Best Practices for Utilizing Modeling Approaches to Support Generic Product Development

Team Leader for Locally-Acting PBPK Modeling Team, DQMM, ORS, OGD, CDER, FDA

Dr. Andrew Babiskin currently holds the position of Team Leader for the locally-acting Physiologically Based Pharmacokinetic modeling 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). His current work focuses on advancing mechanistic-based absorption modeling of local-acting complex products to develop/support novel in vitro and in vivo pharmacokinetic-based methods to establish bioequivalence in lieu of a bioequivalence study with clinical endpoints. 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.

CEO, FLUIDDA INC

Jan De Backer graduated from Delft University of Technology, The Netherlands as Aerospace Engineer. He attained an M.Sc. degree in Aerodynamics and specialized in applied biomedical computational fluid dynamics leading to a Ph.D. from the University of Antwerp, Belgium. He is an alumnus of the MBA programs at London Business School, London and Columbia Business School, New York. Dr. De Backer has received several awards for his innovative research in the field of airway modeling in respiratory and sleep medicine. His work has been published in international journals. Dr. De Backer founded FLUIDDA in 2005 and he has held the position of Chief Executive Officer since 2007.

Chief Scientific Officer, Swati Spentose Pvt. Ltd.

Mr. Francis-Xavier Barretto is the Chief Scientific Officer at Swati Spentose Pvt. Ltd. He has extensive scientific experience and expertise in a complex polysaccharide generic molecule over the last 15 years. He heads the scientific programs to develop and launch new health solutions, and his primary goal is taking science to market. Mr. Barretto has worked with research institutes and globally renowned researchers and scientists in Europe, USA, and Australia since the inception of the company and has extensive experience and skill in process chemistry and analytical complexities related to polysaccharide science. Mr. Barretto has an M.Sc. in Microbiology from the Institute of Science, Mumbai, and has been an integral part of Swati Spentose since 2007.

Professor, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde in Glasgow

Professor Hannah Batchelor is a pharmaceutical scientist who has worked in academia, the NHS, and within pharmaceutical industry. She is currently based at the Strathclyde Institute of Pharmacy and Biomedical Science, University of Strathclyde in Glasgow.

She works on the design and manipulation of medicines to create age appropriate drug formulations to maximize clinical efficacy in pediatric patients. Her research interests lie in the optimization of drug formulations to maximize their biopharmaceutical performance and acceptability to children. Her research is informed by the views of children, young people, and parents to ensure that the patients are at the center of new developments.

Dr. Batchelor is the current chair of the Academy of Pharmaceutical Sciences in the UK. She is still passionate about pharmaceutical sciences and is motivated to inspire the next generation of scientists.

President & Global Chief Scientific Officer, Cipla Ltd.

Pradeep Bhadauria is the President and Global Chief Scientific Officer (CSO) at Cipla. In his current role, Mr. Bhadauria leads Cipla’s Global Integrated Product Development (IPD) organization to strengthen the company’s position as an innovation driven generic, biosimilars, and specialty pharmaceutical organization. Mr. Bhadauria is also a member of the Management Council of Cipla. He joined the organization in February 2020.

Prior to joining Cipla he served as Chief Scientific Officer and member of the Executive Committee at Amneal Pharmaceutical Inc. Mr. Bhadauria also served as Executive Vice President, Global R&D for Apotex Inc. Prior to joining Apotex, he served as Vice President – Generic R&D for Allergan/Actavis. Mr. Bhadauria has also held leadership positions with increasing responsibilities with Watson Pharmaceuticals Inc, Sandoz Inc and Cardinal Health (now Catalent).

With more than two decades of experience, Mr. Bhadauria is an industry veteran with expertise in building the industry’s largest pipelines for several leading generic and specialty pharmaceutical companies. Throughout his career, his leadership has resulted in the development and filing of more than 250 products, including numerous first-to-file and first-to-market opportunities. He has deep R&D expertise across nearly all dosage form, and has extensive experience on complex generics, 505(B)2, specialty, Biosimilars and other difficult-to-formulate products.

Mr. Bhadauria holds a Master of Pharmacy (M. Pharm) from the Birla Institute of Technology in India and a Bachelor of Pharmacy from SGSITS, Devi Ahilya University in India. He also holds several patents and has published research in various publications.

