Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products

Senior Pharmacologist, DQMM, ORS, OGD, CDER, FDA

Dr. Khondoker Alam is currently working as a senior staff fellow in the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD) in FDA. Dr. Alam is serving as scientific lead for complex injectables such as long-acting injectables, liposomal injections etc. His role in the division is to utilize physiologically-based pharmacokinetic (PBPK) modeling and other quantitative tools to address specific questions pertinent to drug development process and/or regulatory decision making. He is responsible for reviewing pre-abbreviated new drug applications (pre-ANDA) meeting packages, ANDA post complete response letter (post-CRL) scientific meeting packages, ANDA consults and controlled correspondences on complex injectables and topical dermatological drug products where model based alternative bioequivalence approach is proposed by ANDA applicant. He is serving as project lead and key technical member for multiple FDA research projects on complex injectables, topical dermatological drug products, buccal/sublingual drug products as well as projects related to mitigation strategy for N-nitrosamine impurities. His research interests include PBPK modeling, development of computational tools for virtual bioequivalence, studying the role of transporter proteins and metabolizing enzymes in drug disposition and drug-drug interactions.

Principal Scientist, Chemical Development, Pharmaceutical Tech & Development, AstraZeneca

Dr. Ian Ashworth is currently the Principal Scientist of Physical Organic Chemistry and Chemical Development at AstraZeneca in Macclesfield, UK. He received a B.Sc. in Chemistry from Durham University and his Ph.D. in Chemistry from Cambridge University. His doctoral studies on intramolecular catalysis started an ongoing interest in pH-dependent reactions.

Dr. Ashworth has 20 years’ experience with AstraZeneca, working as a subject matter expert in Chemical Development to apply physicochemical concepts to support drug substance process development. During this time, he developed an interest in degradation chemistry across the drug substance-drug product interface and was responsible for introducing Zenith to support degradation assessments. Since 2019, a significant focus has been on understanding the formation of nitrosamines during drug substance processing. Ian has led the Nitrosamine Formation sub-team of the IQ Consortium’s Nitrosamine Working Group, driving the science behind nitrosamine risk assessments. A significant focus of Ian’s work has been the development and validation of kinetics-based tools to support drug substance and drug product nitrosamine risk assessments. Ian has authored or co-authored 50 patents and scientific papers.

Executive Director, Nonclinical Safety and Pathobiology, Gilead Science

Dr. Joel Bercu is the Executive Director of the Nonclinical Safety and Pathobiology group at Gilead Science and has over 20 years of public health/toxicology experience in pharmaceuticals. His mission in these positions has been to protect the safety of staff, patients, and the environment. He leads the Environmental and Occupational Toxicology (EOT) group at Gilead. Part of the remit of the EOT group is pharmaceutical safety impurity assessments (including mutagenic/carcinogenic impurities), QSAR assessments of impurities for ICH M7 compliance, and the safety evaluation of potential nitrosamine impurities. Prior to joining Gilead Sciences, he worked at Eli Lilly and Amgen. He is a member of the Society of Toxicology and the Risk Assessment, Occupational and Public Health (where he served as President and Endowment Steward), Computational Toxicology and Medical Devices Specialty Sections, and American College of Toxicology (ACT). He leads several external committees, such as the IQ/Drusafe Impurities Working Group and the nitrosamine study effort at the Health and Environmental Sciences Institute (HESI). He received his B.S. from Texas A&M University, his MPH from the University of Texas – Houston, School of Public Health, and his Ph.D. from Indiana University. He is also a Diplomate of the American Board of Toxicology (DABT).

Senior Biologist, OPQA I, OPQ, CDER, FDA

Dr. Dan Berger is a Senior Scientist in the Office of Pharmaceutical Quality (OPQ) at FDA’s Center for Drug Evaluation and Research (CDER). In his current role as a Chemistry Manufacturing and Control (CMC) reviewer, Dan is mainly focused on the assessment of drug product quality. Since 2021, Dan has become a subject matter expert on nitrosamine formation/risk factors in various drug products and serves on several FDA internal committees addressing scientific and regulatory aspects of nitrosamine control. Prior to joining the FDA, Dan acquired more than 22 years of experience in medicinal chemistry research at Wyeth Research and OSI Pharmaceuticals. Dan obtained his Ph.D. in chemistry from Columbia University and a B.S. from Stony Brook University.

