Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches

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

Dr. Khondoker Alam obtained his Ph.D. in Pharmaceutical Sciences at the University of Oklahoma Health Sciences Center in 2017 and completed one-year Fellowship in Office of Clinical Pharmacology. Dr. Alam is currently a Staff Fellow at the Division of Quantitative Methods and Modeling at the Office of Research and Standards. His role in the division
is to utilize translational tools such as physiologically-based pharmacokinetic (PBPK) modeling to address specific questions pertinent to drug development process and/or regulatory decision making. 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 interaction.

Senior Scientist, Biopharmaceutics Group, The Janssen Pharmaceutical Companies of Johnson & Johnson

Dr. Sumit Arora is a Senior Scientist in Biopharmaceutics group at The Janssen Pharmaceutical Companies of Johnson & Johnson. His primarily responsibility involves leading cross-functional teams to implement biopharmaceutical development strategies across preclinical development, clinical development, and CMC development. Before joining Janssen, he worked as senior research scientist in the field of virtual bioequivalence in the modeling and simulation (M&S) group at Certara UK, Simcyp Division. At Certara, he led the FDA awarded grant investigating the integration of formulation drug product quality attributes in dermal physiologically based pharmacokinetic models for topical/transdermal drug products and involved in the development of oral absorption module in the Simcyp simulator. His research interests include all aspects of biopharmaceutics with a focus on the application of M&S approaches. He received his Ph.D. from National Institute of Pharmaceutics Education and Research (NIPER), SAS Nagar, India and was recipient of Endeavor Research Fellowship at University of Sydney and DAAD Scholar at Max Planck Institute of Polymer Research, Germany.

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

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.

Professor of Pharmaceutical Sciences, State University of New York at Buffalo

Dr. Bies is Professor of Pharmaceutical Sciences at the School of Pharmacy and Pharmaceutical Sciences as well as a member of the Institute for Computational Data Science (ICDS) at the State University of New York at Buffalo. Prior to this, he served as Associate Professor of Medicine and Medical and Molecular Genetics at the Indiana University School of Medicine and Director of the Disease and Therapeutic Response Modeling program for the Indiana CTSI. He is a consulting scientist at the Centre for Addiction and Mental Health, University of Toronto; North American senior and executive editor for the British Journal of Clinical Pharmacology; and on the editorial boards of the Journal of Pharmacokinetics and Pharmacodynamics, Clinical Pharmacology and Therapeutics, Pharmacometrics and Systems Pharmacology, and Biopharmaceutics and Drug Disposition. He is a member of AAPS, ISoP, ACCP, and ASCPT and served as a board member of ISoP until December 2017. Dr. Bies was elected a Fellow in ISoP in 2020.Dr. Bies received a BSc degree in Pharmacy from the University of Toronto (1991), a Pharm.D. from the UTHSCSA and the UT Austin (1994), and a Ph.D. Pharmacology from Georgetown University in 1998. This was followed by postdoctoral training at the Center for Drug Development Sciences at Georgetown University. His research has two main tracks: an applied track focuses on the application of pharmacometrics and PBPK approaches in HIV, addiction, psychiatry, oncology, neurology, and cardiovascular disease; and a novel methods development track, including machine learning approaches to model selection and optimization methods for parameter estimation in dynamic systems.

VP Scientific and Corporate Communications, Absorption Systems, a Pharmaron company

As VP of Scientific and Corporate Communications, one of Dr. Bode’s responsibilities is to capture and disseminate the mission and messages of Absorption Systems to the world. He has had multiple roles since joining the company in 2006. Over the past ten years, he has been Study Director for most of the Biopharmaceutics Classification System (BCS) conducted by Absorption Systems in support of numerous BCS-based biowaivers. He has also directed several transporter studies, serves as Scientific Reviewer for many types of studies, and either directs or provides scientific input into various research projects, grants, and contracts. One example of this last role is directing the FDA contract that led to the data presented today. Prior to Absorption Systems, Dr. Bode spent seventeen years in the pharmaceutical industry, working on both pharmacokinetics and pharmacodynamics. He was VP of Operations for Tissue Transformation Technologies, a leading provider of tissue-based in vitro reagents for drug metabolism studies. His Ph.D. in Pharmacology is from the University of Colorado, and postdoctoral research was conducted at UC San Diego, where he began the work on cyclic nucleotide phosphodiesterases that continued in his first pharmaceutical industry position, with Sterling Winthrop in Rensselaer, NY and Collegeville, PA.

Senior Product Development Scientist, Teva Pharmaceutical

Clare Butler is a senior product development scientist at Teva Pharmaceutical’s global inhalation R&D department. Following completion of a Ph.D. in Pharmacology, she spent a year working at Sanofi in lyophilisation and analytics. She joined Teva in 2018 and is responsible for leading Teva’s inhaled IVIVC initiative. Clare has a keen interest in advancing the application of IVIVC and mechanistic modelling for respiratory drug product development.

Director of Advanced Drug Delivery Research & Biopharmaceutics/IVIVC, Pharmaceutical R&D, Lupin Ltd., Pune, India

Dr. Sajeev Chandran completed his B Pharm (Hons) from IIT, Varanasi, India, M Pharm and Ph.D. in NDDS Design & Development from Birla Institute of Technology & Science, Pilani, India and MBA in Operations Management from IGNOU, New Delhi. Currently at Pharmaceutical R & D of Lupin, as Director- Advanced Drug Delivery Systems (ADDS)
Research & IVIVC, he is involved in leading a diverse research group of formulators, analysts, biopharmaceutics & IVIVC experts in design, development & regulatory submission of advanced drug delivery technologies based brand & difficult to do generic products. At Lupin, he also leads a group involved in design & development of bio-relevant methodologies and application of IVIVC/R based interventions that facilitates reverse engineering, BE outcome prediction in oral generic product development (especially extended release products) and providing IVIVC/R support in interactions with various generic drug regulators (US-FDA, EMEA, TGA- Australia and Health Canada) for BE waiver, dissolution specification modification and/ or relaxation.

