Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products

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 April, 13, 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

Senior Vice President and Head-Clinical Research and Biopharmaceutics Department, Mankind Pharma Ltd.

Dr. Tausif Ahmed is currently working as Sr. Vice President & Head-Clinical Research & Biopharmaceutics Department at Mankind Pharma Limited, Delhi, India. He is responsible for managing all Bioequivalence studies, preclinical Tox and Phase III clinical trials supporting domestic and global complex generic products across all dosage forms at Mankind. Prior to joining Mankind, Dr. Tausif worked as Sr. VP Bioequivalence and CT at Aizant Drug Research solution Pvt., Ltd. Hyderabad, India.  In past he has worked as Vice President & Head-Biopharmaceutics & Bioequivalence in the Global Clinical Management group, IPDO at Dr. Reddy’s Laboratories Limited (DRL), Hyderabad. He was responsible for managing all Bioequivalence studies supporting global complex generic products at DRL. He was also involved in PK/Modelling and Simulation activities supporting global generic development. Prior to joining DRL, he was Associate Director and Head-DMPK (preclinical discovery, Clinical dev., and Generic) & Dy. Test Facility Mgt. GLP toxicology dept. at Piramal Enterprises Limited, Mumbai. Dr. Ahmed has been associated with different pharmaceutical companies such as Dr. Reddy’s Research Foundation (DRF), Ranbaxy Research Laboratories, Sai Life Sciences Limited, and Piramal Enterprises Limited in the past. He obtained M.S. in Pharmaceutics from NIPER and Ph.D. in Pharmaceutical Medicine (specialization: Biopharmaceutics and PK/PD) from Hamdard University (Ranbaxy, now Sun Pharma Sponsored). He has been working in the field of drug discovery, development, phase I/II, and generic BA-BE studies for more than 23 years. His area of specialization includes DMPK, metabolite-ID, population PK, PK-PD modelling, and simulation, generic BA/BE studies and GLP bioanalysis. In recent years his focus is on use PBBM/PBPK modelling in generic drug development. He has extensive experience in outsourcing preclinical and clinical studies to CROs both in and outside of India. Dr. Ahmed has contributed to >15 IND filings, multiple ANDAs, and Phase I/II/III regulatory submissions, nationally and globally. He has co-authored two book chapters and over 50 papers and presentations. He is a reviewer for many international journals and is on the Editorial board of Int. J. Pharma Research. Dr. Ahmed is a guest faculty at Hamdard University, NMIMS (Mumbai), NIPER, and various other universities in India. He has also supervised many Master’s and Ph.D. students. 

Director, Biopharmaceutics & Pharmacokinetics, Cipla Ltd.

Dr. Yasvanth Ashokraj holds a Master’s degree and a Ph.D. in Pharmaceutics from NIPER, India, and has more than 20 years of experience in the generic pharmaceutical industry. He is currently working as Director, Biopharmaceutics and Pharmacokinetics at Cipla Ltd., India. He is responsible for leading technical teams involved in in vitro evaluatory method development, BA/BE studies, and PK/PD modeling and simulation across generics, complex generics, and 505(b)(2) products covering a wide range of dosage forms. He is presently focused on various applications of model‑based BE frameworks to address challenges related to bioequivalence. He has published over 25 research and review papers and also serves as a key contributor to the Education and Training Wing of the Society of Pharmacometrics and Health Analytics (SOPHAS), supporting the advancement of quantitative sciences in India. 

Lead Pharmacokineticist, DQMM, ORS, OGD, CDER, FDA

Dr. Andrew Babiskin is a Lead Pharmacokineticist in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs, CDER. He previously led the Locally-acting Physiologically Based Pharmacokinetic Modeling Team and the Quantitative Clinical Pharmacology Team in DQMM. Dr. Babiskin’s expertise lies in modernization of bioequivalence evaluation practices through model-integrated evidence. Dr. Babiskin received his B.S. degree from the University of Maryland (College Park) in Chemical Engineering and his M.S. and Ph.D. degrees from the California Institute of Technology in Chemical Engineering. He joined the FDA in 2012 as an ORISE postdoctoral fellow in the OGD Science Staff (now ORS) and became an employee within DQMM in 2014. 

Team Lead, Biopharmaceutics, Dr. Reddy’s Laboratories Ltd.

Dr. Rajkumar Boddu received his Ph.D. from Jawaharlal Nehru Technological University (JNTU), Hyderabad, and his M. Pharmacy degree in Pharmaceutical Technology from Andhra University, Visakhapatnam, India. He is currently serving as Team Lead in the Biopharmaceutics Department within the Global Clinical Management group at the Integrated Product Development Organization (IPDO), Dr. Reddy’s Laboratories Limited (DRL), Hyderabad. He is responsible for biopharmaceutics evaluations through model-informed drug development, bioequivalence (BE) risk assessment, and BE predictions for both conventional and complex generic products. Prior to joining DRL, he worked with organizations such as AET Labs, Aizant Research Solutions, and Hetero Drugs. With over 15 years of experience in biopharmaceutics and formulation development, Dr. Raj is an accomplished pharmaceutical scientist whose core expertise includes physiologically based biopharmaceutics Modeling (PBBM) and physiologically based pharmacokinetic Modeling (PBPK). These advanced modeling approaches are applied to oral solid dosage forms, long-acting injectables, topical formulations, and differentiated 505(b)(2) products. He has extensive experience in regulatory justifications, including biowaivers, dissolution specifications, dissolution similarity evaluations, drug-drug interactions (DDI) supported by physiological modeling techniques. Dr. Raj has authored or co-authored more than 30 peer-reviewed publications and serves as a scientific reviewer for several journals. He is also a sought-after speaker at international conferences, where he has delivered numerous talks on PBPK/PBBM applications in new drug and generic product development. 

