Co-hosts: FDA and the Center for Research on Complex Generics (CRCG)
In person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop.
The supplementary information documents contain additional information on discussion topics for the Small Group Discussion Session (in-person only), MMF proposed definition and two MMF case studies that we will be discussing at the workshop. It also contains additional information from two workshops co-hosted by the FDA and the (CRCG) in the past that introduced and discussed the MMF framework. A second document includes operational facts of master files.
The purpose of this workshop is to engage stakeholders among model developers, industry, and FDA in a discussion on the concept, scope, and regulatory application of a Model Master File (MMF). The goals of this workshop are to illustrate how MMFs can improve the efficiency with which evidence from modeling and simulation (M&S) can facilitate drug product development. Additionally, the workshop will explore how M&S can increase efficiency in application assessment and consistency in regulatory use and acceptance of established models.
The MMF is a framework aimed at model-sharing and model-reusability. Similar to drug master files, MMFs can be referenced by multiple applications for a similar purpose of use, thus improving model sharing, model standardization, and regulatory consistency and efficiency. Quantitative models which include, but are not limited to, physiologically based pharmacokinetic models, population pharmacokinetics models, and mechanistic in vitro in vivo correlations may be developed as MMFs. Discussions are essential on practical aspects and best practices for MMFs that are included in regulatory submissions with modeling and simulation approaches.
The workshop will discuss the concept, scope, and operational aspects for MMF implementation in regulatory submissions. The workshop will engage experts from the FDA, new and generic drug developers, academic institutions, contract research organizations (CROs), consultants and others involved in drug product development to improve understanding of the role of MMFs in supporting drug product development and enhancing regulatory consistency and efficiency. The workshop will also allow all interested parties to coordinate and collaborate toward the implementation of model integrated evidence (MIE) to increase efficiency in drug product development and to streamline drug product approval.
Virtual Attendees will have free access to all sessions of the workshop except the small group working sessions. They will be able to:
In-Person Attendees will play an active part in advancing the role of MMF in regulatory submissions by:
This workshop is primarily developed for the generic and new drug industry and associated collaborators, including consultants and CROs whose work supports new and generic drug applications.
The introduction to the workshop will provide a brief overview of the emerging role of modeling and simulation (M&S) approaches in advancing drug product development and regulatory assessment. The practical utility of these M&S approaches has been recognized by the FDA and other regulatory agencies, the new and generic drug industry, academic institutions, contract research organizations (CROs), consultants, and others involved in drug product development. The introduction will provide context, explaining how this workshop is designed to explore and address challenges that might impact the implementation and usefulness of MMFs in regulatory submissions. The goal of this event is to establish an operational framework within which MMFs can facilitate the development and documentation of regulatory submissions that contain model integrated evidence (MIE) and, thereby, improve acceptance for M&S approaches by regulatory agencies.
In each session, regulatory professionals, drug developers (of brand name products and generics) and consultants/CROs will share their perspectives on how the MMF framework can support drug product development and facilitate regulatory assessments to accelerate patient access to different classes of important medicines.
Format: Presentations and a Panel Discussion Q&A (Virtual and In-Person Attendees)
Format: Presentations and a Panel Discussion Q&A (Virtual and In-Person Attendees)
Format: Presentations and a Panel Discussion Q&A (Virtual and In-Person Attendees)
Format: Small Group Working Sessions (In-Person Attendees Only)
Format: Presentations and a Panel Discussion Q&A (Virtual and In-Person Attendees)
Format: Presentations and a Panel Discussion Q&A (Virtual and In-Person Attendees)
Format: Small Group Working Sessions (In-Person Attendees Only)
Small group working sessions will involve structured activities for in-person attendees, focusing on the areas discussed during Day 1 and Day 2 of the workshop. Discussions will consider the potential types of MMFs and impactful use cases for MMFs, key considerations and challenges with the preparation and submission of MMFs. A key objective of the working sessions will be to collaborate on the development of efficient strategies for the pharmaceutical industry, regulatory agencies, consultants, CROs and other stakeholders to realize the benefits of M&S approaches by incorporating MMFs in regulatory submissions for new and generic drugs.
Vice President & Head, Biopharmaceutics & Bioequivalence, Global Clinical Management, Dr. Reddy’s Laboratories Ltd., Hyderabad, India
Dr. Tausif Ahmed is currently working as Vice President & Head-Biopharmaceutics & Bioequivalence in the Global Clinical Management group, IPDO at Dr. Reddy’s Laboratories Limited (DRL), Hyderabad. He is responsible for managing all Bioequivalence studies supporting global complex generic products at DRL. He is 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.