Senior Vice President and Head, Pharmaron US Lab Services and CGT

Dr. Sid Bhoopathy is Senior Vice President and US Head for Pharmaron Lab Services and CGT. In this role Dr. Bhoopathy’s primary responsibilities are to strengthen Pharmaron as a leading provider for Development DMPK, Specialty in vivo, medical device testing, CGT services, and Regulated bioanalysis. Additionally, Dr. Bhoopathy is an integral part of the global leadership team that is developing Pharmaron’s end-to-end CGT capabilities, by building on Pharmaron’s scale and complementary site offerings.

Prior to this position, Dr. Bhoopathy was President and COO at Absorption Systems, a CRO with expertise in the development of novel non-clinical tools and bioassays for predicting human outcomes; CEO of Clayton Pharmaceuticals, a biopharmaceutical company focused on the development and approval of drug products with significant challenges to market entry; and a Founding Member of SAAMnow (Scientists Advancing Affordable Medicines), a nonprofit organization that provides a platform to share cutting-edge research for the development of high-quality, affordable medicines.

Dr. Bhoopathy possesses a thorough understanding of the processes that support lead optimization, candidate selection, preclinical drug development, and translatable biopharmaceutics. He received his Bachelors in Pharmacy from Kakatiya University and a Ph.D. in Pharmaceutical Sciences from Virginia Commonwealth University. He has been honored as a Leader by Pennsylvania Bio; recognized as a 40 under Forty, Most Talented Leader by the Philadelphia Business Journal for his vision and commitment to the life sciences industry; and more recently, Dr. Bhoopathy was selected as a winner of the Executive Management Award for his creative management and innovative growth strategies.

Pharmacometrics Team Leader, DPM, OCP, OTS, CDER, FDA

Dr. Youwei Bi is the Team Leader at the Division of Pharmacometrics, Office of Clinical Pharmacology, Center of Drug Evaluation and Research, FDA. He received his Ph.D. in Clinical Pharmaceutical Sciences and Master’s in Biostatistics from the University of Iowa. He has been reviewing oncology, immunology and dermatology drug products at FDA since 2016. His primary responsibilities include reviewing IND and NDA applications, assessing the drug dosing at the individual and population levels, and evaluating the application of quantitative methods to support regulatory review, labeling and policy development.

Scientific Leader, Biowaiver and Biocorrelation, Apotex Inc.

Sumon Chakraborty is currently working at Apotex Inc. as Scientific Leader, Biowaiver and Biocorrelation Group where he serves as a biopharmaceutics and PBBM expert in oral solid dosage form. Prior to that, Mr. Chakraborty worked at Sandoz Development Center India as a Principal Scientist in Dissolution & IVIVC team. He has more than 11 years of experience in the field of biopharmaceutics in generic industry. Mr. Chakraborty has expertise in developing clinically relevant dissolution method and bioequivalence safe space to address the specific questions pertinent to Product development process (e.g., Bioequivalence risk assessment and mitigation plan, IVIVC/R in support of post approval changes, setting up clinically relevant dissolution specification, food effect prediction etc.). He received his Master’s degree in Pharmacology from Jadavpur University India.

Senior Research Scientist, Simcyp Division, Certara

Dr. James Clarke is a Senior Research Scientist in the Simcyp Division of Certara, specializing in mechanistic dermal absorption modelling. He obtained his Ph.D. at the University of Bath, UK, in the field of dermal absorption in 2017. Since then, he has worked to develop and enhance dermal absorption Physiologically Based Pharmacokinetic (PBPK) models of the Simcyp Simulator Platform.

Dr. Clarke currently leads a team of scientists working on two FDA Grant awards, the first is focused on developing diseased skin models to simulate patient populations for virtual bioequivalence assessment. The second, is focused on verifying and enhancing complex formulation models and improving integration of in vitro characterization data to inform formulation models. Dr. Clarke also works on development, enhancement, and implementation of the Virtual Bioequivalence (VBE) Module of the Simcyp Simulator. Further, he leads several consultancy projects applying dermal absorption and VBE modules to simulate complex generic products for regulatory applications.

President and CEO, Learn and Confirm Inc., Professeur Associe, Faculte de Pharmacie, University of Montreal

Professor Ducharme has thirty years of academic, clinical, and industrial experience in pharmacometrics, infectious diseases, drug metabolism, and clinical drug and biological development. He has an undergraduate Pharmacy degree and a graduate diploma in Hospital Pharmacy from the University of Montreal, Canada, and a graduate Pharm.D. degree from the College of Pharmacy and Allied Health Professions of Wayne State University in Michigan, USA. He has presented more than 300 seminars and posters internationally and published more than 150 abstracts, manuscripts, and book chapters in clinical pharmacology. Dr. Ducharme has been involved in thousands of clinical trials as a PI or sub-PI, and has served as an expert consultant in the drug development field for dozens of pharmaceutical companies located in the USA, Europe, Middle East, Africa, Asia, or Canada.