Lead Pharmacokineticist, DTP II, ORS, OGD, CDER, FDA

Dr. Heather Boyce serves as a Lead Pharmacokineticist for the Modified Release Oral Drug Products Team in the Division of Therapeutic Performance II (DTPII), Office of Research and Standards (ORS), Office of Generic Drugs, Center for Drug Evaluation and Research at the Food and Drug Administration in White Oak, MD.  

Dr. Boyce brings 15 years of experience in the pharmaceutical industry with expertise in good manufacturing processes (GMP), pharmaceutical manufacturing and product development, clinical trial design and analysis, and clinical pharmacology. 

Dr. Boyce received her Ph.D. in Pharmaceutical Sciences at the University of Maryland, Baltimore, School of Pharmacy where her research focused on excipient properties and formulation design of pharmaceutical drug products. She received her Bachelor of Science degree in chemistry with a minor in mathematics from Temple University of Philadelphia, PA.  

Research Scientist, DQMM, ORS, OGD, CDER, FDA

Dr. Yi-Hsien Cheng is currently working as a research scientist at the Division of Quantitative Methods and Modeling (DQMM) within the Office of Research and Standards (ORS), Office of Generic Drugs (OGD) at FDA. She received her Ph,D, degree in Bioenvironmental Systems Engineering from National Taiwan University in 2013, where she completed her first postdoctoral fellowship. Before joining FDA in 2021, she completed her second postdoctoral fellowship in the Institute of Computational Comparative Medicine (ICCM) at Kansas State University.  

Dr. Cheng’s work at the Oral PBPK Team in DQMM focuses on applying physiologically based pharmacokinetic (PBPK) modeling and simulation approaches to support bioequivalence (BE) assessment for oral drug products. Her work focuses on utilizing PBPK modeling and virtual BE simulations to evaluate the sensitivity of using parent vs. metabolite as analytes in BE assessment, assessing the impact of food-formulation variability on BE studies, evaluating the effect of non-comparable in vitro dissolution or alcohol dose dumping (ADD) results on BE evaluation, supporting single-sex study population justification in generic drug BE evaluations, and assessing the impact of reformulation on the bioavailability (BA) and BE of nitrosamine-impacted BCS-IV oral drug products.  

Senior Vice President, Clinical Pharmacology, A2-Ai, LLC

Dr. Jack Cook joined A2-Ai in June of 2023 and is a Senior Vice President in the Clinical Pharmacology Department   Prior to that, Jack spent 33 years at Pfizer, Inc.  where he worked in a multitude of therapeutic areas.  Dr. Cook holds adjunct faculty positions at the Universities of Michigan and Florida Colleges of Pharmacy. He received B.S. degrees in Applied Mathematics and Pharmacy from Ferris State College, and his Ph.D. in Pharmaceutics from the University of Michigan. He has authored/co-authored over 85 peer-reviewed publications. He served as an industrial representative for the United States Food and Drug Administration’s Pharmaceutical Science and Clinical Pharmacology Advisory Committees from 2012 to 2019. He is a fellow of the AAPS. His current interests include improving therapy by optimizing drug delivery and the use of modeling and simulation to make rational decisions in the development of drugs. 

Senior Pharmacologist, DB III, OB, OGD, CDER, FDA

Dr. Pamela Dorsey is a Senior Pharmacologist in the Division of Bioequivalence III. She is a secondary assessor for controlled correspondences and serves as a subject matter expert for the Generic Drug Structured Assessment-Bioequivalence development group and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, M13A guideline implementation group. Dr. Dorsey has extensive knowledge in the use of alternate comparator products for bioequivalence determination of generic drug products. 

Prior to joining the FDA in 2014, Dr. Dorsey was a Cardiovascular Clinical Research Ruth Kirschstein Post-Doctoral Fellow at Boston University. Dr. Dorsey earned her Doctorate in Pharmaceutical Science from The University of Georgia, College of Pharmacy. In addition, Dr. Dorsey received a Bachelor of Science and Master of Science in Chemical Engineering from North Carolina Agricultural and Technical State University.  

Division Director, DQMM, ORS, OGD, CDER, FDA

Dr. Lanyan (Lucy) Fang serves as Deputy Director of the Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards, Office of Generic Drugs (OGD), CDER/FDA. In this role, Dr. Fang oversees data analytics and leads the development of AI strategies for FDA’s generic drug program. She has established herself as a leading FDA expert in the application of modeling and simulation approaches for the review and regulation of generic drugs. 

Prior to her career at OGD, Dr. Fang worked as a senior clinical pharmacology reviewer in FDA’s Office of Clinical Pharmacology and as a senior pharmacokinetist at Merck. She earned her Ph.D. in Pharmaceutical Sciences from The Ohio State University and is a graduate of the Excellence in Government Fellows program (2014-2015). 

