Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generics

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.

Vice President of Scientific Affairs, Pharmaron

Dr. Bode has been part of the scientific leadership team of Pharmaron and Absorption Systems (which was acquired by Pharmaron in 2020) since 2006, fulfilling multiple roles during that time. For the past decade, he has been Study Director for most of the Biopharmaceutics Classification System (BCS) studies conducted in support of numerous BCS-based biowaivers. He has also directed transporter studies, serves as scientific reviewer, and directs and/or provides scientific input into various research projects, grants, and contracts. One example of this last role is directing the portion of the FDA contract that led to the data presented today. Dr. Bode had spent almost twenty years in the pharmaceutical industry prior to joining Absorption Systems. 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 University of California San Diego.

Head, Early Development, Sandoz Development Center, Slovenia (SDC SI) Lek d.d., Sandoz

Dr. Zdenko Casar received his PhD in organic chemistry from the Université de Rennes 1, France. He has 19 years of experience in the generic pharmaceutical industry. His experience spans from product pre-development phase to scale-up to industrial scale activities and includes classical as well as complex generic products. The main areas of his research and development work are linked to the synthesis of active pharmaceutical ingredients, drug analytics and drug stability. During his career at Novartis/Sandoz, Zdenko was heading the Organic Synthesis Department and the Analytics Department at the Sandoz Development Center in Slovenia. In addition, he was Sandoz’s Head of Global Portfolio Management API, where he led Sandoz’s Global Polymorphism Competence Center and API Portfolio Management Team. Currently, at Sandoz he is the Head of the Early Development Department at the Sandoz Development Center in Slovenia. Zdenko is also a full professor of Medicinal Chemistry and Faculty of Pharmacy at the University of Ljubljana in Slovenia. He published over 60 articles in peer-reviewed journals.

Director, DPTR, OSCE, OGD, CDER, FDA

Dr. Robert (Bob) Dorsam is Director for the Division of Pharmacology/Toxicology Review (DPTR) which is responsible for the safety assessment of impurities and excipients in generic drugs. Bob earned his Ph.D. in Pharmacology from Temple University School of Medicine and then conducted postdoctoral research at the National Institutes of Health (NIH). He then joined the FDA where he performed Pharm/Tox review for oncology products and over the counter (OTC) products in the Office of New Drugs (OND). In 2014, he joined the Office of Generic Drugs (OGD) as a team leader where he helped to build OGD’s Pharmacology/Toxicology team. He later assumed a supervisory role when he became Associate Director of Pharmacology/Toxicology in OGD’s Division of Clinical Review. More recently, Bob became Director of the Division of Pharmacology/Toxicology Review in OGD. He is committed to the growth of the Pharm/Tox discipline by advancing several technical areas, promoting process-improvement, and through contributing to innovations in review tools. Bob has been a member of the CDER Nitrosamine Task force since its inception. He has presented on nitrosamines in various forums and is also an active member of review teams that conduct safety assessments on nitrosamines.

Vice-President, Global API R&D, Apotex, Inc.

Dr. Martin Ehlert obtained a B.Sc. in Applied Chemistry at McMaster University in 1987. He subsequently obtained a Ph.D. in Chemistry at the University of British Columbia in 1992. In 1994, Dr. Ehlert commenced his career in the pharmaceutical industry as an industrial Postdoctoral Fellow at Phytogen Life Sciences and continued with the company for the next four years working in the areas of API process development, engineering, and production operations. In 1998, he joined Apotex Pharmachem Inc., serving in various capacities within API R&D and Operations. In 2015, Dr. Ehlert moved to Apotex Inc. and currently holds the role of Vice President, Global API R&D.

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

Dr. Lanyan (Lucy) Fang serves as Deputy Director of the Division of Quantitative
Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs (OGD), CDER/FDA. Since her joining OGD in 2014, Lucy has held roles of increased responsibilities, Team Lead of the Quantitative Clinical Pharmacology team, Associate Director, and Deputy Director within DQMM. She has established herself as the FDA expert in the use of quantitative clinical pharmacology approaches in the review and regulation of generic drugs. She coleads 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 PhD in Pharmaceutical Sciences from The Ohio State University and is a graduate of the Excellence in Government Fellows program (2014-2015).