Senior Pharmacologist, DQMM, ORS, OGD, CDER, FDA
Dr. Khondoker Alam is currently working as a senior staff fellow in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD) in FDA. Dr. Alam is serving as scientific lead for complex injectables such as long-acting injectables, liposomal injections etc. His role in the division is to utilize physiologically-based pharmacokinetic (PBPK) modeling and other quantitative tools to address specific questions pertinent to drug development process and/or regulatory decision making. He is responsible for reviewing pre-abbreviated new drug applications (pre-ANDA) meeting packages, ANDA post complete response letter (post-CRL) scientific meeting packages, ANDA consults and controlled correspondences on complex injectables and topical dermatological drug products where model based alternative bioequivalence approach is proposed by ANDA applicant. He is serving as project lead and key technical member for multiple FDA research projects on complex injectables, topical dermatological drug products, buccal/sublingual drug products as well as projects related to mitigation strategy for N-nitrosamine impurities. His research interests include PBPK modeling, development of computational tools for virtual bioequivalence, studying the role of transporter proteins and metabolizing enzymes in drug disposition and drug-drug interactions.
Team Leader, Locally-Acting PBPK Modeling Team, DQMM, ORS, OGD, CDER, FDA
Dr. Andrew Babiskin, Ph.D., 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, 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.
Pharmaceutical Scientist (Contractor), DQMM, ORS, OGD, CDER, FDA
Dr. Yi-Hsien Cheng is currently working as a pharmaceutical scientist (contractor) 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 is currently working on applying physiologically based pharmacokinetic (PBPK) modeling and simulation approaches to evaluate bioequivalence (BE) for different oral drug products at Oral PBPK Team in DQMM. Her research interests include implementing PBPK modeling and virtual BE simulations to evaluate the sensitivity of using parent vs. metabolite as analytes on BE assessment, food-formulation impact on fed BE studies, effect of non-comparable in vitro alcohol dose dumping results on BE evaluation, as well as impact of single-sex study subjects on BE outcome.
Chemical Engineer, DQMM, ORS, OGD, CDER, FDA
Dr. Steven Chopski is a chemical engineer in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs, Center of Drug Evaluation and Research at the U.S. Food and Drug Administration (U.S. FDA). His research interests include physiologically-based pharmacokinetic (PBPK) modeling and computational fluid dynamics (CFD) modeling of both nasal and orally-inhaled drug products. He engages in regulatory science research initiatives related to generic drug-device combination products.
Dr. Chopski received his Ph.D. in Mechanical Engineering and his B.S. in Biomedical Engineering from Virginia Commonwealth University in Richmond, Virginia. Prior to working at the FDA, Steven completed a postdoctoral fellowship in the School of Biomedical Engineering, Science, and Health Systems at Drexel University, funded by the American Heart Association.
Associate Principal Scientist, Simcyp Division, Certara
Dr. James Clarke is an Associate Principal 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 recently received a three-year NIH/FDA grant to continue development of dermal formulation models, focusing on evaporation and dynamic formulation changes. He also currently leads a team of scientists working towards two other 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 of the Virtual Bioequivalence (VBE) Module in the Simcyp Simulator. Further, he is involved in several consultancy projects applying dermal absorption and VBE modules to simulate complex generic products for regulatory applications.
CEO, FLUIDDA
Dr. Jan De Backer graduated from Delft University of Technology in The Netherlands as an 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 in Belgium. He is an alumnus of the MBA programs at the London Business School in London and the Columbia Business School in 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.
President and CEO, Learn and Confirm Inc., Montreal, Canada; Professor Associé, Faculté de Pharmacie, University of Montreal, Canada
Professor Ducharme has thirty years of academic, clinical, and industrial experience in pharmacometrics, infectious diseases, drug metabolism, and clinical drug and biological development. Murray 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, book chapters, and books in clinical pharmacology. He 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. Murray has directed the work of 8 Ph.D. candidates, 7 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. Murray 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, Murray 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 serves as Deputy Director of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs (OGD), CDER/FDA. Since her joining OGD in 2014, Lucy has held roles of increased responsibilities, Team Lead of the Quantitative Clinical Pharmacology team, Associate Director, and Deputy Director within DQMM. 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. Prior to her OGD career, Lucy worked as senior clinical pharmacology reviewer in the FDA’s Office of Clinical Pharmacology and senior Pharmacokineticist in Merck. Lucy 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).
Senior Principal Scientist, Inhalation Product Development, AstraZeneca
Dr. Markus Fridén earned his Ph.D. in 2010 from Uppsala University with a thesis on experimental and computational approaches to quantify drug exposure in the brain. In the Department of Drug Metabolism and Pharmacokinetics (AstraZeneca), Markus subsequently focused on characterizing various aspects of inhaled drug exposure in the lung following inhalation, including mathematical modeling thereof. He held various leading roles, including head of the modeling and simulation section and interim department head. In addition, Markus holds a part-time position as co-opted associate professor at Uppsala University. Since 2020, Markus has led the biopharmaceutics team in the Department of Inhalation Product Development at AstraZeneca, Gothenburg, Sweden.