Director, Biopharmaceutics & Statistics, Apotex Inc

Dr. Emilija Fredro-Kumbaradzi is Director of Biopharmaceutics and Statistics at Apotex. She is responsible for Biopharmaceutics aspects in the development of generic drug products. Her work spans dissolution science, in vitro comparisons, in silico modeling, and biowaiver justifications, ensuring alignment with global regulatory standards. She also oversees clinical research activities related to bioequivalence studies and clinical study design, with a focus on regulatory strategy and scientific integrity. With over 20 years at Apotex, Dr. Fredro-Kumbaradzi brings extensive experience in the biopharmaceutic evaluation of solid oral dosage forms. She holds a Ph.D. in Pharmaceutical Sciences from the University of Skopje, Macedonia, where she previously served as a Professor of Pharmaceutical Technology.

Lead Pharmacologist, DQMM, ORS, OGD, CDER, FDA

Dr. 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.  

Pharmacokineticist, DB I, OB, OGD, CDER, FDA

Dr. Min Guo is a Pharmacokineticist in the Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs at the FDA’s Center for Drug Evaluation and Research, a position he has held since April 2024. Previously, Dr. Guo served as a bioequivalence reviewer in the Division of Generic Animal Drugs at the FDA’s Center for Veterinary Medicine from 2019 to 2024. Prior to joining the FDA, Dr. Guo conducted postdoctoral research at the National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health (2015-2019), where he specialized in development and GMP production of C-11 and F-18 based PET imaging radiopharmaceuticals for studying substance abuse effects on the brain in clinical neuroimaging studies. 

Dr. Guo earned his Ph.D. in Organic Chemistry and Biochemistry from the University of Maryland, College Park, and holds an M.S. and B.S. in Chemistry from Nanjing University, China.  

Research Scientist, DQMM, ORS, OGD, CDER, FDA

Dr. Robert Hopefl is a Contractor working in the Quantitative Clinical Pharmacology team of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD). He joined the FDA as an ORISE Fellow in September of 2023. During his time as a fellow, he leveraged modeling and simulation approaches to investigate bioequivalence evaluation of topical products and carryover effects in products with a long elimination half-life. His current work focuses on pharmacokinetics and clinical pharmacology to develop guidances to facilitate development of various generic drug products, including oral drugs, long-acting injectables, and orally inhaled drug products. His research interests include quantitative modeling, pharmacokinetics, and innovative bioequivalence approaches. Prior to joining the FDA, Robert earned his PharmD from Larkin University. 

Director, DTP II, ORS, OGD, CDER, FDA

Dr. Myong Jin Kim serves as Director of the Division of Therapeutic Performance II within the Office of Research and Standards, Office of Generic Drugs at CDER/FDA. Since joining the FDA in 2001, she has held several key positions, including Deputy Director of the Division of Quantitative Methods and Modeling and Team Leader in the Office of Clinical Pharmacology.

Dr. Kim earned her Bachelor of Science degree in Chemistry from the Georgia Institute of Technology. She went on to receive her Doctor of Pharmacy degree from Temple University School of Pharmacy and completed a two-year postdoctoral fellowship in clinical pharmacology at Bassett Healthcare, a major teaching affiliate of Columbia University College of Physicians and Surgeons, in New York.

Senior Manager, Formulation R&D, Orals, Sun Pharmaceuticals Industries Ltd.

Dr. Lalit Kumar Khurana holds a Ph.D. in Pharmaceutical Medicine from Jamia Hamdard Delhi and brings over 19 years of industrial experience in generic formulation development and clinical pharmacology. His expertise spans pharmacokinetic (PK) analysis, biopharmaceutic evaluations, and modelling and simulation to support formulation development, bioequivalence studies, and regulatory submissions. He has a proven track record in applying advanced PK principles, integrating in vitro–in vivo extrapolation (IVIVE) and mechanistic modelling for complex compounds, as well as implementing bridging strategies across global markets.

Lalit is highly skilled in PBPK modelling, with hands-on experience using platforms such as GastroPlus, PK-Sim, and SimBiology (MATLAB). His work includes developing and validating mechanistic models, interpreting clinical pharmacokinetic data, and supporting decision-making in both early and late-stage drug development.

Head, Bioavailability & BE Division, Sun Pharmaceuticals Industries Ltd.

Dr. Arshad H. Khuroo currently serves as the Head of the Bioavailability and Bioequivalence Division at Sun Pharmaceuticals, India. He holds a Ph.D. in pharmacokinetics and brings over 30 years of extensive expertise in the field. His professional strengths include deep knowledge of GCP/GLP guidelines, protocol design, biopharmaceutical evaluation, clinical operations, and regulated bio-analysis for pharmacokinetic and pharmacodynamic endpoint studies supporting ANDA/NDA 505(b)(2) filings. 

As Test Facility Manager, Dr. Khuroo ensures GLP compliance in the conduct of pre-clinical studies. Over his distinguished career, he has successfully navigated more than 100 regulatory inspections worldwide. He has authored or co-authored over 100 scientific articles published in leading international journals. 

