharmacy and Pharmaceutics\, University of Maryland; co-Director\, CRCG \nDr. James Polli is Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption\, involving laboratory and clinical research. He has served as the advisor to 26 PhD graduates. He is co-Director of the Center for Research on Complex Generics (CRCG). He is Director of the online M.S. in Regulatory Science program. He is a fellow of the American Association for Pharmaceutical Scientists (AAPS) and served as an editor of Pharmaceutical Research for 12 years. He is the 14th recipient of the American Pharmacists Association Takeru Higuchi Research Prize. He was the recipient of the 2024 American Association of Colleges of Pharmacy Volwiler Research Achievement Award\, the 2022 AAPS Global Leadership Award\, and the 2021 TOPRA Education Award. He is a member of the University of Maryland General Clinical Research Center Advisory Committee and the University of Maryland institutional review board (IRB). \n\n \n \n \n \n \n Sam Raney\, Ph.D.\n \n \n \n \nAssociate Director for Science & Chief Scientific Advisor\, ORS\, OGD\, CDER\, FDA \nDr. Sam Raney is the Associate Director for Science and Chief Scientific Advisor in the FDA’s Office of Research and Standards and Office of Generic Drugs\, where he oversees the research portfolio of FDA’s generic drug research program. He has over 30 years of experience in pharmaceutical drug development\, specializing in topical and transdermal products\, and producing numerous research manuscripts\, review articles\, book chapters and patents. He has been a researcher and adjunct professor within academia\, was the longest serving Chair of the AAPS Topical and Transdermal Community\, has been a principal or sub investigator on over 400 pharmaceutical product studies\, has held senior management roles in industry\, serves on multiple expert committees and panels for the U.S. Pharmacopeia\, and is frequently invited to speak at scientific meetings around the world. Dr. Raney holds a Bachelor’s Degree in Molecular Biophysics & Biochemistry from Yale University\, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada. \n\n \n \n \n \n \n Irene Rossi\, Ph.D.\n \n \n \n \nRespiratory Science Expert\, Harro Höfliger \nAs Harro Höfliger’s Expert in Respiratory Science\, Dr. Irene Rossi supports the team and her clients on product development and respiratory drug delivery matters. She is also part of the INTO technical team together with experts from DFE Pharma and Sterling. \nIrene obtained a M.Sc. in 2014 and a Ph.D. in Drugs\, Biomolecules and Health Products at the University of Parma (Italy) in 2019. In the same year she joined Nanopharm\, An Aptar Pharma Company (UK) where she covered different roles. Most recently\, she was leading a group focused on the development and characterization of new formulation technologies for OINDP products comprising both small and large molecules. \nIrene has published her work in several original papers and filed 4 patent applications. She presented her work at more than 50 international conferences. \nShe also serves in the Drug Delivery to the Lungs Scientific Advisory Board and as co-chair of the ISAM Formulation Networking Group. \n\n \n \n \n \n \n Chirag Shah\, M.Pharm. \n \n \n \n \nDirector\, R&D\, Formulation Development\, Transpire Bio Inc. \nMr. Chirag Shah currently leads the formulation development activities for multiple generic Ellipta® franchise drug products at Transpire Bio Inc.\, where he is responsible for advancing complex inhalation programs from development through regulatory submission and approval. \nPrior to joining Transpire Bio\, Mr. Shah served as Director\, Research & Development at Apotex Inc. He has also held leadership positions of increasing responsibility at EmpowerPharm Inc.\, Alembic Research Centre\, Zydus Lifesciences Ltd.\, Jubilant Organosys Ltd.\, and Dr. Reddy’s Laboratories. \nWith more than 25 years of experience in the pharmaceutical industry\, Mr. Shah has developed extensive expertise in complex drug product development\, including a deep scientific understanding of in vitro bioequivalence methodologies and their integration with in vivo bioequivalence strategies to address evolving regulatory and legal requirements. Throughout his distinguished career\, he has successfully led the development and regulatory filing of more than 150 pharmaceutical products\, including numerous first-to-file and first-to-market opportunities. His broad experience encompasses complex generics\, 505(b)(2) products\, inhalation drug products\, and other challenging formulation platforms. \nMr. Shah holds a Master of Pharmacy (M.Pharm.) degree from L.M. College of Pharmacy and a Bachelor of Pharmacy (B.Pharm.) degree from K.B. Institute of Pharmaceutical Education and Research (K.B.I.P.E.R.)\, Gujarat University\, India. He is also an inventor on several patents and has authored numerous scientific publications in peer-reviewed journals and industry publications. \n\n \n \n \n \n \n Lucas W. S. Silva\, Molecular and Cellular Biology\, Bs.C.\n \n \n \n \nSenior Specialist\, Technical Specialist Manager\, Nanopharm\, An Aptar Pharma Company \nMr. Lucas Silva is a Molecular and Cellular Biologist by academic training from the University of Lisbon (NOVA) and currently is working as a Technical Specialist leading the Analytical and Formulation services at Nanopharm\, an Aptar Pharma company. \nPrior to his experience in Nanopharm\, Lucas did a research internship at University College London focused on the development of particle engineered Dry Powder Inhalers (DPIs) for pulmonary infections. \nWith over 10 years of immersion in the pharmaceutical industry\, Lucas has cultivated expertise spanning analytical services\, formulation technology\, and drug delivery devices\, predominantly within the realm of research and development\, particularly in orally inhaled and nasal drug products. \nHis key research areas are the development of more realistic respiratory and nasal analytical methods\, the application of specialized in vitro performance data to de-risk and accelerate drug product development. \nLucas has showcased his research findings at numerous international conferences through both poster presentations and podium talks. Additionally\, he has contributed as a co-author to a peer-reviewed paper centered on enhancing impactor testing for assessing the bioequivalence of DPIs. \nCurrently\, Lucas actively engages in discussions within the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS)\, contributing valuable insights to navigate the evolving landscape of inhaled and nasal drug products. \n\n \n \n \n \n \n Nuno M. N. Silva\, M.Pharm.\n \n \n \n \nAssociate Director Product Development\, Respiratory\, Nasal\, Semi Solids & Liquids (RNSSL) R&D\, Hikma Pharmaceuticals \nMr. Nuno Silva is Associate Director Product Development at Hikma Pharmaceuticals\, responsible for the scientific and strategic leadership of Hikma’s generic respiratory programs. Mr. Silva is a pharmaceutical industry program leader with over 20 years of product development experience focused primarily on inhalation drug-device combination products. Mr. Silva’s career in the industry has included positions at Hovione\, Novartis Pharma and Hikma. Mr. Silva has been working as project/program leader since 2013\, for small molecules and inhaled biologic products\, including application and approvals in EU and US. \nMr. Silva has represented his different companies at EPAG and IPAC-RS\, being currently Hikma’s board member at IPAC-RS.  Mr. Silva received a Degree in Pharmaceutical Sciences (pre-Bologna) from the University of Lisbon\, Portugal\, in 2006. \n\n \n \n \n \n \n Gur Jai Pal Singh\, Ph.D. \n \n \n \n \nChief Scientific Advisor\, BBSG Pharm Associates\, LLC \nDr. Gur Jai Pal Singh has served as Chief Scientific Advisor at BBSG\nPharm Associates since June 2023. He earned his Ph.D. from the University of\nBirmingham\, England\, and has built a distinguished career spanning regulatory science\,\npharmaceutical development\, and executive leadership in respiratory drug products.\nPrior to his current role\, Dr. Singh served as Senior Vice President and Head of a\npharmaceutical company’s Respiratory Center of Excellence\, where he provided end-toend\, hands-on leadership for the development of state-of-the-art inhalation drug\nproducts. His work included the strategic pursuit of innovative and scientifically sound\nalternatives to resource-intensive clinical endpoint studies for demonstrating the safety\nand efficacy of generic orally inhaled drug products. Under his leadership\, multiple\norally inhaled products were successfully developed and advanced for the United\nStates\, European Union\, and other global markets. \n\n \n \n \n \n \n Nick Smalley\, B.Sc.\n \n \n \n \nVice President of Regulatory Affairs\, Kindeva \nMr. Nick Smalley is Vice President of Regulatory Affairs at Kindeva\, a global Contract Development and Manufacturing Organization (CDMO) which specializes in the development and manufacturing of inhalation\, transdermal and injectable products.  He also serves as the Chair of the Board of Directors of the International Pharmaceutical Aerosol Consortium (IPAC)\, which advocates worldwide for proportionate environmental regulation of medical aerosols\, and is a Board Member of IPAC-RS\, an organization focused on ensuring that global regulations and guidance for orally inhaled and nasal drug products (OINDPs) meet the needs of the industry. \nGraduating in 1995 with a B.Sc. in Chemistry from the University of Loughborough\, Nick began his pharmaceutical industry career in 1996 working on formulation and analytical development for inhalation products firstly at Rhone Poulenc Rorer and then Ivax Pharmaceuticals\, before moving into Regulatory Affairs in 1999.  He has since held increasingly senior regulatory roles at Ivax\, Celltech\, UCB Pharma\, and Perrigo before joining 3M in 2019 shortly prior to the divestment of their Drug Delivery Systems business as Kindeva. \nIn addition to his Regulatory Affairs functional leadership role at Kindeva\, Nick is also heavily involved in much of Kindeva’s external advocacy activity on sustainability\, particularly with respect to the transition to next generation propellants for pMDI. \n\n \n \n \n \n \n Maria L Smith\, M.S.\n \n \n \n \nDirector of Applications and Business Development\, Proveris Laboratories \nMs. Maria L Smith is the Director of Applications and Business Development at Proveris Laboratories\, bringing over 20 years of expertise in the contract development and manufacturing of orally inhaled and nasal drug products. She is a recognized authority in spray characterization\, with a strong focus on method development and performance evaluation. \nThroughout her career\, Maria has collaborated with industry leaders and key opinion leaders on a wide range of nasal and oral spray devices. She has worked extensively with generic and innovator pharmaceutical companies\, device manufacturers\, CDMOs/CROs\, and regulatory agencies worldwide. \nHer deep technical knowledge has contributed to the successful submission of more than sixteen combination NDA/ANDA products. Maria has applied her knowledge and understanding across R&D and QC environments\, focusing on combining scientific and regulatory rigor with innovative characterization approaches to support robust product development and identify new pathways for addressing complex development challenges. She has co-authored 10+ publications on spray characterization and is well known across the industry. \n\n \n \n \n \n \n Marie Solcher\, Ph.D.