Prior to joining Lupin, he served as Assistant Professor and Assistant Dean, at Birla Institute of Technology & Science, Pilani, India. In his research career, he has 10 granted patents, 25+ patent applications currently under various stages of examination, 50 research publications in peer- reviewed journals and over 60 research presentations in national & international conferences/ symposia. He has delivered more than 35 invited talks and supervised three PhD thesis work in Novel Drug Delivery System Design & Development.

He is recipient of FDD Leadership Awards 2019 under the Rising Stars Category, (Jun 2019) at 3rd Formulation Development & Drug Delivery (FDD) Conclave, Hyderabad by Express Pharma, Indian Express Group; Young Pharmacy Teacher Award- 2008 instituted by Association of Pharmaceutical Teachers of India; and Young Scientist Award in 2005 by Dept. of Sci. & Tech., Govt of India, New Delhi.

Director, OGD, CDER, FDA

Sally Choe, Ph.D., serves as Director of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research. This office is responsible for the review and approval of Abbreviated New Drug Applications (ANDAs). Its mission is to ensure, through a scientific and regulatory process, that generic drugs are safe and effective for the American public.

From 2006 to 2011, Dr. Choe was leader of the metabolism and endocrinology team in CDER’s Office of Clinical Pharmacology, Office of Translational Sciences (OTS). Between 2011 and 2016, she served as senior director at PAREXEL International Corporation,  overseeing the Asia-Pacific region and Japan offices, as well as managing the global Vice President Technical consultant group. Dr. Choe returned to FDA in January 2017 and served as deputy director of the Office of Study Integrity and Surveillance in OTS. With more than 20 years of experience in global drug development, Sally is a recognized expert in drug review, clinical pharmacology, biopharmaceutics, and pharmacokinetics.

She received her undergraduate degree in Electrical Engineering from Virginia Polytechnic and State University and her M.S. and Ph.D. degrees in Pharmaceutics from the University of Michigan.

Principal Deputy Director, CDER, FDA

Jacqueline Corrigan-Curay, J.D., M.D., is the Principal Deputy Center Director in FDA’s Center for Drug Evaluation and Research (CDER). Most recently, she served as the Acting Center Deputy Director for Operations, directing center and agency-level priority and initiative programs and leading GDUFA III reauthorization negotiations.

Previously, Dr. Corrigan-Curay was director of CDER’s Office of Medical Policy (OMP). In that role, she led the development, coordination, and implementation of medical policy programs and strategic initiatives. She worked collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.

Dr. Corrigan-Curay brings to the position a unique legal, scientific policy, and clinical background with expertise in risk and scientific assessment, and clinical trial design and oversight. Before joining FDA, she served as supervisory medical officer with the Immediate Office of the Director, National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH). She also served in director and acting director roles with the Office of Biotechnology Activities (OBA), Office of Science Policy at NIH, where she was executive secretary of the NIH Recombinant DNA Advisory Committee. She has held positions as an attending physician with the VA Medical Center, a policy analyst with the Congressional Office of Technology Assessment, and as a practicing attorney in Washington, D.C.

Dr. Corrigan-Curay earned her law degree from Harvard Law School, her medical degree from University of Maryland School of Medicine, and a Bachelor’s degree in History of Science from Harvard/Radcliffe College in Cambridge, MA. She completed her training in internal medicine at Georgetown University Medical Center, where she also served as a clinical assistant professor of medicine. She has continued to practice internal medicine part-time at the Veterans Affairs Medical Center in Washington, D.C.

Research Scientist, DAM, OSEL, CDRH, FDA

Brent Craven is a Research Scientist in the Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health (CDRH) at the U.S. FDA. He received his Ph.D. in Mechanical Engineering from the Pennsylvania State University in 2008. His areas of expertise include computational fluid dynamics (CFD), fluid- structure interaction (FSI), multiphysics modeling, patient-specific modeling, and verification and validation (V&V) of computer modeling applied to medical devices such as mechanical circulatory support devices, artificial heart valves, intravascular blood clot filters, and inhalers. His research at the FDA primarily focuses on (i) advancing the use of V&V for physics-based computational modeling of medical devices, and (ii) developing improved models for reliably predicting flow-induced blood damage in cardiovascular devices. He has authored 50 refereed journal papers and more than 100 conference proceedings and abstracts. He is currently an Associate Editor for the Journal of Verification, Validation and Uncertainty Quantification. In addition to research, he regularly serves as a subject matter expert and technical consulting reviewer on regulatory submissions to CDRH. He was a recipient of an FDA Commissioner’s Special Citation Award in 2021 for his regulatory contributions in the technical review of emergency use ventilators, the FDA CDRH Excellence in Scientific Research Award in 2018, the American Society for Artificial Internal Organs (ASAIO) Kolff Award in 2016, and his research was featured in the 2015-2016 FDA Regulatory Science Progress Report to Congress.

Assistant Professor at the Center for Pharmacometrics & Systems Pharmacology, University of Florida

Dr. Cristofoletti is an Assistant Professor at the Center for Pharmacometrics & Systems Pharmacology at the University of Florida. 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 Dr. Jennifer Dressman. Before joining the University of Florida, the Biopharmaceutics & Clinical Pharmacology Office of the Brazilian Drug Regulatory Agency (ANVISA) was Dr. Cristofoletti’s place of employment for 15 years.

Dr. Cristofoletti’s lab focuses on translational research integrating molecular pharmaceutics, biorelevant in vitro tools, like multi-stage dissolution and microphysiological systems, and (patho)physiology-based modeling to assess interpatient variability in pharmacokinetics. Currently his lab is developing a segment-specific intestine-on-a-chip to investigate drug- and disease-related mechanisms affecting intestinal membrane integrity (leaky gut) as well as transport-mediated kinetics and drug-drug interactions. Dr. Cristofoletti published more than 55 peer-reviewed articles in highly respected journals in the pharmaceutics field, 5 book chapters and he is currently co-editing, with Dr. Amin Rostami-Hodjegan, a PBPK related textbook entitled “Science and Art in Physiology-Based Modeling” to introduce young investigators to this exciting scientific field. Dr. Cristofoletti received the Simcyp Academic Award “Most Informative and Scientific Report” in 2017 and 2020 for his translational research. He has been serving as a member of the Special Interest Group on BCS and Biowaiver of the International Pharmaceutical Federation (FIP) and the Brazilian Pharmacopoeia.

