BEGIN:VCALENDAR VERSION:2.0 PRODID:-//The Center for Research on Complex Generics (CRCG) - ECPv6.14.1//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:20260101T000000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=UTC:20260923T083000 DTEND;TZID=UTC:20260924T173000 DTSTAMP:20260730T033548 CREATED:20250918T215130Z LAST-MODIFIED:20260729T203611Z UID:38345-1790152200-1790271000@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\n\n\nAboutEvent OutlineTravel & AccomodationsOrdering LunchSpeaker Bios\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 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 \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.  \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 Basil 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 $1.00) \nOlipop-Ginger Lemon (additional $1.00) \nOlipop-Cherry Cola (additional $1.00) \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 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 \nActing Center Director\, OCD\, CDER\, FDA \nDr. Michael Davis is the Acting Center 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 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 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 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 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 \nScientific Researcher\, 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 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 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 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.  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:20260730T033548 CREATED:20250918T215559Z LAST-MODIFIED:20260716T165952Z 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 \n\n\n\nAboutEvent OutlineTravel & Accommodations\n \n With the transition of bioequivalence recommendations for locally acting inhalation products to option-based frameworks\, new in vitro\, in vivo\, and in silico methods have been incorporated that can serve as alternatives to comparative clinical endpoint studies. These new methods can present complex challenges for their development and conduct\, which may affect the timing for generic product development and assessment. This workshop will explore these challenges with the goal of identifying potential strategies to enhance study development\, eliminate redundancies\, and streamline evaluations to minimize review cycles while also exploring pathways for generic products with compositional differences relative to the reference listed drug. \nThe two-day workshop is designed to discuss and understand the challenges and recommendations related to 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 to identify areas where reduced study recommendations may offer ways to streamline abbreviated new drug application (ANDA) submissions. \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 conducting in vitro and in vivo methods recommended to support demonstration of bioequivalence for metered dose inhalers (MDIs) and dry powder inhalers (DPIs) without significant formulation differences. 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 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: 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\nSession 7: 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 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 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 \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 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:20260730T033548 CREATED:20250918T220039Z LAST-MODIFIED:20260716T165539Z UID:38351-1796112000-1796233500@www.complexgenerics.org SUMMARY:Long-Acting Injectable (LAI) Generics: Navigating Technical Hurdles in Product Development and Regulatory Assessment DESCRIPTION:Long-Acting Injectable (LAI) Generics: Navigating Technical Hurdles 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 OutlineTravel & Accommodations\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 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 \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 URL:https://www.complexgenerics.org/education-training/long-acting-injectable-lai-generics-navigating-technical-hurdles-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