Navigating the GLP-1 Generic Drug Pathway

The workshop will be held at the Universities at Shady Grove (USG).

Address: Building II, Ballroom (please follow signs), 9630 Gudelsky Drive, Rockville, MD 20850

• Travel 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.
• As 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.
• The 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.

More links and information:

• Directions and transportation options to USG
• Public transportation
• Campus map

• The 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.
• Visitor 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.
• Guests are responsible for the cost of parking; parking will not be validated. Parking is $16 for all day.

Click for parking information from the USG website.

Please click on the following “all transportation options” links to find transportation from the airport via subway, bus, taxi, car, and town car.

• Reagan National Airport (DCA): 21.1 miles from Rockville, MD (all transportation options from DCA) (train options from DCA)
• Dulles International Airport (IAD): 27.8 miles from Rockville, MD (all transportation options from IAD) (train options from IAD)
• Baltimore/Washington International Thurgood Marshall Airport (BWI): 37.5 miles from Rockville, MD (all transportation options from BWI) (train options from BWI)

Train tickets (Omio)

• Washington, DC to Baltimore: Approximately 35 minutes
• Penn Station Marc SB (Baltimore): Approximately 41 miles from campus

Empire Sedan & Limo Services (empiresedan12@gmail.com):  240-988-1796

Washington Flyer Taxi:  703-572-TAXI or 706-853-6094

Regency Taxi:  301-984-1900

Bob’s Limo Service (Email): 301-525-2525

B&B Executive Sedan (Email): 240-533-6262

East Coast Limousine (Email): 301-527-0413 or 240-793-8196

Uber: Baltimore, BWI Airport, Washington, DC, Dulles (IAD) Airport

Guests should mention they are attending a conference at Universities of Shady Grove; most hotels offer discounts.

There are many hotels within a short driving distance to the USG campus including:

• Hilton Garden Inn Rockville-Gaithersburg (Book your room (CRCG rate) by Sept. 1, 2026)
  14975 Shady Grove Road, Rockville, MD 20850 (0.6 miles from USG)
  240-507-1800
• Homewood Suites by Hilton Rockville-Gaithersburg
  14975 Shady Grove Road, Rockville, MD 20850 (0.6 miles from USG)
  240-507-1900
• Courtyard by Marriott Rockville
  2500 Research Boulevard, Rockville, MD 20850 (0.9 miles from USG)
  301-670-6700
• Sleep Inn Rockville
  2 Research Ct., Rockville, MD 20850 (1.2 miles from USG)
  301-507-8000
• The Rockville Hotel, a Ramada by Wyndham
  3 Research Ct., Rockville, MD 20850 (1.2 miles from USG)
  301-202-1098
• Spring Hill Suites by Marriott Gaithersburg
  9715 Washingtonian Blvd, Gaithersburg, MD 20878 (1.4 miles from USG)
  301-987-0900
• Sheraton Rockville Hotel
  920 King Farm Blvd, Rockville, MD 20850 (1.4 miles from USG)
  240-912-8200
• Courtyard by Marriott Gaithersburg Washingtonian Center
  204 Boardwalk Place, Gaithersburg, MD 20878 (1.6 miles from USG)
  301-527-9000
• Comfort Inn Shady Grove-Gaithersburg-Rockville
  16216 Frederick Rd., Gaithersburg, MD 20877 (2.2 miles from USG)
  301-330-0023
• EVEN by IHG Hotel Rockville
  1775 Rockville Pike, Rockville, MD 20852 (5.5 miles from USG)
  855-879-3836

Vice President-Research, Synthetic Molecule Design and Development, Eli Lilly and Company

Dr. 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.  

Physician, DCR, OSCE, OGD, CDER, FDA

Dr. 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.

Research Chemist, OPQ, OPQR, CDER, FDA

Dr. 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. 

Acting Center Director, OCD, CDER, FDA

Dr. 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. 

Dr. 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. 

Assistant General Manager, Advanced Characterization Lab, Peptides & Complex Injectables, R&D, Alembic Pharmaceuticals, Vadodara Gujrat, India​​ 

Mr. 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.  

His core educational background lies in pharmaceutical sciences. He completed his Masters in Pharmaceutical Sciences (M.Pharm.) from the University of Pune in 2013. 