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

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

Senior Pharmacologist, DTP-I, ORS, OGD, CDER, FDA

Dr. Priyanka Ghosh is a senior pharmacologist within the Division of Therapeutic Performance. Her areas of expertise include products in the topical and transdermal drug delivery area. In her current role, Dr. Ghosh leads regulatory science research initiatives related to topical and transdermal drug products, including projects related to development of noninvasive imaging techniques for evaluation of cutaneous pharmacokinetics, under the GDUFA regulatory science program. Dr. Ghosh also leads the development of general and product-specific guidances, review strategies for pre-ANDA meeting requests and citizen petitions and is the co-chair of the Bioequivalence Standards for Topicals Committee within OGD. Prior to joining FDA, Dr. Ghosh completed her Bachelor’s degree in Biotechnology from West Bengal University of Technology (India) and a Ph.D. in Pharmaceutics and Drug Design from the University of Kentucky.

Director, DBVIII, OB, OTS, CDER, FDA

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

Biopharmaceutics Expert, Merck & Co., Inc.

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

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

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

Professor of Pharmaceutics, University of Florida

Dr. Hochhaus received his Ph.D. in 1984 at the Institute of Pharmaceutical Chemistry, Westf. Wilhems University (Münster, Germany). He completed a postdoctoral fellowship at the University of California-San Francisco and subsequently joined the University of Florida’s College of Pharmacy as an Assistant Professor in 1987, where he continues to serve today as a Professor of Pharmaceutics. Dr. Hochhaus’ research is interested in evaluating inhalation drugs through in vitro and pharmacokinetic/dynamic approaches. He collaborates with regulatory authorities to improve methodology for drug approval of generic inhalation drugs.

Dr. Hochhaus is a Fellow of AAPS and the American College of Clinical Pharmacology (ACCP). In 1998, he was recipient of the young investigator award of the German Airway and Lung Research Society and received ACCP’s Tanabe Young Investigator Award. He was awarded the University of Florida Foundation Research Professorship in 2015-2018; 2019-2022, American College of Clinical Pharmacology’s Bristol-Myers Squibb Mentorship in Clinical Pharmacology Award (2019) and is Honorary Regent of ACCP. He has published more than 230 research papers.

Deputy Director, OCP, OTS, CDER, FDA

Dr. 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.

Scientist, Sandoz Pharmaceuticals

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

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

Dr. 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 7 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.

Distinguished Scientist, Merck & Co., Inc.

Filippos Kesisoglou is a Distinguished Scientist at Merck & Co., Inc., (Kenilworth, NJ) where he is currently leading the Biopharmaceutics team and oversees the translational biopharmaceutics efforts in the Pharmaceutical Sciences department. Filippos has more than 15 years of experience in the fields of biopharmaceutics and formulation development, pharmacokinetics, PBPK and IVIVC modeling as related to clinical, drug product development and CMC regulatory applications. He has been a key contributor to more than 10 new drug applications across therapeutic areas. He has authored/co- authored more than 80 manuscripts/book chapters and more than 80 conference abstracts/podium presentations in several national/international meetings in the fields of biopharmaceutics, PBPK modeling, formulation development and drug delivery. Filippos has been involved in several cross-industry and academia consortia such as PQRI where he was a chair of the Biopharmaceutics Technical Committee, IQ Consortium where he’s currently co- chairing the Food Effect PBPK WG, OrBiTo and UNGAP. He is currently serving as an Editor for the Journal of Pharmaceutical Sciences and as an Editorial Advisory Board member for the AAPS Journal and Pharmaceutical Research. In 2017 he was elected a AAPS Fellow.

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

Dr. Myong-Jin (MJ) Kim currently serves as the Acting Director of the Division of Therapeutic Performance II, Office of Research and Standards, Office of Generic Drugs, CDER/FDA. Since her joining the OGD in 2016, MJ 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, she serves as the FDA Deputy Topic Lead for the ICH Expert Working Group on M13: Bioequivalence for Immediate Release Solid Oral Dosage Forms. MJ graduated from Georgia Institute of Technology in Atlanta, GA, with a Bachelor of Science degree in chemistry. Subsequently, she 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.

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

Dr. Darby Kozak is the Deputy Division Director for the Division of Therapeutic Performance in the FDA’s Office of Generic Drugs. Dr. Kozak leads a group of interdisciplinary scientists on the development of new analytical methods and equivalence evaluation methodologies for complex drug substances and parenteral, ophthalmic, otic, and inhalation formulations. Prior to joining the FDA, Dr. Kozak was Chief Scientist for Izon Science and Research Fellow at the Australian Institute for Bioengineering and Nanotechnology. Dr. Kozak has a B.Sc. in Chemical Engineering from the University of Washington (Seattle, WA) and Ph.D. in Chemistry from the University of Bristol (United Kingdom).

Vice President, Pharma R&D, Amneal Pharmaceuticals

Anita Kumar currently serves as Vice President, Research and Development within Amneal Pharmaceuticals. Holding a broad spectrum of scientific and management experience from industry, Anita oversees a comprehensive product development pipeline comprising generic and specialty oral dosage products. In the 13 plus years at Amneal, she has led interdisciplinary teams in research, formulation and clinical development, regulatory review and approval with launch of several first to file products, complex and locally acting drugs, high barrier to entry generics, multiphasic soft gelatin capsules and modified release systems. Prior to Amneal, Anita completed 6 years in the pharmaceutical industry conducting work on formulation, process development and scale up for various dosage forms.

Anita received her undergraduate degree and M Pharm from Nagpur University in Pharmaceutical Sciences, and a M S in Industrial Pharmacy from Long Island University, working on modeling of targeted enhanced solubilization of poorly soluble compounds. .