Professor, School of Pharmacy and School of Medicine, University of Maryland
Dr. Joga Gobburu is Professor with the School of Pharmacy and the School of Medicine, University of Maryland, Baltimore, MD, USA. He held various positions at the U.S. FDA between 1998 and 2011. He has experience with overseeing the review of 1000s of Investigational New Drug Applications (INDs), over 250 New Drug and Biological Licensing Applications, numerous FDA Guidances and policies pertaining to drug approval and labeling. At the FDA, he was part of the committee responsible for 21st Review Process and provided input into PDUFA planning. He received numerous FDA awards such as the Outstanding Achievement Award and recognized with the Senior Biomedical Research Scientist appointment. He also received the Outstanding Leadership Award from the American Conference on Pharmacometrics (2008), the Tanabe’s Young Investigator Award from the American College of Clinical Pharmacology (2008), and Sheiner-Beal Pharmacometrics Award from the American Society of Clinical Pharmacology and Therapeutics (2019). He is also a Fellow of AAPS and ACCP. Dr. Gobburu is on the Editorial Boards of several journals. He has published over 100 papers and book chapters.
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, DB VIII, OB, OTS, CDER, FDA
Dr. Stella Grosser is Director of the Division of Biometrics 8 in the Office of Biostatistics and the Office of Translational Sciences (OTS), CDER, FDA. This division provides statistical support in review and research to the Office of Generic Drugs. She has been at the FDA for over 20 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 PhD in biostatistics from UCLA and spent several years there afterwards as an assistant professor in the School of Public Health.
Research Associate, School of Pharmacy, University of Waterloo, Canada
Dr. Abdullah Hamadeh received his Ph.D. in control systems engineering from the University of Cambridge and conducted his postdoctoral work in systems and synthetic biology at MIT. He is currently a Research Associate with the School of Pharmacy at the University of Waterloo. His main research interests include the development of optimization algorithms for complex systems, with applications in pharmacokinetic modeling, systems pharmacology, and epidemiology. His current work focuses on the development of open-source computational tools for robust in vitro-in vivo extrapolation, virtual bioequivalence assessment and global sensitivity analysis, with an emphasis on mechanistic dermal absorption modeling. He is also an active contributor to the development of the Open Systems Pharmacology Suite.
Senior Principal Scientist/Director, Merck Research Laboratories
Dr. Tycho Heimbach is a Senior Principal Scientist at Merck & Co. in the Biologics Development and Biopharmaceutics Group (BDB5) which is part of the Sterile and Specialty Products Group. There he serves as a biopharmaceutics and PBBM/PBPK expert for oral and long-acting injectables drug development, which includes establishing the bioequivalence safe space of new drug candidates using Physiologically Based Biopharmaceutics Modeling (PBBM). Prior to that, Tycho was Director in DMPK at Novartis where he led a global PBPK modeling group and served as PBPK and biopharmaceutics expert and implemented PBPK/PBBM for oncology drugs.
Tycho is currently serving as the Merck representative on the PBBM Innovation & Quality (IQ) Consortium Working Group and was one of the core organizers for the 2023 Glob PBBM M-CERSI-FDA workshop. He has authored/coauthored ~65 peer-reviewed publications in ADME, PBPK and formulation sciences and was recognized as an AAPS Fellow in 2021.
Professor of Pharmacometrics, Department of Pharmacy, Uppsala University, Sweden
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 Ph.D. degree and mentored 11 post-docs.
ORISE Fellow, Quantitative Clinical Pharmacology, DQMM, ORS, OGD, CDER, FDA
Dr. Robert Hopefl is an ORISE Fellow working in the Quantitative Clinical Pharmacology team in the Division of Quantitative Methods and Modeling, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), FDA. He joined the FDA in September of 2023, and his current research interests include leveraging modeling and simulation to assess bioequivalence of topical products. Prior to joining the FDA, Robert earned his Pharm.D. from Larkin University.
Deputy Director, OCP, OTS, CDER, FDA
Dr. Shiew-Mei Huang is Deputy Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration. She received her B.S. in Pharmacy from National Taiwan University, School of Pharmacy in 1975 and her Ph.D. from University of Illinois, Medical Center in Pharmacokinetics and Biopharmaceutics in 1981. She has 15+ year drug development experience (Ortho pharmaceutical and Dupont-Merck) before joining the FDA in 1996. She has over 160 publications focusing on topics in clinical pharmacology, drug metabolism/transport interactions, and physiologically-based pharmacokinetic modeling and pharmacogenomics areas. Dr. Huang is a fellow of the American Association of Pharmaceutical Scientists and a diplomate of the American Board of Clinical Pharmacology. She was President of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) from 2009 to 2010. She received ASCPT Awards “Gary Neil Prize for Innovation in Drug Development” in March 2014 and “Henry Elliott Distinguished Service Award” in March 2016.
Senior Clinical Pharmacology Assessor, Medicines and Healthcare Products Regulatory Agency (MHRA)
Dr. Essam Kerwash is a leading Senior Clinical Pharmacology Assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK). Essam obtained his Ph.D. in Clinical Pharmacology from University of London (UK) studying the interindividual variabilities in response to anti-cancer drugs. He received post-doctoral training at Barts Cancer Institute where his research was focused on the discovery of novel biomarkers that can predict activity/toxicity of the cytotoxic agents using Omics approach. At the MHRA, Essam assessed the clinical pharmacology aspects of license applications to support early patient access to number of innovative medicines. Essam is recognized for expertise in modelling techniques such as population and physiologically based modelling where he contributed to number of peer-reviewed articles and international guidelines. He is currently serving as a topic lead for the ICH M15 model informed drug development guideline. Essam is co-leading an active research program investigating the use of modelling to support dose optimization for medicines commonly used during pregnancy and lactation. Essam has received merit awards such as Conquer Cancer the ASCO Foundation merit award.