Beyond his scientific contributions, Dr. Khuroo is also an accomplished author of two books—Echoes of Experience: 30 Insights from Life’s Journey and Perceivable Interactions—both of which have been well-received by readers globally. 

Vice President & Head, Biopharmaceutics, Dr. Reddy’s Laboratories Ltd.

Dr. Sivacharan Kollipara is currently working as Vice President & Head, Biopharmaceutics department in the Global Clinical Management group, IPDO at Dr. Reddy’s Laboratories Limited (DRL), Hyderabad. He is responsible for biopharmaceutics evaluation, bioequivalence risk assessment, and bioequivalence prediction for conventional as well as complex generic products at DRL. He is also involved in PK modeling and simulations activities supporting generic drug development of various immediate release, modified release, and complex products at DRL and involved in utilizing novel PBPK and PBBM modeling approaches for regulatory justifications for various markets. Prior to joining DRL, Dr. Kollipara was Principal Scientist (Global Pharmaceutical Development) at Novartis Healthcare Pvt Ltd., Hyderabad. Previously he also has been associated with Ranbaxy Research Laboratories, Gurgaon (Metabolism and Pharmacokinetics). He obtained Masters in Pharmaceutical Sciences from BITS, Pilani, Rajasthan, India and Ph.D. in Biopharmaceutics. Dr. Kollipara is also Chair Person, Scientific Planning Committee for SOPHAS (Society of Pharmacometrics & Health Analytics), India. Overall Dr. Kollipara has an experience of 18 years in the field of drug discovery, development and generic product development, bioanalytical method development and validation, PK data modelling and simulations. He has authored/co-authored more than 60 peer-reviewed publications and is scientific reviewer for many peer-reviewed journals. His research interests include PBPK/PBBM modeling, biowaivers, virtual bioequivalence simulations, IVIVC/R, drug-drug interactions, dissolution/bioequivalence safe space, bio-predictive dissolution methodologies, biowaivers, alternative BE approaches, pharmacometrics and novel statistical tools for dissolution similarity analysis and food effect evaluations. Dr. Kollipara has been invited as speaker in various international conferences and delivered numerous scientific talks on PBPK, PBBM approaches in new drug and generic product development, use of model integrated bioequivalence approaches and biowaivers. 

Head Clinical Innovation, Clinical Pharmacology M&S, Sandoz Global Development

Dr. Dejan Krajcar holds a Master’s degree in Pharmacy and a Ph.D. in Biomedicine from the University of Ljubljana, Faculty of Pharmacy. He has over 16 years of experience in clinical development, including clinical trial strategy, clinical pharmacology, pharmacometrics, IVIVC, biostatistics, study planning, execution and oversight. His development experience spans a wide range of products, including oral solid dosage forms, nasal, topical, respiratory, and injectable products. 

His work focuses on bioequivalence (BE) strategy and data-driven decision-making for complex and challenging development programs. He has authored publications related to machine learning driven bioequivalence risk assessment and has contributed to peer-reviewed work involving physiologically based pharmacokinetic (PBPK) modelling. 

Since 2023, he has led a team in Sandoz dedicated to model integrated drug development, with a particular focus on innovative and regulatorily acceptable approaches when conventional clinical study designs are not feasible. 

Assistant Professor, University of Maryland Baltimore

Dr. Brooke Langevin is an Assistant Professor in the Center for Translational Medicine at the University of Maryland School of Pharmacy. She received her Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore. Her work focuses on applying quantitative and model-informed approaches to support decision-making in drug development and clinical practice, with a particular emphasis on data-limited settings. This work spans applications in rare disease, pregnancy, and bioequivalence, where limited data require alternative quantitative strategies for regulatory evaluation.

Associate Director for Science, OB, OGD, CDER, FDA

Dr. Bing V. Li is the Associate Director for Science in the Office of Bioequivalence within the Office of Generic Drugs at the U.S. Food and Drug Administration (FDA). In this role, she provides scientific leadership and expertise in the assessment of bioequivalence (BE) studies submitted through Abbreviated New Drug Applications (ANDAs) and oversees the scientific initiatives within the Office of Bioequivalence. Dr. Li is an Expert Pharmacologist at the FDA, specializing in the bioequivalence of aerosolized drug products. Before joining the FDA in 2004, Dr. Li was a Research Investigator at Bristol-Myers Squibb. She earned her Ph.D. in Pharmaceutical Sciences from the University of Wisconsin–Madison in 2001, and her bachelor’s degree in Medicinal Chemistry from Peking University, China, in 1990. 

Pharmacologist, DTP II, ORS, OGD, CDER, FDA

Dr. Hyelim Lim is a Pharmacologist in the Immediate Release (IR) Team in DTP II as a Visiting Associate (Staff Fellow). She works on regulatory activities including product-specific guidance (PSG) development, controlled correspondence review, and pre-ANDA for IR oral drug products. The DTP II is proactively developing PSGs for suitability petition-enabled generic products. Her research includes administration methods for chewable products, baseline correction for bioequivalence studies of endogenous compounds, and translating pharmacokinetic science for locally acting gastrointestinal products. She serves as Project Officer for research on Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drugs (RFA-FD-009). Hyelim presents her research at scientific meetings including the American College of Clinical Pharmacology and American Society for Clinical Pharmacology and Therapeutics. Before joining the IR team, Hyelim was an ORISE fellow in the Modified Release Team in DTP II, where she conducted research supporting PSG development. Hyelim received a PharmD from University of Wisconsin – Madison.  