\n \n \n \n \nTechnical Lead\, Pharmaceutical Development\, Sandoz \nDr. Marie Solcher is an inhalation drug product development specialist with combined industrial and academic expertise in respiratory drug delivery. As Technical Lead at Sandoz (Sandoz Development Center\, Aeropharm GmbH)\, she leads cross-functional teams and defines scientific strategies for the development of inhaled drug products\, ensuring alignment with regulatory and business objectives. Prior to her current role\, Marie worked as a Scientist\, leading development activities for orally inhaled drug products. She has broad experience in inhalation product development\, including formulation development and analytical characterization. \nMarie holds a Ph.D. in Pharmaceutics and Biopharmaceutics from Kiel University\, where she specialized in nasal and pulmonary drug delivery. Her academic work included international research collaborations at King’s College London\, the University of Copenhagen\, and the Woolcock Institute of Medical Research\, Sydney. She co-founded the DDL New Researcher Network and has presented her work at international conferences including DDL (Edinburgh) and the World Meeting on Pharmaceutics\, Biopharmaceutics and Pharmaceutical Technology (Granada). \n\n \n \n \n \n \n Stephen Stein\, M.S. Mechanical Engineering\n \n \n \n \nPresident\, CGT Pharma Consulting LLC \nMr. Stephen Stein is an expert in the development and characterization of orally inhaled drug products with 30 years of experience in the industry\, first with 3M Drug Delivery Systems\, then Kindeva and now as an independent consulting. He has been involved in the development and commercialization of numerous inhaler products – both innovator and generic products. \nHe has an extensive knowledge of the development of pMDI and DPI products and has experience with in vitro bioequivalence testing and the development of biologically relevant test methods. He has more than 20 granted US patents and numerous others granted worldwide and more than one hundred peer reviewed publications or conference presentations. He recently started CGT Pharma Consulting LLC to assist companies seeking to develop and commercialize inhaler products. \n\n \n \n \n \n \n Ryan Swart\, BS\n \n \n \n \nAssociate Director Research and Development\, Respiratory\, Nasal\, Semi Solids & Liquids (RNSSL) R&D\, Hikma Pharmaceuticals  \nMr. Ryan Swart is currently leading analytical development activities for Respiratory and Nasal products at Hikma Pharmaceuticals\, Columbus\, Ohio.  He has extensive experience in inhalation and nasal product development\, extractables and leachables and in vitro studies.  Mr. Swart was involved in the development and approval of the Hikma generic Fluticasone Propionate and Salmeterol Inhalation Powder.  Prior to joining Hikma\, Mr. Swart worked in product development for AAV based gene therapies and personal care and cosmetic products.  Mr. Swart has over 20 years of experience developing complex and combination drug products. \n\n \n \n \n \n \n James Tibbatts\, M.Eng.\n \n \n \n \nInhalation Product Development Specialist\, Sandoz \nMr. James Tibbatts is an inhalation product development specialist with over 20 years of industrial experience. In his current role\, he is responsible for the technical and scientific development strategy for Sandoz’ DPI pipeline. \nJames holds a master’s degree in engineering from the University of Cambridge\, where he specialized in fluid mechanics and thermodynamics. After leaving University\, James pursued a career in Computational Fluid Dynamics (CFD) and developed an expertise in the application of CFD to inhalation products\, particularly DPIs. In parallel to his CFD work\, James gained important industrial experience in all aspects of inhalation product development including device development\, API processing\, formulation development\, and analytical testing. Since 2012 James has led several generic MDI and DPI development programs from lab-scale through to clinical development. \nIn recent years James has spent considerable time working with a range of Sandoz experts on in-vitro methods for the new FDA bioequivalence frameworks including rAPSD\, dissolution\, and MDRS. \n\n \n \n \n \n \n Siva Vaithiyalingam\, Ph.D.\n \n \n \n \nSenior Vice President\, Regulatory Affairs\, Cipla Ltd. \nDr. Siva Vaithiyalingam currently serves as Senior Vice President /Head of US Regulatory Affairs at Cipla LTD.  His expertise includes pharmaceutical research\, product development\, complex generics and new drug reg. strategies\, regulatory Initiatives\, and regulatory Affairs. \nPreviously\, He served in organizations such as Teva Pharmaceuticals\, CDER\, Office of Generic Drugs at FDA and Barr Laboratories.  He graduated from School of Pharmacy\, Texas Tech University with a Ph.D. in Pharmaceutical Sciences and M.S. degree in Pharmaceutics from IIT\, BHU. \n\n \n \n \n \n \n Vivek Viswanathan\, Ph.D.\n \n \n \n \nSenior Manager\, R&D\, Rubicon Research Canada Limited \nDr. Vivek Viswanathan has worked in the area of pharmaceutical product development for more than 15 years & specializes in the area of orally inhaled & Nasal drug products (OINDPs). These include dry powder inhalers (DPIs)\, metered dose inhalers (MDIs) & nasal products. Vivek also has considerable experience around combination product development including regulatory documentation. In addition to working on novel & specialty products for delivery via nasal & inhalation route\, Vivek is also involved in development of complex generic products which require extensive BE studies. He has been involved in end-to-end combination product development from formulation development\, scale up\, technology transfer\, analytical development including niche techniques for demonstrating bioequivalence & design history file compilation. Additionally\, Vivek’s area of research also involves device development with special emphasis on user interface design\, verification studies & comparative studies. \nVivek holds a Ph.D. degree in Pharmaceutical Sciences from University of Mumbai (India). In his current position\, Vivek is heading Rubicon’s Canada R&D center based out of Concord\, ON in which he is responsible for OINDP product development. \n\n \n \n \n \n \n Ross Walenga\, Ph.D.\n \n \n \n \nSenior Chemical Engineer\, DQMM\, ORS\, OGD\, CDER\, FDA \nDr. Ross Walenga joined the FDA in 2015 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. He is currently a Senior Chemical Engineer and the Acting Team Lead for the Locally Acting PBPK Team in the Division of Quantitative Methods and Modeling within the Office of Generic Drugs. He began his career at Virginia Polytechnic Institute and State University (Virginia Tech)\, where he earned a Bachelor Science in Aerospace Engineering. He later earned his Ph.D. in Engineering (mechanical track) from Virginia Commonwealth University in 2014\, where he also spent seven months as a postdoctoral fellow prior to joining the FDA. His research interests include computational fluid dynamics (CFD) and physiologically based pharmacokinetic (PBPK) modeling of orally inhaled\, nasal\, ophthalmic\, topical\, and long-acting injectable drug products to answer questions pertaining to bioequivalence. \n\n \n \n \n \n \n Yan Wang\, Ph.D. \n \n \n \n \nDeputy Director\, DTP I\, ORS\, OGD\, CDER\, FDA \nDr. Yan Wang is the Deputy Division Director in the Division of Therapeutic Performance I (DTP-I)\, ORS\, OGD at the U.S. Food and Drug Administration. The division advances regulatory science to support generic drug development and establish standards for demonstrating therapeutic equivalence. \nSince joining FDA in 2013\, Dr. Wang has served in multiple scientific and leadership roles\, including as a subject matter expert in complex long-acting drug products and Team Lead for the Complex Drug Substance and Complex Formulation Team. Her work focuses on analytical methods\, in vitro characterization\, and drug release testing for complex drug products. \nHer expertise spans complex parenteral\, ophthalmic\, otic\, intravaginal\, and intrauterine products\, with an emphasis on linking formulation and manufacturing to product performance and bioequivalence. \n\n \n \n \n \n \n Brandon Wood\, B.Sc. \n \n \n \n \nSenior Director\, Regulatory Affairs\, Complex Gx\, Teva Pharmaceuticals USA\, Inc. \nMr. Brandon Wood is an accomplished regulatory affairs leader with 15+ years of experience in the pharmaceutical industry\, specializing in complex generic drug development. As Senior Director of Regulatory Affairs at Teva Pharmaceuticals USA\, Inc.\, he leads regulatory strategy\, submissions\, and lifecycle management for complex generics spanning complex APIs\, long acting injectables\, respiratory therapies\, combination products\, and non sterile complex products. Brandon has played a pivotal role in advancing and securing approvals for complex generic submissions\, including GLP 1–based therapies\, navigating scientific\, CMC\, and regulatory challenges to enable first to market or highly differentiated generic outcomes. Since joining Teva in 2018\, he has driven regulatory strategies for some of the company’s most technically demanding programs\, building on prior experience in regulatory affairs\, quality assurance\, and R&D at CorePharma and Impax Laboratories\, and an early technical foundation as a chemist at West Ward Pharmaceuticals. He holds a B.S. in Chemistry with a concentration in Organic Chemistry from Monmouth University. \n\n \n \n \n \n \n Zhen Xu\, Ph.D.\n \n \n \n \nSenior Staff Fellow\, DB III\, OB\, OGD\, CDER\, FDA \nDr. Zhen Xu currently serves as a Senior Pharmacologist in the Office of Bioequivalence in FDA. In his role\, he reviews abbreviated new drug applications\, study protocols\, control correspondences\, and other regulatory submission for generic drug products. He also serves as a subject matter expert on orally inhaled and nasal drug products in the Office of Bioequivalence. \nDr. Xu earned his Ph.D. in Pharmaceutical Sciences from Eshelman School of Pharmacy\, University of North Carolina\, focusing on dry powder inhalers. He also received his M.S. degree in Chemistry at Michigan State University\, exploring the structural richness of carbohydrates for chiral synthesis. Prior to joining the FDA\, he had extensive experience in both academia and industry across a variety of aerosol drug delivery systems at different stages of development. \n\n \n \n \n \n \n Yang Yang\, Ph.D.\n \n \n \n \nResearch Staff Fellow\, DPQR V\, OPQR\, OPQ\, CDER\, FDA \nDr. Yang Yang is a Research Staff Fellow in the Office of Pharmaceutical Quality Research at the U.S. Food and Drug Administration (FDA). She earned her bachelor’s degree in Biopharmaceutical Sciences and master’s degree in Molecular Pharmacology from Peking University\, China\, followed by a Ph.D. in Biopharmaceutical Sciences from the University of Illinois Chicago. Her doctoral research focused on the development of polymeric nanoparticles for drug delivery. \nDr. Yang’s research focuses on advancing regulatory science through the development and implementation of in vitro methods to evaluate the quality and absorption of complex drug products\, including nasal\, orally inhaled\, and dermal drug products. Her work also encompasses the manufacturing of complex drug products and directly supports the development of FDA Product-Specific Guidances\, helping to advance safe and effective drug formulation and regulatory decision-making. \n\n \n \n \n \n \n Xian-Ming Zeng\, Ph.D.\n \n \n \n \nCEO\, Transpire Bio Inc. \nDr. Xian-Ming Zeng is CEO and founder of Transpire Bio Inc.\, where he leads the development and manufacturing of inhaled medicines designed to improve patient access and address unmet medical needs. He holds a Ph.D. in Pharmaceutical Sciences\, with a focus on inhalation drug delivery\, from King’s College London. His career spans more than 30 years across academic research and global pharmaceutical R&D leadership in the US and UK. Dr. Zeng previously served as a Maplethorpe Fellow and Visiting Professor at King’s College London\, and as Professor of Pharmaceutics and Director of Research at the Medway School of Pharmacy\, University of Kent. He also established Teva’s Respiratory R&D center in Miami and Lupin’s Inhalation Research Center in Coral Springs. He has co-authored three textbooks and more than 50 peer-reviewed publications\, is named on more than 20 patents and patent applications\, and has led the successful development of multiple generic and branded inhalation products. He is a frequent invited speaker at national and international conferences and currently serves as a board advisor for BioFlorida. \n\n \n \n\n\n\n\n\n \n \n \n Location\n \n \n \n The workshop will be held at the Universities at Shady Grove (USG). \nAddress: Building II\, Ballroom (please follow signs)\, 9630 Gudelsky Drive\, Rockville\, MD 20850 \n\n \n \n \n \n \n Directions and Transportation\n \n \n \n \nTravel from local airports to Rockville\, MD. (The Universities at Shady Grove (USG)) will require an Uber or Lyft\, which is by far the best way to obtain car service.\nAs there is road traffic in the region\, the fastest way to the Shady Grove campus is the DCA airport\, then taking the Metro subway from the airport to Shady Grove\, then taking Uber or Lyft. Alternatively\, fly into any WAS airport and take Uber or Lyft. If flying into BWI airport\, we suggest taking Uber or Lyft to USG.\nThe Metro subway serves DCA and IAD airports\, which connects with the Shady Grove stop on the red line. If flying into IAD\, taking the Metro will save some cost\, but will probably take extra time\, even if traffic is heavy.\n\nMore links and information: \n\nDirections and transportation options to USG\nPublic transportation\nCampus map\n\n\n \n \n \n \n \n Parking\n \n \n \n \nThe Traville-Gateway Garage is the closest parking garage to the venue (parking map). Attendees may also park in Lot 2 and Shady Grove Garage but will need to allow more walking time to reach the event.