Senior Interdisciplinary Scientist, DPQA XII, OPQA II, OPQ, CDER, FDA

Dr. Hansong Chen initially joined the Office of Study Integrity and Surveillance in 2013, where he conducted two years of BA/BE inspection. In 2015, he joined the Division of Biopharmaceutics/ONDP. Currently, he works at the Division of Product Quality Assessment XII/ OPQA II. Before joining the FDA, he worked at a biopharmaceutics company as a Chemist.

Senior Scientific Officer, FEEDCO Unit, EFSA

Dr. Anna Christodoulidou is a Senior Scientific Officer in the Feed Additives and Contaminants (FEEDCO) Unit of the European Food Safety Authority (EFSA). She leads the scientific coordination of several EFSA Panels on Contaminants in the Food Chain (CONTAM Panel) expert Working Groups. As such, she is actively involved with developing EFSA Scientific Opinions in the area of Contaminants. Dr. Christodoulidou holds a Ph.D. in Applied Biology and Biotechnology from the University of Crete, Greece, and a diploma in Toxicology from the University of Surrey, UK.

Head of Science, Instem

Dr. Kevin P. Cross is the Head of Science at Instem, acting as the Principal Investigator of the U.S. FDA/Instem research collaboration. He has been developing chemoinformatics tools and products for over 40 years. He is involved in several collaborative efforts creating in silico protocols and procedures for performing chemical hazard and risk assessments for regulatory purposes and developing and assessing the performance of QSAR models. He has recently been focusing on QSAR risk assessment of nitrosamines. He has published over 45 papers and three book chapters.

Director, DPTR, OSCE, OGD, CDER, FDA

Dr. Robert (Bob) Dorsam is the Director of the Division of Pharmacology/Toxicology Review (DPTR). It is responsible for the safety assessment of impurities and excipients in generic drugs. Bob earned his Ph.D. in Pharmacology from the Temple University School of Medicine and conducted postdoctoral research at the National Institutes of Health (NIH). He joined the FDA, performing Pharm/Tox reviews for oncology 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 the Associate Director of Pharmacology/Toxicology in OGD’s Division of Clinical Review. More recently, Bob became the Director of the Division of Pharmacology/Toxicology Review in OGD. He shows his commitment to the growth of the Pharm/Tox discipline by advancing several technical areas, promoting process improvements, and contributing to innovations in review tools. Dr. Dorsam 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 from McMaster University and a Ph.D. in Chemistry from the University of British Columbia. In 1994, Dr. Ehlert commenced his career in the pharmaceutical industry at Phytogen Life Sciences 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.

Postdoctoral Research Fellow, DPQR V, OPQR, CDER, FDA

Dr. Martha Essandoh is a postdoctoral research fellow within the Office of Pharmaceutical Quality Research, CDER, US FDA. Her areas of expertise include organic and analytical chemistry. Martha received her Ph.D. in chemistry from Oklahoma State University. In her current role, Dr. Essandoh’s research relates to nitrosamine impurities, including the effect of excipients on the formation of nitrosamines.

Senior Pharmacologist, DPTR, OSCE, OGD, CDER, FDA

Dr. Xin Fu serves as a Pharmacology/Toxicology (Pharm/Tox) reviewer in the Office of Safety and Clinical Evaluation (OSCE) of the Office of Generic Drugs (OGD) within the Center for Drug Evaluation and Research (CDER) at the FDA. Her primary role is conducting safety-related Pharm/Tox reviews of generic drug products and drug substances. Before joining OGD in 2017, Dr. Fu was a research scientist, a premarket reviewer of medical devices, and a nonclinical reviewer of tobacco products at the FDA. In her 20-year career in various centers of the FDA, while mostly serving as, a regulatory scientific reviewer, Dr. Fu has led and participated in various research projects and activities under different roles and responsibilities. She has been a Diplomate of the American Board of Toxicology (DABT) since 2005.

Director, DGMT, OR, NCTR, OCS, FDA

Dr. 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 the Division Director of Genetic and Molecular Toxicology, supervising approximately 35 scientists and administrative assistants. His present research involves the development of approaches to measure and analyze mutations in laboratory animals, most recently using the endogenous Pig-a gene as a reporter of mutation in mice, rats, and humans. His other research interests include evaluating the risks of nitrosamine drug impurities and developing and characterizing relevant in vitro organotypic assays, especially 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).