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. 

Associate Director, DTP II, ORS, OGD, CDER, FDA

Dr. Dongmei Lu obtained her Ph.D. degree in Pharmaceutical Sciences from University of North Carolina at Chapel Hill. Her extensive industry experience includes pre-formulation and formulation at GlaxoSmithKline, Wyeth, and Pfizer. Dr. Lu served as a reviewer and team leader in the Office of Bioequivalence within the Office of Generic Drugs before transitioning to the Office of Policy for Pharmaceutical Quality in OPQ. There, she developed numerous policies, notably the guidance for nitrosamine-impacted products. Currently, Dr. Lu oversees the research portfolio and activities on oral dosage forms in bioequivalence perspective in DTP II/ORS.

Dr. Lu’s expertise is recognized widely, as evidenced by her role as an FDA Expert supporting ICH M13A and 13B global harmonization efforts. She is also a member of the FDA Biopharmaceutic Classification Systems Committee. Additionally, Dr. Lu contributes to several professional organizations, serving as a member of the PQRI Biopharmaceutics Technical Committee, FDA Liaison for USP nitrosamine and relevant research areas, and as an Editorial Advisory Board Member for the journal of AAPS Open.

Senior Principal Scientist, PBPK R&D, Simulations Plus, Inc.

Dr. Deanna Mudie is a Senior Principal Scientist in PBPK R&D at Simulations Plus, where she leads development of Physiologically Based Biopharmaceutics Models (PBBMs), designs mechanistic software features, and serves as technical lead and consultant on biopharmaceutics related projects. Deanna has over twenty years of experience in the pharmaceutical field spanning diverse roles in academia, large pharma, CDMO, and software companies. In addition to PBBM, Deanna has led projects in formulation development for oral bioavailability enhancement, biorelevant in vitro methodologies, and solid oral dosage form manufacturing. She is a recognized leader and has publications in physiological parameters impacting oral delivery, biopredictive dissolution testing and mechanistic modeling, and design and evaluation of amorphous solid dispersions. Deanna earned her BSE in Chemical Engineering and her Ph.D. in Pharmaceutical Sciences at the University of Michigan.  

Director, Global Clinical Operations, Gx-Pharmacokinetics, US, Teva Pharmaceuticals

Ms. Suparna Mukherjee is Director of Global Clinical Organization at Teva Pharmaceuticals, bringing over 20 years of experience in generic drug development. She is an expert in designing and executing bioequivalence (BE) studies, shaping clinical strategy, and leading regulatory interactions. Her work spans biopharmaceutics, PK/IVIVR, CRO oversight, and agency engagement across the entire product lifecycle—from early development through commercial launch.

She holds a Master of Pharmacy (MPharm) from Jadavpur University, India, and a Bachelor of Pharmacy from N.M.V.P.S. College of Pharmacy, Pune University.

Staff Fellow, DQMM, ORS, OGD, CDER, FDA

Dr. Arindom Pal is a Staff Fellow in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs at the U.S. Food and Drug Administration (FDA). Dr. Pal earned his Ph.D. in Pharmaceutical Sciences from the University of California, Pacific in 2019. Following his doctoral studies, he completed a three-year postdoctoral fellowship at Johns Hopkins University School of Medicine, where he contributed to the DMPK group within the Johns Hopkins Drug Discovery Center.  Dr. Pal joined the FDA in 2023 as an ORISE Fellow and transitioned to his current role as Staff Fellow in 2024.

His research expertise encompasses physiologically-based pharmacokinetic (PBPK) modeling, drug metabolism and pharmacokinetics (DMPK), and targeted drug delivery systems. At the FDA, Dr. Pal focuses on oral PBPK modeling and simulations to support regulatory reviews and advance research initiatives within DQMM. His multidisciplinary training in biopharmaceutics, pharmaceutical chemistry, and pharmacology provides a strong foundation for his contributions to pharmaceutical science and regulatory science. 

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. Blaž Robnik is a Group Head in Analytical Development at Sandoz, based in Ljubljana, Slovenia. He leads a team focused on mechanistic understanding of drug product stability, impurity formation, and the development of robust control strategies for standard and specialty generics. 

He holds a Ph.D. in Biomedicine (Pharmacy) from the University of Ljubljana, where his doctoral research focused on reactions of amine‑containing active ingredients with reactive excipient impurities, work that laid the foundation for his continued focus on degradation pathways and nitrosamine risk. He played a key role in the application of kinetic and predictive modeling to drug product development, enabling early risk identification, sensitivity analysis, and data‑driven formulation decisions. 

Research Fellow, Drug Product Design & Supply, Pfizer Global R&D

Dr. Kazuko Sagawa is a Research Fellow at Pfizer Research and Development in Groton, Connecticut.  As a member of a multidisciplinary team within Pfizer, she has been involved in developing biopharmaceutics strategy for drug product development.  The work includes biopharmaceutics risk assessment, PBPK model development, and clinical bioequivalence risk assessment.  Dr. Sagawa received her B.Sc in Pharmacy from Tokyo University of Pharmacy and Life Sciences (Tokyo Japan) and her Ph.D. in Pharmaceutical Sciences from the University of New York at Buffalo (Buffalo, NY) 

Global Head, Global Clinical Management, Dr. Reddy’s Laboratories Ltd.