He has directed the work of 8 Ph.D. candidates, 6 post-doctoral fellows, and 11 M.Sc. candidates at the University of Montreal. He has trained thousands of pharmacy students in PK/PD and infectious diseases, and has given special workshops and training sessions to regulatory agencies and pharmaceutical companies in Canada, USA, Asia, Middle East, Africa, and Europe. Dr. Ducharme was elected as a Fellow of the American College of Clinical Pharmacy in 2000 and nominated as a Fellow of the American College of Clinical Pharmacology in 2001. Since 2012, he also serves as a Core Member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology.

Deputy Director, DQMM, ORS, OGD, CDER, FDA

Dr. Lanyan (Lucy) Fang currently serves as acting Deputy Director and has served as Associate Director of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, since February 2019. Prior to that, she served as Team Lead of the Quantitative Clinical Pharmacology team within DQMM for 5 years. She has established herself as the FDA expert in the use of quantitative clinical pharmacology approaches in the review and regulation of generic drugs. She co-leads CDER work group tasked with the use of partial area under the curve for the bioequivalence assessment. Dr. Fang also served as the co-chair of Generic Drug Science Committee in 2018 and moderated the 2018 Generic Drug Science Day. Prior to her current position, Dr. Fang worked as senior clinical pharmacology reviewer in the FDA’s Office of Clinical Pharmacology (2009–2014) and senior pharmacokinetist at Merck (2007–2009). Dr. Fang obtained her Ph.D. in Pharmaceutical Sciences from The Ohio State University and is a graduate of the Excellence in Government Fellows program (2014-2015).

Pharmacologist, DQMM, ORS, OGD, CDER, FDA

Dr. Yuqing Gong is currently a Pharmacologist at the Quantitative Clinical Pharmacology Team in the Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, CDER/FDA. Her current role in the division is to utilize quantitative tools such as population pharmacokinetics, modeling and simulations, to address specific questions relate to generic drug development process and/or regulatory decision making. Before joining the FDA, she received comprehensive trainings in pharmaceutical sciences with focuses on drug delivery, pharmacokinetics, and drug-drug interactions. 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 in the central nervous system across the blood-brain barrier. She also worked on projects that focused on pharmacokinetics and pharmacodynamics of antiretroviral drugs, especially on drug-drug interactions relate to cytochrome P450s.

Director, DBV III, OB, OTS, CDER, FDA

Dr. Stella Grosser is Director, Division of Biometrics 8 in the Office of Biostatistics, CDER. This division provides statistical support to the Office of Generic Drugs. She has been at the FDA for 21 years, beginning as a statistical reviewer for new drug products and serving as a team leader before assuming her current position. Dr. Grosser received her Ph.D. in Biostatistics from UCLA and spent several years there afterwards as an Assistant Professor in the School of Public Health.

Biopharmaceutics Expert, Director, Biopharmaceutics & Specialty Dosage Group, Merck & Co., Inc.

Dr. Tycho Heimbach recently joined Merck in the Biopharmaceutics & Specialty Dosage Group where he serves as a biopharmaceutics expert in oral and parenteral drug development. Prior to that he was at Novartis where he led a global PBPK modeling group in DMPK and served as PBPK and biopharmaceutics expert.

Dr. Heimbach also served as a co-chair a global team which reviews and makes recommendations and conducts predictions to inform clinical trials, including food-effect studies, within the global biopharmaceutics function. He served as cochair on working groups for the PBPK Modeling and the PBPK renal and hepatic impairment WG and the pediatric PBPK WG for the Innovation and Quality in Pharmaceutical Development (IQ) consortium.

Dr. Heimbach co-authored a workshop summary paper on PBBM (Physiologically Based Biopharmaceutics Modeling) and implemented PBBM for FIH trials. He worked at Pfizer for 14 years in PharmSci and DMPK departments supporting neuroscience and antibacterial projects. Dr. Heimbach contributed to a priori PBPK modeling for 25+clinical trials and has authored/coauthored 15+ INDs. Dr. Heimbach has been a speaker at 42 national and international conferences. He has authored/coauthored ~60 peer-reviewed publications, 3 book chapters and 2 patents. He received his Ph.D. in Pharmaceutics from the University of Michigan. Dr. Heimbach has served in multiple roles at AAPS over the past 5 years, including serving on the Student Program Support Committee, and the AAPS Ambassador Committee as well as the legacy PPB section.