Office Director, OPQR, OPQ, CDER, FDA

Dr. David Keire received a Ph.D. in Analytical Chemistry at the University of California, Riverside, in 1990. He performed academic research at the Beckman Research Institute of the City of Hope National Medical Center and the David Geffen School of Medicine at UCLA from 1992 to 2008. In 2008, Dr. Keire joined what is now called the CDER/OPQ/Office of Pharmaceutical Quality Research (OPQR). Since then, he has applied his analytical chemistry skills to issues that arise with complex drugs (e.g., heparin, glatiramer acetate, transdermal systems, inhalers, modified-release dosage forms, and protein-based therapeutics). He has over 130 peer-reviewed research articles and book chapters describing his work. In 2019, David won the prestigious St. Louis American Chemical Society Award for his contributions to the chemical profession. His current position is as the Office Director of OPQR, which has about 170 staff across St Louis, Missouri, and Silver Spring and Beltsville, MD sites.

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

Dr. Sruthi King earned her Ph.D. in pharmacology from Georgetown University and completed her postdoctoral training at Stanford University in the Department of Dermatology. Sruthi joined the U.S. Food and Drug Administration in 2008 as a pharmacologist in the Division of Gastroenterology and Inborn Error Products within the Office of New Drugs. In 2015, she joined OGD as a Pharm/Tox team leader in the Division of Clinical Review. Since 2021, Sruthi has served as Deputy Director in the Division of Pharmacology/Toxicology Review in the Office of Safety and Clinical Evaluation within the OGD. Sruthi has been a member of the CDER nitrosamine task force since 2018 and is actively involved in CDER’s nitrosamine review and policy and research efforts. She also serves on several expert working groups with international regulators to harmonize approaches related to nitrosamine safety assessments.

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

Mr. Sivacharan Kollipara is currently working as Team Lead, Biopharmaceutics in the Global Clinical Management group, IPDO at Dr. Reddy’s Laboratories Limited (DRL), Hyderabad. He is responsible for biopharmaceutics evaluation, bioequivalence risk assessment, and bioequivalence prediction for conventional as well as complex generic products at DRL. He is also involved in PK modeling and simulations activities supporting generic drug development of various immediate release, modified release, and complex products at DRL and involved in utilizing novel PBPK and PBBM modeling approaches for regulatory justifications for various markets. Prior to joining DRL, Mr. Kollipara was Principal Scientist (Global Pharmaceutical Development) at Novartis Healthcare Pvt Ltd., Hyderabad. Previously he also has been associated with Ranbaxy Research Laboratories, Gurgaon (Metabolism and Pharmacokinetics). He obtained Masters in Pharmaceutical Sciences from BITS, Pilani, Rajasthan, India and currently pursuing Ph.D. Overall Mr. Kollipara has an experience of 17 years in the field of drug discovery, development and generic product development, bioanalytical method development and validation, PK data modelling and simulations. He has authored/co-authored ~35 peer-reviewed publications. His research interests include PBPK/PBBM, virtual bioequivalence simulations, IVIVC/R, drug-drug interactions, dissolution/bioequivalence safe space, bio-predictive dissolution methodologies, biowaivers, novel statistical tools for dissolution similarity analysis and food effect evaluations.

Associate Professor and M.S. Program Advisor, Chemistry, Co-Director, M.S. Environmental Green Chemistry Program, George Washington University, Co-Founder and Principal, ToFix

Dr. Jakub Kostal is an Associate Professor of Chemistry at George Washington University, where his group develops computational methods for the design of safer chemicals. At GWU, Dr. Kostal directs the M.S. Program in Environmental and Green Chemistry, which trains chemists in predictive toxicology and safer chemical and process design. Dr. Kostal is co-founder and principal at ToxFix, which has served the pharmaceutical and personal care industries for ten years in reducing animal testing using the CADRE suite of predictive tools. He holds a Ph.D. from Yale University (Ph.D. ’12) in Theoretical and Biophysical Chemistry and a B.A. in Chemistry from Middlebury College (B.A. ’06).

Scientific Lead, Computational Toxicology Consultation, 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 22 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 47 peer-reviewed articles and book chapters describing data standardization, transformation, classification for modeling purposes, as well as the creation and regulatory application of (Q)SAR models with chemical interpretability. Most recently, she led the development of the Carcinogenic Potency Categorization Approach for predicting the carcinogenic potency of nitrosamine impurities. Dr. Kruhlak holds B.Sc. and Ph.D. degrees in chemistry from the University of Salford, England, and the University of Calgary, Canada, respectively.

