Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development

Vice-President & Head, Biopharmaceutics & Bioequivalence, Dr. Reddy’s Laboratories Ltd., 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 an 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 21 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 has been on the use of 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, ~400 ANDAs, and multiple 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.

Lecturer, Institute of Pharmaceutical and Biomedicinal Sciences, Johannes Gutenberg University Mainz, Germany, Adjunct Assistant Professor, Department of Pharmaceutical Sciences, University of Michigan

A pharmacist by education (B.Sc. in Pharmacy, June 2009, University of Jordan, Amman, Jordan), Jozef Al-Gousous finished his Ph.D. in the field of Biopharmaceutics and Pharmaceutical Technology at the Johannes Gutenberg University Mainz in Germany (under the supervision of Prof. Peter Langguth) graduating with distinction in June 2016.  He then worked as a postdoctoral researcher in the lab of Prof. Gordon L. Amidon at University of Michigan (Ann Arbor, MI, USA).  Currently, he holds the position of a Lecturer at JGU Mainz and an Adjunct Assistant Professor at University of Michigan. His research activities involve employing mechanistic mass transport analysis for understanding the performance of drug products, biopredictive dissolution method development for oral dosage forms, characterization of the physical chemistry of intestinal bicarbonate buffer, developing novel enteric polymers for improved pH-dependent drug delivery, and transdermal drug delivery systems. He is also currently involved in teaching undergraduate and post-graduate student courses in Mainz and Michigan as well as mentoring both undergraduate and post-graduate students of Pharmacy and Pharmaceutical Sciences.

Senior Staff Fellow, 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 preabbreviated 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.

Clinical Development and Safety Director, Medicines for Europe, Brussels, Belgium

Dr. Susana Almeida is Clinical Development and Safety Director at Medicines for Europe (formerly EGA). Before joining Medicines for Europe, Susana was the Chair of the Association’s Bioequivalence Working Group for almost 15 years. She has worked in clinical trials and pharmacovigilance in Europe and in North America, and her experience includes the pharmaceutical industry and clinical research organizations. She has overseen the conduction of dozens of clinical trials carried out in Europe, North and South America, and Asia.

At Medicines for Europe, Susana is responsible for the coordination of multiple working groups, working on different aspects involving policy and regulatory science; Susana coordinates activities related to clinical development, pharmacovigilance/drug safety and medical devices (EU Medical Device Regulation article 117).

She has represented the International Generic and Biosimilar Medicines Association (IGBA) in multiple Expert Working Groups at the International Council for Harmonisation (ICH): M13, Generic Discussion Group and M9. She is also involved in the Therapeutics Pillar of the Access to COVID-19 Tools (ACT) Accelerator partnership, launched by WHO and partners. She holds a Ph.D. in Clinical Pharmacology from the Faculty of Medicine, Universidad Autònoma de Barcelona (UAB), Spain and has authored several scientific papers.

Laboratory Chief, DPQR, OTR, OPQ, CDER, FDA

Dr. Muhammad Ashraf is a Laboratory Chief in the Division of Product Quality Research with the Office of Testing and Research for the Office of Product Quality, CDER, FDA. He leads a team that conducts research to understand elements which affect the quality, safety, and efficacy of drug products of small and large molecules. He has over 15 years of industry experience in drug delivery, product, and process design in Wyeth and Pfizer where he led the development of many NMEs to market. He has authored over 70 peer reviewed articles and several patents. He obtained his Ph.D. in Industrial Pharmacy and Pharmacokinetics at the University of Maryland, Baltimore.

Associate Director for Pediatrics, OCP, CDER, FDA

Dr. Gilbert Burckart is presently Associate Director for Pediatrics, Office of Clinical Pharmacology, U.S. Food and Drug Administration.  Dr. Burckart received his B.S. in Pharmacy from the University of Pittsburgh in 1972, his Pharm.D. from the University of Kentucky in 1975 and did his pediatric residency at the UK Medical Center in Lexington and Norton Children’s Hospital in Louisville.  He served on the faculties of the State University of New York at Buffalo at Buffalo Children’s Hospital, and the University of Tennessee at LeBonheur Children’s Hospital.  He joined the University of Pittsburgh and the Pittsburgh Children’s Hospital in 1982 where his research focused on drug therapy in organ transplant patients.  He has been Principal Investigator on NIH grants in both liver and lung transplantation.  At Pitt, he was a Professor of Pharmacy, Pediatrics and Surgery, and served as Director of Research for the Division of Cardiothoracic Surgery.