Senior Mathematical Statistician, DB VIII, OB, OTS, CDER, FDA
Dr. Martin Klein is a Senior Mathematical Statistician in the Division of Biometrics 8, Office of Biostatistics, OTS, CDER, FDA, where he focuses on providing support for research and regulatory evaluation of generic drug products and biosimilar products. Martin’s research areas include statistical analysis in the presence of missing data, statistical analysis using pharmacokinetic models, adaptive design in bioequivalence studies, statistical ranking of populations, and statistical computing. Martin received his Ph.D. in Statistics from the University of Maryland, Baltimore County.
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 and involved in utilizing novel PBPK and PBBM modeling approaches for regulatory justifications for various markets. 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 Masters in Pharmaceutical Sciences from BITS, Pilani, Rajasthan, India and currently pursuing Ph.D. Overall Mr. Kollipara has an experience of 16 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 ~25 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, novel statistical tools for dissolution similarity analysis and food effect evaluations.
Professor and Allen Chao Endowed Chair, Industrial and Molecular Pharmaceutics Dept., Purdue University
Dr. Tonglei Li is Professor and Allen Chao Endowed Chair in the Department of Industrial and Molecular Pharmaceutics at Purdue University. He received B.S. and M.S. in Chemistry and Computational Chemistry from Nankai University, China. He obtained his Ph.D. in Pharmaceutics and M.S. in Computer Science from Purdue University. He joined the University of Kentucky faculty and became an Associate Professor before returning to his alma mater and holding his current title. His research interests include computational chemistry and mathematics, multiscale modeling and simulation, high-performance computing, and drug development. Over the last several years, Dr. Li has ventured into chemical data learning by pioneering manifold learning of quantum information of molecules, striving to solve challenging problems in molecular engineering and drug research. Dr. Li currently serves as Editor-in-Chief of Pharmaceutical Research.
Director, OGD, CDER, FDA
Dr. Iilun Murphy, M.D. is the Director for Office of Generic Drugs since June 2023. Dr. Murphy began her FDA career in 2007, joining CDER’s Office of New Drugs, Division of Gastroenterology and Inborn Errors of Metabolism Products as a Medical Officer. In 2011, Dr. Murphy transitioned to the Center for Tobacco Products serving in various leadership roles within the Office of Science until she returned to CDER in 2020 as the Deputy Director for Clinical and Regulatory Affairs in the Office of Generic Drugs.
Dr. Murphy holds a Bachelor of Arts from Cornell University and a Doctor of Medicine from Stanford University, School of Medicine. She completed the Harvard University and Boston University Combined Residency Program in Pediatrics and is board certified in pediatric medicine. Dr. Murphy practiced pediatrics in both the private practice and inpatient hospital settings prior to joining the FDA. Dr. Murphy continues to be involved in clinical teaching as an Assistant Clinical Professor of Pediatrics at George Washington University School of Medicine.
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, Therapeutic Review, DPM, OCP, OTS, CDER, FDA
Dr. Jiang Liu is the Associate Director for Therapeutic Reviews of the Division of Pharmacometrics, Office of Clinical Pharmacology, OTS/CDER/FDA. Dr. Liu received his Ph.D. in pharmaceutical sciences and his Master’s degree in statistics from the University of Florida. He joined the FDA as a pharmacometrics reviewer 15 years ago. Dr. Liu had also served as a QT-IRT scientific lead for three years and a pharmacometrics team leader for four years before taking his current role. He is focusing on pharmacometrics regulatory activities particularly in the areas of oncology, immunology, rare diseases, etc.
Chief Scientist, Simulations Plus, Inc.
Dr. Viera Lukacova is the Chief Scientist at Simulations Plus, Inc. Over the last nearly two decades, she has been contributing to the research and development of GastroPlus®, DDDPlus™, and MembranePlus™ software packages widely used throughout the pharmaceutical industry in early drug development, formulation, pre-clinical, and clinical research; with the main focus on mechanistic absorption and PBPK modeling.
She is also involved in modeling studies helping companies with their drug development programs in early discovery stage, formulation development, clinical pharmacology applications, and interactions with regulatory agencies. She authored a number of papers in computational chemistry, basic research of transport of small molecules through artificial membranes, and pharmacokinetic and pharmacodynamic modeling in peer-reviewed journals and served as a reviewer of publications in the same areas.
Pharmaceutical Scientist, IO, OPQA II, OPQ, CDER, FDA
Dr. Rebecca Moody works in the Immediate Office (IO) of the Office of Drug Product Quality II (OPQA II) at the FDA. Previously, she was a Biopharmaceutics Reviewer in the Division of Biopharmaceutics (DB). Dr. Moody received a Bachelor of Science in Biology and Chemistry from Emory University, and a Ph.D. in Chemical Biology from the University of Michigan. She has experience evaluating biopharmaceutics and quality information (e.g., in vivo biowaivers, in vitro dissolution method development, etc.) in New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Investigational New Drug Applications (INDs). In addition, Dr. Moody serves as a scientific lead for physiologically based biopharmaceutics modeling (PBBM) in the DB Modeling and Simulation Committee.