Senior Scientist, Simulations Plus

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

Associate Director for Scientific Innovation, OB, OGD, CDER, FDA

Dr. Bing V. Li serves as Associate Director for Scientific Innovation for Office of Bioequivalence within the Office of Generic Drugs. In this role, she provides scientific leadership and expertise for the assessment of the bioequivalence studies submitted by pharmaceutical industry through Abbreviated New Drug Applications (ANDAs), and oversees the scientific programs including guidance development and implementation in Office of Bioequivalence. Dr. Li is an Expert Pharmacologist at the FDA in the area of bioequivalence of aerosolized drug products. Prior to joining FDA in 2004, she was a Research Investigator at Bristol-Myer-Squibb where her responsibilities included formulation identification, development and optimization for oral solid dosage form formulations. Dr. Bing V. Li received her Ph.D. in Pharmaceutical Sciences from University of Wisconsin at Madison in 2001, and a Bachelor’s degree in Medicinal Chemistry in 1990 in Beijing University, China.

Director, ORS, OGD, CDER, FDA

Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. ORS also provides pre-submission advice on complex generics through pre-ANDA meetings, product specific guidance and correspondence responses.

He received his undergraduate degree from Stanford University in Chemical Engineering, and a Ph.D. from Princeton University in Chemical Engineering. After his Ph.D., he conducted post- doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the FDA 18 years ago, he was an Assistant Professor of Chemical Engineering at the University of Michigan.

Professor, Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University

Dr. Worth Longest is a Professor in the Department of Mechanical and Nuclear Engineering at Virginia Commonwealth University and has a joint appointment in the VCU Department of Pharmaceutics. His current research at VCU centers on (i) developing in vitro and CFD models to assess respiratory drug delivery and (ii) developing effective methods for targeting inhaled medications to and within the lungs. As an individual and in collaboration with the VCU Department of Pharmaceutics, Dr. Longest’s research has been funded by both corporate and federal sponsors. Dr. Longest has published more than 100 peer-reviewed papers and approximately 60 abstracts related to particle transport and aerosol technology, authored several book chapters, and spoken at numerous national and international meetings.

Dr. Longest’s recent projects, many in collaboration with the VCU Department of Pharmaceutics, include developing controlled condensational growth techniques for orally and nasally inhaled pharmaceutical aerosols (sponsored by NIH) and developing validated numerical models to assess inhaler effectiveness for establishing bioequivalence (sponsored by the US FDA).

Chief Scientist, Simulations Plus, Inc.

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

Director and Supervisory Physician (Dermatology), DTP-I, ORS, OGD, CDER, FDA

Markham C. Luke, M.D., Ph.D., F.A.A.D., serves as FDA Supervisory Physician  (Dermatology) and Director of the Division of Therapeutic Performance 1 (DTP1) in the Office of Research and Standards, Office of Generic Drugs at FDA. DTP1 is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Markham has an M.D. and a Ph.D. in Pharmacology from Johns Hopkins University and completed his dermatology residency and fellowship at Washington University, St. Louis, MO and the National Institutes of Health, Bethesda, MD. Markham serves as Associate Professor in Dermatology at the Uniformed Services University of the Health Sciences, Bethesda, MD. Markham has research interests in dermatopharmacology, clinical pharmacology, clinical study design and endpoints assessment (including patient- reported outcomes) for medical, surgical, and aesthetic products and serves as consultant dermatologist to various parts of FDA. Markham has been at FDA since 1998 serving various roles, including as the Lead Medical Officer for dermatology drugs, Chief Medical Officer and Deputy Director for the Office of Device Evaluation in the Center for Devices and Radiologic Health, and as Acting Director for Cosmetics in the Center for Food Safety and Applied Nutrition. In each of these roles including his current one in OGD, Markham has been involved in programs and initiatives dealing with product innovation as related to public health for our nation.

President and CEO of Enhanced Pharmacodynamics, LLC, Professor and Vice Chair of Pharmaceutical Sciences, University at Buffalo, SUNY

Dr. Mager is Professor and Vice Chair of Pharmaceutical Sciences at the University at Buffalo, State University of New York. He is also President and CEO of Enhanced Pharmacodynamics, LLC. He has served previously on the Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee to the FDA and as a Visiting Professor at the University of Paris. He is a Fellow and the current President of the American College of Clinical Pharmacology and is a Fellow and former President of the International Society of Pharmacometrics. Dr. Mager is a Fellow of AAPS and AAAS, is an expert member of the Board of Pharmaceutical Sciences at FIP, and serves on the Scientific Advisory Board to Simcyp. His research focuses on identifying molecular and physiological factors that control the pharmacological properties of drugs by combining experimental data with pharmacometrics and systems pharmacology, with a focus on anti-cancer and immunomodulatory agents. Current efforts seek to combine network-based analysis with empirical and systems models to explore combinatorial anti-cancer drug regimens, heterogeneity in cancer responses, and chemotherapy-induced adverse drug reactions. He served as a Co-Editor of the book Systems Pharmacology and Pharmacodynamics and has contributed to 150+ peer-reviewed publications.

Director, Clinical Pharmacology & Pharmacometrics, Janssen R&D

Amitava is currently a Clinical Pharmacology Leader, where he supports global drug development programs. He has 13 years of experience in the pharmaceutical industry supporting various therapeutic areas and has previously worked at Merck and Novartis. Amitava has a Ph.D. in Pharmaceutical Sciences from University of Maryland, Baltimore.
Amitava’s main research interests include clinical pharmacology, modeling & simulation, pharmacokinetics, and biopharmaceutics. He has interacted with several regulatory agencies like FDA, EMA and PMDA on these topics, as part of project support as well as in workshops and consortia. Amitava has published more than 50 research and review articles, and has 30 podium presentations in national & international conferences, on these topics. Amitava has won several awards including the Novartis VIVA Leading Science award in 2019 for his modeling efforts, an award that celebrates exceptional contribution by scientists across the company’s R&D organization worldwide. Amitava has been involved in several cross-industry consortia such as IMI-OrBiTo and IQ. He is also active in AAPS and ASCPT.