In 2003, he moved to the University of Southern California in Los Angeles, where he was Chairman of the Department of Pharmacy, Director of the Clinical Pharmacogenomics Laboratory, Professor of Pharmacy, and Professor of Pediatrics.  Dr. Burckart was an investigator at the Children’s Hospital of Los Angeles.

Dr. Burckart has previously served as the President of the American College of Clinical Pharmacy, and as President of the American College of Clinical Pharmacology. He is a member of the Pediatric Pharmacy Advocacy Group and received their Sumner J. Yaffe Lifetime Achievement Award in Pediatric Pharmacology and Therapeutics in 2014.

Dr. Burckart moved to the U.S. FDA in 2008.  His duties include the direction of the Pediatric Clinical Pharmacology program within the Office of Clinical Pharmacology, and participation in the FDA’s Pediatric Review Committee.  His present research program includes analyses of pediatric drug development studies from 1997 to present.

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, Taiwan 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, alcohol dose dumping effect on BE results, as well as single-sex impact on BE evaluation.

Assistant Professor, Center for Pharmacometrics & Systems Pharmacology, Department of Pharmaceutics, University of Florida

Dr. Rodrigo Cristofoletti is an Assistant Professor at the University of Florida (UF), Department of Pharmaceutics and the Associate Director of the Center for Pharmacometrics and Systems Pharmacology at the UF. Before joining the Gator Nation, he served as a Reviewer/Inspector in the Biopharmaceutics & Clinical Pharmacology Office of the Brazilian Health Regulatory Agency (Anvisa) for 15 years.  He received his B.S. in Pharmaceutical Sciences from the University of Sao Paulo, Brazil in 2004.  Dr. Cristofoletti received his Ph.D. summa cum laude from the Johann Wolfgang Goethe University, Frankfurt am Main, Germany, under the supervision of Prof. Dr. Jennifer Dressman in 2017.  He has also been a member of the Biopharmaceutics Classification System (BCS) and Biowaivers Focus Group which is part of the Special Interest Group on Regulatory Sciences of the International Pharmaceutical Federation (FIP). Dr. Cristofoletti’s lab focuses on translational PK and molecular pharmaceutics. His research interests are developing organotypic models and microphysiological systems to model ADME in special populations (e.g., Down Syndrome, Cystic Fibrosis, Allan-Herndon-Dudley syndrome patients and others) and to investigate disease mechanisms affecting the gastrointestinal system (i.e., inflammatory and genetic diseases) and integrity of the biological barriers (i.e., leaky BBB and inflammatory diseases affecting the lung epithelium). His lab is also interested in applying PBPK and QSP modeling to inform drug development. Dr. Cristofoletti has published more than 65 peer-reviewed articles in highly respected journals in the pharmaceutical sciences arenas and he is co-editing a novel PBPK book to be released in Q1/24.

Senior Staff Fellow, DPM, OCP, OTS, CDER, FDA

Dr. Jianghong Fan is a Senior Staff Fellow in PBPK team in the Division of Pharmacometrics (DPM)/Office of Clinical Pharmacology (OCP)/Office of Translational Sciences (OTS)/CDER. Her main responsibility includes the review of PBPK submissions in IND/NDA/BLAs and research in PBPK. Prior to joining OCP, Dr. Fan was a scientific reviewer in Office of Research and Standards (ORS)/Office of Generic Drugs (OGD) where she focused on applying PBPK absorption modeling and simulation to address issues in ANDA reviews, controlled correspondences, citizen petitions, and bioequivalence guidance development. She received her Doctoral degree in Pharmaceutical Sciences and Master’s degree in 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 (ORS), Office of Generic Drugs (OGD), CDER/FDA. Since 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).