\nVisitor Parking: Levels 2-6 of Traville Gateway Garage. PLEASE NOTE: The ground floor of Traville Gateway Garage requires a USG employee permit at all times.\nGuests are responsible for the cost of parking; parking will not be validated. Parking is $16 for all day.\n\nClick for parking information from the USG website. \n\n \n \n \n \n \n Airports\n \n \n \n Please click on the following “all transportation options” links to find transportation from the airport via subway\, bus\, taxi\, car\, and town car. \n\nReagan National Airport (DCA): 21.1 miles from Rockville\, MD (all transportation options from DCA) (train options from DCA)\nDulles International Airport (IAD): 27.8 miles from Rockville\, MD (all transportation options from IAD) (train options from IAD)\nBaltimore/Washington International Thurgood Marshall Airport (BWI): 37.5 miles from Rockville\, MD (all transportation options from BWI) (train options from BWI)\n\n\n \n \n \n \n \n Train\n \n \n \n \nTrain tickets (Omio)\nWashington\, DC to Baltimore: Approximately 35 minutes\nPenn Station Marc SB (Baltimore): Approximately 41 miles from campus\n\n\n \n \n \n \n \n Taxi and Car Service\n \n \n \n Empire Sedan & Limo Services (empiresedan12@gmail.com):  240-988-1796 \nWashington Flyer Taxi:  703-572-TAXI or 706-853-6094\n(Syed Z Shah\, Cab #381\, 571-243-0020\, can book ride\, requires one day notice) \nRegency Taxi:  301-984-1900 \nBob’s Limo Service (Email): 301-525-2525 \nB&B Executive Sedan (Email): 240-533-6262 \nEast Coast Limousine (Email): 301-527-0413 or 240-793-8196 \n  \n\n \n \n \n \n \n Uber\n \n \n \n Uber: Baltimore\, BWI Airport\, Washington\, DC\, Dulles (IAD) Airport \nIf using Uber\, plese see the Uber Map for the designated spot for drop off and pick up for the workshop.  Do not request to be picked up/dropped off at the Traville-Gateway parking garage. \nAddress for Uber:\nUniversiites at Shady Grove\nLot 5\n9631 Gudelsky Drive\nRockville\, MD 20850 \n\n \n \n \n \n \n Hotels/Lodging\n \n \n \n Guests should mention they are attending a conference at Universities of Shady Grove; most hotels offer discounts. \nThere are many hotels within a short driving distance to the USG campus including: \n\nHilton Garden Inn Rockville-Gaithersburg (Book your room (CRCG rate) by Sept. 22\, 2026)\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1800\nHomewood Suites by Hilton Rockville-Gaithersburg\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1900\nCourtyard by Marriott Rockville\n2500 Research Boulevard\, Rockville\, MD 20850 (0.9 miles from USG)\n301-670-6700\nSleep Inn Rockville\n2 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-507-8000\nThe Rockville Hotel\, a Ramada by Wyndham\n3 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-202-1098\nSpring Hill Suites by Marriott Gaithersburg\n9715 Washingtonian Blvd\, Gaithersburg\, MD 20878 (1.4 miles from USG)\n301-987-0900\nSheraton Rockville Hotel\n920 King Farm Blvd\, Rockville\, MD 20850 (1.4 miles from USG)\n240-912-8200\nCourtyard by Marriott Gaithersburg Washingtonian Center\n204 Boardwalk Place\, Gaithersburg\, MD 20878 (1.6 miles from USG)\n301-527-9000\nComfort Inn Shady Grove-Gaithersburg-Rockville\n16216 Frederick Rd.\, Gaithersburg\, MD 20877 (2.2 miles from USG)\n301-330-0023\nEVEN by IHG Hotel Rockville\n1775 Rockville Pike\, Rockville\, MD 20852 (5.5 miles from USG)\n855-879-3836\n\n\n \n \n\n\n\n\n \n For the October 14-15 workshop\, you will need to pre-order your lunch for each day; lunch is not provided.  Lunch will be delivered to the main building where the workshop will be held (Building II\, Ballroom) and labeled with your name.  You will pick up your ordered food at the registration desk\, each day. \n(Note:  please disregard the confirmation message that states food will be available for pick up the next day; all food will be delivered to the Ballroom for each day of the workshop) \nYou can go to Dawson’s Market as well\, located in Building III\, first floor.  Hours are 9 AM-5 PM ET.  The cafe has additional food and beverage options there.  You are welcome to bring your lunch\, as well. \nLink for Wednesday\, October 14: https://square.link/u/w8Htc9eV \nLink for Thursday\, October 15: https://square.link/u/ciatk7ft \nMake your selection and Add to Order.  Once you have made your selection\, you will then click on the shopping cart icon to check out.  If you want to purchase more than one meal for the same day\, you will need to place two separate orders.  You will Continue to Payment\, where you can pay with Google Pay\, Credit Card\, or Cash App Pay.  Then hit Place Order. \nDuring checkout\, there is a spot for Note to Seller\, to use when placing your order\, if needed for modifications to your order. \nThe deadline for ordering lunch is Monday\, October 5th by 5 PM ET. \nCoffee\, hot tea\, water\, and soft drinks will be available throughout each day in the conference room (Ballroom).  \nFood will be provided in the morning\, and AM and PM breaks each day. \nUSG Lunch (Dawson’s Market) \nChicken Caesar Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nTurkey & Swiss Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nTuna Salad Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nGrilled Vegetables & Hummus Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nEggless Egg Salad Wrap (VEGAN) $14.99 Includes chips\, cookie\, and choice of beverage \nYou will have the option to remove tomatoes and/or cheese\, if needed \nGreek Salad $14.99 Includes romaine lettuce\, tomatoes\, onion\, kalamata olives\, bell peppers\, feta cheese\, pepperoncini peppers served with Dijon vinaigrette. Includes chips\, cookie\, and choice of beverage \nGrilled Salmon Caesar Salad $15.99 Includes chopped romaine\, house made croutons\, shredded parmesan & Caesar dressing. Includes chips\, cookie\, and choice of beverage \nGoat & Greens $14.99 Includes spinach\, cranberries\, pecans\, tomatoes\, goat cheese served with balsamic vinaigrette. Includes chips\, cookie\, and choice of beverage \nHot Items \nTomato Bisque Soup  $6.99 \nTaco Bowl  $15.99 Your choice of [fajita chicken\, ground beef\, or vegetables] on a bed of rice with mixed greens\, fajita vegetables\, black beans\, shredded cheese\, and toppings on the side (guacamole\, sour cream\, and salsa) \nBeverage Choice \nCoke \nDiet Coke \nSprite \nWater \nJust Tea-Mango White (additional $1.00) \nJust Tea-Original Green (additional $1.00) \nJust Tea-Half & Half (additional $1.00) \nDr. Browns-Cream \nDr. Browns-Black Cherry \nDr. Browns-Root Beer \nOlipop-Grape (additional $1.50) \nOlipop-Ginger Lemon (additional $1.50) \nOlipop-Cherry Cola (additional $1.50) URL:https://www.complexgenerics.org/education-training/advancing-bioequivalence-frameworks-for-inhalation-drug-products-optimizing-in-vitro-in-vivo-and-in-silico-methods/ ATTACH;FMTTYPE=image/png:https://www.complexgenerics.org/wp-content/uploads/2026/06/Oct-Pic5-updated-2.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20261201T080000 DTEND;TZID=UTC:20261202T174500 DTSTAMP:20260911T155529Z CREATED:20250918T220039Z LAST-MODIFIED:20260911T155529Z UID:38351-1796112000-1796233500@www.complexgenerics.org SUMMARY:Long-Acting Injectable (LAI) Generics: Advancing Innovation in Product Development and Regulatory Assessment DESCRIPTION:Remove \n\n\n \n \n \n \n \n Long-Acting Injectable (LAI) Generics: Advancing Innovation in Product Development and Regulatory Assessment\n \n \n HomeEducation and Training\n \n \n \n \n \n Explore This Section\n \n \n Upcoming Events\n \n \n Event Summary\n \n \n \n \n\n\n\n\n\n\n\n\n\n\nCo-hosts: FDA and the Center for Research on Complex Generics (CRCG) \n\n\n\nIn person (at The Universities at Shady Grove; Rockville\, MD) and virtual workshop. \n\n\n\n \n \n \n \n \n Registration Now Open\n \n \n \n \n \n \n \n Register here \n \n \n \n \n \n \n\n\n\nAboutEvent OutlineSpeaker BiosTravel & AccommodationsOrdering Lunch\n \n The development and regulatory assessment of long-acting injectable (LAI) generic products present some of the most technically demanding challenges in the generic drug space. From complex excipient characterization and reverse engineering to in vitro release testing (IVRT) and pharmacokinetic (PK) study design\, LAI generics require a sophisticated\, multi-disciplinary approach that spans formulation science\, analytical chemistry\, modeling\, and regulatory strategy. The purpose of this two-day workshop is to facilitate an in-depth examination of current challenges and emerging solutions relating to LAI product development and regulatory assessment. \nAttendees will gain valuable insights into the intricacies of developing generic LAI products across a range of dosage forms\, including drug substance suspensions\, polymeric microspheres\, implants\, in situ forming depots\, etc. The 2-day workshop will explore the connections between drug release mechanisms\, relevant in vitro methodologies\, and predictive modeling approaches\, with a focus on defining their current utility in specific regulatory contexts. Sessions will discuss common deficiencies identified during ANDA assessment of LAI products\, alternative bioequivalence study designs\, and model-integrated evidence approaches that enable more efficient and feasible bioequivalence assessment. \nIn addition to expert-led presentations and panel discussions\, in-person attendees will have the opportunity to engage directly with experts from industry\, academia and regulatory agencies through the open exchange and small group working sessions. These sessions are designed to deepen participants’ understanding of current practices and challenges\, regulatory expectations\, and emerging trends in the field. \nChoose your experience: \nVIRTUAL ATTENDANCE: \nAll attendees will enjoy a series of expert-led presentations and panel discussions that provide valuable insights into critical aspects of LAI product development including formulation\, excipient characterization\, and manufacturing considerations; drug release mechanisms and the role of IVRT studies to support a demonstration of bioequivalence; novel in vivo pharmacokinetics study designs; and the use of model-integrated evidence. Virtual attendees will be able to: \n\nAttend all presentations and panel discussions\nParticipate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists\nEnjoy free access to workshop recordings of presentations and panel discussions (not including the in-person-only sessions)\n\nIN-PERSON ATTENDANCE: \nIn-person attendees will enjoy all the benefits of virtual attendance and\, additionally\, interact directly with experts from FDA\, academia\, industry\, consulting groups\, and others to deepen their understanding of current practices and challenges\, regulatory expectations\, and emerging trends. These high-engagement scientific interactions will be facilitated through two in-person-only sessions: \n\nA session dedicated to interactive discussions and candid dialogue with FDA\, Industry\, Academic\, and other subject matter experts about scientific and regulatory challenges for complex LAI products.\nA guided session for small groups of in-person attendees including real-world case studies and consensus mapping to identify priorities and actionable outcomes by working through challenging issues for LAI formulation and excipient characterization\, IVRT method development\, alternative BE approaches\, and model-integrated evidence strategies.\n\nWorkshop Topics\n\nFormulation\, excipient characterization and manufacturing considerations\nMechanistic understanding of drug release mechanisms and in vitro drug release testing\nAlternative bioequivalence approaches and alternative pharmacokinetics study design\nModel-integrated evidence approaches\n\nAudience\nThis workshop is designed for professionals involved in the development\, manufacturing\, and regulation of generic products. The target audience includes pharmaceutical scientists (formulation and product development scientists\, analytical chemists\, quality assurance and control experts)\, regulatory affairs professionals\, clinical development professionals\, and manufacturing experts. Additionally\, the workshop will be valuable for academic researchers in pharmaceutical sciences\, representatives from contract research organizations (CROs) and contract manufacturing organizations (CMOs)\, regulatory agency staff\, and healthcare professionals interested in generic complex drug products. The content is tailored to accommodate participants with varying levels of expertise in LAI products\, from those seeking to understand the fundamentals to advanced practitioners looking to stay abreast of the latest regulatory considerations and development strategies. \n\nVirtual Attendance is ideal for those who wish to access expert presentations and panel discussions remotely\, eliminate travel requirements\, and have the flexibility to engage with content in real time or on demand.