Professor of Pharmacometrics, Department of Pharmacy, Uppsala University

Dr. Andrew Hooker is a Professor of Pharmacometrics at Uppsala University, Sweden. Andrew received a B.S. in Physics with a Mathematics Minor at the University of Colorado and received a Master’s and then a Ph.D. in Bioengineering from the University of Washington, Seattle. Andrew joined the faculty at Uppsala University in 2006. His research ranges between methodological and applied pharmacometrics, including optimal (adaptive) experimental design, methodological problems associated with building and evaluating pharmacometric models (including using models for bioequivalence evaluation) and the development and use of PKPD models in a range of therapeutic areas and drug classes. Andrew is a co-developer of a number of software programs including Xpose, PsN and the optimal design program PopED. Andrew has published over 75 papers in peer reviewed journals, supervised 12 students to their PhD degree and mentored 11 post-docs.

Team Lead for Data Analytics Team, DQMM, ORS, OGD, CDER, FDA

Dr. Meng Hu received both his Bachelor of Engineering in Biomedical Engineering and Ph.D. in Physics from the Zhejiang University, China. He conducted his post-doctoral training at Drexel University, Philadelphia. He joined the FDA’s Center for Drug Evaluation & Research as a staff fellow in 2015 and currently serves as a scientific lead in the Division of Quantitative Methods and Modeling under the Office of Research and Standards in the Office of Generic Drugs. His main research interests include the development and application of advanced data analytics tools to promote business intelligence in government, big data management, generation of real-world evidence, and quantitative methods to facilitate assessment for invitro bioequivalence study.

Dr. Hu’s published works include: machine learning based time-to-event analysis, predictive analysis of first abbreviated new drug application submission for new chemical entities based on ML methodologies, equivalence assessment of complex particle size distribution, quantitative method to facilitate active pharmaceutical ingredient sameness assessment for complex peptide products, and analysis of dissolution failure of solid oral drug products in field alert reports.

Scientist, Sandoz Pharmaceuticals

Dr. Rebeka Jereb is a Scientist in Clinical Development, Sandoz Development Center Ljubljana, Slovenia. She received her Master’s degree and Ph.D. in Pharmaceutics at the University of Ljubljana, Faculty of Pharmacy. Dr. Jereb has expertise in physiologically based pharmacokinetic modeling and IVIVC/IVIVR and has developed various PBPK models for regulatory purposes, e.g., to set drug product specification criteria. She has published several research articles with focus on using PBPK modeling in generic drug development.

Senior Manager Materials Science, Global Inhalation Research and Development, Teva Pharmaceuticals

Mr. Marc Kelly is a Senior Manager in Teva Pharmaceuticals Global Inhalation Research and Development Department. He leads the Material Sciences group whose primary responsibilities encompass the definition of critical material attributes and subsequent material process controls for respiratory platform products. Mr. Kelly is a materials scientist with 15 years of experience across various drug delivery platforms, having spent the last 6 years at Teva building materials science capability. His research focus on the structural elucidation of aerosols and the link between material composition and product performance have naturally led to an interest in the broader aspects of additional alterative bioequivalence methods. Now part of Teva’s inhaled IVIVC initiative, his team have been growing Teva’s capability in this initiative by establishing new analytical capabilities in support of mechanistic modelling strategies.

Distinguished Scientist, Merck & Co., Inc.

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

Dr. Myong-Jin (MJ) Kim currently serves as the Acting Director of the Division of Therapeutic Performance II, Office of Research and Standards, Office of Generic Drugs, CDER/FDA. Since her joining the OGD in 2016, she has been leading the efforts to develop product-specific guidances for solid oral dosage forms. In addition to her efforts in product-specific guidance development, Dr. Kim serves as the FDA Deputy Topic Lead for the ICH Expert Working Group on M13: Bioequivalence for Immediate Release Solid Oral Dosage Forms. She graduated from Georgia Institute of Technology in Atlanta, GA, with a Bachelor of Science degree in Chemistry. Subsequently, Dr. Kim received a Doctor of Pharmacy degree from the Temple University School of Pharmacy in Philadelphia, PA and completed her postdoctoral training in Clinical Pharmacology at Bassett Healthcare (a major teaching affiliate of Columbia Univ. of Physicians & Surgeons) in Cooperstown, NY.