Professor of Biopharmaceutics, Centre of Therapeutic Innovation (CTI), Department of Life Sciences, University of Bath, UK

Dr. Nikoletta Fotaki is a Professor of Biopharmaceutics at the University of Bath, UK. She graduated in Pharmacy from the National and Kapodistrian University of Athens in Greece and she holds an M.Sc. in Toxicology and a Ph.D. in Biopharmaceutics-Pharmacokinetics. Her expertise and research are focused on PBPK modeling/PBBM, in vitro and in silico tools for predicting absorption in normal populations and in special populations, dissolution methods, IVIVCs, and biowaivers. Her scholastic work includes 90 peer reviewed publications, one book, ten book chapters, 87 published conference contributions, and two patents. She is an AAPS Fellow and a member of the AAPS Board of Directors with leading roles in the OBAM and IVRDT AAPS Communities. She is also the chair of the Biopharmaceutics Group of APS and she is a member of a USP expert panel and of several scientific societies and has been an invited speaker at several conferences.

Senior Principal Scientist, Merck & Co., Inc., Rahway, NJ, USA

Dr. Tycho Heimbach is a Senior Principal Scientist at Merck in the Biologics Development and Biopharmaceutics Group which is part of the Sterile and Specialty Products Group.  There he serves as a biopharmaceutics and PBBM/PBPK expert in oral and long-acting injectables drug development, which includes establishing the bioequivalence safe space of new drug candidates.  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 served as cochair on working groups for the PBPK Modeling and the PBPK renal and hepatic impairment WG and the PBBM WG for the Innovation and Quality in Pharmaceutical Development (IQ) consortium. He is currently serving as the Merck representative on the PBBM Innovation & Quality (IQ) Consortium Working Group.

Dr. Heimbach has been a speaker at 50 national and international conferences.  He has authored/coauthored ~65 peer-reviewed publications in ADME, PBPK, and formulation sciences and was recognized as an AAPS Fellow in 2021.

Senior Scientist Clinical Innovations, Lek, a Sandoz Company

Dr. Rebeka Jereb is a Senior Scientist in Clinical Innovations, 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, population PK modeling, model-based BE assessment, 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.

Deputy Director, DBII, OB, OGD, CDER, FDA

Dr. Xiaojian Jiang is currently the Deputy Director for the Division of Bioequivalence II, Office of Bioequivalence. The Division of Bioequivalence is responsible for the review of bioequivalence studies (with pharmacokinetic endpoint) submitted to support approved of ANDAs.

Dr. Xiaojian Jiang received her Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore. She joined the Division of Bioequivalence in 2003 as a pharmacologist reviewer. During her tenure in the FDA, Dr. Jiang made significant contributions to the approval and regulation of many complex generic products. She is an active member on multiple FDA committees and working groups. She has presented and published on a range of complex regulatory, scientific issues including, but not limited to BE approaches for locally acting drug products, in vitro alternative approach for NG tube administration, Uses of Adaptive Design Approach for Generic Bioequivalence Studies, and BE assessments for NTI drug products.

SUNY Distinguished Professor & Former Chair of Pharmaceutical Sciences, University of Buffalo

Dr. William Jusko is SUNY Distinguished Professor & former Chair of Pharmaceutical Sciences at the University of Buffalo. He received his B.S, in Pharmacy (1965) and Ph.D. (1970) degrees from Buffalo. He then served as Clinical Pharmacologist at the Boston VA Hospital and Assistant Professor of Pharmacology at Boston University. He returned to Buffalo in 1972 as Director of the Clinical Pharmacokinetics Laboratory and Assistant Professor. He received the Doctor Honoris Causae from the Jagiellonian University in Poland (1987) and from the University of Paris Descartes (2015) and has many other awards including the 2018 Oscar B Hunter Career Award from ASCPT and the 2020 Distinguished Pharmaceutical Scientist Award from AAPS. He serves on the Editorial Boards of seven journals and is former Editor-in-Chief of JPKPD. His research covers clinical, basic, and theoretical PK/PD of diverse drugs, particularly immunosuppressants, anti-diabetics, anti-cancer drugs, and antibodies with over 650 publications.

Director, DTPII, ORS, OGD, CDER, FDA

Dr. Myong-Jin (MJ) Kim currently serves as the Director of the Division of Therapeutic Performance II, Office of Research and Standards, Office of Generic Drugs, CDER/FDA. Since 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.