\nIn-Person Attendance is best for participants seeking high-level engagement through collaborative small group working sessions\, direct interaction with experts from industry\, academia and FDA\, and immersive learning focused on real-world challenges and problem-solving.\n\nRegistration Fees: \n\nThis workshop is FREE for virtual attendees.\nThe combined cost for the two-day workshop in-person attendance and activities is:\n\n$350\, in-person attendees – general\n$150\, in-person attendees – government (must have an email ending in “.gov” to register at this rate)\n\n\n\nFor faculty and students from the University of Maryland\, Baltimore\, The Universities at Shady Grove\, and University of Michigan\, please contact CRCG (info@complexgenerics.org) regarding registration. \nContinuing education (CE) credits will not be provided for attending this workshop.  A certificate of attendance will only be provided to individuals attending in-person\, when requested. \nFor in-person attendees\, beverages and food for breaks will be provided; Lunch will not be provided. Please visit the CRCG website regarding pre-ordering lunch instructions. Links will be provided once they are available. Orders must be placed by November 16 (5 PM ET). Also there is an onsite cafe for purchasing food or you are welcome to bring your own lunch. \n\n\n\n\n\n\n\n\n \n Introduction to the Workshop \nThis two-day workshop will address the most pressing scientific and regulatory challenges in the development and assessment of long-acting injectable (LAI) generic products. The program will explore the technical hurdles associated with LAI formulation development\, including complex excipient characterization\, reverse engineering\, and manufacturing considerations that influence product performance and batch consistency. Sessions will cover drug release mechanisms across diverse LAI platforms and the development of discriminatory in vitro release testing (IVRT) methods. \nThe workshop will also address alternative bioequivalence strategies and innovative pharmacokinetic (PK) study designs that reduce the burden of traditional BE studies while maintaining scientific rigor. Model-integrated evidence (MIE) approaches\, including population PK modeling and mechanistic physiologically-based pharmacokinetic (PBPK) modeling\, will be discussed as tools to accelerate generic LAI development and support regulatory submissions. Common deficiencies identified during ANDA assessment for LAI products will be highlighted\, with an emphasis on best practices and actionable solutions. \nSessions will feature expert presentations\, case studies\, and interactive panel discussions. In-person attendees will have an additional opportunity to participate in the open exchange and small-group working sessions focused on real-world challenges\, best practices\, and actionable solutions\, offering direct engagement with regulators and thought leaders from industry and academia. \nDAY 1\nSession 1: Critical Aspects of LAI Development: Formulation\, Excipient Characterization\, and Manufacturing Considerations \nFormat: Presentations and Panel Discussion (Virtual and In-Person Attendees) \n\nThis session will explore the scientific and technical challenges in developing LAI products\, with an emphasis on establishing formulation sameness from characterizing complex excipients and reverse engineering. Presenters will highlight analytical challenges in excipient identification and quantitation\, critical formulation properties affecting drug release\, and manufacturing consideration influencing performance and batch consistency. Industry and FDA speakers will provide insight into regulatory experiences\, common ANDA deficiencies\, and best practices to aid in facilitating successful product development and approval.\n\nSession 2: Drug Release Mechanism Understanding of LAI products: From IVRT to Totality of Evidence Approach. \nFormat: Presentations and Panel Discussion (Virtual and In-Person Attendees) \n\nThis session will focus on the mechanistic understanding of drug release from LAI products and the development of appropriate IVRT methods to support BE assessments. Presenters will discuss the scientific principles underlying drug release from various LAI platforms\, from crystalline suspensions\, polymeric microspheres\, in situ forming depots\, to non-biodegradable matrix systems\, and the challenges in developing IVRT methods designed to be discriminatory and reflective of in vivo performance. The session will also address the totality of evidence approach for establishing BE of complex LAI products\, integrating understanding of formulation characterization\, IVRT data\, and potential in vitro-in vivo correlations (IVIVC) to support regulatory submissions and reduce reliance on clinical endpoint studies.\n\nSession 3: Small Group Working Sessions \nFormat: Interactive Working Session (In-Person Attendees Only) \n\nIn this collaborative session\, participants will join small-group discussion tables facilitated by FDA\, industry\, and academic experts. In-Person Attendees will engage in discussions related to the challenges and opportunities presented in Day 1 sessions\, including formulation characterization\, excipient quality\, IVRT method development\, and drug release mechanisms. Attendees will engage in guided discussions\, consensus mapping\, and reporting of actionable research or policy recommendations.\n\nDAY 2\nSession 4: Alternative Bioequivalence Approaches and Alternative Pharmacokinetic Study Designs for LAI Products \nFormat: Presentations and Panel Discussion (Virtual and In-Person Attendees) \n\nThis session will focus on alternative BE strategies and innovative PK study designs for LAI products. Presenters will discuss the practical challenges of conducting traditional PK BE studies\, including extended study durations and large sample size requirements\, and will explore alternative approaches that reduce these burdens while maintaining scientific rigor. The session will also address in vitro BE approaches that may support waiving PK BE studies and the totality of evidence framework for integrating in vitro and in vivo data to support regulatory submissions.\n\nSession 5: Small Group Working Sessions \nFormat: Interactive Working Session (In-Person Attendees Only) \n\nIn this collaborative session\, participants will join small-group discussion tables facilitated by FDA\, industry\, and academic experts. In-Person Attendees will engage in discussions related to the challenges and opportunities presented in Day 2 sessions\, including alternative BE approach\, innovative PK study design\, and model-integrated evidence approach. Attendees will engage in guided discussions\, consensus mapping\, and reporting of actionable research or policy recommendations.\n\nSession 6: Open Exchange \nFormat: Interactive Discussions on Focused Product Development and Assessment Areas (In-Person Attendees Only) \n\nThis session is dedicated to interactive discussion and candid dialogue with FDA\, Industry\, Academic\, and other subject matter experts about scientific and regulatory challenges for complex LAI generic products.\n\nSession 7: Accelerating LAI Generic Development Using Model-Integrated Evidence \nFormat: Presentations and Panel Discussion (Virtual and In-Person Attendees) \n\nThis session will focus on the application of model-integrated evidence (MIE) approaches to accelerate generic development of LAI products. Presenters will discuss how industry is leveraging modeling approaches\, including population PK and mechanistic PBPK models and release kinetics modeling\, to streamline LAI generic development programs. Regulatory expectations for MIE submissions will be addressed\, along with successful case examples demonstrating acceptable approaches for incorporating modeling data into regulatory packages.\n\n  \n\n\n\n\n\n\n \n \n \n Tausif Ahmed\, Ph.D.\n \n \n \n   \n \nSenior Vice President & Head\, Department of Clinical Research and Biopharmaceutics\, Mankind Research Centre \nDr. Tausif Ahmed is currently working as Sr. Vice President & Head-Clinical Research & Biopharmaceutics Department at Mankind Pharma Limited\, Delhi\, India. He is responsible for managing all Bioequivalence studies\, preclinical Tox and Phase III clinical trials supporting domestic and global complex generic products across all dosage forms at Mankind. Prior to joining Mankind\, Dr. Tausif worked as Sr. VP Bioequivalence and CT at Aizant Drug Research solution Pvt.\, Ltd. Hyderabad\, India.  In past he has worked as Vice President & Head-Biopharmaceutics & Bioequivalence in the Global Clinical Management group\, IPDO at Dr. Reddy’s Laboratories Limited (DRL)\, Hyderabad. He was responsible for managing all Bioequivalence studies supporting global complex generic products at DRL. He was also involved in PK/Modelling and Simulation activities supporting global generic development. Prior to joining DRL\, he was Associate Director and Head-DMPK (preclinical discovery\, Clinical dev.\, and Generic) & Dy. Test Facility Mgt. GLP toxicology dept. at Piramal Enterprises Limited\, Mumbai. Dr. Ahmed has been associated with different pharmaceutical companies such as Dr. Reddy’s Research Foundation (DRF)\, Ranbaxy Research Laboratories\, Sai Life Sciences Limited\, and Piramal Enterprises Limited in the past. He obtained M.S. in Pharmaceutics from NIPER and Ph.D. in Pharmaceutical Medicine (specialization: Biopharmaceutics and PK/PD) from Hamdard University (Ranbaxy\, now Sun Pharma Sponsored). He has been working in the field of drug discovery\, development\, phase I/II\, and generic BA-BE studies for more than 23 years. His area of specialization includes DMPK\, metabolite-ID\, population PK\, PK-PD modelling\, and simulation\, generic BA/BE studies and GLP bioanalysis. In recent years his focus is on use PBBM/PBPK modelling in generic drug development. He has extensive experience in outsourcing preclinical and clinical studies to CROs both in and outside of India. Dr. Ahmed has contributed to >15 IND filings\, multiple ANDAs\, and Phase I/II/III regulatory submissions\, nationally and globally. He has co-authored two book chapters and over 50 papers and presentations. He is a reviewer for many international journals and is on the Editorial board of Int. J. Pharma Research. Dr. Ahmed is a guest faculty at Hamdard University\, NMIMS (Mumbai)\, NIPER\, and various other universities in India. He has also supervised many Master’s and Ph.D. students.   \n\n \n \n \n \n \n Andrew Babiskin\, Ph.D.\n \n \n \n \nDeputy Division Director\, DQMM\, ORS\, OGD\, CDER\, FDA \nDr. Andrew Babiskin is the Deputy Division Director of the Division of Quantitative Methods and Modeling (DQMM)\, Office of Research and Standards (ORS)\, Office of Generic Drugs\, CDER. He previously led the Locally-acting Physiologically Based Pharmacokinetic Modeling Team and the Quantitative Clinical Pharmacology Team in DQMM. Dr. Babiskin’s expertise lies in modernization of bioequivalence evaluation practices through model-integrated evidence. Dr. Babiskin received his B.S. degree from the University of Maryland (College Park) in Chemical Engineering and his M.S. and Ph.D. degrees from the California Institute of Technology in Chemical Engineering. He joined the FDA in 2012 as an ORISE postdoctoral fellow in the OGD Science Staff (now ORS) and became an employee within DQMM in 2014. \n\n \n \n \n \n \n Diane J. Burgess\, Ph.D. \n \n \n \n \nDistinguished Professor of Pharmaceutics\, Pfizer Distinguished Endowed Chair in Pharmaceutical Technology\, University of Connecticut \nB.Sc. Pharmacy\, University of Strathclyde (1979) and Ph.D. Pharmaceutics\, University of London (1984). Fellow of AAPS\, CRS\, APSTJ\, AIMBE and the National Academy of Inventors. 2010 CRS President; 2002 AAPS President. Editor of International Journal of Pharmaceutics (2009 – 2018). Editorial board member of 14 international journals. Recipient of: 2026 AAPS Distinguished Scientist Pharmaceutical Award; 2024 NIPTE David J. W. Grant Distinguished Scholar in Basic Pharmaceutics; 2023 AAPS Alice E. Till Advancement of Women in Pharmaceutical Sciences Recognition; 2023 University of Connecticut AAUP Edward C. Marth Mentorship Award; 2018 AAPS Wurster Award in Pharmaceutics; 2014 AAPS Research Achievement Award; 2014 AAPS Outstanding Educator Award; 2014 CRS Distinguished Service Award; 2013 AAPS IPEC Ralph Shangraw Award; 2010 CRSI Fellowship\, 2011 APSTJ Nagai International Woman Scientist Award. Over 324 refereed publications\, over 790 research presentations\, over 365 invited presentations\, 34 keynote and plenary addresses. Major advisor to 51 Ph.D.