Mr. 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.  

Over 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. 

Associate Professor of Medicine and Director of the Pharmaceutical Policy & Outcomes Lab, UCLA

Dr. 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. 

Principal Human Factors Consultant, Core Human Factors, A Rimkus Company

Mr. 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. 

 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). 

Senior 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

Dr. 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. 

SVP, Head of Human Factors and Usability Engineering, Global Healthcare, Cambridge Consultants

Dr. 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. 

Suresh 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.

Pharmacokineticist, DTP I, ORS, OGD, CDER, FDA 

Dr. 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.  

 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. 

Physician, DCR, OSCE, OGD, CDER, FDA 

Dr. 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.

Dr. 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.

Deputy Director, OGD, CDER, FDA

Dr. 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). 

Director, Research & Development, Dr. Reddy’s Laboratories 

Sushil Kurade is an Associate Director in Research & Development at Dr. Reddy’s Laboratories, with over 20 years of experience spanning sterile product development, complex injectables, and drug-device combination products. He leads end-to-end development of peptide and GLP-1 portfolios, oncology products, ophthalmics, and lyophilized dosage forms, from inception through ANDA/dossier filing for US and EU markets. 

His work integrates device design, human factors engineering, and advanced data modelling, including mathematical models for lyophilization, rheology, and non-inferiority margin estimation. He has deep expertise in combination-product regulatory frameworks (21 CFR Part 4/820, ISO 13485, ISO 11608) and hands-on audit experience with FDA, MHRA, and ANVISA. 

Sushil established a non-inferiority margin estimation model for Human Factor Studies and conducted studies on 80 subjects in India, with an abstract selected by the European Association for the Study of Diabetes (EASD) as primary author. He holds advanced qualifications from BITS Pilani, Purdue University, and IMT Ghaziabad, and is a granted patent holder. 

Senior Pharmaceutical Quality Assessor, DPQA I, OPQA I, OPQ, CDER, FDA

Dr. 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. 

Director, ORS, OGD, CDER, FDA

Dr. 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.    

He 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.

Director, DTP I, ORS, OGD, CDER, FDA

Dr. 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.  

Pharmaceutical Quality Assessor, DPQA IV, OPQA I, OPQ, CDER, FDA

Dr. 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. 

Prior 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.

Senior Pharmacologist, ORS, OGD, CDER, FDA

Dr. 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.

Human Factors Team Leader, DMEPA I, OMEPRM, OSE, CDER, FDA

CDR 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). 

CDR 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.

Acting Team Lead, Senior Pharmacokineticist, DTP I, ORS, OGD, CDER, FDA

Dr. 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. 

Dr. 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. 

Associate Director, OCHEN, OND, CDER, FDA

Dr. 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.  

Ralph F. Shangraw/Noxell Endowed Professor, Industrial Pharmacy and Pharmaceutics, University of Maryland; co-Director, CRCG

Dr. 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).

Group Head Analytics, Sandoz Global Development, Sandoz 

Dr. 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. 

Associate Director for Science & Chief Scientific Advisor, ORS, OGD, CDER, FDA

Dr. 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. 

Medical Affairs Manager, BioPharma Systems, Becton Dickinson 

Dr. 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. 

Dr 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).  

Chemist, DPQR II, OPQR, OPQ, CDER, FDA

Dr. 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.

Supervisory Pharmaceutical Scientist, OPQ, CDER, FDA 

Dr. 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.  

Supervisory Pharmaceutical Scientist, DPQA IV, OPQA I, OPQ, CDER, FDA

Dr. 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. 

Senior Pharmaceutical Quality Assessor, DPQA IV, OPQA I, OPQ, CDER, FDA 

Dr. 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. 

Dr. 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. 

Human Factors Practice Leader, Core Human Factors, A Rimkus Company 

Ms. 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. 

Sam 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).

Scientific Researcher, DTP II, ORS, OGD, CDER, FDA

Dr. 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.

Senior Scientist II, Pipeline Development, Global Biologics, USP

Mr. 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).

Derrick’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

Human Factors Reviewer, DMEPA I, OMEPRM, OSE, CDER, FDA

Dr. 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.