Chemist, DPQA XIX, OPQA III, OPQ, CDER, FDA

Dr. G. Kumaran is a Chemist in the Division of Product Quality Assessment XIX, Office of Pharmaceutical Quality Assessment III under the Office of Pharmaceutical Quality. Prior to joining the FDA, he worked in the pharma industry for over eleven years. He received his Ph.D. in organic chemistry from the University of Pune, India. Over the past ten years, he has worked at the FDA assessing Chemistry Manufacturing and Control (CMC) aspects in generic drug master files (DMF), evaluating the toxicity of drug impurities using computational (Q)SAR models, and performing surrogate analysis of nitrosamine impurities.

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

Dr. Bing V. Li serves as the Associate Director for Science for the Office of Bioequivalence within the Office of Generic Drugs at CDER/FDA. In this role, she provides scientific leadership and expertise for assessing bioequivalence studies submitted by the pharmaceutical industry through Abbreviated New Drug Applications (ANDAs). She also oversees the scientific programs, including guidance development and implementation in the Office of Bioequivalence. Dr. Li is an Expert Pharmacologist at the FDA in bioequivalence of aerosolized drug products. Prior to joining the FDA in 2004, she was a Research Investigator at Bristol-Myers 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 the University of Wisconsin at Madison in 2001 and a bachelor’s degree in Medicinal Chemistry in 1990 from 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.

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

Dr. Dongmei Lu obtained her Ph.D. in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill. She has experience in pre-formulation and formulation from working at GlaxoSmithKline, Wyeth, and Pfizer. Dongmei had worked in the Office of Bioequivalence in the Office of Generic Drugs as a reviewer and team leader. After she joined the Office of Policy for Pharmaceutical Quality in OPQ, Dongmei worked on the establishment of numerous policies, including the policies of nitrosamine-impacted products. She was the primary author of the FDA guidance for industry, “Control of Nitrosamine Impurities in Human Drugs.” Dongmei also led a couple of FDA-sponsored research projects on nitrosamine mitigations. She now serves as a member of the PQRI Biopharmaceutics Technical Committee.

Vice President and Head, Formulation R&D Orals, Sun Pharmaceutical Industries Limited

Dr. Sumit Madan is the Vice President of R&D at Sun Pharmaceutical Industries Limited and heads the Formulation Research and Development Department for Oral Formulation. In his current role, he leads a talented group of Scientists engaged in developing complex generics, value-added generics, and specialty products for Global markets. Dr. Madan earned his Master’s in Pharmaceutical Sciences from the University of Delhi and his Doctorate in Biomedical Engineering from the Indian Institute of Technology, Delhi. He has 25 years of rich professional experience in pharmaceutical research. With an established core expertise in multiple dosage forms technologies, he is listed as an inventor/co-inventor of several patents worldwide.

Director, OFCSDSI, FDA

Dr. Kristi Muldoon Jacobs is the Director (Acting) for the FDA’s Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). OFCSDSI is responsible for ensuring the safety of direct and indirect food additives, color additives, and GRAS substances and supporting safety and innovation in food from new plant varieties made with cultured animal cells. Dr. Muldoon Jacobs earned a Ph.D. from the UMDNJ/Rutgers University program in Biomedical Sciences and continued her studies and research at the NIH/National Cancer Institute on mechanisms of tumor suppression and carcinogenesis. In her previous roles at the FDA and USP, Dr. Muldoon Jacobs has served as a toxicologist with expertise in the safety assessment of FDA-regulated products, including food ingredients, indirect and direct additives, dietary supplements, and drug impurities. She has extensive knowledge of regulatory systems globally to ensure the quality and safety of products and has served as an expert to JECFA, OECD, and ICH committees. She is internationally recognized as an expert in new and alternative safety and risk assessment methods, such as TTC, QSAR, and read-across methodology. She has served as an expert on 15 international working groups and has published over 30 peer-reviewed publications in areas related to her expertise.