Director Oral Solid Dose (OSD), DFE Pharma

Sander van Gessel holds a Master of Science in Chemical Engineering from Groningen University, the Netherlands. He has been working for DFE Pharma, a leading excipient manufacturer, since 2005. After joining DFE Pharma as an R&D Scientist he has worked in several scientific and commercial roles for the company across the globe. Prior to his current role he was Innovation Director and Sales Director for APAC and Japan. As Director OSD Sander is currently responsible for DFE Pharma’s global portfolio of OSD excipients including Lactose, MCC, Superdisintegrants and starches. Recently he has lead DFE Pharma’s investigations into the role excipients play in potential nitrosamine formation in drug products through nitrite and nitrate precursors in excipients as well as numerous other projects . With over 15 years of excipient industry knowledge Sander specializes in detailed excipient intricacies and the role they play within the pharmaceutical industry.

Head, Analytical Research Department, Sandoz Development Center, Slovenia (SDC SI), Lek d.d., Sandoz

Dr. Rok Grahek is Head of Analytica Research at the Sandoz Development Center, Slovenia. Rok received his BSc in Chemistry and his PhD from the University of Ljubljana, Slovenia. Rok began his career at Research and Development in Lek Pharmaceuticals, d.d., Slovenia. As a researcher, he started with Gas Chromatography (GC), later focusing on High-Performance Liquid Chromatography (HPLC) and Mass Spectrometry (MS), related to impurities in drugs, and HPLC, mainly as a tool for impurities isolation and industrial-scale API purification. Trace analysis of impurities (Genotoxic Impurities, Synthetic Tracers, Nitrosamines) with Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatograph–Mass Spectrometry (GC–MS) is also an important area of Rok’s research. For the past 25 years, Rok lead a group or researchers as a department head, dealing primarily with impurity profiles, isolation, identification, and trace analytics. Rok authored or co-authored nearly 40 patents and scientific papers and over 50 scientific conference contributions.

Director, DGMT, NCTR, FDA

Dr. Robert (Bob) Heflich received a Ph.D. in Microbiology from Rutgers-The State University of New Jersey in 1976, followed by postdoctoral training with Veronica Maher and Justin McCormick at the Michigan Cancer Foundation and Michigan State University, where he studied DNA repair and mutagenesis in normal human fibroblasts. Bob joined the U.S. FDA’s National Center for Toxicological Research in 1979, where he is currently Director, Division of Genetic and Molecular Toxicology, supervising approximately 35 scientists and administrative assistants. His present research interests include evaluating the risks of nitrosamine drug impurities and degradation products, and the development and characterization of relevant in vitro organotypic assays, especially as related to evaluating the risks associated with inhaled substances. Bob has published over 200 papers in peer reviewed journals, has served as Editor-in-Chief of Environmental and Molecular and Mutagenesis, and participates on several FDA and international committees, including leading the effort to develop an OECD Test Guideline for the in vivo Pig-a gene mutation assay (TG470).

Vice President of R&D, USP India

Dr. Mrunal is a Vice President of R&D at USP India and has been associated with USP for the last seven years. Dr. Mrunal has over 27 years of experience in the pharmaceutical industry. She is overseeing the Compendial Development Laboratory, the Synthetic Chemistry Laboratory, and the Analytical Research and Development Laboratory at USP India. The main responsibilities are to develop and validate analytical methods, synthesize bulk materials of impurities and APIs, and characterize them to support the development of Documentary standards (such as Monographs for Drug substances, Drug products, Excipients, and Food) and Reference standards.

She has successfully led the Analytical Research and Development Department in various
capacities in India as well as Multi-National Organizations and contributed to Development, Validation and Transfer of Stability Indicating Analytical Methods for Drug Substances and Drug Products. She has also been actively involved in the Estimation of Potential Genotoxic Impurities by LC-MS/MS, GCMS/MS, etc.

She was the recipient of the ‘Prof. Dr. R. T. Sane – Outstanding Pharmaceutical Analyst Award’ in 2018 and the ‘Excellent Contribution in the field of Pharmaceutical Research’ in 2021. Dr. Mrunal is leading the Nitrosamine Impurities Workstream globally which is responsible for formulating the “Focused Nitrosamine Strategy” for USP.