Pharmacologist, DBII, OB, OGD, CDER, FDA

Dr. Vidula Kolhatkar is a Pharmacologist in the Division of Bioequivalence II in the Office of Generic Drugs (OGD). Her work primarily involves assessment of the bioequivalence section of Abbreviated New Drug Applications. Prior to joining OGD, she was acting biopharmaceutics lead in the Division of Biopharmaceutics/Office of New Drug products at OPQ. Dr. Kolhatkar received her Ph.D. in Pharmaceutical Sciences from the University of Maryland and was a post-doctoral fellow at University of Illinois Chicago working in the area of novel drug delivery systems before joining FDA.

Professor of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg University, Mainz, Germany

Dr. Peter Langguth is a Pharmaceutical Scientist by training and Professor of Pharmaceutical Technology and Biopharmaceutics at the School of Pharmacy, Gutenberg University, Mainz, Germany. Undergraduate & graduate studies in Pharmacy at the University of Frankfurt; Ph.D. in Pharmacology (1985); Post-doctoral Research Fellow in Pharmacokinetics with Prof. Edward R. Garrett/University of Florida (1986-1988); Senior Research Fellow Department of Pharmaceutical Technology, Swiss Federal Institute of Technology (ETH) Zürich; Group Head Drug Absorption Research at Astra Hässle AB, Mölndal, Sweden (1996-1998); since 1998 Head Department of Pharmaceutical Technology and Biopharmaceutics, J. Gutenberg University, Mainz, Germany. He has published more than 280 articles and patents in the areas of Biopharmaceutics, Pharmaceutical Technology, and Drug Delivery: h-index 47 (Web of Science). Co-editor of the Scientific Commentary to the European Pharmacopoeia. Service as “Qualified Person” GMP for the clinical sample batch production at the University of Mainz.

In 2004, Dr. Langguth received the APV Research Award for Outstanding Achievements in Pharmaceutical Sciences; 2007 PHOENIX Scientific Award for Pharmaceutical Technology; 2010 recipient of the APV Silver Medal, and 2010 designated as AAPS Fellow.

His main research interests include pharmaceutic carrier systems for challenging drugs (small and large molecules) aiming at improvement of pharmaceutic and biopharmaceutic quality, targeting, therapeutic effectiveness, and biopredictive in vitro methods including biowaivers. Several research projects, also in collaboration with pharmaceutical industry, have led to clinical phase-I and phase-II studies, conducted in-house and in collaboration with the University Clinics Mainz.

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.

Senior Director, Head of PBPK, Bristol Myers Squibb

Dr. Gaohua Lu is Senior Director at BMS in the USA. For the last three years, Gaohua has been leading the PBPK group in the Clinical Pharmacology and Pharmacometrics (CPP) department. Under Gaohua’s leadership, the PBPK group has significantly developed its capability in supporting the portfolios through the whole phases of drug discovery and development, including FTIH, DDI, special populations, biopharmaceutics (FE/ARA, particle size, excipients, and biowaiver), biologics, and new therapeutic modalities.

Gaohua received his Ph.D. from Tokyo Medical & Dental University in 2004. Previously, he studied Thermal Engineering at Northeastern University in China.

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.

Biopharmaceutics Reviewer, DB, ONDP, OPQ, CDER, FDA

Dr. Rebecca Moody is a Biopharmaceutics Reviewer in the Division of Biopharmaceutics (DB), Office of New Drug Products (ONDP), Office of Pharmaceutical Quality (OPQ) at the FDA. 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 evaluates 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.

Assistant Professor, Pharmacokinetics and Biopharmaceutics, Lisbon University
INFARMED, Clinical Pharmacology Assessor, Member, MWP, EMA

Dr. Paulo Paixãois is an Assistant Professor in Pharmacokinetics and Biopharmaceutics at the Pharmacy Faculty of Lisbon University since 2012. He is also a Clinical Pharmacology assessor at INFARMED (Portuguese Regulatory Agency) since 2003 and a member of the Methodology working Party (MWP) from EMA. He serves as EMA’s Deputy Topic Lead on the ICH M13 Expert Working Group. In his regulatory work, he has been involved in the assessment of bioequivalence and general clinical pharmacokinetics in Centralized, Decentralized, Mutual Recognition and National Procedures. He has also been involved in Scientific Advices Procedures both at the National and European level. Regarding research, his main topics of interest have been related to pharmacokinetics and therapeutic drug monitoring. In particular, he has been involved with creating and optimizing drug development tools, namely, on the use of QSAR and data integration procedures with PBPK models. Regarding PBPK models, he has mainly been focused in modelling and simulation on oral drug absorption with several papers with direct implication on bioavailability/bioequivalence regulatory sciences, namely on the establishment of pharmacokinetics metrics for bioequivalence of modified release formulations, and on the evaluation of similarity metrics for dissolution profiles. Latter research interests are related to the better understanding of the physiology of the GI tract and its consequences in clinical variability for oral drug products.