\, 4 M.S. 23 postdoctoral and 240 undergraduate students. \nFounder\, DIANT Pharma (2019). DIANT Pharma (https://diantpharma.com) develops proprietary continuous manufacturing technology for nanoparticles with a wide array of applications throughout multiple industries\, such as lipid nanoparticles and liposomes for pharmaceutical formulations. \nInventor on 17 patents/patent applications\, thirteen of which have been licensed to companies\, and 12 products/product lines have been commercialized. \nResearch is focused on complex parenterals and ranges from fundamental to applied science of high significance to the industry and regulatory authorities. Scholarship exemplifies the translation of cutting-edge science to public health impact. Contributions are not only widely cited academically but also operationalized in product development and regulatory review. Research work has directly and indirectly resulted in new drug products\, pharmaceutical devices and advanced manufacturing technology. \n\n \n \n \n \n \n Andrew Clark\, Ph.D.\n \n \n \n \nSenior Director\, Research and Strategy\, digiM Solution LLC \nDr. Andrew Clark is the Senior Director of Research and Strategy at digiM Solution\, where he leads the team of application scientists in structural characterization of pharmaceutical products across the development pipeline. Dr. Clark has been extensively involved in the characterization of long acting and complex systems where he has championed the implementation and design of imaging-based characterization methods. He has pioneered the utilization of advanced synchrotron-based characterization methods as well as designed improved experimental methodologies for true density characterization of microscopic systems. His and his team’s focus on research and development of tools focused on microstructural understanding and their correlation to performance and manufacturing of pharmaceutical products seeks to broaden community knowledge and reduce the burden on product development time. Prior to joining digiM he earned his Ph.D. in Physics at Tufts University focusing on solid-state material characterization of novel polymer systems\, and their relationship to the thermodynamic description of amorphous systems. \n\n \n \n \n \n \n Lanyan (Lucy) Fang\, Ph.D.\n \n \n \n \nDirector\, DQMM\, ORS\, OGD\, CDER\, FDA \nDr. Lanyan (Lucy) Fang serves as Director of the Division of Quantitative Methods and Modeling (DQMM) within the Office of Research and Standards\, Office of Generic Drugs (OGD)\, CDER/FDA. In this capacity\, she oversees quantitative medicine and leads the development of artificial intelligence strategies for FDA’s generic drug program.  Dr. Fang has established herself as a recognized FDA expert in applying modeling and simulation methodologies to the review and regulation of generic drugs. She serves on the executive board of CDER’s Quantitative Medicine Center of Excellence\, contributing to the advancement of quantitative approaches across the center’s regulatory activities. \nPrior to her current role at OGD\, Dr. Fang worked as a senior clinical pharmacology reviewer in FDA’s Office of Clinical Pharmacology and as a senior pharmacokinetist at Merck. She holds a PhD in Pharmaceutical Sciences from The Ohio State University and is a graduate of the Excellence in Government Fellows program (2014-2015). \n\n \n \n \n \n \n Yuqing Gong\, Ph.D.\n \n \n \n \nLead Pharmacologist\, DQMM\, ORS\, OGD\, CDER\, FDA \nDr. Yuqing Gong is currently the Team Lead at the Quantitative Clinical Pharmacology Team in the Division of Quantitative Methods and Modeling (DQMM)\, Office of Research and Standards (ORS)\, Office of Generic Drugs (OGD)\, Center for Drug Evaluation and Research (CDER)/FDA. She has led critical research priorities utilizing quantitative clinical pharmacology approaches and model-integrated evidence (MIE) to develop innovative study designs and methods supporting bioequivalence (BE) demonstrations for generics with complex in vivo study considerations. Dr. Gong received her Ph.D. degree in Pharmaceutical Sciences at the University of Tennessee Health Science Center (Memphis\, TN\, US) in 2020. Her Ph.D. thesis work was to develop a nanoformulation for antiretroviral drugs to suppress the viral load in the central nervous system across the blood-brain barrier.   \n\n \n \n \n \n \n Jernej Grmaš\, Ph.D.\n \n \n \n \nHead\, Laboratory Informatics\, Lek d.d. (Sandoz) \nDr. Jernej Grmaš is Head of Laboratory Informatics at Lek d.d. (Sandoz)\, where he leads the implementation of digital laboratory systems\, data platforms\, and artificial intelligence solutions across the pharmaceutical development environment. His work focuses on accelerating innovation through digital transformation\, improving laboratory efficiency\, and enabling data-driven decision-making throughout the R&D lifecycle.  \nWith 18 years of experience in pharmaceutical research and development\, Dr. Grmaš has held a range of scientific and leadership roles across analytical development\, complex product characterization\, and digital innovation. His experience encompasses more than 25 analytical techniques\, including material characterization\, microscopy\, rheology\, and inhalation and nasal spray testing\, supporting the development of complex generic products. While now focused on digital transformation and AI-enabled laboratories\, he continues to contribute as a scientific advisor in the development of complex products\, particularly in areas requiring advanced characterization and in vitro bioequivalence strategies. Throughout his career\, he has contributed to numerous development programs\, scientific publications\, and cross-functional innovation initiatives.  \nHe holds a Master of Pharmacy and a Ph.D. in Biomedicine from the University of Ljubljana.  \n\n \n \n \n \n \n Sunil S. Iyer\, Ph.D.\n \n \n \n \nVice President & Head\, Biopharmaceutics and Clinical Development\, Pharmaceutical Technology Center\, Zydus Lifesciences Limited\, Ahmedabad\, India \nDr. Sunil Iyer heads Biopharmaceutics and Clinical Development at Zydus Lifesciences Ltd.\, Ahmedabad\, India\, where he oversees global clinical development and registration strategies for Oral and Non-oral generic products. His team provides critical inputs on alternative bioequivalence study designs for Complex Generics and 505(b)(2) filings\, advanced pharmacokinetic modeling (including PBPK\, IVIVC and POP-PK)\, and key immunological and toxicological initiatives. \nAn accomplished professional with ~28 years of experience in clinical development\,\nbioequivalence and regulated bioanalysis\, Dr. Iyer has held escalating levels of responsibility at Sun Pharma and Mankind Pharma prior to joining Zydus\, besides having served as an expert consultant to industry based at Virginia Commonwealth University (VCU)\, Richmond-VA. \nFurther to his Ph.D. degree in Pharmaceutical Sciences from VCU\, Dr. Iyer pursued Postdoctoral Scholarship with Drs. William Barr and Thomas Karnes. In recognition of demonstrated excellence in scholarship\, research\, teaching and service\, he received several awards and grants\, including the Rector & Rorrer Dean’s Award for Graduate Studies\, University Leadership Award\, John Wood Award\, Kamlesh Thacker Award and AAPS-APQ Section Symposium Award. He previously earned a Master of Pharmacy degree from Birla Institute of Technology\, India\, after graduating his Bachelor of Pharmacy degree as a Gold Medalist on University Roll of Honors. \nDr. Iyer is active in professional pharmaceutical organizations such as AAPS\, SPDS & ISCR\, is widely published and serves as a reviewer for reputed journals. He has been invited to speak at several international fora on bioequivalence\, clinical research and biopharmaceutics\, and furthermore\, endeavors to mentor pharmacy students at various career levels. \n\n \n \n \n \n \n Young Kuk Jhon\, Ph.D.\n \n \n \n \nSenior Chemist\, DPQA IV\, OPQA I\, OPQ\, CDER\, FDA  \nDr. Young K. Jhon is currently a senior chemist working at Division of Product Quality Assessment IV (DPQA IV)\, Office of Product Quality Assessment I (OPQA I)\, Office of Pharmaceutical Quality (OPQ)\, Center of Drug Evaluation and Research (CDER) at the FDA.  He has more than 20 years of experience in the field of long-acting injectables\, drug-delivery system\, polymers\, colloids (emulsions and suspensions)\, nanotechnology\, implants\, fluid mechanics\, thermodynamics\, and rheology.  In OPQ\, he has been involved in assessment of complex dosage forms for oral\, ophthalmic\, parental\, and topical routes\, and in working groups for multiple guidances and research for complex drugs\, including complex API sameness and the drug products that contain PLGA.  Also\, he serves as application technical lead (ATL) for regulatory drug application assessments and as USP liaison for General Chapters.  Prior to joining FDA\, he worked as an NRC fellow in Chemistry division at U.S. Army Research Office\, RTP\, NC.  He received a Ph.D. in Chemical Engineering from North Carolina State University\, Raleigh.  \n\n \n \n \n \n \n Coleman Johnson\, Ph.D.\n \n \n \n \nPostdoctoral Research Fellow\, OPQR\, OPQ\, CDER\, FDA  \nDr. Coleman Johnson earned his B.S. in Chemistry and M.S. in Chemistry/Polymer Sciences from the University of Oregon. He started his career in the pharmaceutical industry at Lonza Pharma and Biotech in Bend\, OR as a formulation scientist. He then earned his Ph.D. in Pharmaceutical Sciences at the University of Texas at Austin. He is currently a postdoctoral research fellow at the US Food and Drug Administration in the Office of Pharmaceutical Quality Research.  \n\n \n \n \n \n \n Nirav Khatri\, Ph.D. \n \n \n \n \nVice President & Delivery Manager\, Injectable-Formulation R&D\, Dr. Reddy’s Laboratory Ltd.\, India \nDr. Nirav Khatri leads complex injectable development programs at Dr. Reddy’s Laboratories Ltd.\, India\, spanning long-acting injectables (LAIs)\, liposomes\, peptide-based products\, and conventional sterile dosage forms. His work focuses on advancing long-acting injectable technologies\, particularly microsphere-based drug delivery systems\, through formulation development\, advanced product characterization\, and evaluation of critical material attributes that influence product performance. He has contributed to the development and scale-up of complex LAI products by addressing challenges related to microparticle manufacturing\, process robustness\, scalability\, and batch-to-batch consistency\, while supporting CMC and bioequivalence strategies for global regulatory submissions. Dr. Khatri also serves as an Expert Advisor to the USP Microparticle Expert Panel under the Dosage Forms Expert Committee of the United States Pharmacopeia (USP).  \n\n \n \n \n \n \n Ajay J. Khopade\, Ph.D.\n \n \n \n \nVice President & Head\, Formulation Development (Non-Orals)\, Sun Pharmaceutical Industries Limited R&D  \nDr. Ajay J. Khopade is a pharmaceutical scientist with more than 26 years of experience in the development of sterile and complex pharmaceutical products\, including liposomes\, long-acting depot injections\, nanoparticles\, peptides\, ophthalmic products\, drug-device combination products\, and large volume parenterals. He currently serves as Vice President\, Site Head and Head of Formulation Development (Non-Orals) at Sun Pharmaceutical Industries Limited R&D Centre at Vadodara\, India\, where he leads formulation and process development activities supporting complex generic and specialty pharmaceutical programs from early development through commercialization. His responsibilities include CMC strategy\, scale-up\, technology transfer\, regulatory submissions\, intellectual property development\, and cross-functional project leadership.  \nDr. Khopade earned his Ph.D. in Pharmaceutics from Dr. Harisingh Gour Vishwavidyalaya\, India\, and was subsequently awarded the prestigious Alexander von Humboldt Fellowship at the Max Planck Institute of Colloids and Interfaces\, Germany. He is the inventor of several drug delivery platform technologies\, including Nanotecton\, TearAct\, Trisurf\, and Lipixelle\, many of which have progressed to late-stage clinical development or commercialization. He has authored approximately 87 peer-reviewed publications\, contributed numerous book chapters\, and is an inventor on over 170 patent applications worldwide. Dr. Khopade has represented industry in interactions with global regulatory agencies including the US FDA\, EMA\, and TGA\, and serves on several academic and scientific advisory boards. His current work focuses on the development and commercialization of complex generics\, nanomedicines\, ophthalmic products\, and advanced drug delivery systems.   \n\n \n \n \n \n \n Martin Klein\, Ph.D.