Dr. Anuj Kumar Saini is the Global Head – Global Clinical Management at Dr.
Reddy’s Laboratories Limited, Hyderabad, India. He leads global preclinical and
clinical development strategy and operations, with oversight across
biopharmaceutics, clinical operations, immunogenicity, biostatistics and data
management, medical writing, program management, bio-innovation, and
external collaborations.

With over 22 years of experience across the pharmaceutical industries and
contract research organizations, including 17 years in senior leadership roles, Dr.
Saini brings deep expertise in the development of small molecules, peptides,
biosimilars, complex injectable and drug-device combination products,
respiratory therapies, topical, and transdermal formulations. His work spans
preclinical through late-phase clinical development, with strong strengths in
PK/PD, immunogenicity, PBPK modelling, and global regulatory submissions.
Dr. Saini is passionate about delivering data-driven development strategies that
enable efficient global product approvals while meeting the highest scientific and
regulatory standards.

Team Head, Biopharmaceutics (CPP), Sun Pharmaceuticals Industries Ltd.

Ms. Pradnya Shahapure currently serves as Team Head – Biopharmaceutics within the Clinical Pharmacology and Pharmacokinetics department at Sun Pharmaceutical Industries Limited, Gurugram, India. In her role, she leads the development and implementation of modeling based strategies for Virtual Bioequivalence (VBE) assessments to support clinical study waivers. She also provides mechanistic, model informed insights to guide formulation development, leveraging advanced in silico tools and biopharmaceutics modeling approaches. 

Ms. Shahapure earned her Master’s degree in Pharmacy (Biopharmaceutics) from Shivaji University, Kolhapur. With more than 23 years of experience in the bioequivalence domain, she has contributed extensively across multiple functional areas, including bioanalysis, quality control, and oversight of clinical and bioanalytical phases of BE studies.  

Associate Director of Clinical Safety, DTP II, ORS, OGD, CDER, FDA

Dr. Jihong Shon possesses extensive scientific and regulatory expertise spanning clinical pharmacology, clinical trials, and drug safety assessment. Since 2020, Dr. Shon has held the position of Clinical Assessor in the Clinical Safety and Human Research Team and currently serves as Associate Director of Clinical Safety, DTP-II, ORS, OGD. He also serves as Co-Chair of the Generic Drug Development Safety Committee (GDDSC) at OGD. He previously served as a Senior Clinical Pharmacology Reviewer in the Office of Clinical Pharmacology (OCP), the Office of Translational Science (OTS), CDER. 

Dr. Shon earned his degrees from Inje Univ. College of Medicine in Korea. Throughout his research career, he participated in more than 80 early-phase clinical trials as either primary or sub-investigator, including bioavailability/bioequivalence studies in healthy subjects and patient populations for new and generic drug development programs. He served as a committee member and secretary for the IRB and Pharmacovigilance Unit at Busan Paik Hospital, Korea. Dr. Shon also held a teaching faculty appointment at Inje Univ. College of Medicine in Korea.  

Head of R&D and Technical Quality Global Quality, Viatris

Global Head, Regulatory Strategies Center of Excellence, Simulations Plus, Inc.

Dr. Sandra Suarez-Sharp’s academic journey began with Industrial Pharmaceutical Chemistry studies at the National Polytechnic Institute of Mexico City. After gaining practical experience at Johnson and Johnson in Mexico, she earned her Ph.D. in Pharmaceutical Sciences from the University of Florida in 1997. Her postdoctoral research at Chapel Hill University focused on Pulmonary Drug Delivery and Pharmacokinetics. Dr. Suarez-Sharp’s tenure at the U.S. FDA commenced in 1999, where she held diverse roles, including reviewer positions within the Office of Clinical Pharmacology and  scientific advisor within the Division of Biopharmaceutics, Office of Product Quality. Her expertise extended to in vitro-in vivo correlations/relationships (Safe Space), clinically relevant drug product specifications, real-time release testing, and physiologically based biopharmaceutics modeling (PBBM). Notably, she contributed to key industry guidance documents (eg., PBBM guidance) and represented the FDA at multiple scientific events.  

Joining Simulations Plus as Vice President of Regulatory Affairs in 2020, Dr. Suarez-Sharp now leads the Regulatory Strategies Center of excellence, a team of talented scientists applying advanced modeling and simulation techniques for strategic planning, decision-making, and risk management in drug development to support regulatory decision making. Her extensive publication record and contributions have significantly influenced pharmaceutical sciences and regulatory practices. 

Master Mathematical Statistician, DB VIII, OB, OTS, CDER, FDA

Dr. Wanjie Sun is a Master Mathematical Statistician at the FDA/CDER/OTS/Office of Biostatistics/DB8. She was the 2024 President of the 2024 FDA Statistical Association. Wanjie joined the FDA in 2013 after working in industry for a couple of years and spending twelve years at George Washington University as a Principal Investigator, Co-Principal Investigator, and Lead Research Scientist. She received her PhD degree in Biostatistics from the George Washington University.  