IVIVC Manager, Respiratory & Complex Products, Sandoz Pharmaceuticals

Dr. Raja Mohamed, has over 12 years of experience in generic industry in the areas of Product Development, Bio-strategy, Biopharmaceuticsand IVIVC (respiratory, oral & injectable) on regulated and non-regulated markets, He obtained his Ph.D. from Indian Institute of Technology Delhi, India & Technical University, Dresden, Germany. He is also a DAAD fellow with post-doctoral experience in the area of Nano drug delivery systems.
He has several international and national publications on novel drug delivery systems (NDDS) and has presented his views on drug delivery and bioequivalence studies in many renowned workshops/conferences. He has also mentored several under- & post- graduate students for their thesis work. He is passionate about using modelling and simulations as an alternate tool to waive off bioequivalence studies and employing Artificial Intelligence for the prediction of clinical success.

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

Dr. Mousa is a Staff Fellow at the Division of Quantitative Methods and Modeling (DQMM) at the Office of Research and Standards (ORS)/Office of Generic Drugs (OGD)/US.FDA. He received his B.S. in Pharmacy from Al-Azhar University, Gaza Strip in 2009. He received his M.S in Clinical Pharmacy from University of Jordan, Jordan in 2014. Dr. Mousa received his Ph.D. in Pharmaceutical Sciences from Auburn University, Alabama in 2019. He joined the FDA as Oak Ridge Institute for Science and Education (ORISE) fellow in DQMM in 2019 and became a Staff Fellow in 2020.

Dr. Mousa has experience in oral PBPK modeling and he is a scientific reviewer in the oral PBPK group in DQMM where he reviews PBPK models applied in generic drugs development.

Pharmacologist, DTP-I, ORS, OGD, CDER, FDA

Bryan Newman, Ph.D., is a pharmacologist and acting team lead for inhalation and nasal drug products in the Division of Therapeutic Performance 1 (DTP-1), Office of Research and Standards (ORS), under the Office of Generic Drugs (OGD). Dr. Newman’s work focuses on developing product-specific guidances, and addressing controlled correspondences, citizen petitions, consults, and Pre-ANDA meeting requests. He also serves as a project officer and contracting officer’s representative for regulatory science research initiatives related to inhalation and nasal drug products. Dr. Newman received his B.S. degree from Louisiana State University in Biochemistry and his M.S. and Ph.D. degrees from the University of Michigan in Pharmaceutical Science.

Senior Inhalation Consultant, Emmace Consulting

Dr. Olsson has 35 years of experience of inhaled formulations having spent about equal time on CMC and clinical pharmacology at his former employer, AstraZeneca. In 2015 he took a position as a senior inhalation consultant at Emmace Consulting AB. His specialty is in vivo-in vitro correlations with particular emphasis on predicting in vivo outcomes, such as regional lung disposition, from in vitro data using in silico methods, and is a well-known author and speaker on this topic. For many years he was part of the aerosol committees of USP and EP and member of industry groups such as IPAC-RS and EPAG. He was part of the teams developing the multi-stage liquid impinger, the next generation impactor and the OPC mouth-throat models. He is author and owner of the Mimetikos Preludium software, a commercial application for physiologically-based mechanistic prediction of lung deposition and pharmacokinetics of inhaled pharmaceuticals.

Dr. Olsson earned his Ph.D. in Analytical Chemistry from Lund University 1985 and has authored more than 60 publications in the fields of analytical chemistry, aerosol science, and respiratory science.

Distinguished Scientist in Modeling and Simulation, Pharmaceutical Research, Roche Pharma Research and Early Development, Roche Innovation Center Basel

Neil Parrott works in the translational modelling and simulation group which is part of the Pharmaceutical Sciences department of Roche Pharmaceutical Research and Early Development in Basel, Switzerland. Neil specializes in physiologically based pharmacokinetic (PBPK) modeling and its application to Roche projects from early discovery to the market. Neil has a particular interest in the applications of PBPK modelling for first in human PK prediction, to guide formulation development, to guide studies in special populations such as children and to help manage drug-drug interactions by integrating novel in vitro data such as organ-on-chip. He is involved in various research activities to develop better PBPK models and is active in cross- industry consortia such as the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ). Neil has published over 100 papers and has given numerous presentations at international conferences.

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

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

Senior Scientific Advisor and Head of Mechanistic Dermal Modeling, Simcyp

Dr. Sebastian Polak joined Simcyp in April 2007, currently Senior Scientific Advisor and Head of Mechanistic Dermal Modelling. Dr. Polak also holds Professorship position at the Faculty of Pharmacy Jagiellonian University, Cracow, Poland where he is Head of Pharmacoepidemiology Unit.

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 21 Ph.D. graduates. He is co-Director of the recently initiated Center for Research on Complex Generics, an FDA-funded collaborative agreement with the Agency. He is Director of the online M.S. in Regulatory Science program (www.pharmacy.umaryland.edu/regulatoryscience).

CTO and Sr. VP for Research, CFD Research Corp.

Dr. Andrzej Przekwas, CTO and Sr. VP for Research at CFD Research Corp., Huntsville, AL, received his education at Wroclaw Institute of Technology in Poland and at Imperial College of Science and Technology in London, England. He is heading the Computational Medicine and Biology (CMB) Div. developing of multi-bio-physics tools, CoBi, for computational pharmacology in military and civilian applications. He has been the PI on several projects with DARPA, DoD, FDA, NIH, CDC and US Pharma in collaboration with US Academia. Dr. Przekwas has published over 290 papers, three book chapters, and currently serves in the Technical Advisory Committee for the US Dept. of Commerce Bureau of Industry and Security.

Associate Director/Chief Scientific Advisor, ORS, OGD, CDER, FDA

Dr. Sam Raney is a thought leader in topical and transdermal drug products, with over 30 years of experience in skin research, producing numerous research manuscripts, review articles, book chapters and patents in pharmaceutical product development. Dr. Raney has been a researcher and adjunct professor within academia, a principal or sub investigator on over 400 pharmaceutical product studies, has held senior management roles in industry, and serves on multiple expert committees and panels for the U.S. Pharmacopeia. He is the Associate Director for Science in the FDA’s Office of Research and Standards, and serves as the Chief Scientific Advisor for topical product bioequivalence issues in FDA’s Office of Generic Drugs. Dr. Raney holds a Bachelor’s Degree in Molecular Biophysics & Biochemistry from Yale University, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada.