\n \n \n \n \nSenior Mathematical Statistician\, DB VIII\, OB\, OTS\, CDER\, FDA \nDr. Martin Klein is a Senior Mathematical Statistician in the Division of Biometrics VIII\, Office of Biostatistics\, Office of Translational Sciences\, CDER\, FDA. His work focuses on regulatory review and research of generic drug products and biosimilar products\, and the use of modeling in drug development. Dr. Klein’s research areas include group sequential design in bioequivalence studies\, statistical analysis using pharmacokinetic models\, statistical approaches to address missing data\, statistical ranking of populations\, and statistical computing. He received his Ph.D. in Statistics from the University of Maryland\, Baltimore County. \n\n \n \n \n \n \n Sivacharan Kollipara\, Ph.D.\n \n \n \n \nVice President & Head\, Biopharmaceutics\, Dr. Reddy’s Laboratories Ltd.  \nDr. Sivacharan Kollipara is currently working as Vice President & Head\, Biopharmaceutics department in the Global Clinical Management group\, IPDO at Dr. Reddy’s Laboratories Limited (DRL)\, Hyderabad. He is responsible for biopharmaceutics evaluation\, bioequivalence risk assessment\, and bioequivalence prediction for conventional as well as complex generic products at DRL. He is also involved in PK modeling and simulations activities supporting generic drug development of various immediate release\, modified release\, and complex products at DRL and involved in utilizing novel PBPK and PBBM modeling approaches for regulatory justifications for various markets. Prior to joining DRL\, Dr. Kollipara was Principal Scientist (Global Pharmaceutical Development) at Novartis Healthcare Pvt Ltd.\, Hyderabad. Previously he also has been associated with Ranbaxy Research Laboratories\, Gurgaon (Metabolism and Pharmacokinetics). He obtained Masters in Pharmaceutical Sciences from BITS\, Pilani\, Rajasthan\, India and Ph.D. in Biopharmaceutics. Dr. Kollipara is also Chair Person\, Scientific Planning Committee for SOPHAS (Society of Pharmacometrics & Health Analytics)\, India. Overall Dr. Kollipara has an experience of 18 years in the field of drug discovery\, development and generic product development\, bioanalytical method development and validation\, PK data modelling and simulations. He has authored/co-authored more than 60 peer-reviewed publications and is scientific reviewer for many peer-reviewed journals. His research interests include PBPK/PBBM modeling\, biowaivers\, virtual bioequivalence simulations\, IVIVC/R\, drug-drug interactions\, dissolution/bioequivalence safe space\, bio-predictive dissolution methodologies\, biowaivers\, alternative BE approaches\, pharmacometrics and novel statistical tools for dissolution similarity analysis and food effect evaluations. Dr. Kollipara has been invited as speaker in various international conferences and delivered numerous scientific talks on PBPK\, PBBM approaches in new drug and generic product development\, use of model integrated bioequivalence approaches and biowaivers.  \n\n \n \n \n \n \n Darby Kozak\, Ph.D.\n \n \n \n \nDeputy Director\, OGD\, CDER\, FDA \nDr. Darby Kozak is the Deputy Director for the Office of Generic Drugs (OGD) where he serves as a senior agency advisor in the development and implementation of FDA policies and long-range objectives for generic drug scientific programs and activities\, including the development of a strategic plan for the Generic Drug Program. Dr. Kozak started his FDA career in April 2015 in OGD’s Office and Research and Standards where he helped develop new analytical methods and equivalence evaluation methodologies for complex generic drug substances and parenteral\, ophthalmic\, otic\, and inhalation formulations. Prior to joining the FDA\, Dr. Kozak was Chief Scientist for Izon Science and Research Fellow at The University of Queensland’s Australian Institute for Bioengineering and Nanotechnology. Dr. Kozak has a B.Sc. in Chemical Engineering from the University of Washington (Seattle\, WA) and Ph.D. in Chemistry from the University of Bristol (United Kingdom).  \n\n \n \n \n \n \n Kai Kwok\, Ph.D.\n \n \n \n \nSenior Pharmaceutical Quality Assessor\, DPQA I\, OPQA I\, OPQ\, CDER\, FDA  \nDr. Kai Kwok is a Senior Pharmaceutical Quality Assessor (SPQA) in the Division of Product Quality Assessment I\, Office of Product Quality Assessment I\, Office of Pharmaceutical Quality\, CDER at FDA. In this role\, he serves as the application technical lead for integrated quality assessment of generic parenteral\, ophthalmic\, topical\, nasal\, and oral solid/solution drug products. Over the past 10 years\, he has reviewed ANDA\, Bio-IND\, IND\, and Pre-ANDA meeting packages involving complex drug products\, such as drug-device peptide products. He has also served as an FDA liaison to the USP Packaging and Distribution Expert Committee\, contributing to the development of USP packaging chapters and standards\, and as a member supporting FDA guidance development for drug delivery performance of drug-device combination products. Prior to joining FDA\, Dr. Kwok spent over 10 years as a formulation scientist in pharmaceutical companies focused on drug product and process development. He received his Ph.D. in Pharmaceutical Sciences from the University of Michigan.  \n\n \n \n \n \n \n Hiren Mehta\, Ph.D.\n \n \n \n Global Biometrics\, Veeda Lifesciences Ltd. \nDr. Hiren Mehta has been into the pharmacometrics and generic drug development for about 21 years now\, engaged in discovering\, validating\, adopting and applying new techniques of data analysis\, modelling & simulations related to pharmacokinetics\, pharmacodynamics integrated with biostatistics principles using evidence-based approach. He worked for 2 major generic pharma companies Cadila and Torrent in past and into the CRO sector for last 16 years with most recent role at Veeda Lifesciences preceded by Altasciences\, Syneos Health and Lambda\, helping generic sponsors to get the complex generics into the market with newer study designs & data analysis techniques which are regulatory acceptable. Some of these works have been published into journals. \n\n \n \n \n \n \n Naresh Mittapelly\, Ph.D.\n \n \n \n \nSenior Research Scientist\, Mechanistic Modelling & Simulation\, Certara Predictive Technologies (Simcyp Division) \nDr. Naresh Mittapelly is a Senior Research Scientist in the Modelling and Simulation group at Certara Predictive Technologies\, specializing in mechanistic modelling of complex and specialized drug delivery systems — including dermal and rectal absorption and long-acting injectable (LAI) formulations\, areas of growing strategic importance in pharmaceutical development. He received his Ph.D. from the CSIR-Central Drug Research Laboratory (CDRI)\, India. Prior to joining Certara in 2021\, he served as Deputy Manager of Product Development at Cipla Ltd\, leading ANDA and 505(b)(2) programs for the US market — bringing a strong industry and regulatory perspective to his modelling work. His core expertise spans complex injection systems\, transdermal delivery\, liposomes\, and peptide formulations. Dr. Mittapelly has authored more than 25 peer-reviewed publications spanning drug delivery and mechanistic modelling. \n\n \n \n \n \n \n Natalie Morris\, Ph.D.\n \n \n \n \nResearch Scientist\, MID 3\, Certara \nDr. Natalie Morris is a PBPK modelling scientist who works on the development of the Simcyp Simulator at Certara. She holds a BSc in Molecular Biology from the University of Sheffield and a PhD from the University of Bristol\, where her doctoral research applied pharmacokinetic modelling\, global sensitivity analysis\, and parameter optimization to antivenom design for snakebite envenoming. \nSince joining Certara in 2024\, Natalie has contributed to a range of projects including long-acting injectable (LAI) models\, virtual bioequivalence (VBE)\, population file development\, and the Simcyp R package. She currently leads the VBE team within Simcyp. In this workshop she will present on recent work within an FDA-funded grant which focused on the development of statistical workflows for PBPK-based VBE assessment of LAIs. This core workflow has been integrated into a new VBE module within Pirana that interfaces with Simcyp\, and has resulted in two recent publications in the AAPS Journal. \n\n \n \n \n \n \n James Mullin\, M.S.\n \n \n \n \nSr. Principal Scientist\, Research and Development\, Simulations Plus\, Inc. \nMr. James Mullin is a Senior Principal Scientist at Simulations Plus\, Inc. and has a graduate degree in Chemical Engineering from Washington State University.  In his role at Simulations Plus\, he contributes to modeling and simulation development and consulting activities across multiple programs including GastroPlus\, MembranePlus\, and DDDPlus.  Most recently\, James is participating in an FDA grant project to extend the capability of Gastroplus pulmonary module to predict local tissue concentrations by enhancing the model structure.  Furthermore\, James has contributed toward FDA grant projects with respect to IVIVC and long-acting injectables. James has 22 years’ experience in PBPK modeling\, computational fluid dynamics\, and mathematical modeling. \n\n \n \n \n \n \n Alhan Oraha\, M.Sc.\n \n \n \n \nScientific Leader\, Clinical R&D\, Apotex Inc.  \nMs. Alhan Oraha is a Scientific Leader in Clinical R&D at Apotex Inc. with 20 years of experience in clinical pharmacology\, pharmacokinetics/pharmacodynamics\, bioequivalence\, and regulatory science. She holds both an MSc and an Honours BSc in Pharmacology from the University of Toronto. Throughout her career\, she has led the design and scientific evaluation of clinical and bioequivalence studies across a wide range of dosage forms. Her work involves applying clinical pharmacology and regulatory science principles to support the successful development and registration of complex generic medicines. She is also a co-author of peer-reviewed publications in the fields of clinical pharmacology and neuroscience.  \n\n \n \n \n \n \n Simone Perazzolo\, Ph.D.\n \n \n \n \nSenior Research Scientist\, Department of Pharmaceutics\, School of Pharmacy\, University of Washington\, Seattle \nDr. Simone Perazzolo is an engineer and pharmaceutical scientist with a Ph.D. in mechanistic modeling of biological systems. He has over 15 years of experience in compartmental\, PBPK\, and PD modeling\, with applications in long-acting drug delivery and infectious diseases. He received the Journal of Pharmaceutical Sciences Outstanding Early Career Scientist Award in 2022 and 2024. \nHe recently published a position article proposing CS-BLAP\, a classification system for long-acting drug products based on the mechanisms governing absorption from the injection site into systemic circulation\, with effective molecular size as a key determinant. Drawing on the principles of the classic BCS\, the framework aims to support discussions around scaling and regulatory approval of generic long-acting injectables. \n\n \n \n \n \n \n Bin Qin\, Ph.D.\n \n \n \n \nSenior Staff Fellow\, DTP I\, ORS\, OGD\, CDER\, FDA  \nDr. Bin Qin is currently a senior staff fellow in the Division of Therapeutic Performance I\, in OGD’s Office of Research and Standards. In his current role\, Dr. Qin is responsible for the development of product-specific guidance for generic drug development\, reviewing and responding to controlled correspondences\, pre-ANDA meeting requests and internal consults. Dr. Qin is also a project officer on multiple regulatory science research initiatives related to complex drug products\, under the GDUFA regulatory science research program.  \n\n \n \n \n \n \n Haiou Qu\, Ph.D.\n \n \n \n \nStaff Fellow\, OPQR\, OPQ\, CDER\, FDA \nDr. Haiou Qu is a Research Scientist in the Division of Pharmaceutical Quality Research within the Office of Pharmaceutical Quality. His work focuses on advanced analytical characterization and the development of predictive in vitro methods to support bioequivalence and pharmaceutical equivalence assessments for generic drug products with complex active ingredients\, formulations\, or dosage forms. Dr. Qu is a subject matter expert in nanomaterials characterization and serves as a government liaison in the development of international standards for nanoparticle characterization using light scattering and flow-based separation methods. \nDr. Qu received his B.S. in Biotechnology from the University of Science and Technology of China and his Ph.D. in Materials Chemistry from the University of New Orleans. \n\n \n \n \n \n \n Sam Raney\, Ph.D.