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

Dr. James Polli is Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption, involving laboratory and clinical research. He has served as the advisor to 25 Ph.D. graduates. He is co-Director of the University of Maryland Center of Excellence in Regulatory Science and Innovation and the Center for Research on Complex Generics, each an FDA-funded collaborative agreement with the Agency. He is Director of the online M.S. in Regulatory Science program. He is a fellow of the American Association for Pharmaceutical Scientists (AAPS) and served as an editor of Pharmaceutical Research for 12 years. He is the 14th recipient of the American Pharmacists Association Takeru Higuchi Research Prize. He was the recipient of the 2024 American Association of Colleges of Pharmacy Volwiler Research Achievement Award, the 2022 AAPS Global Leadership Award, and the 2021 TOPRA Education Award. He is a member of the University of Maryland General Clinical Research Center Advisory Committee and the University of Maryland institutional review board (IRB).

Associate Director, Science and Communication, OPQA I, OPQ, CDER, FDA

Dr. Andre Raw received his B.S. from the Massachusetts Institute of Technology and his Ph.D. in chemistry from the University of California at Berkeley. During his tenure with the FDA, he has been promoted to FDA Agency Expert and then to Chemistry Division Director. Now, he works as an Associate Director for Science and Communication in the Office of Pharmaceutical Quality Assessment I in the Office of Pharmaceutical Quality.

Dr. Raw was involved in several important FDA initiatives, including the Guidances on Pharmaceutical Solid Polymorphism and Co-crystals, Regulations on Listing of Polymorph Patents, Question-Based Review, and Quality by Design Examples 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). Currently, he is involved in Risk and Quality Informatics Initiatives as a principal architect of Knowledge-Aided Assessment and Structured Application (KASA). More recently, Dr. Raw has taken an active role with nitrosamine impurities.

Division Director, Biopharmaceutics, DPQA VI, OPQA I, OPQ, CDER, FDA

Dr. Bhagwant Rege is the Division Director for Biopharmaceutics in CDER/OPQ at the FDA. His division at the FDA is responsible for the 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 the FDA in 2010, he worked in the industry for many years in oral biopharmaceutics and formulation development groups. Bhagwant has served as a team leader and review chemist in the Office of Generic Drugs, where he was part of the team that developed the QbD examples for the generic industry. He is a member of the FDA Emerging Technology Team (ETT) and ICH Q12 Expert/Implementation Working Group. He served as FDA liaison on the USP expert committee on dosage forms general chapter (2015-2020). Bhagwant received his B.S. and M.S. in pharmacy from the University of Mumbai, India, and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore.

Principal Scientist, Science Division, USP

Mr. Naiffer Romero has more than 20+ years of pharmaceutical industry experience. In his 15-year tenure with USP, he has served several roles: Lead scientist in performance testing compendial reference standards development, Manager in charge of LATAM Compendial engagement and education with users and national regulatory bodies. Naiffer is also a certified USP Education instructor.

Naiffer’s journey with USP continued in 2020 when he joined the Scientific Affair performance cell. Here, he spearheads scientific outreach and technical engagement for the LATAM & US region on critical national health priority topics. His broad pharmaceutical expertise encompasses Analytical development, salt and polymorph selection, the development of dissolution methods, IVIVC modeling, and impurity analytical strategy. However, his true passion lies in nitrosamine impurities, where he is a recognized subject matter expert with several publications. He also plays a crucial role as a member of USP’s Nitrosamine workstream Committee and as a community manager for the ‘Nitrosamine Exchange’, a knowledge community hosted by USP in All-things Nitrosamines impurities.
Naiffer also liaises technical discussions on pharmacopeial collaboration, including the International Meeting of World Pharmacopeias (part of WHO) and the International Compendial Discussion Groups (PDG). He is a member of several regional regulatory agencies’ nitrosamines working groups. Naiffer recently joined the ICH M7 subgroup in charge of revising international guidelines.

Director/Principal Expert, EMD Serono, Healthcare Quality Unit, Merck

Dr. Joerg Schlingemann is a director and principal expert within EMD Serono’s healthcare quality unit. He studied molecular biology in Uppsala and Heidelberg, where he completed his doctorate at the German Cancer Research Center in 2005. He has fifteen years of experience in the pharmaceutical industry, working in various quality control and quality assurance roles. Since late 2019, Joerg has been leading EMD Serono’s analytical activities for N-nitrosamines, based on which he has authored or co-authored several scientific publications dealing with analytical challenges, NDMA in metformin, nitrite in excipients and the prevalence of NDSRIs. Joerg advocates for scientific collaboration, data sharing, and expressive data visualization. He is married and has three children.