Senior Principal Scientist and PBPK Lead, Bristol Myers Squibb

Arian is an experienced drug development leader with a passion for model-informed drug development. She completed her undergraduate and Master’s studies in Pharmacology at the University of Toronto in 2010 and moved to Germany to pursue her Ph.D. degree at the University of Tuebingen through a fellowship program. She received her Ph.D. degree in Pharmaceutical Sciences in 2014. Since her Ph.D., Arian has worked at Certara, AbbVie and now BMS as a subject matter expert in translational modeling and mechanistic ADME. She has authored various manuscripts and white papers on best practices in translational modeling and chaired an IQ consortium working group focusing on assessing the predictability of PBPK models for understanding food effect. Furthermore, Arian has received multiple AbbVie Pharmaceutical R&D President’s awards, including one for her contributions to understanding the venetoclax food effect through modeling. She also currently serves on the editorial advisory board of the Journal of Pharmacokinetics and Pharmacodynamics.

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

The scientific work of Professor Rostami covers wide areas of drug development over last 30 years, ranging from pharmaceutics (e.g. bioequivalence) to clinical pharmacology (e.g. mixture pharmacology of drug/metabolites) and beyond (e.g. provision of drug-independent system parameters for scaling from in vitro to in vivo studies).

As a leader in the field of physiologically-based pharmacokinetics (PBPK) and quantitative systems pharmacology, Amin is internationally recognized for his expertise in the use of in vitro information to predict the behaviour of drugs in human body and associated inter-individual variabilities under the so called “bottom up” modelling.

Amin is a Professor of Systems Pharmacology and the Director of the Centre for Applied Pharmacokinetic Research (CAPKR) at the University of Manchester. In addition, he is the Senior Vice President of Research & Development and Chief Scientific Officer at Certara. He facilitates the incorporation of the latest advances in translational modelling to biosimulation platforms offered by Certara to its pharmaceutical clients to accelerate regulatory approvals and bring safer drug products to the patients faster.

More than 280 highly cited articles have been authored by Amin (>17,500 citations, H-Factor = 72). In 2017 ISI listed him as one of the world’s most highly cited researchers (under ‘Pharmacology & Toxicology’). He was a founding editor of Pharmacometrics and System Pharmacology, and serves on the Editorial Boards of several other journals.

Supervisory Pharmacologist and Branch Chief, DB, ONDP, OPQ, CDER, FDA

Dr. Kimberly Raines is a Supervisory Pharmacologist at the FDA, currently serving as a Branch Chief in the Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality. She received her Ph.D. in Pharmaceutical Sciences from the University of Maryland School of Pharmacy and a B.S. in Chemistry from Duke University. Prior to joining the FDA, Dr. Raines received post-doctoral training at the University of North Carolina Lineberger Comprehensive Cancer Center. Her tenure at the Agency began in the Office of Generic Drugs as a bioequivalence reviewer and controlled correspondence team lead. Currently Dr. Raines and ONDP/DB/Branch 3 lead efforts in establishing in vitro dissolution/release specifications for ANDAs and assessing biopharmaceutics topics (e.g., biowaiver, bridging, IVIVC, etc.) for NDAs in the following OND clinical divisions, Cardiology and Nephrology; Diabetes, Lipid Disorders, and Obesity; General Endocrinology; Medical Imaging and Radiation Medicine; Non-Malignant Hematology; Nonprescription Drugs 1 and 2 and Ophthalmology. Additionally, Dr. Raines develops CDER biopharmaceutic guidances, leads research projects within her division, and provides subject matter expertise to FDA policy initiatives. She has co-authored original research articles and presented on bioequivalence, biowaivers, in vitro dissolution, and physiologically based model informed quality risk assessment.

Director, OB, OGD, CDER. FDA

Partha Roy, Ph.D. serves as Director of the Office of Bioequivalence (OB) in the Office of Generic Drugs (OGD), CDER, FDA. Dr. Roy is a recognized senior clinical / regulatory strategist and a proven business leader with 21 years of drug development experience in both US FDA and industry involving new drugs, novel biologics, generics and biosimilars. He currently leads an FDA/CDER Office that oversees the thorough assessment of bioequivalence data required to support Abbreviated New Drug Application (ANDAs). Partha plans, manages, organizes, and directs all the regulatory review operations, program segment(s), functions, and activities of OB.

Dr. Roy received his PhD in Toxicology from the University of South Florida, Tampa, Florida and completed a post-doctoral fellowship in drug metabolism and pharmacokinetics at Boston University. Prior to his current FDA role, Partha was Vice President in PAREXEL’s Regulatory and Access Consulting Global Business Unit, focused on driving corporate growth and delivery. In his previous FDA role from 2006-2012, Partha supported US FDA’s Division of Pulmonary, Allergy and Rheumatology (DPARP) and Office of Non-Prescription Products (ONP) as part of the clinical pharmacology review team.

Associate Director of Product Development, Teva Pharmaceuticals

Srinivasa Sammeta, Ph.D. Is currently working as an Associate Director Product Development at Teva Pharmaceuticals, Salt Lake City, Utah. Sri has ~10 years of industrial experience working on the formulation/product development of complex dosage forms like topical and transdermal products in addition to sublingual/buccal films and ophthalmic dosage forms. Sri has Ph.D. in Pharmaceutical Sciences from University of Mississippi with emphasis on transdermal drug delivery and has published over 15 research papers in peer-reviewed journals and is an author of two book chapters.

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

ORISE Fellow, DQMM, ORS, OGD, CDER, FDA

Abdullah Al Shoyaib works as an ORISE fellow at the Division of Quantitative Methods and Modeling (DQMM) under the Office of Research and Standard (ORS)/OGD/CDER in US Food and Drug Administration (FDA).