Wanjie is actively engaged in regulatory research and has contributed to multiple ICH and FDA guidance. She has received numerous FDA awards recognizing her contributions to regulatory research, scientific communication, and leadership. She has authored/co-authored 60+ publications and serves as an Associate Editor for Pharmaceutical Statistics. 

Senior Scientific Advisor, Head of Mechanistic Oral Absorption Modeling, Certara Predictive Technologies UK Ltd. (Simcyp Division)  

Dr. David Turner’s main role at Certara Predictive Technologies lies in the development and application of mechanistic oral absorption models embedded in PBPK platforms, including tools for virtual bioequivalence assessments and safespace identification. In addition, I am a strong advocate of the mechanistic modelling of in vitro biopharmaceutic experiments (the digital twin concept) to better parameterise and add confidence to PBPK models. I joined Simcyp in 2004 prior to which I worked in a Computational Chemistry Group (Synt:em SA, Nîmes, France) focussed mainly upon high throughput in silico discovery and virtual screening projects. I have a PhD in QSAR modelling and am author or co-author on 46 peer-reviewed papers mostly in the area of PBPK modelling. 

Senior Pharmacologist, DQMM, ORS, OGD, CDER, FDA

Dr. Fang Wu is a senior pharmacologist reviewer and scientific lead for oral Physiologically–based Pharmacokinetic modeling in Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD) in FDA. Dr. Wu has been with FDA for more than 14 years. She is responsible for using modeling and simulations tools for reviewing pre-abbreviated new drug applications (pre-ANDA) meeting packages, ANDA consults and controlled correspondences. Prior to joining DQMM, Dr. Fang Wu was a biopharmaceutics reviewer for more than 4 years and responsible for NDA and ANDA reviews. She has been a principal and co-principal investigator for multiple FDA research projects and involved in several guidance working groups and grant review panels. 

Division Director, DPQA XII, OPQA II, OPQ, CDER, FDA

Dr. Hailing Zhang serves as Division Director of the Division of Product Quality Assessment XII (DPQA XII) in the Office of Product Quality Assessment II (OPQA II), Office of Pharmaceutical Quality (OPQ). Dr. Zhang earned her Ph.D. in Organic Chemistry and Physical Organic Chemistry from Emory University in Atlanta, Georgia. Prior to joining the FDA in 2014, she was an Associate Professor of Pharmaceutical Science in the College of Pharmacy at Mercer University in Atlanta, Georgia. In her current role as Division Director of DPQA XII, Dr. Zhang leads a team of accomplished pharmacokineticists who provide biopharmaceutic assessments and approvals for various submissions under the GDUFA and PDUFA programs. 

Deputy Director, ORS, OGD, CDER, FDA

Dr. Lei Zhang serves as the Deputy Director of Office of Research and Standards within Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She oversees the Generic Drug User Fee Amendments (GDUFA) science and research program to ensure the therapeutic equivalence of generic drug products. Dr. Zhang was previously Senior Advisor for Regulatory Programs and Policy in the Office of Clinical Pharmacology at CDER, FDA.  Dr. Zhang is an accomplished professional with more than 27 years of combined experiences in the areas of drug research, development and regulatory review and approval. She has contributed to numerous guidance development and research projects focused on science-based regulatory decision making. Before joining FDA in 2002, she worked at Bristol Meyers Squibb as a Research Investigator and Preclinical Candidate Optimization Team Leader. Dr. Zhang is an Adjunct Professor in the Department of Bioengineering and Therapeutic Sciences, University of California at San Francisco (UCSF), Schools of Pharmacy and Medicine. Dr. Zhang received her Ph.D. in Biopharmaceutical Sciences from UCSF.  She is currently the Rapporteur for the ICH M13 Expert Working Group that is developing harmonized guidelines on bioequivalence (BE) for immediate-release solid oral dosage form drugs including M13A, M13B and M13C. Dr. Zhang was inducted American Association of Pharmaceutical Scientists (AAPS) Fellow in 2013. She received the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Malle Jurima-Romet Mid-Career Leadership Award in 2023. She is a member of ASCPT, ISSX, AAPS, and ACCP.  She serves/has served various volunteer and leadership roles in these organizations. She has published more than 140 peer-reviewed papers and book chapters. 

Lead Pharmacologist, DTP II, ORS, OGD, CDER, FDA

Dr. Qi Zhang is the Team Lead for Immediate Release Drug Products in the Division of Therapeutic Performance II, Office of Research and Standards at the U.S. Food and Drug Administration. In her current role, she leads regulatory reviews, product-specific guidance development, and research initiatives addressing critical gaps in generic drug development and approval. Since joining the FDA in 2014, Dr. Zhang has served in various roles across the Office of New Drug Products, Office of Pharmaceutical Quality, and Office of Generic Drugs. She has evaluated biopharmaceutics and clinical pharmacology sections for new and generic drug applications supporting multiple clinical divisions, as well as inter-center consults. A primary focus of her work has been her leadership of the ICH M13A Implementation, where she developed: risk-based frameworks and mitigation strategies for vulnerable populations (including oncology, pediatric, and nitrosamine-impacted products), new and alternative methodologies for high-risk products, and regulatory frameworks for products where reference standards are unavailable. Dr. Zhang specializes in complex drug products, oral complex generics, Biopharmaceutics Classification System (BCS), biowaiver and bridging strategies, and clinically relevant dissolution/drug release. 