Deputy Director, DPTR, OSCE, OGD, CDER, FDA

Dr. Sruthi King earned her Ph.D. in Pharmacology from Georgetown University and completed postdoctoral training at Stanford University in the Department of Dermatology. Sruthi joined the FDA in 2008 as a Pharmacologist in the Division of Gastroenterology and Inborn Error Products within the Office of New Drugs and later moved to the Office of Generic Drugs as Team Leader in 2015. Sruthi now serves as Deputy Director in the Division of Pharmacology/Toxicology Review in the Office of Safety and Clinical Evaluation within the Office of Generic Drugs (OGD) at the U.S. Food and Drug Administration (FDA). Sruthi has been a member of the CDER nitrosamine task force and serves on several working groups with international regulators to harmonize approaches related to nitrosamine safety assessments.

Scientific Lead, Computational Toxicology Consultation Service, DARS, OCP, OTS, CDER, FDA

Dr. Naomi Kruhlak has worked for US FDA’s Center for Drug Evaluation and Research (CDER) as a computational toxicologist for over 20 years, developing and applying (quantitative) structure-activity relationship ((Q)SAR) models to support the regulatory review of pharmaceuticals. She is the Scientific Lead for CDER’s Computational Toxicology Consultation Service and is the Principal Investigator on three FDA/CDER Research Collaboration Agreements with commercial (Q)SAR software vendors, as well as an Inter-Agency Agreement with NIH generating in silico-based drug safety predictions. Dr. Kruhlak has published 45 peer-reviewed articles and a book chapter describing data standardization, transformation, and classification for modeling purposes, as well as the creation and regulatory application of (Q)SAR models with chemical interpretability. Dr. Kruhlak holds B.Sc. and Ph.D. degrees in chemistry from the University of Salford, England, and the University of Calgary, Canada, respectively.

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

Dr. Bing V. Li serves as the Associate Director for Science for the Office of Bioequivalence in the Office of Generic Drugs at CDER/FDA. 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 the 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 forms. 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

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.

Policy Lead, OPPQ, OPQ,CDER, FDA

Dr. Dongmei Lu obtained her Ph.D. degree in Pharmaceutical Sciences from University of North Carolina at Chapel Hill. She has pre-formulation and formulation working experience in GlaxoSmithKline, Wyeth, and Pfizer. Before joining Office of Policy for Pharmaceutical Quality, she was a team leader in Office of Bioequivalence in Office of Generic Drugs.

Principal Scientist, Merck & Co., Inc. Pharmaceutical Sciences and Clinical Supply

Justin Moser is a Principal Scientist at Merck & Co., Inc. within the research and development division. His role is in vaccine drug product development focusing on formulation and process design, clinical supply support and scale-up and technology transfer to the manufacturing division. Prior to this assignment and at the beginning of 2020, Justin led the drug product N-nitrosamine risk evaluation team chartered with building data and understanding that can be utilized to assess risk for Merck & Co., Inc. marketed products. He took over leadership of the overall cross-functional N-nitrosamines core risk team which authored and submitted the risk assessment outcomes to health authorities.

He has a B.S in Chemical Engineering from The Pennsylvania State University and has been working at Merck for over 21 years. Justin’s experience in drug product development spans candidate approval through commercial process validation and product registration. He has held roles of increasing responsibility from bench level scientist through team leader of cross-functional teams developing oral solid dosage drug products from drug candidate approval into phase 3 and registration stability lot execution. He has also led technology implementation of spray drying at Merck for over 13 years including managing outsourced development and manufacture, design and installation of a pilot scale spray drying plant and authoring several core sections of the dossier for Merck’s first spray dried amorphous dispersion product Zepatier. He is an author on 17 publications, co-inventor on 8 patents and presented at numerous conferences. Most recently, he served as an author of the editorial for the J. Pharmaceutical Sciences special edition on N-nitrosamines and lead author on an included publication addressing N-nitrosamine formation risk in solid drug products.

Senior Director Impurity Expert, Teva Pharmaceutical Industries Ltd.

Dr. Raphael (Raphy) Nudelman is a medicinal chemist by training with over 20 years of pharmaceutical industry experience. At Teva Pharmaceuticals he has filled several roles, including working in the Medicinal Chemistry department, the Patent department, and the Non-Clinical Safety department. His current position is the impurity Expert of the company. Raphy’s main topics of expertise are impurity and excipient qualification in drug substances and drug products. Over the past few years, he has specialized in risk assessment of nitrosamine impurities in pharmaceuticals.