He completed his Ph.D. in Pharmaceutical Sciences from Texas Tech University Health Sciences Center, USA, in 2020. He did his Bachelor of Pharmacy and Master of Pharmacy in Pharmaceutical Technology from University of Dhaka, Bangladesh.

Currently, he is working on quantitative methods development, such as physiologically based pharmacokinetic model (PBPK) and population based pharmacokinetic model, for assessing the impact of food and excipients on bioavailability and bioequivalence of oral dosage forms. His works also involve dermal PBPK model and mechanistic in-silico IVPT (in-vitro permeation test) model development for topical formulations.

Senior Consultant and PBPK-QSP Platform Leader, Pharmetheus, Associate Professor in Biopharmaceutics, Uppsala University

Dr. Erik Sjögren received his Ph.D. in 2010 from Uppsala University, Sweden. Currently, he is a senior consultant at Pharmetheus, and leads the PBPK-QSP platform, where he provides modelling expertise in the fields of physiologically based pharmacokinetics (PBPK), quantitative system pharmacology (QSP) and biopharmaceutics for prediction, translation, and analysis across all phases of drug development. In his role as Associate Professor at the Department of Pharmaceutical Biosciences, Erik conducts research in biopharmaceutics, drug absorption, pharmaceutical formulations, drug delivery, pharmacokinetics, PBPK, QSP and the application of mechanistic modelling and simulation. In addition to research, he tutors courses, supervises students, and supports multiple scientific networks and contributes to conferences, workshops, and meetings. He currently also acts as Pharmetheus’ and Uppsala University’s representative in the Management Team of the Open System Pharmacology community. He has published over 50 articles in peer-reviewed journals.

Senior Scientist II, Simulations Plus, Inc.

Dr. Jessica Spires is a senior scientist at Simulations Plus, Inc. Since 2013, she has focused on PBPK modeling of non-oral routes of administration, including dermal, ocular, and pulmonary administration, in the GastroPlusTM and MembranePlusTM software platforms. She is currently the principal investigator on FDA grantU01FD006526, focusing on transdermal drug products quality and performance attributes via enhanced virtual bioequivalence simulations, and grant 1U01FD006927, which focuses 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 Ph.D. in Biomedical Engineering.

Charles Walgreen Jr. Professor of Pharmacy, Professor of Pharmaceutical Sciences, College of Pharmacy, The University of Michigan

Dr. Duxin Sun is the Charles Walgreen Professor of Pharmacy and Professor of Pharmaceutical Sciences in the College of Pharmacy at the University of Michigan. Dr. Sun serves as the Director of Pharmacokinetics (PK) Core. Dr. Sun also has joint appointment in the Chemical Biology program, the Interdisciplinary Medicinal Chemistry program, and University of Michigan’s Comprehensive Cancer Center.

Dr. Sun’s research interests focus on direct measurement of drug dissolution in human GI tract, drug discovery and nanomedicine for cancer therapeutics, and pharmacokinetics. Dr. Sun has published more than 240 papers, mentored 35 PhD students and 40 postdoctoral fellows/ visiting scientists. Dr. Sun is a Fellow of American Association of Pharmaceutical Scientists (AAPS) and has served as chair of the PPB (Physical Pharmacy and Biopharmaceutics) section in AAPS. Dr. Sun served on FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee. Dr. Sun has served on study sections for NIH, FDA, Cancer Research UK, French National Research Agency, and Italian Ministry of Health.

Acting Associate Director for Scientific Quality, OB, OGD, CDER, FDA

Dr. Nilufer Tampal is the Acting Associate Director for Scientific Quality in OGD’s Office of Bioequivalence. In this role, Dr. Tampal develops strategies and oversees implementation of data quality and the scientific integrity of bioequivalence data submitted in Abbreviated New Drug Applications (ANDAs). She provides expertise in utilization of advanced analytic data tools supporting ANDA reviews. As a leading senior expert within the Office of Bioequivalence for international harmonization efforts regarding bioequivalence in ANDAs, she serves as the Rapporteur for the International Council for Harmonization (ICH) Generic Drug Discussion Group. She is also the FDA’s Topic Leader on ICH M13 Expert Working Group that is developing a harmonized M13 guideline on bioequivalence of immediate release solid oral dosage form drugs.

Dr. Tampal received her Ph.D. in Toxicology from University of Kentucky and a M.S. in Chemistry from Bombay University, India. She started her career at the FDA in 2002, as an investigator in the Office of Study Integrity and Surveillance (pka DSI) and has held various leadership positions in the Office of Bioequivalence for the last 12 years. Her multi disciplinary knowledge and training in pharmacology, toxicology, chemistry, bioanalysis, site inspections and regulatory science have positioned her to contribute towards a multitude of FDA and CDER Committees working to advance regulatory science and policies in areas of on-going importance to the Agency. Dr. Tampal’s most noteworthy contribution at the Agency is her recognition of the need for recommending additional testing of incurred samples to assure the reliability of data from the bioanalytical studies submitted to the Agency. This contribution has made a global impact in the field of bioanalysis. Prior to her FDA career, as a Chemist, she gained years of experience in synthesis and analysis of ‘small molecules’, at a multinational pharmaceutical in India.

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

Dr. Ming-Liang Tan is a Staff Fellow in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD). In his current role, Dr. Tan’s responsibilities include managing research projects to support
bioequivalence studies, addressing controlled correspondences and citizen petitions, providing response to pre-ANDA meeting requests and internal consults, and developing product specific guidance. His main research interests include the physiologically-based pharmacokinetics (PBPK) modeling and simulations, with a focus on the area of locally-acting complex products such as ophthalmic drug products.

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

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

Chief Scientific Officer, Biopharmaceutics-Biostatistics, Global Regulatory Affairs

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

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. Dr. Wu has been with FDA for more than 9 years. She is responsible for using modeling and simulations tools for reviewing pre-abbreviated new drug applications (pre-ANDA) meeting packages, ANDA consults and controlled correspondences. Prior to joining DQMM, Dr. Fang Wu was a biopharmaceutics reviewer for more than 4 years and responsible for NDA and ANDA biopharmaceutics 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.