Director, Scientific Affairs, Capstone Development Services Co, LLC
Jay Mowli joined Capstone Development Services in 2015 and is currently the Director of Scientific Affairs. With his expertise in clinical study design and analysis, one primary focus is the integration of quantitative modeling and simulation for a portfolio of complex drug and device products. Experience at different stages of development across multiple disciplines has been beneficial in collaboratively executing innovative strategies. Prior to joining Capstone, he worked in product development at Fresenius Kabi characterizing complex drugs (peptide, protein, and glycosaminoglycans) and developing in vitro bioassays. Jay earned his M,S, in Biostatistics and Epidemiology from Northwestern University. Additional interests include medical cost-effectiveness analysis as well as development and validation of patient reported outcome measures to study clinical outcomes and patient preferences.
Professor, University of Namur, Belgian Federal Agency for Medicines and Health Products (FAMHP)
Dr. Flora Musuamba holds a Ph.D. in Pharmacy and Biomedical Sciences from Université Catholique de Louvain, in Belgium. She is a Pharmacometrics and Pharmacovigilance internal expert at the Belgian Federal Medicines Agency (FAMHP). She is currently a member of the EMA scientific advice working party (SAWP) and the newly established methodology working party (MWP) at the European Medicines Agency (EMA). She is also Associate Professor of Clinical Pharmacology at University of Namur and University of Lubumbashi.
VP, Scientific Research, Global Head, Pharmacometrics and Systems Pharmacology, Translational Clinical Sciences, Pfizer
Dr. Cynthia J. (C.J.) Musante is Vice President of Scientific Research and Global Head of Pharmacometrics and Systems Pharmacology (QSP) within Translational Clinical Sciences at Pfizer. She received her Ph.D. in Applied Mathematics from North Carolina State University and has over twenty years of experience in model informed drug discovery and development (MIDD). At Pfizer, her group is responsible for developing and applying MIDD approaches across the portfolio to enhance the robustness and quality of decision-making at the program- and therapeutic strategy-level. C.J. is an advocate for MIDD, both internally and externally. She is a frequent organizer and invited speaker at national and international conferences and is the Immediate Past President of the International Society of Pharmacometrics (ISoP).
Head of Technology and Innovation, Pharmacometrics and Systems Pharmacology, Pfizer
Dr. Timothy Nicholas is Head of Technology and Innovation within the Pharmacometrics and Systems Pharmacology group at Pfizer. His organization supports model informed drug development (MIDD) through innovative pharmacometrics strategy and application from first in human/patient through approval and into post-marketing. He received his B.S. from University of California at Berkeley, an M.S. in Clinical Science from San Francisco State University, and a Ph.D. in Pharmaceutical Sciences from University of Connecticut. Timothy has worked in the field of quantitative pharmacology for a myriad of pharmaceutical companies over the past 25+ years. He served as the founding Chair for the International Society of Pharmacometrics (ISoP) Technology committee, Co-chair for the Disease Modeling Workgroup for Critical Path for Parkinson’s (CPP), Co-lead for the Coalition Against Major Diseases (CAMD) Modeling Workgroup and has been an invited lecturer for multiple symposia at FDA and academic workshops. Prior to becoming Head of Technology and Innovation, he had focused on quantitative drug development in the neuroscience and I&I areas. Areas of interest are applications of modeling to pharmacokinetic/pharmacodynamic (PK/PD) and longitudinal disease progression data, clinical trial design through simulation, model based meta-analysis (MBMA), artificial intelligence and machine learning (AIML), and process automation.
ORISE Fellow, DQMM, ORS, OGD, CDER, FDA
Dr. Arindom Pal is a Pharmaceutical Scientist with research experiences in PBPK modeling, DMPK, and targeted drug delivery. He received his Ph.D. in Pharmaceutical Sciences from the University of the Pacific, California in 2019. Dr. Pal has three years of post-doctoral experience at the Johns Hopkins University, School of Medicine in the DMPK group of Johns Hopkins Drug Discovery center. In this position, he published eight high-impact manuscripts, received one grant from NIMH (National Institute of Mental Health), provided two invited-talks, and presented multiple posters in national/international meetings. His academic training and research experience have provided him with an excellent background in multiple disciplines including chemical biology, biopharmaceutics, pharmaceutical chemistry, analytical chemistry, pharmacology, and biochemistry. Dr. Pal joined as an ORISE fellow at the ORS/OGD/CDER/FDA in 2023 and has been working in the division of quantitative modeling and simulation (DQMM). Currently, he is working on oral PBPK modeling and simulations to support several research projects of DQMM.
Senior Director of PBPK Consultancy Services, Certara Inc.