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

Mr. Sivacharan Kollipara is currently working as Team Lead, Biopharmaceutics 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. Prior to joining DRL, Mr. 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 a Masters in Pharmaceutical Sciences from BITS, Pilani, Rajasthan. Overall Mr. Kollipara has an experience of 15 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 ~17 peer-reviewed publications. His research interests include PBPK/PBBM modeling, virtual bioequivalence simulations, IVIVC/R, drug-drug interactions, dissolution/bioequivalence safe space, bio-predictive dissolution methodologies, biowaivers, and food effect evaluations.

Deputy Division Director, DTP I, ORS, OGD, CDER, FDA

Dr. Darby Kozak is the Deputy Division Director for the Division of Therapeutic Performance I in the FDA’s Office of Generic Drugs. Dr. Kozak leads a group of interdisciplinary scientists on the development of new analytical methods and equivalence evaluation methodologies for complex drug substances and parenteral, ophthalmic, otic, and inhalation formulations. Prior to joining the FDA, he was Chief Scientist for Izon Science and Research Fellow at the 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).

Senior Scientist, Simulations Plus

Dr. Maxime Le Merdy is now a Senior Scientist at Simulations Plus, the world leader company in innovative modeling and simulation software applied to the pharmaceutical research and development. Before joining Simulations Plus, Dr. Le Merdy received a Pharm.D. from University Paris-Descartes in 2015. In 2014, he received his master’s degree in Pharmacometrics from the same university. He joined the FDA in 2017 as a post-doctoral fellow in the Division of Quantitative Method and Modeling within the Office of Generic Drugs, where he developed his expertise in PBPK models for locally acting drug products and published multiple papers on ocular delivery models. Prior to this experience, Dr. Le Merdy published on Ethyl-glucuronide, a biomarker of alcohol consumption as well as the physiological modification affecting children’s pharmacokinetics.

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 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-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.

Chief Scientist, Simulations Plus, Inc.

Dr. Viera Lukacova is Chief Scientist at Simulations Plus, Inc. Over the last decade she has been contributing to the research in the area of mechanistic absorption and PBPK modeling and the development of GastroPlus®, DDDPlusTM, and MembranePlusTM software packages widely used throughout the pharmaceutical industry in early drug development, formulation, pre-clinical, and clinical research. Dr. Lukacova also contributes to modeling studies helping companies with their drug development programs in the early discovery stage, formulation development, clinical pharmacology applications and interactions with regulatory agencies.

Pharmacologist, DQMM, ORS, OGD, CDER, FDA

Dr. Youssef Mousa is a Pharmacologist at the Division of Quantitative Methods and Modeling (DQMM) at the Office of Research and Standards (ORS)/Office of Generic Drugs (OGD)/US FDA. He received his B.S. in Pharmacy from Al-Azhar University, Gaza Strip in 2009 and his M.S. in Clinical Pharmacy from University of Jordan, Jordan in 2014. Dr. Mousa received his Ph.D. in Pharmaceutical Sciences from Auburn University, Alabama in 2019. He joined the FDA as Oak Ridge Institute for Science and Education (ORISE) fellow in DQMM in 2019 and became a Staff Fellow in 2020. Dr. Mousa has experience in oral PBPK modeling and he is a scientific reviewer in the oral PBPK group in DQMM where he reviews PBPK models applied in generic drugs development.

Adjunct Professor at UCSF, Cofounder and Expert Consultant, NDA Partners/ProPharma

Dr. Carl Peck is Adjunct Professor, UCSF, and is Cofounder and Expert Consultant of NDA Partners/ProPharma. His career long interest in quantitative clinical pharmacology is expressed in more than 175 published peer-reviewed papers and chapters. As former Director of the FDA Center for Drug Evaluation and Research (CDER), Dr. Peck championed incorporation of advanced quantitative clinical pharmacology approaches in regulatory science and medical product development. His contributions have been recognized via an Honorary degree from Sweden’s Uppsala University, the 1999 FDA Distinguished Alumnus Award, 2012 ASCPT Gary Neal Prize for Innovation in Drug Development, 2017 ASCPT Sheiner-Beal Pharmacometrics Award, and the 2018 Gary Levy Memorial Lectureship.