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

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

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

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

Acting Director, DB-II, OB, OGD, CDER, FDA

Dr. Hongling Zhang is currently an acting division director of the Division of Bioequivalence II in the Office of Bioequivalence of OGD, FDA. Since joining in OGD in 2008, she has been involved in evaluating bioequivalence (BE) submissions in ANDAs for many complex drug products and BE studies with complex scientific and/or regulatory issues. She is also involved in developing BE guidance of complex drug products, such as MDIs, nasal sprays, ophthalmic emulsions, and some other locally acting drug products, for which in vivo BE study is not suitable or in vivo BE study per se is not sufficient to demonstrate BE. Dr. Zhang received her Ph.D. degree in Pharmacology from University of South Florida and completed a post-doctoral training at Moffitt Cancer Institute.

Deputy Director, ORS, OGD, CDER, FDA

Dr. 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. Dr. Zhang is an accomplished professional with more than 23 years of combined experiences in the areas of drug research, development and regulatory review and approval. In addition to regulatory reviews, she 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. Dr. Zhang received her Ph.D. in Biopharmaceutical Sciences from UCSF. Dr. Zhang is a member of the International Transporter Consortium (ITC) that published a transporter whitepaper in 2010 and several whitepapers/position papers in 2013 and 2018. 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. Dr. Zhang has published more than 120 journal articles and book chapters.

Senior Advisor for Oral Drug Products, DTP-II, ORS, OGD, CDER, FDA

CDR Yi Zhang is currently serving as a senior advisor for oral drug products in Office of Research and Standards (ORS). As a Bioequivalence (BE) Director back in the Office of Bioequivalence (OB), she pioneered by establishing and leading the successful Product Specific Guidance (PSG) Program to guide the generic industry by recommending the optimal path to demonstrate BE between generic and reference drugs. She continued to lead multiple teams productively (including PSG Dermatological and Topical Product Team, and Immediate Release Oral Solid Dosage Forms Drug Team), further optimize and advance the successful PSG program after it was transferred to ORS from OB. She is a subject matter expert in overseeing publication of PSGs to develop and establish optimal and rigorous BE standards and approaches for various drug dosage forms to promote generic drug development. CDR Zhang also leads multiple research projects to address broad regulatory scientific issues encountered throughout generic drug approvals including Biopharmaceutics Classification System (BCS) III biowaiver, the novel in vitro BE approaches for topical products, classification of complex drug products, selection of appropriate study population for kinase inhibitor drugs, food effect on narrow therapeutic index drugs, and the application of artificial intelligence to improve PSG review automation by optimizing machine learning and etc. By publishing PSGs, responding to public inquires (including controlled correspondences and citizen petitions), managing pre-ANDA meetings, addressing internal consults, and leading research projects to establish novel BE approach by effectively collaborating with internal and external stakeholders, CDR Zhang and her groups have improved FDA’s generic drug approval process, provided the transparency to the generic drug industry with regard to regulatory and scientific perspectives, and facilitated the generic industry develop generic drug products more efficiently and effectively by submitting high quality applications to the FDA.

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

Senior Program Officer, Integrated Development-Quantitative Sciences, Bill & Melinda Gates Foundation

Ping obtained his B.S. in Pharmacy from the Beijing Medical University in China in 1994, and his Ph.D. in Pharmaceutics from University of Washington in Seattle, WA, USA in 2002. Since then, Ping worked as a DMPK scientist at Pfizer in La Jolla CA (2002-2005), a pharmacokineticist at Sonus Pharmaceuticals in Seattle (2005-2007), a clinical pharmacologist at Amgen in Seattle (2008), and the Scientific Lead of PBPK (physiologically-based pharmacokinetic modeling) Program and Expert Pharmacologist at the Office of Clinical Pharmacology, US FDA in Silver Spring, MD (2008-2017). At the FDA, Ping led the review of PBPK submissions in IND/NDA/BLAs, research in PBPK, and development of policy on PBPK, including authoring the agency’s first draft PBPK guidance (2016) and updating the in vitro and in vivo drug- drug interaction guidances (2017). In June 2017, Ping joined the Bill and Melinda Gates Foundation in Seattle, WA as a Senior Program Officer of Quantitative Sciences, where he applies pharmacology concepts and manages Model-informed Drug development (MiDD) efforts in programs funded by the foundation.

Deputy Director, DPM, OCP, OTS, CDER, FDA

Dr. Hao Zhu is the deputy director at the Division of Pharmacometrics, Office of Clinical Pharmacology, Center of Drug Evaluation and Research, U.S. Food and Drug Administration. Dr. Zhu received his Ph.D. in Pharmaceutical Sciences and Master’s 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 14 years ago. Dr. Zhu has been a clinical pharmacology team leader for more than 6 years and a QT-IRT scientific lead for 2 years. His division reviews the pharmacometrics related submissions and supports pharmacometrics -related policy development across CDER.

Biopharmaceutics Team Lead, DB, ONDP, OPQ, CDER, FDA

Banu Zolnik is an acting Biopharmaceutics Team Lead in the Office of New Drug Products in Office of Pharmaceutical Quality within the Center of Drug Evaluation and Research at the FDA. Her responsibilities are to evaluate and review biopharmaceutics section of the New Drug Applications, Abbreviated Drug Applications. Previously in the Office of Pharmaceutical Science, Dr. Zolnik was involved in various regulatory science policy projects related to nanotechnology, bioequivalence of generic drugs and drug product quality issues. Dr. Zolnik reviewed and evaluated clinical pharmacokinetic and in vitro data for the assessment of bioequivalence between generic drugs and reference listed drugs in the Office of Generic Drugs. Dr. Zolnik was a post-doctoral fellow in the Nanotechnology Characterization Laboratory at the National Cancer Institute/NIH where she conducted in vitro cell culture and small animal pharmacokinetic studies for various nanoparticle platforms such as liposomes, nano emulsions, dendrimers and gold nanoparticles. She obtained her Doctorate in Pharmaceutical Sciences from the University of Connecticut and a B.S. degree in Pharmacy from Istanbul University.