Dr. Nikunjkumar Patel is a Senior Director of PBPK Consultancy Services in the Simcyp division of Certara. Dr. Patel partners with Pharma companies to employ advanced PBPK modelling approaches to expedite internal decision making, support biowaivers via virtual bioequivalence assessments, develop model-informed regulatory strategies for novel products, generic formulations, scale-up and post-approval changes (SUPAC), and set dissolution specifications. He has more than 15 years’ experience in computer-aided drug design and PKPD modelling, including 12+ years’ experience focusing on PBPK modelling.
Adjunct Professor, University of California, San Francisco; Co-Founder and Expert Consultant, NDA Partners, a ProPharma Company
Dr. Carl Peck, M.D. is an Adjunct Professor at the University of California, San Francisco (UCSF) and the Co-Founder and an Expert Consultant of NDA Partners, a ProPharma Company. His career long interest in quantitative clinical pharmacology is expressed in more than 175 peer-reviewed publications and book chapters. As former Director of the FDA Center for Drug Evaluation and Research (CDER), he championed incorporating 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, the 2012 ASCPT Gary Neal Prize for Innovation in Drug Development, the 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. He is the 14th recipient of the American Pharmacists Association Takeru Higuchi Research Prize. Dr. Polli is co-Director of the 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 program (www.pharmacy.umaryland.edu/regulatoryscience).
Division Director, Biopharmaceutics, OPQA I, OPQ, CDER, FDA
Dr. Bhagwant Rege is the Division Director for Biopharmaceutics in CDER/OPQ at the FDA. His division at FDA is responsible for assessment of clinically relevant in vitro release specifications for drug products, in vitro-in vivo correlations (IVIVC), physiologically-based biopharmaceutics models (PBBM), scientific bridging strategies, biowaivers, and BCS classification requests. Most recently he served as a division director for CDER/OPQ/OLDP/ Division of Immediate and Modified Release Products III. Prior to joining FDA in 2010, he worked in industry for many years in oral biopharmaceutics and formulation development groups. Bhagwant has served as a team leader and review chemist in the Office of Generic Drugs where he was part of the team that developed the QbD examples for the generic industry. He is a member of the FDA Emerging Technology Team (ETT) and ICH Q12 Expert/Implementation Working Group. He served as FDA liaison on the USP expert committee on dosage forms general chapter (2015-2020). Bhagwant received his B.S. and M.S. in Pharmacy from the University of Mumbai, India and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore.
Deputy Director, DB III, OB, OGD, CDER, FDA
Dr. Ke Ren is the Deputy Division Director for 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. Ke 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, Systems Pharmacology, Director of Centre for Applied Pharmacokinetic Research (CAPKR), University of Manchester, UK; SVP, R&D, CSO, Certara, Princeton, USA
The Institute of Scientific Information (ISI, Clativate) listed Dr. Amin Rostami-Hodjegan as one of the world’s most highly cited researchers (under ‘Pharmacology & Toxicology’) in 2017. Amin is also at 0.07% top rank of the Highly Cited Researchers List by Stanford University (published by Elsevier) for pharmacology (2022). He has published over 320 peer reviewed highly influential scientific articles (>22,800 citations, h-index = 82).
The work of Professor Rostami covers wide areas of drug development over the last 30 years, ranging from pharmaceutics (e.g., bioavailability and bioequivalence) to clinical pharmacology (e.g., mixture pharmacology of drug/metabolites), translational and systems pharmacology (e.g., quantitative proteomics of enzymes and transporter for in vitro to in vivo (IVIVE) scaling).
As the Director of Centre for Applied Pharmacokinetic Research (CAPKR) at the University of Manchester, Amin collaborates with many pharmaceutical companies with a view to transfer latest scientific applications into modern drug development. Amin was co-founder of two spin-off companies from the University of Sheffield (Simcyp Limited [now part of Certara Inc]) and Diurnal Limited [now part of Neurocrine Bioscience]). As a leader in the field of Physiologically-based Pharmacokinetics (PBPK) and Quantitative Systems Pharmacology (QSP), he is internationally recognized for his expertise in IVIVE to predict the behavior of drugs in human body and understanding the associated inter-individual variabilities. He was one of the founding editors of Pharmacometrics and System Pharmacology and serves on the Editorial Boards of several other journals.
As the Senior Vice President of Research & Development (SVP) and Chief Scientific Officer at Certara, he facilitates the incorporation and integration of the latest advances in translational modelling to bio-simulation platforms offered by Certara to its clients, with the aim of accelerating the development and regulatory approval of safer drug products and bringing them to the patients.
Director, OB, OGD, CDER, FDA
Dr. Partha Roy is a senior regulatory expert with 23 years of drug development experience. He currently serves as the Director of the Office of Bioequivalence in the Office of Generic Drugs, an FDA/CDER Office that oversees assessment of all bioequivalence (BE) data required to support Abbreviated New Drug Application (ANDA) applications. Partha manages a multi-disciplinary program, providing leadership and management oversight to OB Division Management and primary and secondary assessors.