Co-Director of CRCG, Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics, University of Maryland

Dr. James E. Polli is Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption and formulation, involving laboratory and clinical research. He has served as advisor to 24 Ph.D. graduates. Dr. Polli is co-Director of the recently initiated Center for Research on Complex Generics, an FDA-funded collaborative agreement with the Agency. He is Director of the online M.S. in Regulatory Science (www.pharmacy.umaryland.edu/regulatoryscience). program

Acting Deputy Division Director, DB III, OB, OGD, CDER, FDA

Dr. Ke Ren is currently an acting Deputy Director in the Division of Bioequivalence III (DB III) in the Office of Bioequivalence of Office of Generic Drugs, CDER, FDA. In this role, she leads a team of scientists responsible for the assessment of the bioequivalence section of Abbreviated New Drug Applications. During her time in DB III, Dr. Ren has developed extensive expertise in generic drug development in various therapeutic areas, including orally inhaled and nasal drug products. She has participated in the drafting of numerous Agency guidances pertaining to bioequivalence. Dr. Ren received her Ph.D. in Pharmaceutical Science from the University of Florida in 2005 and then undertook post-doctoral training at the University of Florida before joining OGD in 2008.

Professor of Systems Pharmacology and Director of CAPKR, University of Manchester

Director, OB, OGD, CDER, FDA

Dr. Partha Roy serves as Director of the Office of Bioequivalence (OB) in the Office of Generic Drugs (OGD), CDER, FDA. Dr. Roy is a recognized senior clinical/regulatory strategist with 22 years of drug development experience in both US FDA and industry involving new drugs, novel biologics, generics, and biosimilars. He currently leads an FDA/CDER Office that oversees the assessment of bioequivalence data required to support Abbreviated New Drug Application (ANDAs).

Prior to his current FDA role, he was Vice President in PAREXEL’s Regulatory and Access Consulting Global Business Unit, focused on driving corporate growth and delivery. In his previous FDA role from 2006-2012, Dr. Roy supported US FDA’s Division of Pulmonary, Allergy and Rheumatology (DPARP) and Office of Non-Prescription Products (ONP) as part of the clinical pharmacology review team. Dr. Roy held several clinical pharmacology industry positions with increasing responsibility at MDS Pharma Services, Duramed Pharma and Forest Labs before joining FDA in 2006. Dr. Roy received his Ph.D. in Toxicology from the University of South Florida, Tampa, Florida and undertook post-doctoral training in drug metabolism and pharmacokinetics at Boston University.

Professor, Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco (UCSF)

Dr. Rada Savic is a Professor at the University of California San Francisco and Associate Director of the UCSF Center for Tuberculosis. Her research focuses on data integration and modeling to solve problems in drug development and routine drug therapy in infectious diseases including special populations such as children and pregnant women. She has applied innovative, quantitative, and systems pharmacology methods to propose optimized and precision dosing strategies, data driven risk stratification algorithms, and inspired new clinical simulation tools across the infectious disease landscape. Dr. Savic is a world recognized pharmacologist and expert on drug regimen design and optimal dosing approaches and was named the 2021 Leon I. Goldberg Early Investigator Award recipient, which recognizes and honors young scientists for outstanding accomplishments in the field of clinical pharmacology achieved early in their career.

Vice President, IDD, Certara

Co-Director of CRCG, William I Higuchi Collegiate Professor of Pharmacy, Associate Professor of Pharmaceutical Sciences, Biointerfaces InstituteCollege of Pharmacy, University of Michigan

Team Lead, DB VI, OB, OTS, CDER, FDA

Dr. Meiyu Shen is an expert mathematical statistician and a team leader at the Center of Drug Evaluation and Research, Food and Drug Administration (FDA). She obtained her Ph.D. in Statistics from Statistics Program of Department of Mathematics at University of Maryland, College Park, in 2015. She obtained her Ph.D. in Chemical Engineering from Department of Chemical Engineering at Iowa State University in 1999. She received one FDA scientific achievement award for excellence in review science, the Leadership Excellence Honor Award, and four FDA Outstanding Service Awards for significant efforts and contributions in statistics related to reviews and research in Chemistry and Manufacturing Control and biosimilar evaluation. Dr. Shen has published 50+ papers in the statistical, medical, and engineering journals and three book chapters on statistics.