Head, Genetic Toxicology Group, Pfizer, Global Research and Development

Dr. Maik Schuler received his Ph.D. from the University of Kaiserslautern in Germany, where he worked on detecting chromosomal damage induced by environmental and synthetic estrogens. During a postdoctoral fellowship with Dr. David Eastmond at the University of California, he developed fluorescence in situ hybridization methods for detecting aneugenic and clastogenic damage in vitro and in rodent target tissue in vivo. Dr. Schuler joined Pfizer Global Research and Development in 2000 and is now the current head of the Genetic Toxicology group, the most innovative research organization in the industry. In addition, Dr. Schuler leads the development of novel screening and risk management tools. He is the recipient of two WRD Achievement awards for his contributions to the understanding of kinase toxicities in 2006 and the development of a novel genotoxicity screening assay in 2015. Dr. Schuler has organized several workshops for the Genetic Toxicology Association (GTA) on using risk management tools and the Mode of Action (MOA) assessment of genotoxic agents. He is involved in the International Working Groups on Genetic Toxicology (IWGT). He is currently the chair of a workgroup looking into the risk assessment for nitrosamines as part of the Genetic Toxicology Technical Committee (GTTC) at the Health and Environmental Sciences Institute (HESI).

Co-Director of CRCG, Larry and Ann Hsu Professor of Pharmacy, Chair, Department of Pharmaceutical Sciences, Biointerfaces, College of Pharmacy, University of Michigan

Dr. Anna Schwendeman is a Larry and Ann Hsu Collegiate Professor and Chair of the Department of Pharmaceutical Sciences at the University of Michigan. Her research focus is on optimization of high-density lipoprotein (HDL) nanoparticles for treatment of atherosclerosis, sepsis, and drug delivery purposes. In 2016, she co-founded a company EVOQ Therapeutics (www.evoqtherapeutics.com) focused on the use of HDL Nanodiscs for delivery of personalized neoantigen cancer vaccines. Dr. Schwendeman received her B.S. from Moscow Institute of Physics and Technology and Ph.D. in Pharmaceutics from The Ohio State University. Prior to starting her academic career in 2012, Dr. Schwendeman spent 12 years in the pharmaceutical industry at Cerenis Therapeutics, Pfizer, and Esperion Therapeutics. She was involved in discovery and translation HDL drugs to clinical trials. She successfully submitted FDA INDs for seven different products including nanoparticles, liposome, recombinant proteins, peptides, and small molecules. Her laboratory’s research in regulatory sciences is focused on analytical characterization of liposomes, polymer microspheres, peptides, and biosimilar products. She is co-Director of FDA sponsored Center for Research in Complex Generics (http://www.complexgenerics.org). Dr. Schwendeman is an Associate Editor for Nanomedicine NBM and Eur. J. Pharm and Biopharm.

Senior Research Scientist, DPQR V, OPQR, OPQ, CDER, FDA

Dr. Diaa Shakleya is a Senior Research Scientist within the Office of Pharmaceutical Quality Research, CDER, US FDA. His areas of expertise include drug product quality, opioids, 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 NDSRI impurities in pharmaceutical drug products and the effect of excipients on the formation of nitrosamines. Dr. Shakleya also leads the opioid research project on the risk associated with opioids and opioid antagonists and creates an in vitro surrogate model platform to assess in vivo permeation and risk associated with vaping opioids.

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

Dr. Shakleya has over 60 peer-reviewed publications and more than 100 scientific podium and poster presentations.

Assistant Professor, Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research

Dr. Nitish Sharma has served as an Assistant Professor in the Department of Pharmaceutical Analysis at the National Institute of Pharmaceutical Education and Research in Ahmedabad, India, since April 2021. He has almost 20 years of research experience in the field of pharmaceutical analysis. Before his current position, Dr. Nitish worked for Dr. Reddy’s Laboratories, Ltd. and Sun Pharmaceutical Industries, Ltd. in the Analytical Research and Development Department.

He is the recipient of the Professor M.L. Khorana Memorial Award from the Indian Pharmaceutical Association (IPA) for best publication of 2013.  He is also associated with the National Accreditation Board for the Testing and Calibration Laboratories (NABL) as a Technical Assessor for ISO17025.  He has published ~32 research papers in international Journals.