Prior to his current role, Partha was Vice President in PAREXEL’s Regulatory and Access Consulting Global Business Unit, providing executive management, regulatory strategy and thought leadership focused on driving corporate growth and delivery. Partha spent many years in the pharmaceutical industry as a clinical pharmacologist with increasing responsibility in both brand and generic companies and previously worked as an assessor in the Office of Clinical Pharmacology, CDER, FDA. Partha completed his Postdoctoral Fellowship in Drug Metabolism and Pharmacokinetics (DMPK) from Boston University, Boston, MA. He obtained his Ph.D. in Biochemical Toxicology from University of South Florida, Tampa, FL and B.S. in Pharmacy degree from Jadavpur University, Kolkata, India.
Executive Director, CMC Regulatory Innovation, AstraZeneca
Greg Rullo is an Executive Director of CMC Regulatory Innovation at AstraZeneca and has a wide range of experience in the strategic and tactical aspects of pharmaceutical drug development and global regulatory CMC requirements. His duties include leadership in the use of modeling such as Physiological Based Biopharmaceutical Models, Machine Learning, and AI. He is also leading a document to data transition within CMC RA including delivery of future data centric submissions such as PQ/CMC. He has extensive regulatory knowledge/experience of global CMC requirements with a detailed understanding of submission requirements in Brazil. He has direct experience with Health Authorities meetings throughout the world including FDA, EU health authorities, ANVISA, Health Canada, and Chinese authorities.
Director, Biopharmaceutics, Drug Product Development, GlaxoSmithKline (GSK)
Dr. Pratik Saha is an innovative leader with experience in matrix and line leadership roles. At GSK, he has held positions in areas of Early Development, Drug Product Design, and CMC. In his current role, Pratik heads the Global Biopharmaceutics group in Drug Product Development that is responsible for integrated biopharmaceutics support across dose forms.
Pratik has 25 plus years of pharmaceutical industry experience and is passionate about product design and performance. Prior to GSK, he worked at FMC Corp. and Schering-Plough in pharmaceutical drug delivery and formulation research. Pratik holds a Ph.D. in Pharmaceutical Sciences from University of Southern California.
Co-Director of CRCG, Hans W. Vahlteich Professor of Pharmacy, Professor of Pharmaceutical Sciences, Biointerfaces, College of Pharmacy, University of Michigan
Dr. Anna Schwendeman is Hans W. Vahlteich Professor of Pharmacy and Professor of Pharmaceutical Sciences at the University of Michigan. Her research focuses on optimization of high-density lipoprotein (HDL) nanoparticles for treatment of atherosclerosis, sepsis, and drug delivery purposes. In 2016, she co-founded EVOQ Therapeutics (www.evoqtherapeutics.com), a company focused on the use of HDL nanodiscs for delivery of immunotherapies focused on improving the lives of individuals fighting autoimmune diseases. Dr. Schwendeman received her B.S. from Moscow Institute of Physics and Technology and Ph.D. in Pharmaceutics from The Ohio State University. Prior to starting her academic career in 2012, Dr. Schwendeman spent 12 years in the pharmaceutical industry at Cerenis Therapeutics, Pfizer, and Esperion Therapeutics. She was involved in discovery and translation HDL drugs to clinical trials. She successfully submitted FDA INDs for seven different products including nanoparticles, liposome, recombinant proteins, peptides, and small molecules. Her laboratory’s research in regulatory sciences is focused on analytical characterization of liposomes, polymer microspheres, peptides, and biosimilar products. Dr. Schwendeman is a co-Director of FDA sponsored Center for Research in Complex Generics (http://www.complexgenerics.org) and an Associate Editor for Nanomedicine NBM and Eur. J. Pharm and Biopharm.
Scientist II, Simulations Plus
Dr. Daniela Silva is a Scientist II at Simulations Plus, whose research is focused on the modeling of absorption of complex formulations in GastroPlus, such as Long Acting Injectables and locally acting drug products on the GI tract.
Daniela obtained her B.Sc. in Pharmacy and Biochemistry from the University of Sao Paulo, Brazil and Ph.D. in Pharmaceutical Sciences from the University of Alberta, Canada. Her graduate work focused on the development of novel biopharmaceutical investigations towards drug and formulation performance optimization. She joined Simulations Plus as Post-doctoral fellow in 2021 and has been working there since.
Supervisory Chemist, OPQA III, OPQ, CDER, FDA
Erin Skoda is currently a Supervisory Chemist in the Office of Product Quality Assessment III within OPQ in CDER at FDA. She has worked on CMC quality assessment of Type II Drug Master Files (DMFs), division initiatives and policies, and collaborations with several offices within the Agency. Prior to joining the FDA in 2014, Erin worked as a medicinal chemist at the University of Pittsburgh and the Broad Institute of Harvard and MIT. She holds a Ph.D. in organic chemistry from the University of Pennsylvania.
Vice President, Drug Product Development, R&D, Medicine Development & Supply, GlaxoSmithKline (GSK)
Dr. Sujatha Sonti is the Vice President of Drug Product Development based at the GSK Upper Providence site in Philadelphia. In her current role she leads a global team of outstanding scientists across disciplines including formulation, packaging, biopharmaceutics, engineering, modeling, and process analytics to develop innovative and robust, patient-centric medicines. This team is accountable for the design, development, and industrialization of drug products (Oral, Sterile, and Inhaled) and manufacturing processes for all GSK small molecule and biopharmaceutical products.