Associate Director, Lifecycle Management, OCP, OTS, CDER, FDA

Dr. Ethan Stier is the Associate Director of Lifecycle Management in the Office of Clinical Pharmacology, OTS/FDA. Prior to that he served as Division Director of Bioequivalence and Acting Associate Director for Science in the Office of Bioequivalence OGD/FDA. He is an expert in application of a variety of bioequivalence approaches to bridge formulations in generic and new drug applications. Dr. Stier is a recognized leader in guidance and policy development including PSG, FDA Guidance, and ICH Guidance. He currently oversees scientific response to Citizen Petitions, 505B2 policy development, ICH Guidance development on BE/BA topics and coordination of lifecycle activities with partners across CDER. He earned in Ph.D. in Pharmaceutical Sciences from the University of Michigan and Bachelor in Pharmacy from the University of Connecticut.

Vice-President and Head, Biopharmaceutics and Bioequivalence, Global Clinical Management, Dr. Reddy’s, Laboratories Ltd

Director, DB VI, OB, OTS, CDER, FDA

Senior PharmacologistDQMM, ORS, OGD, CDER, FDA

Dr. Eleftheria Tsakalozou joined the FDA in 2015 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. She is currently a Senior Pharmacologist at the Division of Quantitative Methods and Modeling at the Office of Research and Standards. Dr. Tsakalozou obtained her Ph.D. in Pharmaceutical Sciences at the University of Kentucky in 2013 and completed a two-year Fellowship in Clinical Pharmacokinetics and Pharmacodynamics at the University of North Carolina at Chapel Hill. Her research interests include skin absorption physiologically-based pharmacokinetic modeling, interactions between excipients and molecular targets including gut transporters, and development of quantitative modeling and simulation tools to support bioequivalence assessments.

Chief Scientific Officer, Biopharmaceutics-Biostatistics, Global Regulatory Affairs, Apotex

Dr. Yu Chung Tsang is currently working at Apotex Inc. as Chief Scientific Officer, Biopharmaceutics and Biostatistics. He obtained his Bachelor’s degree (1984) in Pharmacy and Ph.D. degree in the area of Pharmacokinetics in 1990 from the University of Toronto. He has been with Apotex since then. His main responsibilities are to provide pharmacokinetic and statistical advices in preparing protocol and study report for pharmacokinetic/pharmacodynamic and clinical studies of complex drug and biosimilar products, and in the design of bioequivalence/clinical endpoint studies and the analysis of data for the development of traditional drug products in the Apotex group of companies. To date, Dr. Tsang has been involved with the design and data analysis of over a thousand bioequivalence/clinical studies for the registration of complex drug and biosimilar products and over 300 traditional drugs in Canada, US, EU, and many other international marketplaces. He is currently the Chair of the Bioequivalence Committee in the Canadian Generic Pharmaceutical Association, and the Past Chair of the Generic Pharmaceuticals Focus Group of the American Association of Pharmaceutical Scientists. Aside from his industrial experience, Dr. Tsang also holds an appointment (status only) at the Leslie Dan Faculty of Pharmacy, University of Toronto.

Pharmacokinetics Assessor, Medicines Evaluation Board

Mr. Michiel van den Heuvel obtained his M.Sc. in Mathematical Statistics at the Technical University of Eindhoven in 1988. He worked as a statistician and later on as a  pharmacokineticist in various roles within the pharmaceutical industry (Organon, Netherlands). Now he works as a PK assessor at the Dutch Medicines Evaluation Board to conduct pharmacokinetic and PK-PD assessments of applications for medicinal products to be authorized in Europe through national and EU Community procedures, with a focus on human pharmacokinetics, pharmacodynamics, statistics, and bioequivalence. Furthermore, Mr. van den Heuvel is Member of the EMA Methodology Working Party (MWP), as representative of the previous Modelling and Simulation Working Party (MSWP). In this role, he is providing support to EMA’s scientific committees and working parties on modelling and simulation, supporting also more general methodological discussions and qualification procedures.

Chemical Engineer, DQMM, ORS, OGD, CDER, FDA

Dr. Ross Walenga joined the FDA in 2015 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. He is currently a Chemical Engineer at the Division of Quantitative Methods and Modeling at the Office of Research and Standards. He began his career at Virginia Polytechnic Institute and State University (Virginia Tech), where he earned a Bachelor Science in Aerospace Engineering. Dr. Walenga later earned his Ph.D. in Engineering (mechanical track) from Virginia Commonwealth University in 2014, where he also spent seven months as a postdoctoral fellow prior to joining the FDA. His research interests include computational fluid dynamics modeling of orally inhaled, nasal, ophthalmic, and dermal drug products to answer questions pertaining to bioequivalence.