\n \n \n \n \nAssociate Director for Science & Chief Scientific Advisor\, ORS\, OGD\, CDER\, FDA  \nDr. Sam Raney is the Associate Director for Science and Chief Scientific Advisor in the FDA’s Office of Research and Standards and Office of Generic Drugs\, where he oversees the research portfolio of FDA’s generic drug research program. He has over 30 years of experience in pharmaceutical drug development\, specializing in topical and transdermal products\, and producing numerous research manuscripts\, review articles\, book chapters and patents. He has been a researcher and adjunct professor within academia\, was the longest serving Chair of the AAPS Topical and Transdermal Community\, has been a principal or sub investigator on over 400 pharmaceutical product studies\, has held senior management roles in industry\, serves on multiple expert committees and panels for the U.S. Pharmacopeia\, and is frequently invited to speak at scientific meetings around the world. Dr. Raney holds a Bachelor’s Degree in Molecular Biophysics & Biochemistry from Yale University\, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada.   \n\n \n \n \n \n \n Dinesh Satone\, M.Pharm.\n \n \n \n   \nGeneral Manager\, Orbicular Pharmaceutical Technologies Ltd.\, Hyderabad. \nMr. Dinesh Satone is a pharmaceutical professional with over 19 years of experience in the development\, analytical characterization\, and regulatory support of complex drug products. He holds a Bachelor of Pharmacy (B.Pharm) and Master of Pharmacy (M.Pharm) from Nagpur University and qualified GATE 2005 with an impressive 97 percentile. \nThroughout his career\, Dinesh has held scientific and leadership positions at leading pharmaceutical organizations\, including Sun Pharmaceutical Industries\, Dr. Reddy’s Laboratories (DRL)\, and Orbicular Pharmaceutical Technologies Ltd.\, Hyderabad\, where he has been contributing for the past 10 years. His expertise spans the analytical characterization of complex active pharmaceutical ingredients (APIs)\, including peptides\, and complex formulations such as liposomes\, colloids\, suspensions\, emulsions\, long-acting injectables\, and implantable drug delivery systems. \nHe has extensive experience in designing and implementing analytical characterization strategies to support product development\, in vitro bioequivalence assessments\, and regulatory submissions. His work has contributed to successful approvals from major global regulatory agencies\, including the US FDA\, EMA\, and Health Canada. \nCurrently serving as General Manager at Orbicular Pharmaceutical Technologies Ltd.\, Dinesh leads analytical characterization and in vitro bioequivalence programs for peptide-based drug products and PLGA-based long-acting injectables and implants intended for global markets. \nHis areas of focus include comparative physicochemical and structural (Q3) characterization\, In Vitro Release Testing (IVRT)\, polymer characterization\, and the application of advanced orthogonal analytical techniques to establish equivalence between proposed products and reference listed drugs (RLDs). These efforts support the development of high-quality\, scientifically robust\, and globally compliant pharmaceutical products. \n\n \n \n \n \n \n Anna Schwendeman\, Ph.D.\n \n \n \n \nCo-Director of CRCG\, Professor of Pharmacy\, Department of Pharmaceutical Sciences\, Biointerfaces\, College of Pharmacy\, University of Michigan \nDr. Anna Schwendeman is a Professor in the Department of Pharmaceutical Sciences at the University of Michigan. Her research focus is on optimization of high-density lipoprotein (HDL) nanoparticles for treatment of atherosclerosis\, sepsis\, and drug delivery purposes. In 2016\, she co-founded a company EVOQ Therapeutics (www.evoqtherapeutics.com) focused on the use of HDL Nanodiscs for delivery of personalized neoantigen cancer vaccines. Dr. Schwendeman received her B.S. from Moscow Institute of Physics and Technology and Ph.D. in Pharmaceutics from The Ohio State University. Prior to starting her academic career in 2012\, Dr. Schwendeman spent 12 years in the pharmaceutical industry at Cerenis Therapeutics\, Pfizer\, and Esperion Therapeutics. She was involved in discovery and translation HDL drugs to clinical trials. She successfully submitted FDA INDs for seven different products including nanoparticles\, liposome\, recombinant proteins\, peptides\, and small molecules. Her laboratory’s research in regulatory sciences is focused on analytical characterization of liposomes\, polymer microspheres\, peptides\, and biosimilar products. She is co-Director of FDA sponsored Center for Research in Complex Generics (http://www.complexgenerics.org). Dr. Schwendeman is an Associate Editor for Nanomedicine NBM and Eur. J. Pharm and Biopharm. \n\n \n \n \n \n \n Steve Schwendeman\, B.S.E.\, Ph.D.\n \n \n \n \nAra G. Paul Professor and Chair\, Pharmaceutical Sciences\, Professor of Biomedical Engineering\, University of Michigan Biointerfaces Institute \nDr. Steve Schwendeman is Ara G. Paul Professor and Chair of Pharmaceutical Sciences and Professor of Biomedical Engineering at the University of Michigan (UM) Biointerfaces Institute. He is also co-director of the UM Bioinnovations in Brain Cancer program and Advanced Materials and Drug Delivery Thrust Leader of the Biointerfaces Institute at UM. He trained in Chemical Engineering (B.S.E.) and Pharmaceutics (Ph.D.) from UM and was an NIH postdoctoral fellow at MIT. He received the Young Investigator Award and a Best Paper Award from the Controlled Release Society (CRS). He is a Fellow of CRS and American Association of Pharmaceutical Sciences and elected to the National Academy of Inventors (2019). He is co-recipient of a $15 MM UM Bioscience Initiative Award to develop technological innovations in brain cancer. He was Associate Editor of Journal of Controlled Release from 2007-2021 and Pharmaceutical Research from 2004-2007. He has co-authored >150 publications\, trained >25 PhD and 12 postdoctoral students\, delivered >125 invited lectures\, consulted for >25 companies\, published >150 abstracts\, and has nine issued and several pending patents. His principal contribution to science involves the theory and application of microencapsulation\, stabilization\, and controlled release of bioactive agents of all sizes with/in poly(lactic-co-glycolic acid) delivery systems with a special focus on peptides and proteins. More recently his lab has investigated buccal\, nasal\, and pulmonary delivery of hydrophobic drugs\, vaccine antigens and nitric oxide\, and invented organic solvent-free PLGA microencapsulation of large molecules by self-healing and ion-pairing. He is currently funded by NIH\, US FDA\, large corporations and private foundations\, including FHI360\, Gates and USAID. \n\n \n \n \n \n \n Jaymin Shan\, Ph.D.\n \n \n \n \nSenior Research Fellow and Global Head of Biopharmaceutics\, Pharmaceutical Sciences Small Molecules\, Pfizer Worldwide Research and Development\, Groton CT\, USA \nDr. Jaymin Shah is a Senior Research Fellow in Pharmaceutical Sciences and heads a global biopharmaceutics group in Pfizer R & D. He also holds an adjunct faculty appointment at the University of Houston and University of Connecticut. He obtained his Ph.D. in Pharmaceutics from University of Houston.  From 1988-1999 he served as Associate Professor (Tenured) of Pharmaceutical Sciences at Medical University of South Carolina\, where he led a lab developing sustained release parenteral delivery systems and modeling of skin transport and mentored 7 Ph.D. and 2 MS graduates.  Jaymin joined Pfizer in 1999 where he has led formulation groups and project teams supporting development of various candidates such as parenteral/ophthalmic dosage forms\, peptide and oligonucleotides development and research initiatives in parenteral and ophthalmic delivery including LAI\, depots\, sterile suspensions\, implants\, and nanoparticles.  Jaymin has been recognized with achievement awards for leadership and innovation in Pfizer.  Jaymin has published 70 papers\, 10 patents/patent applications\, 75 abstracts and made more than 114 presentations at various scientific forums such as Arden House Conference\, AAPS symposia\, CRS\, FDA and academic centers. His current research interests include PBPK modeling and in vitro translational studies to predict biopharmaceutics risk for drug candidates\, parenteral sustained release\, nanoparticles\, ophthalmic delivery\, and topical formulation development. Currently he leads a global biopharmaceutics group providing biopharma risk assessment and strategy for biopharmaceutical aspects for drug development using in vitro performance and PBPK modeling. \n\n \n \n \n \n \n Andrew Shaw\, Ph.D.\n \n \n \n \nHead of Global Clinical Pharmacology\, Global Clinical Pharmacology Department\, Viatris\, Inc. \nDr. Andrew Shaw is the Head of Global Clinical Pharmacology for Viatris\, Inc. In this role\, Andrew leads a talented global team of scientists and statisticians focused on innovative and generic pharmaceutical programs concentrating on early phase human clinical and bioequivalence studies involving oral solids\, transdermals\, complex long-acting injectables\, respiratory\, and biosimilars.  Andrew has been with the company in increasing levels of responsibility since 2000 when it was known as Mylan Pharmaceuticals\, Inc. before merging with Upjohn to form Viatris in 2020.  Andrew holds a B.S. degree in Pharmacy from the Philadelphia College of Pharmacy & Science and a Ph.D. in Industrial Pharmacy from Purdue University.  \n\n \n \n \n \n \n William (Billy) C. Smith\, Ph.D.\n \n \n \n \nResearch Scientist\, DPQR V\, OPQR\, OPQ\, CDER\, FDA \nDr. William C. Smith (Billy) is a Research Scientist in the Division of Pharmaceutical Quality Research\, working on complex drug formulations from topicals to injectables and implantable polymeric devices. Dr. Smith runs the DPQR Micromeritics “Particle Size” Lab working on the physicochemical characterization of nano- and micro-scale materials to support regulatory assessment and review\, and evaluation of drug product quality. His work focuses on the characterization and performance evaluation of complex drug products for both the assessment of advanced manufacturing processes and in the determination of bioequivalence. Dr. Smith received his B.S. degree in Chemistry from the Evergreen State College. In 2017\, he was a guest researcher at the Leibniz Institute for Polymer Research (IPF) in Dresden\, Germany. He earned his Ph.D. in 2019 from the Colorado School of Mines\, where his doctoral work focused on the development of advanced separation techniques for the characterization of complex polymers and colloidal nanomaterials. He currently acts as the young scientist representative to the steering board for International Symposium on Field- and Flow– Based Separations. \n\n \n \n \n \n \n Prasad NV Tata. M. Pharm.\, Ph.D.\, PG DAS \n \n \n \n \nSenior Director\, Pharmacokinetics and Bioequivalence\, American Regent Inc.\, a Daiichi Company\, USA \nDr. Prasad N. V. Tata earned his B.S.\, M.S.\, and Ph.D. in Pharmaceutical Sciences from Andhra University in Waltair\, India. His professional career spans more than 40 years and includes affiliations with several academic institutions\, including Andhra University\, Berhampur University\, Annamalai University\, and the University of Pittsburgh\, as well as industrial research organizations in India and the United States.  \nWhile working in Professor Raman Venkataramanan’s group at the University of Pittsburgh\, Dr. Tata’s focus shifted from the development of novel drug delivery systems to the clinical and non-clinical development of investigational products\, including tacrolimus\, mycophenolic acid\, and cyclosporine. His work emphasized the integration of bioanalytical\, drug metabolism\, and pharmacokinetic findings into the design and execution of non-clinical and clinical development studies. During his tenure with Otsuka America\, Shire Pharmaceuticals\, and Salix Pharmaceuticals\, he focused on regulated bioanalysis\, drug metabolism\, —with an emphasis on drug-drug interactions\, and pharmacokinetics in support of NDA and 505(b)(2) NDA development. His work at Mallinckrodt\, Inc. and Sandoz focused on 505(b)(2) NDAs and ANDA development.  \nDr. Tata currently serves as Senior Director of Pharmacokinetics and Bioequivalence at American Regent\, Inc.\, where he focuses on the development of complex generics and innovative 505(b)(2) NDAs for complex long-acting injectable formulations. His work involves the efficient application of biostatistics\, physiologically based pharmacokinetic modeling\, and population pharmacokinetic principles to develop innovative study designs based on model-informed drug development and model-informed evidence.   \nDr. Tata has been an active contributor to professional forums\, including the American Association of Pharmaceutical Scientists\, the International Society for the Study of Xenobiotics\, and the Indian Pharmaceutical Association. He has published nearly 50 peer-reviewed articles and delivered a comparable number of conference presentations and invited talks. He also enjoys mentoring future professionals through adjunct faculty appointments and informal collaborations with academic institutions.  \n  \n\n \n \n \n \n \n Eleftheria Tsakalozou\, Ph.D.