Head of Global Quality Compliance, Viatris

Dr. Daniel Snider received his Doctor of Philosophy degree in Chemistry from West Virginia University in 1995 and, soon after, began his career at Mylan Pharmaceuticals in Research and Development. Dan is currently the Head of Global Quality Compliance at Viatris. He has worked on several initiatives with the industry and the U.S. FDA, such as Polymorphism in Generic Drug Products and Quality by Design and other Chemistry Manufacturing Controls related topics.

Associate Director, DB I, OB, OGD, CDER, FDA

Dr. Rong Wang is the Associate Director in the Division of Bioequivalence I (DBI), Office of Bioequivalence (OB), Office of Generic Drugs (OGD). Dr. Wang embarked on her regulatory science career at the Food and Drug Administration (FDA) in 2010 and has since gained over 14 years of extensive experience within OGD. Throughout her tenure, Dr. Wang has served as a primary, secondary, and tertiary assessor of abbreviated new drug applications (ANDAs), Control Correspondences (CCs), Protocols, and various other generic drug-related regulatory submissions. Dr. Wang has played an active role in several working groups within the Agency, where she has contributed her expertise and experience to revising or developing general guidance for ANDAs and establishing work processes for ANDA assessment. Dr. Wang has actively engaged in cross-office and intra-office working groups focused on nitrosamine-related issues. She received her undergraduate degree in pharmacy from the Shanghai Medical University and her Ph.D. in Microbial and Biochemical Pharmaceutical Science from the Institute of Medicinal Biotechnology, Chinese Academy of Medical Science & Peking Union Medical College. Dr. Wang also holds a Pharm.D. degree from the University of Florida.

Senior Pharmacologist, DQMM, ORS, OGD, CDER, FDA

Dr. Fang Wu is a senior pharmacologist reviewer and scientific lead for oral Physiologically-based Pharmacokinetic modeling in Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD) in FDA. Dr. Wu has been with FDA for more than 12 years. She is responsible for using modeling and simulations tools for reviewing pre-abbreviated new drug applications (pre-ANDA) meeting packages, ANDA consults and controlled correspondences. Prior to joining DQMM, Dr. Fang Wu was a biopharmaceutics reviewer for more than four years and responsible for NDA and ANDA reviews. She has been a principal and co-principal investigator for multiple FDA research projects and involved in several guidance working groups and grant review panels.

Senior Research Scientist, DPQR I, OPQR, OPQ, CDER, FDA

Dr. Jingyue (Jan) Yang is a Senior Research Scientist in the Division of Pharmaceutical Quality Research I (DPQR I) in the Office of Pharmaceutical Quality Research (OPQR), Office of Pharmaceutical Quality (OPQ) at the FDA’s Center for Drug Evaluation and Research (CDER). With expertise on LC-MS techniques and method development and validation, Dr. Yang develops and applies analytical methods to assess the quality of pharmaceutical products and conducts research to advance the characterization of complex drug products. Since 2019, Dr. Yang has concentrated on projects related to nitrosamine contamination, developing methods to detect and quantitate nitrosamines in pharmaceutical products and conducting laboratory research to understand risk factors of formation and risk mitigate strategies.

Senior Biologist, OPQA I, OPQ, CDER, FDA

Dr. Xiang Yu is a Senior Biologist with over eight years of experience in drug product quality assessment and regulatory informatics at the U.S. Food and Drug Administration (FDA). He earned his Ph.D. in Chemical Engineering from The University of Akron, where he specialized in molecular dynamics and structure simulations. Prior to his tenure at the FDA, Dr. Yu was a research fellow at the National Center for Biotechnology Information (NCBI), part of the National Library of Medicine (NLM) at the National Institutes of Health (NIH). At the NCBI, he focused on data mining and developing novel algorithms for PubChem and the Molecular Modeling Database (MMDB) projects.

In his current role within the Office of Pharmaceutical Quality (OPQ) at the FDA’s Center for Drug Evaluation and Research (CDER), Dr. Yu initially worked as a drug product quality assessor for Abbreviated New Drug Applications (ANDAs). He has since shifted his focus to regulatory informatics research, where he has played a pivotal role in developing innovative IT solutions to enhance regulatory processes. Notably, Dr. Yu has served as the lead developer of the prototype for the Knowledge-Aided Assessment and Structured Application (KASA) system, which was piloted across OPQ. He also spearheaded initiatives leveraging artificial intelligence (AI) to estimate risk and reporting categories for ANDA supplements, significantly advancing the efficiency and consistency of quality assessments.