Senior Pharmacologist and Scientific Lead, 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. She has been with FDA for more than nine years. Dr. Wu 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, she was a biopharmaceutics reviewer for more than four years and responsible for NDA and ANDA biopharmaceutics reviews. Dr. Wu has been a principal and co-principal investigator for multiple FDA research projects and involved in several guidance working groups and grant review panels.

Co-Lead of PBPK Program, DPM, OCP, OTS, CDER, FDA

Dr. Yuching Yang is currently the Co-Lead of PBPK (physiologically-based pharmacokinetic modeling) Program, Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Food and Drug Administration (FDA). She obtained her Ph.D. in Exposure Assessment and Biomedical Science from Rutgers University in 2006. She worked as a computational toxicologist at Hamner Institute and a Research Investigator/Model Developer at Hamner-DILIsim Initiative (later DILIsym Services, Inc). In December 2015, Dr. Yang joined the Office of Clinical Pharmacology at FDA. Her primary responsibilities include reviewing IND and NDA applications, assessing the effect of multiple patient factors (intrinsic and extrinsic) using PBPK, and evaluating the application of PBPK tools to support regulatory review and policy development.

Team Lead for Quantitative Clinical Pharmacology Team, DQMM, ORS, OGD, CDER, FDA

Dr. Miyoung Yoon currently serves as the Team Lead for the quantitative clinical pharmacology team in the Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, CDER/FDA. Since her joining the team in 2019, she has been leading the team’s efforts to conduct regulatory and research activities leveraging clinical pharmacology tools and expertise and actively developing collaborations with multiple stakeholders. In addition, Dr. Yoon is contributing to applying mechanistical modeling approaches such as physiologically based pharmacokinetic models to support generic drug assessment. She received her Ph.D. degree in Pharmacology/Toxicology from the School of Pharmacy at Seoul National University in South Korea and completed her post-doctoral training at the US Environmental Protection Agency through the National Research Council of the National Academies of Sciences, Engineering, and Medicine’s Research Associateship program.

Deputy Director, ORS, OGD, CDER, FDA

Dr. Lei Zhang is Deputy Director in the Office of Research and Standards (ORS), OGD, CDER, US FDA. ORS implements the Generic Drug User Fee Amendments (GDUFA) science and research commitments to ensure the therapeutic equivalence of generic drug products. She is an accomplished professional with more than 24 years of combined experiences in the areas of drug research, development and regulatory review and approval. In addition to regulatory reviews, Dr. Zhang has contributed to numerous guidance development and research projects focused on the science-based regulatory decision-making including drug-drug interactions, specific populations, and PBPK modeling. Before joining FDA in 2002, she worked at Bristol-Meyers Squibb Company 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, Schools of Pharmacy and Medicine. She received her Ph.D. in Biopharmaceutical Sciences from UCSF. Dr. Zhang is a member of the International Transporter Consortium (ITC) that published a transporter white paper in 2010 and several white papers/position papers in 2013, 2018, and 2022. She was a member of the ICH Generic Drug Discussion Group (GDG), serving as the US FDA Topic Leader. Additionally, she is the Rapporteur for ICH M13 Informal Working Group that is developing ICH M13 guideline to harmonize bioequivalence (BE) study design for immediate-release oral dosage form drugs. Dr. Zhang was named American Association of Pharmaceutical Scientists (AAPS) Fellow in 2013. She has published more than 125 journal articles and book chapters.

Director, DQMM, ORS, OGD, CDER, FDA

Dr. Liang Zhao has been serving as the Director of Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs, CDER/FDA since 2015. He has a broad spectrum of scientific and management experience from industry and the regulatory agency. Through his 16 year professional career, Dr. Zhao has established his leadership in industrial R&D, quantitative methods and modeling, and model based strategic decision makings in regulatory and industrial settings for generic and new drugs. He initially joined the FDA as a clinical pharmacology reviewer in the Office of Clinical Pharmacology in 2009 and worked as a team leader in the Division of Pharmacometrics in 2013-2015. Prior to joining FDA, he worked at Medimmune for biotech products, BMS for small molecule drug development, and Pharsight as an associate consultant for new drug Research and Development. Dr. Zhao has a diversified educational background in Pharmaceutical Sciences, Applied Statistics, and Business Administration.