Sujatha obtained a Bachelor’s degree in pharmacy from the University of Mumbai, India, and received her Ph.D. in Pharmaceutical Sciences from West Virginia University. Her graduate research focused on the delivery of large molecules: antisense oligonucleotides and gene therapy for the treatment of lung inflammation. Prior to her GSK position, Sujatha worked at Avon Products, Inc., Ionis Pharmaceuticals, SkinMedica, Inc. (a division of Allergan), and Medicis Pharmaceuticals, where she worked on developing both prescription and consumer care products. Through these opportunities, she has gained over 24 years of product development experience, which led her to the incredible fortune of launching several Prescription/Cosmetic/OTC products.
Principal Scientist, Simulations Plus, Inc.
Dr. Jessica Spires is a principal scientist at Simulations Plus, Inc. She is focused on physiologically based pharmacokinetic (PBPK) modeling of non-oral routes of administration, including dermal, ocular, and pulmonary administration, in the GastroPlus™ and MembranePlus™ software platforms. She is currently the principal investigator on FDA grants focusing on transdermal drug products quality and performance attributes via enhanced virtual bioequivalence simulations, and on PBPK/PD modeling of ophthalmic drug products to support translation from pre-clinical species to human. She is a graduate of Case Western Reserve University with a Doctoral degree in biomedical engineering.
Senior Pharmacologist, DQMM, 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 with expertise on physiologically-based pharmacokinetic modeling and simulation approaches for topical and transdermal drug products. 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 also include the development of quantitative modeling and simulation tools to support bioequivalence assessments and the interactions between inactive ingredients and molecular targets including gut transporters.
Senior 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. He later earned his Ph.D. in Engineering (mechanical track) from Virginia Commonwealth University in 2014, where he also spent seven months as a postdoctoral fellow prior to joining the FDA. His research interests include computational fluid dynamics 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 (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD) in FDA. Dr. Wu has been with FDA for more than 11 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 four 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.
Biopharmaceutics Reviewer, DPQA VI, OPQA I, OPQ, CDER, FDA
Dr. Yunming Xu is a Biopharmaceutics Reviewer in the Division of Product Quality Assessment (DPQA) within the Office of Pharmaceutical Quality Assessment (OPQA) at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). His work primarily revolves around Physiologically-Based Biopharmaceutics Modeling (PBBM) for BCS Class II drugs, a critical field in the development of safe and effective medications. Since 2022, he has provided his expertise to the PBPK committee in the Division of Biopharmaceutics, addressing challenges in modeling dissolution and absorption. Yunming earned his PharmD and a Master’s degree in Pharmacometrics from the University of Maryland School of Pharmacy.
Lead Pharmacokineticist, DPM, OCP, OTS, CDER, FDA
Dr. Yuching Yang is the Team Lead of the PBPK (Physiologically-Based Pharmacokinetic) and QSP (Quantitative Systems Pharmacology) Modeling Program within the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, at the Food and Drug Administration (FDA). She earned her Ph.D. in Exposure Assessment and Biomedical Science from Rutgers University in 2006. With nearly 20 years of experience, she has specialized in developing and applying mechanistic models in toxicology (PBPK), human risk assessment (PBPK/Bayesian), and clinical drug development (PBPK/QSP). Dr. Yang joined the FDA in December 2015. Her primary responsibilities include evaluating the applicability of PBPK/QSP modeling submitted in INDs, NDAs, and BLAs across multiple therapeutic areas to support clinical drug development, regulatory approval, and policy development.
Deputy Director, ORS, OGD, CDER, FDA
Dr. Lei Zhang is Deputy Director in the Office of Research and Standards (ORS), OGD, CDER, U.S. 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 25 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 U.S. 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 130 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 demonstrated excellence and leadership in drug development and regulatory science in regulatory and industrial settings for new and generic drugs during his 18+ professional tenue including in Pharsight as an associate consultant, BMS as a research investigator, Medimmune as an Associate Director, FDA as Clinical Pharmacology reviewer and Pharmacometrics team leader. Dr. Zhao has introduced a broad array of innovative tools in the realm of drug deliveries and bioequivalence assessment, as well as big data tools including machine learning to pharmacometrics. He received the 2023 Gary Neil Prize for Innovation in Drug Development from ASCPT as a recognition to his contribution to clinical pharmacology and pharmacometrics.
Director, DPM, OCP, OTS, CDER, FDA
Dr. Hao Zhu is the director of the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center of Drug Evaluation and Research, U.S. Food and Drug Administration. Dr. Zhu received his Ph.D. in Pharmaceutical Sciences and Masters in Statistics from the University of Florida. He started his career in modeling and simulation teams in Johnson & Johnson and Bristol-Myers-Squibb. He joined FDA as a pharmacometrics reviewer more than 17 years ago. Dr. Zhu has been a clinical pharmacology team leader for more than six years and a QT-IRT scientific lead for two years. Then he became the deputy director at the Division of Pharmacometrics. His division reviews the pharmacometrics-related submissions and supports pharmacometrics-related policy development.
If you have any questions about this workshop please contact info@complexgenerics.org.