Dr. Yu’s work has had a transformative impact on regulatory processes at the FDA, helping to integrate advanced technology into agency operations. His contributions continue to drive innovation in drug product quality assessment and regulatory frameworks, offering new insights into IT-enhanced Chemistry, Manufacturing, and Controls (CMC) regulatory activities at OPQ/CDER.

Lead Pharmacologist, DTP II, ORS, OGD, CDER, FDA

Dr. Qi Zhang is the Team Lead for the Immediate Release Drug Product Team in the Division of Therapeutic Performance, Office of Research and Standards, U.S. FDA. She has over eight years of review experience in the Office of Pharmaceutical Quality and the Office of Generic Drugs, evaluating a wide variety of products, including a broad range of dosage forms, NCEs, and complex drug products. In her current role, Dr. Zhang works with a group of interdisciplinary scientists, developing product-specific guidances and communicating with industry through various mechanisms, including controlled correspondences, pre-ANDA submissions and meetings, and citizen petitions. She also leads internal research projects and external research grants and collaborations to ensure the therapeutic equivalence of generic immediate-release products. Dr. Zhang specializes in the Biopharmaceutics Classification System (BCS), biowaivers and bridging, dissolution/drug release of high-risk drug products, clinically relevant specification setting, bioequivalence study design, and alternative bioequivalence approaches.

Professor and Director, Center of Regulatory Science, School of Pharmacy, University of California, San Francisco

Dr. Liang Zhao is a professor and director for the Center of Regulatory Science with the School of Pharmacy at the University of California, San Francisco (UCSF). Prior to joining UCSF, he served as the Director of Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards, the Office of Generic Drugs, and CDER at the FDA between 2015 and 2024. He has demonstrated excellence and leadership in drug development and regulatory science for new and generic drugs during his 19-year professional tenure, including in Pharsight as an associate consultant, BMS as a research investigator, MedImmune as an Associate Director, and FDA as Clinical Pharmacology reviewer, Pharmacometrics Team Leader, and Division Director. Dr. Zhao and his team have introduced a broad array of innovative tools in drug delivery, bioequivalence assessment, and big data tools, including everything from machine learning to pharmacometrics. They have also implemented the Model Integrated Evidence (MIE) Industry Meeting Pilot to support regulatory communications between generic applicants and the FDA. His team has also proposed a regulatory mechanism of using a Model Master File to support regulatory submissions. Liang currently serves as the Chair of the FDA ModSim WG for the Modeling & Simulation community across the FDA centers and offices. He has published over 120 peer reviewed publications and eight book chapters. He received the 2023 Gary Neil Prize for Innovation in Drug Development from ASCPT in recognition to his contribution to clinical pharmacology and pharmacometrics.

Research Scientist, DPQR V, OPQ, CDER, FDA

Dr. Guozhang Zou joined the FDA as a Research Scientist in the Division of Pharmaceutical Quality Research, in the Office of Pharmaceutical Quality/CDER/FDA in 2022, where he conducts research and provides support for quality assessments and guidance development to evaluate generic drugs and biosimilar products. Before joining the FDA, Guozhang worked as an Analytical Research Scientist at the Vaccine Production Program/VRC/NIAID at the National Institute of Health (NIH) to provide analytical support to develop mAb therapeutics and protein nanoparticle vaccines against infectious diseases. Guozhang received his Ph.D. in Chemistry from the State University of New York, College of Environmental Science and Forestry.

Supervisor, DRGS, OPPQ, OPQ, CDER, FDA

Ms. Susan Zuk holds a B.S. in Chemistry from Syracuse University and an M.S. in Biotechnology from Johns Hopkins University. During her 20+ years with the FDA, she has served as a Chemistry Team Leader in the Office of Generic Drugs, specializing in antibiotics. She joined the Office of Policy for Pharmaceutical Quality in 2015 and currently serves as a supervisor in the Division of Regulations and Guidance. In this role, Susan oversees the development of policies in a number of quality-related areas. Since 2018, she has been involved in the FDA’s efforts to develop effective policies for addressing nitrosamine impurities in drugs, including guidance for the industry that provides FDA recommendations for effective mitigation strategies and controls. Susan works with scientific experts across CDER to communicate up-to-date information on nitrosamine impurities through the FDA webpage associated with CDER’s nitrosamine guidances: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) and Control of Nitrosamine Impurities in Human Drugs.