\n \n \n \n \nLead Pharmacologist\, DQMM\, ORS\, OGD\, CDER\, FDA \nDr. Eleftheria Tsakalozou (Lead Pharmacologist\, US Food and Drug Administration (FDA)) obtained her Ph.D. in Pharmaceutical Sciences at the University of Kentucky in 2013 and completed a two-year Fellowship in Clinical Pharmacokinetics and Pharmacodynamics at the University of North Carolina at Chapel Hill before joining the FDA in 2015 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. She is currently a Lead Pharmacologist at the Division of Quantitative Methods and Modeling at the Office of Research and Standards with expertise in physiologically based pharmacokinetic modeling and simulation approaches for topical and transdermal drug products. She is focused on the development and regulatory application of mechanistic modeling and simulation tools to support virtual bioequivalence assessments for non-orally administered drug products.   \n\n \n \n \n \n \n Yan Wang\, Ph.D.\n \n \n \n \nDeputy Director\, DTP I\, ORS\, OGD\, CDER\, FDA  \nDr. Yan Wang is the Deputy Division Director in the Division of Therapeutic Performance I (DTP I)\, ORS\, OGD at the U.S. Food and Drug Administration. The division advances regulatory science to support generic drug development and establish standards for demonstrating therapeutic equivalence. \nSince joining FDA in 2013\, Dr. Wang has served in multiple scientific and leadership roles\, including as a subject matter expert in complex long-acting drug products and Team Lead for the Complex Drug Substance and Complex Formulation Team. Her work focuses on analytical methods\, in vitro characterization\, and drug release testing for complex drug products. \nHer expertise spans complex parenteral\, ophthalmic\, otic\, intravaginal\, and intrauterine products\, with an emphasis on linking formulation and manufacturing to product performance and bioequivalence. \n\n \n \n \n \n \n Daniel Wehrung\, Ph.D.\n \n \n \n \nR&D Formulation Manager\, Research & Development\, American Regent\, Inc. \nDr. Daniel Wehrung is the R&D Formulation Development Manager responsible for all technical aspects of formulation and process development and scale-up of generic and branded drug products developed at American Regent\, Inc.  Prior to joining American Regent\, Inc. Dr. Wehrung completed his Bachelor of Science from Ohio University and his Ph.D. in Integrated Pharmaceutical Medicine from Northeast Ohio Medical University.  Prior to his current role at American Regent\, Inc. his research focused on developing injectable delivery systems from novel polymers and lipid carriers with the goal of achieving spatiotemporal control of drug release. \n\n \n \n \n \n \n Peng Zhang\, Ph.D.\n \n \n \n Senior Principal Scientist\, Excipients\, USP \nDr. Peng Zhang is a Senior Principal Scientist at the United States Pharmacopeia (USP) in Rockville\, MD. In his current role\, he is primarily responsible for standard setting activities related to the development and update of high-priority excipient quality standards and solutions\, including those for lactide-glycolide and lactic acid- glycolic acid polymers (PLGs and PLGAs\, collectively referred as LG polymers) and phospholipids\, under the Excipient Expert Committees. Before joining USP\, he worked as an analytical scientist in the pharmaceutical industry for 10 years. He holds a Ph.D. degree in Analytical Chemistry from Vanderbilt University. \n\n \n \n \n \n \n Qiangnan Zhang\, Ph.D.\n \n \n \n \nStaff Fellow\, DTP I\, ORS\, OGD\, CDER\, FDA \nDr. Qiangnan Zhang is a Staff Fellow in the Division of Therapeutic Performance-I (DTP-I)\, Office of Research and Standards (ORS)\, Office of Generic Drugs (OGD)\, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). She joined the FDA as an ORISE Fellow in February 2020 and has served in her current role since November 2022. Dr. Zhang’s expertise includes long-acting injectable suspensions and other complex long-acting parenteral products\, such as PLGA based microspheres and in situ-forming gels\, and EVA implants. At the FDA\, she provides scientific input on controlled correspondence\, pre-ANDA meeting requests\, citizen petitions\, and internal consults related to the assessment of complex parenteral products. She also oversees and collaborates on GDUFA-funded and internal research projects\, translating research findings into bioequivalence approaches and product-performance testing that support the development and assessment of complex generic parenteral products. \n\n \n \n\n\n\n\n\n \n \n \n Locations\n \n \n \n The workshop will be held at the Universities at Shady Grove (USG). \nAddress: Building II\, Ballroom (please follow signs)\, 9630 Gudelsky Drive\, Rockville\, MD 20850 \n\n \n \n \n \n \n Directions and Transportation\n \n \n \n \nTravel from local airports to Rockville\, MD. (The Universities at Shady Grove (USG)) will require an Uber or Lyft\, which is by far the best way to obtain car service.\nAs there is road traffic in the region\, the fastest way to the Shady Grove campus is the DCA airport\, then taking the Metro subway from the airport to Shady Grove\, then taking Uber or Lyft. Alternatively\, fly into any WAS airport and take Uber or Lyft. If flying into BWI airport\, we suggest taking Uber or Lyft to USG.\nThe Metro subway serves DCA and IAD airports\, which connects with the Shady Grove stop on the red line. If flying into IAD\, taking the Metro will save some cost\, but will probably take extra time\, even if traffic is heavy.\n\nMore links and information: \n\nDirections and transportation options to USG\nPublic transportation\nCampus map\n\n  \n\n \n \n \n \n \n Parking\n \n \n \n \nThe Traville-Gateway Garage is the closest parking garage to the venue (parking map). Attendees may also park in Lot 2 and Shady Grove Garage but will need to allow more walking time to reach the event.\nVisitor Parking: Levels 2-6 of Traville Gateway Garage. PLEASE NOTE: The ground floor of Traville Gateway Garage requires a USG employee permit at all times.\nGuests are responsible for the cost of parking; parking will not be validated. Parking is $16 for all day.\n\nClick for parking information from the USG website. \n\n \n \n \n \n \n Airports\n \n \n \n Please click on the following “all transportation options” links to find transportation from the airport via subway\, bus\, taxi\, car\, and town car. \n\nReagan National Airport (DCA): 21.1 miles from Rockville\, MD (all transportation options from DCA) (train options from DCA)\nDulles International Airport (IAD): 27.8 miles from Rockville\, MD (all transportation options from IAD) (train options from IAD)\nBaltimore/Washington International Thurgood Marshall Airport (BWI): 37.5 miles from Rockville\, MD (all transportation options from BWI) (train options from BWI)\n\n\n \n \n \n \n \n Train\n \n \n \n \nTrain tickets (Omio)\nWashington\, DC to Baltimore: Approximately 35 minutes\nPenn Station Marc SB (Baltimore): Approximately 41 miles from campus\n\n\n \n \n \n \n \n Taxi or Car Service\n \n \n \n Empire Sedan & Limo Services (empiresedan12@gmail.com):  240-988-1796 \nWashington Flyer Taxi:  703-572-TAXI or 706-853-6094\n(Syed Z Shah\, Cab #381\, 571-243-0020\, can book ride\, requires one day notice) \nRegency Taxi:  301-984-1900 \nBob’s Limo Service (Email): 301-525-2525 \nB&B Executive Sedan (Email): 240-533-6262 \nEast Coast Limousine (Email): 301-527-0413 or 240-793-8196 \n\n \n \n \n \n \n Uber\n \n \n \n Uber: Baltimore\, BWI Airport\, Washington\, DC\, Dulles (IAD) Airport \nIf using Uber\, plese see the Uber Map for the designated spot for drop off and pick up for the workshop.  Do not request to be picked up/dropped off at the Traville-Gateway parking garage. \nAddress for Uber:\nUniversiites at Shady Grove\nLot 5\n9631 Gudelsky Drive\nRockville\, MD 20850 \n  \n\n \n \n \n \n \n Hotels/Lodging\n \n \n \n Guests should mention they are attending a conference at Universities of Shady Grove; most hotels offer discounts. \nThere are many hotels within a short driving distance to the USG campus including: \n\nHilton Garden Inn Rockville-Gaithersburg (Book your room (CRCG rate) by Nov. 9\, 2026)\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1800\nHomewood Suites by Hilton Rockville-Gaithersburg\n14975 Shady Grove Road\, Rockville\, MD 20850 (0.6 miles from USG)\n240-507-1900\nCourtyard by Marriott Rockville\n2500 Research Boulevard\, Rockville\, MD 20850 (0.9 miles from USG)\n301-670-6700\nSleep Inn Rockville\n2 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-507-8000\nThe Rockville Hotel\, a Ramada by Wyndham\n3 Research Ct.\, Rockville\, MD 20850 (1.2 miles from USG)\n301-202-1098\nSpring Hill Suites by Marriott Gaithersburg\n9715 Washingtonian Blvd\, Gaithersburg\, MD 20878 (1.4 miles from USG)\n301-987-0900\nSheraton Rockville Hotel\n920 King Farm Blvd\, Rockville\, MD 20850 (1.4 miles from USG)\n240-912-8200\nCourtyard by Marriott Gaithersburg Washingtonian Center\n204 Boardwalk Place\, Gaithersburg\, MD 20878 (1.6 miles from USG)\n301-527-9000\nComfort Inn Shady Grove-Gaithersburg-Rockville\n16216 Frederick Rd.\, Gaithersburg\, MD 20877 (2.2 miles from USG)\n301-330-0023\nEVEN by IHG Hotel Rockville\n1775 Rockville Pike\, Rockville\, MD 20852 (5.5 miles from USG)\n855-879-3836\n\n\n \n \n\n\n\n\n \n For the December 1-2 workshop\, you will need to pre-order your lunch for each day; lunch is not provided.  Lunch will be delivered to the main building where the workshop will be held (Building II\, Ballroom) and labeled with your name.  You will pick up your ordered food at the registration desk\, each day.  \n(Note:  please disregard the confirmation message that states food will be available for pick up the next day; all food will be delivered to the Ballroom for each day of the workshop) \nYou can go to Dawson’s Market as well\, located in Building III\, first floor.  Hours are 9 AM-5 PM ET.  The cafe has additional food and beverage options there.  You are welcome to bring your lunch\, as well. \nLink for Tuesday\, December 1:  https://square.link/u/OPuLlAXV \nLink for Wednesday\, December 2:  https://square.link/u/8BSKiD47 \nMake your selection and Add to Order.  Once you have made your selection\, you will then click on the shopping cart icon to check out.  If you want to purchase more than one meal for the same day\, you will need to place two separate orders.  You will Continue to Payment\, where you can pay with Google Pay\, Credit Card\, or Cash App Pay.  Then hit Place Order. \nDuring checkout\, there is a spot for Note to Seller\, to use when placing your order\, if needed for modifications to your order. \nThe deadline for ordering lunch is Monday\, November 16th by 5 PM ET. \nCoffee\, hot tea\, water\, and soft drinks will be available throughout each day in the conference room (Ballroom).  \nFood will be provided in the morning\, and AM and PM breaks each day. \nUSG Lunch (Dawson’s Market) \nChicken Caesar Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nTurkey & Swiss Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nTuna Salad Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nGrilled Vegetables & Hummus Wrap $14.99 Includes chips\, cookie\, and choice of beverage \nEggless Egg Salad Wrap (VEGAN) $14.99 Includes chips\, cookie\, and choice of beverage \nYou will have the option to remove tomatoes and/or cheese\, if needed \nGreek Salad $14.99 Includes romaine lettuce\, tomatoes\, onion\, kalamata olives\, bell peppers\, feta cheese\, pepperoncini peppers served with Dijon vinaigrette. Includes chips\, cookie\, and choice of beverage \nGrilled Salmon Caesar Salad $15.99 Includes chopped romaine\, house made croutons\, shredded parmesan & Caesar dressing. Includes chips\, cookie\, and choice of beverage \nGoat & Greens $14.99 Includes spinach\, cranberries\, pecans\, tomatoes\, goat cheese served with balsamic vinaigrette. Includes chips\, cookie\, and choice of beverage \nHot Items \nTomato Bisque Soup  $6.99 \nTaco Bowl  $15.99 Your choice of [fajita chicken\, ground beef\, or vegetables] on a bed of rice with mixed greens\, fajita vegetables\, black beans\, shredded cheese\, and toppings on the side (guacamole\, sour cream\, and salsa) \nBeverage Choice \nCoke \nDiet Coke \nSprite \nWater \nJust Tea-Mango White (additional $1.00) \nJust Tea-Original Green (additional $1.00) \nJust Tea-Half & Half (additional $1.00) \nDr. Browns-Cream \nDr. Browns-Black Cherry \nDr. Browns-Root Beer \nOlipop-Grape (additional $1.50) \nOlipop-Ginger Lemon (additional $1.50) \nOlipop-Cherry Cola (additional $1.50) URL:https://www.complexgenerics.org/education-training/long-acting-injectable-lai-generics-advancing-innovation-in-product-development-and-regulatory-assessment/ ATTACH;FMTTYPE=image/png:https://www.complexgenerics.org/wp-content/uploads/2026/07/Dec-2026-LAI-Workshop-Image_website.png END:VEVENT END:VCALENDAR