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

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

Principal Scientist, Lhasa Limited

Dr. David Ponting is a Principal Scientist at Lhasa Limited. He completed his Undergraduate degree in Natural Sciences at the University of Cambridge, specializing in Chemistry, and stayed to study for a Ph.D. under the supervision of Professor Jonathan Goodman, investigating computational – principally quantummechanical modelling – approaches to the prediction of skin sensitization. After successfully defending his thesis, David moved to the University of Gothenburg for Postdoctoral research with Professor Ann-Therese Karlberg, applying the principles for the prediction of covalent-reactivity mediated toxicity developed during his Ph.D. to a series of diverse chemical classes, as well as briefly returning to the experimental side of the lab. Following this, David joined Lhasa Limited, where he has taken on a number of distinct roles utilizing both aspects of his previous experience: David is a core member of the team continually improving the science in Derek Nexus, developing alerts for a wide variety of endpoints – including of course skin sensitization, but also genetic toxicology endpoints from mutagenicity to carcinogenicity. David is applying his quantum-mechanics expertise to develop novel descriptors for aromaticity, reactivity, bond dissociation energy and photochemical parameters in order to improve predictions across Lhasa’s range of products. David is heavily involved in Lhasa’s response to the nitrosamine crisis where, as well as internal Lhasa Limited work, he has been co-leading a major cross-industry working group addressing, and publishing on, aspects of nitrosamine carcinogenic potency, structure-activity relationships, and risk assessment.

Associate Director for Science and Communication, OLDP, OPQ, CDER, FDA

Dr. Andre Raw received his B.S. degree from the Massachusetts Institute of Technology and his Ph.D. in Chemistry from the University of California at Berkeley. Within his tenure at the FDA, he has been promoted to FDA Agency Expert and to Chemistry Division Director. Currently, he is the Associate Director for Science and Communication in the Office of Life Cycle Drug Products (OLDP) in the Office of Pharmaceutical Quality (OPQ).

Dr. Raw was involved in the development of several important FDA initiatives, including the Guidance on Pharmaceutical Solid Polymorphism and Co-crystals, Regulations on Listing of Polymorph Patents, Question Based Review, and QbD Example for Generic Modified Release Products. He was instrumental in the FDA’s approval of generic versions of complex active ingredients, including Lovenox (enoxaparin sodium) and Copaxone (glatiramer acetate). He is currently involved in Risk and Quality Informatics Initiatives and is a principal architect of KnowledgeAided Assessment and Structured Application (KASA). More recently, Dr. Raw has been active in the area of Nitrosamine Impurities.

Division Director, DB, ONDP, OPQ, CDER, FDA

Dr. Bhagwant Rege is the Division Director for the Division of Biopharmaceutics in CDER/OPQ/Office of New Drug Products at the FDA. His division at FDA is responsible for assessment of clinically relevant in vitro release specifications for drug products, in vitro-in vivo correlations (IVIVC), physiologically based biopharmaceutics models (PBBM), scientific bridging strategies, biowaivers, and BCS classification requests. Most recently he served as a division director for CDER/OPQ/OLDP/ Division of Immediate and Modified Release Products III. Prior to joining FDA in 2010, he worked in industry for many years in oral biopharmaceutics and formulation development groups. Bhagwant has served as a team leader and review chemist in the Office of Generic Drugs where he was part of the team that developed the Quality by Design (QbD) examples for the generic industry. He is a member of the FDA Emerging Technology Team (ETT) and ICH Q12 Expert/Implementation Working Group. He served as FDA liaison on the USP expert committee on dosage forms general chapter (2015-2020). Bhagwant received his BS and MS in pharmacy

Co-Director of CRCG, William I Higuchi Collegiate Professor of Pharmacy, 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. Dr. Schwendeman is an Associate Editor for Nanomedicine NBM and Eur. J. Pharm and Biopharm.

Senior Research Scientist (Pharmacologist), OTR, OPQ, CDER, FDA

Dr. Diaa Shakleya is a Senior Research Scientist within the Division of Product Quality Research. His areas of expertise include drug products quality, opioids, and regulated bioanalysis and pharmaceutical analysis. In his current role, Dr. Shakleya leads regulatory science research work related to nitrosamine impurities, including projects related to Mitigation strategies to reduce the risk of the nitrosamine impurities in pharmaceutical drug products and effect of excipients on the formation of nitrosamines in drugs. Dr. Shakleya also leads the Opioids research project on the risk associated with opioids and opioids antagonists and creating an in vitro surrogate model platform to assess in vivo permeation and risk associated with the vaping opioids.