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.

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 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.

Scientist-Biopharmaceutics and IVIVC, Sandoz Development Center

Mohan Krishna Rayeni works as a Scientist at Sandoz Development Center, Hyderabad, India. Mohan’s work focusses on Biopharmaceutical Risk Assessment, Bio-predictive in vitro method development and utilization of physiologically based and statistically based predictive models for generic oral drug product development and optimization. Prior to joining Sandoz, he worked as an Associate Scientist in Biopharmaceutics and Formulation development at Biocon Bristol Myers Squibb Research & Development Center (BBRC), Bangalore and as an Executive in Formulation Development at Strides Pharma Science Limited, Bangalore. Having six years of work experience in development of innovator and generic drug products, Mohan enjoys correlating Physicochemical properties of Drug substance, Formulation variables, Physiology to the pharmacokinetics for the better prediction of clinical study outcome. He holds a Master’s degree in Industrial Pharmacy from JSS College of Pharmacy, Ooty, India.

Professor of Systems Pharmacology and Director of Centre for Applied Pharmacokinetic Research (CAPKR), University of Manchester, UK, SVP of R&D, Chief Scientific Officer (CSO), Certara, Princeton, USA

Dr. Amin Rostami-Hodjegan was listed by The Institute of Scientific Information (ISI, Clativate) as one of the world’s most highly cited researchers (under ‘Pharmacology & Toxicology’) in 2017. Amin is also at 0.05% top rank of the Highly Cited Researchers List by Elsevier for pharmacology (2021). He has published over 300 peer reviewed highly influential scientific articles (>22,000 citations, h-index = 80). 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).

Amin was co-founder of two spin-off companies from the University of Sheffield (Simcyp Limited and Diurnal PLC). 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 biosimulation 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.

Research Fellow, Pfizer Global Research and Development

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

Co-Director of CRCG, William I Higuchi Collegiate Professor of Pharmacy and Professor of Pharmaceutical Sciences, Biointerfaces Institute, College of Pharmacy, University of Michigan

Dr. Anna Schwendeman is William I Higuchi Collegiate Professor of Pharmacy and Associate Professor of Pharmaceutical Sciences at the University of Michigan. Her research focus is on optimization high-density lipoprotein (HDL) nanoparticles for treatment of atherosclerosis, sepsis, and drug delivery purposes. In 2016, she co-founded a company EVOQ Therapeutics (www.evoqtherapeutics.com) focused on the use of HDL nanodiscs for delivery of personalized neoantigen cancer vaccines. 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. She is co-Director of FDA sponsored Center for Research in Complex Generics (http://www.complexgenerics.org). Dr. Schwendeman is an Associate Editor for Nanomedicine NBM and Eur. J. Pharm and Biopharm.

Senior Manager, Bioequivalence, Cosette Pharmaceuticals Inc.

Harshil Shah serves as a Senior Manager, Bioequivalence (BE) at Cosette Pharmaceuticals Inc.’s South Plainfield, NJ site. He is an R&D expert with over 12 years of scientific experience in the pharmaceutical industry. His vast experience includes the development of various complex generic and 505(b)2 products where he has been instrumental in the development of Analytical, Formulation and In vitro/In vivo Bioequivalence strategies.  At Cosette, he is heading Bioequivalence department which is responsible for working collaboratively with other site and departments across the U.S. and he also leads the Bioequivalence activity with different CMO/CRO and Pharma company globally to innovate novel Bioequivalence approaches for the development of complex pharmaceutical dosage forms.

He has worked for various Pharma companies like Amneal Pharmaceuticals, G&W labs, and Solaris Pharma with various scientific positions. Overall, his experience spans from early product development, Bioequivalence, Quality compliance, Product filing, and post approval support for pharmaceutical dosage forms. Harshil received his M.S. in Pharmaceutics specialized in Industrial Pharmacy from Long Island University, Brooklyn, NY.