Regulatory Officer, DTP II, ORS, OGD, CDER, FDA

CDR Yi Zhang holds a Ph.D. in Pharmacology and Master’s and Bachelor’s degrees in Pharmaceutical Sciences. She is a subject matter expert in bioequivalence (BE) standards and approaches for diverse drug dosage forms to promote generic drug development and approval. She pioneered and established the first Product-Specific Guidance (PSG) program while serving as BE Director in the Office of Bioequivalence (OB). She has led multiple teams in the Office of Research and Standards (ORS), including the PSG Development Team, Dermatological and Topical Product Team, and Immediate Release Oral Solid Dosage Forms Drug Team. Her leadership has expedited international harmonization on generic drug guidance and fostered collaboration with external stakeholders to develop automated assessment tools that improve efficiency and accuracy through artificial intelligence and machine learning applications. CDR Zhang also leads multiple research projects addressing critical regulatory scientific issues in generic drug development and approvals, with particular focus on Biopharmaceutics Classification System (BCS) Class III-based biowaivers, locally acting gastrointestinal products, and challenges related to unavailable reference listed drugs (RLD) and reference standards (RS). 

Associate Division Director, DB III, OB, OGD, CDER, FDA 

Dr. Yi Zhang is the Associate Director for Division of Bioequivalence III in the Office of Bioequivalence, Office of Generic Drugs. Dr. Zhang joined Office of Bioequivalence in 2014, and during his tenure, Dr. Zhang has served as a primary, secondary, and tertiary assessor to conduct critical evaluation of bioequivalence studies in abbreviated new drug applications (ANDAs), Control Correspondences (CCs), Protocols, and various other regulatory submissions for generic drug products, where he works collaboratively to address complex issues identified during bioequivalence assessments. Dr. Zhang is currently actively engaged in several working groups and research projects at divisional and office levels to support scientific and regulatory-based decisions making for the review of generic products. Dr. Zhang holds a B.S. in Pharmaceutical Science from Peking University Health Science Center and a Ph.D. in Pharmacology from Chinese Academy of Medical Sciences. 

Master Pharmacologist, DB I, OB, OGD, CDER, FDA 

Dr. Zhen Zhang is a Master Pharmacologist in the Division of Bioequivalence I, Office of Bioequivalence, within the FDA’s Office of Generic Drugs (OGD). His extensive expertise includes data analysis, modeling and simulation, dissolution studies, and topical product evaluations. Dr. Zhang leads efforts to modernize data analysis tools within the Office of Bioequivalence, significantly enhancing the efficiency of bioequivalence reviews. He also co-leads OGD’s Oral PBPK Expert Committee. Over the course of his career, Dr. Zhang has addressed numerous complex bioequivalence challenges and played a key role in the development of several FDA general guidances. Dr. Zhang earned his Ph.D. in Pharmacology from the University of Wisconsin-Madison. 

Research Scientist, DTP II, ORS, OGD, CDER, FDA

Dr. Gang Zhao joined the Division of Therapeutic Performance (DTP) II within the Office of Research and Standards (ORS) as an ORISE fellow in November 2023. As a member of the Immediate Release (IR) Team, he conducts risk assessments for complex oral drug formulations and supports ICH M13A guidance implementation. His work includes developing and revising product-specific guidances (PSGs) for IR oral drug products, reviewing controlled correspondence on bioequivalence study design, and evaluating the impact of critical excipients and formulation strategies on drug absorption and bioequivalence. 

Prior to joining the FDA, Gang served as a senior scientist at Ensign Pharmaceutical, where he led preclinical pharmacology studies and specialized in polymeric prodrug delivery systems for poorly soluble drugs and long-acting therapeutics. He earned his B.S. in Biotechnology from Jilin University and Ph.D. in Pharmaceutical Sciences from the University of Nebraska Medical Center. 

Senior Research Pharmacologist, DPQR V, OPQR, OPQ, CDER, FDA

Dr. Ahmed Zidan is a Senior Research Pharmacologist in the Division of Pharmaceutical Quality Research (DPQR V), Office of Pharmaceutical Quality Research (OPQR), within the Office of Pharmaceutical Quality (OPQ) at the U.S. Food and Drug Administration (FDA). He received his Ph.D. in Pharmaceutics in Zagazig University through a scholarship at Howard University, where his training focused on drug delivery, biopharmaceutics, advanced manufacturing, and formulation science, providing a strong foundation for his work in oral drug product performance and regulatory science. His work focuses on the mechanistic understanding of oral drug product performance and the development of regulatory science frameworks integrating biopredictive dissolution, in vitro–in vivo correlation (IVIVC), and physiologically based pharmacokinetic (PBPK) modeling to support bioequivalence assessment. 

Dr. Zidan has led and contributed to multiple FDA translational and research programs addressing complex generic drug development, including modified-release formulations and products where conventional bioequivalence approaches are challenged. He has authored numerous peer-reviewed publications and scientific reports and has delivered invited presentations at national and international scientific conferences on biopharmaceutics and other regulatory science. He has also received several FDA recognition awards for his contributions to advancing the additive manufacturing and regulatory sciences.