Diaa has been with the Food and Drug Administration (FDA) for over 9 years. Prior to joining FDA, Dr. Shakleya served as an associate director with biotech company where he led a group of scientists in preclinical evaluation of small drug molecules under a drug discovery program. Diaa received his Ph.D.

Senior Principal Scientist, AstraZeneca

Dr. Andrew Teasdale has 30 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role he chairs AstraZeneca’s Impurity Advisory Group. Dr. Teasdale has published a number of papers relating to mutagenic impurities, extractables and leachables, elemental impurities and other impurity related matters. Andrew has also represented EFPIA in ICH Q3C, Q3D and Q3E Expert working groups. He has also advanced several key scientific advancements in the control of impurities, as the inventor of the purge factor concept and the instigator of the development of Elemental Impurities database for excipients. With over 50 scientific papers, he has also written 3 books:

Genotoxic Impurities – Strategies for Identification and control. Editor A Teasdale.
Publisher Wiley. ISBN 978-0-470-49919-1

ICH Quality Guidelines – An Implementation Guide. Editors A Teasdale, D Elder, R W
Nims. Publisher Wiley. ISBN 978-1-118-97111-6.

Mutagenic Impurities – Strategies for Identification and Control Second Edition. Editor A
Teasdale. Publisher Wiley. ISBN 978-1-119-55121-8

Scientist, Early Development, Sandoz Development Center, Slovenia (SDCSI), Lek d.d., Sandoz

Dr. Marko Trampuž works as a scientist in Early Development Department in Sandoz Development Centre Slovenia. He obtained his M.Pharm. degree in 2015 and Ph.D. in Chemical Sciences in 2019 at the University of Ljubljana in Slovenia. During his Ph.D. research work he collaborated extensively with Sandoz on the topics of particle engineering, polymorphism, and mathematical modelling of chemical processes, particularly crystallization. After completing his Ph.D., he worked as a medicinal chemist at Drug Discovery and Development platform in SciLifeLab in Stockholm, Sweden, specializing in drug discovery of novel drugs for psychiatric, autoimmune, and oncological disorders. Since joining Sandoz in 2021, his main responsibilities have been the development of novel analytical approaches for N-nitrosamines and complex APIs, utilizing his skills in synthetic organic chemistry and various spectroscopic methods.

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 (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 4 years and responsible for NDA and ANDA reviews. She has been a principal and co-principal investigator for multiple FDA research projects and involved in several guidance working groups and grant review panels.

Senior Research Scientist, DPA, OTR, OPQ, CDER, FDA

Dr. Jingyue (Jan) Yang is a Sr. Research Scientist in the Division of Pharmaceutical Analysis in the Office of Testing and Research (OTR), Office of Pharmaceutical Quality (OPQ) at the FDA’s Center for Drug Evaluation and Research (CDER). In her various roles, Jan develops and applies analytical methods to assess the quality of pharmaceutical products and investigate adverse events related to their use. She also performs research to improve the characterization and understanding of complex drug substances and products to support generic drug assessment and approval. Jan has been a key team member to provide analytical support to the FDA’s task force responsible for investigating nitrosamine contamination in pharmaceuticals products, having developed important analytical methods to detect and quantitate various nitrosamines in these products. Jan received her Ph.D. in Chemistry from Washington University, Saint Louis, MO, and her B.Sc. in Chemistry from Beijing University in China. Before joining the FDA, she worked as a postdoctoral researcher in biomedical research and as an analytical chemist in the pharmaceutical industry.

Assistant Adjunct Professor, University of California, San Francisco

Dr. Sook Wah Yee is a researcher at the Department of Bioengineering and Therapeutics Sciences at University of California San Francisco (UCSF). Prior to joining UCSF, she earned her Master’s in Pharmacy and Ph.D. at Cardiff University in Wales, United Kingdom. At UCSF, her project focuses on genetic determinants of anti-diabetic response through genomewide association studies. In addition, her research also focuses on determining endogenous roles of membrane transporters through data from genomewide association studies and functional studies in cells. She is actively involved in Pharmacogenomics Global Research Network (PGRN) to enhance scientific exchange and to expand the boundaries of understanding drug response within the context of precision medicine, both within the PGRN and between the PGRN and the scientific community at large.