Senior Vice President, Sun Pharmaceuticals, India

Dr. Romi Singh holds a Bachelor’s in Pharmacy and a Master’s in Pharmaceutical Sciences from the Indian Institute of Technology (IIT), Banaras Hindu University (BHU), Varanasi. She completed her Ph.D. in Pharmaceutics in locally acting drug delivery systems, from IIT, BHU, Varanasi. She joined the pharmaceutical generic industry in 2001 and worked in different roles in formulation development, involving both ANDAs and NDAs of a variety of dosage forms for markets across the globe. She is currently leading the pharmaceutical and nutraceutical development for oral dosage forms for Sun Pharmaceuticals, India. Her role also involves design of strategy to explore in vitro in vivo relationship during formulation development, to understand formulation and physiological variables impacting bioavailability and establish bioequivalence as per current regulatory guidance.

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 OSGD/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 his Ph.D. in Pharmaceutical Sciences from the University of Michigan and Bachelor’s in Pharmacy from the University of Connecticut. He is currently pursuing a certificate in Model Informed Drug Development at the University of Florida.

Pharmacologist, DQMM, ORS, OGD, CDER, FDA

Dr. Sherin Thomas earned her M.S. in Pharmacology from New York Medical College and Ph.D. in Pharmaceutical Sciences from University of Maryland, Baltimore where her research work focused on transdermal pharmacokinetics and in vitro-in vivo correlations. She joined the Division of Quantitative Methods and Modeling at FDA in 2020 where she contributes to regulatory and research projects involving population pharmacokinetic modeling and physiologically based pharmacokinetic modeling focused on bioequivalence and in vitro-in vivo correlations.

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.

Chief Scientific Officer, Biopharmaceutics, Biostatistics, Global Regulatory Affairs, Apotex, Inc.

Dr. Yu-Chung Tsang is currently working at Apotex Inc. as Chief Scientific Officer, Biopharmaceutics and Biostatistics. He obtained his Bachelor’s degree in Pharmacy in 1984 and Ph.D. degree in Pharmacokinetics in 1990 from the University of Toronto. He has been with Apotex since then. His main responsibilities are to provide pharmacokinetic and statistical advice in preparing protocol and study reports 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, he has been involved with the design and data analysis of over one thousand bioequivalence/clinical studies for the registration of complex drug and biosimilar products and over 300 traditional drugs in Canada, U.S., EU, and many other international marketplaces. Dr. Tsang is the Past 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, he also holds an appointment (status only) at the Leslie Dan Faculty of Pharmacy, University of Toronto.

Senior Vice President Regulatory Affairs, Cipla Ltd.

Dr. Siva Vaithiyalingam is Sr. Vice President of Regulatory Affairs, Cipla LTD.  He is responsible for both Generic and New Drugs at Cipla.  He led several leadership positions leading to development and approval of modified and complex dosage forms.  His expertise includes technical, regulatory, and quality aspects of drug development, approval, and life cycle management.  He has previously served at Barr Labs, FDA, and Teva in various positions.  He graduated with a Master’s degree in Pharmaceutical Sciences from Institute of Technology, BHU and a Ph.D. in Pharmaceutical Sciences from Texas Tech University Health Sciences Center.

Senior Pharmacologist Reviewer and Scientific Lead, DQMM, ORS, OGD, CDER, FDA

Dr. Fang Wu is a senior pharmacologist reviewer and scientific lead for oral physiologically based pharmacokinetic (PBPK) modeling in the 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.

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.

Senior Pharmacologist Staff, OTR, OPQ, CDER, FDA

Dr. Ahmed Zidan is a senior staff fellow (Pharmacologist) in the CDER/OPQ. Dr, Zidan leads the manufacturing laboratories and research of Division of Product Quality Research in Office of Pharmaceutical Quality and provides hands-on trainings to reviewers on various topics, including analytical metrices of complex drug products, Preformulation, 3D printing technologies, continuous manufacturing, preclinical development, and scale up processes. Dr. Zidan is the government liaison for complex excipients focus group at USP and is a member of the FDA’s additive manufacturing Group and chaired several international and domestic scientific events. Dr. Zidan is also an editorial board member of several pharmaceutical journals and published various peer-reviewed articles and book chapters.