Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products

Founder and President, ARNAY Services, Affiliate Professor, Department of Medicine, UMass Chan Medical School

Dr. Sudhir Agrawal is the founder and President of ARNAY Sciences. He also serves as an Affiliate Professor in the Department of Medicine at UMass Chan Medical School. Over the last three decades, his research interest has been discovering and developing RNA therapeutics, including antisense and immunotherapy. He focuses on the chemical biology of nucleic acids for creating RNA therapeutics. He has published over 300 research papers and is listed as a co-inventor of more than 400 patents worldwide. He has edited four books on oligonucleotides and antisense technology, including a recent book on ‘Advances in Nucleic Acid Therapeutics’ by The Royal Society of Chemistry. He is currently serving as a member of the scientific advisory board of several biotechnology companies.
He obtained his D.Phil. in Chemistry from Allahabad University in India and conducted postdoctoral research at MRC’s Laboratory of Molecular Biology, Cambridge, UK. His research in the antisense field started in Paul Zamecnik’s laboratory at the Worcester Foundation of Experimental Biology, now UMass Chan Medical School. He was a co-founder of Idera Pharmaceuticals and held various roles until 2017.  In 2022, the Oligonucleotide Therapeutic Society awarded him the Lifetime Achievement Award.

CSO and Chairman of the Board, EpiVax, Inc.

Dr. Annie De Groot served as Chief Executive Officer and Chief Scientific Officer of the biotech company EpiVax for 25 years. Currently, she maintains her role as CSO and continues to lead EpiVax as Chairman of the Board. She is a graduate of the University of Chicago and Smith College, trained in Infectious Disease at New England Medical Center and Vaccines and Immunology at the National Institutes of Health, and is the author of 228 publications and 46 patents. In addition to engaging in a wide range of research at EpiVax, Brown, URI, and the University of Georgia, she maintains an active role in two not-for-profits, Clinica Esperanza and the GAIA Vaccine Foundation.

Biostatistician, ImmunXperts

Dr. Sofie Denies is the founder and director of SD Analytics, providing statistical support to CROs and biotech internationally. Dr. Denies holds a Master’s in Statistics and a Ph.D. in immuno-oncology and has been invited to speak on the analysis of preclinical immunological assays at multiple conferences.
Dr. Denies completed her Master’s in Veterinary Medicine before starting her scientific career with a Ph.D. in immunotherapy. She continued in the immuno-oncology field as a research scientist in a biotech company. Upon completion of her Master’s in statistical data analysis, Dr. Denies used her mixed background to conduct statistical analyses and communicate their result and interpretations to scientists. As a biostatistician at ImmunXperts, she has been doing so for six years by providing statistical support in several areas, such as the qualification of cell-based assays, HLA-based donor selection, and preclinical immunogenicity risk assessment.

Director of Sales, ProImmune

Dr. Jeremy Fry earned his D.Phil. from the University of Oxford, where he conducted research in the Nuffield Department of Surgery under Professor Kathryn Wood. His research focused on developing gene therapy strategies to induce immunological tolerance in transplant recipients. Following a post-doctoral position in the same lab, Jeremy joined the R&D team at ProImmune as a Research Scientist. During his tenure, he played a pivotal role in inventing the MHC class I Pentamer technology, which is used for tracking antigen-specific CD8 T cells and has been cited in several thousand references.
Jeremy later transitioned to a hybrid scientific and commercial role at ProImmune. For the past 23 years, he has served as the Director of Sales, based in Oxford, UK and leading a global team of experts. His work has centered on developing and implementing innovative technologies that significantly enhance our understanding of both desired and undesired immune responses. A critical aspect of his efforts has been providing best-in-class assays to address immunogenicity risk for biotherapeutics, including adapting to rapidly evolving regulatory requirements in the field of complex peptides to ensure robust and accurate data for identifying potential risks.

Research Director, Inserm; CSO, Genoskin, Inc.

Dr. Nico Gaudenzio is the Research Director at the French National Institute of Health (Inserm) and Chief Scientific Officer (CSO) at the biotech company Genoskin (Toulouse, FRA, Salem, MA, USA). Nico received a Master’s in Bioengineering and a Ph.D. in Immunology at the University of Toulouse, France, and completed his postdoctoral training at the University of Stanford (CA, USA). His work has contributed substantially to identifying molecular and cellular targets involved in allergic and non-allergic inflammation and developing new data analysis processes to study preclinical models and clinical samples from patients. Nico currently leads a large research program in partnership between Inserm and Genoskin to develop the next generation of drug immunogenicity assessment tools using biostabilized natural human skin.
He is twice Laureate of the European Research Council and has received international prizes such as the ACTERIA Early Career Research Prize by the European Federation of Immunological Societies (EFIS) and the Rising Star Award by the International Union of Immunological Societies (IUIS). He has (co-)authored more than 50 peer-reviewed publications in prestigious journals, is (co-)inventor of several patents with industrial applications and is a member of the European Academy of Allergy and Clinical Immunology (EAACI).

Director, Immunogenicity Assessment, Teva Pharmaceuticals

Mr. Andrew Graves serves as the Director of Immunogenicity Assessment for Teva Pharmaceuticals. In his role, Andrew leads a talented group of immunologists supporting innovative and generic pharmaceutical candidate programs, spanning nonclinical in vivo studies, human clinical studies, and in vitro immunogenicity prediction studies. Andrew specializes in the development and validation of complex immunoassays. Before joining Teva in 2021, Andrew’s scientific career began at Aeras, where he led assay development activities supporting clinical vaccine studies. He then moved to FlowMetric, where he served as Associate Director of Lab Operations. Andrew holds a B.S. degree in biotechnology from the Rochester Institute of Technology, an M.S. in immunology from the University of Rochester, and earned his Specialist in Cytometry (SCYM) certification in 2016.

Research Veterinary Medical Officer, DARS, OCP, OTS, CDER, FDA

Dr. Kristina Howard is a research scientist in the Division of Applied Regulatory Science (DARS), Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA.  She received her veterinary degree from the Virginia-Maryland Regional College of Veterinary Medicine and her Ph.D. in Immunology from North Carolina State University. Following post-doctoral work supported by an NIH K08 training grant, she joined the FDA in 2010 as a Commissioner’s Fellow and became a Principal Investigator in 2012. Her research has focused on developing and improving in vitro and in vivo models to better predict adverse events associated with biological drug products, and immunogenicity for biosimilar and generic peptide products. She is an expert in the use of immune humanized mice for regulatory research and has investigated their use in prediction of adverse events such as cytokine release syndrome and excess pharmacology of checkpoint inhibitor biologics. Her laboratory recently completed studies assessing the ability of humanized mice to model immunogenicity. In addition, her research includes in vitro immunogenicity assessment of biosimilar and generic drug products using assays that model adaptive immune responses.

Executive Director, Bristol Myers Squibb

Dr. Vibha Jawa has 20+ years of experience in diverse fields of biologics, vaccine development, and gene therapy with the successful support of 20+ IND, BLA, and MAA filings. She is currently an Executive Director in Clinical Pharmacology, Pharmacometrics, Disposition, and Bioanalysis (CPPDB) with the Discovery and Translational Science organization at Bristol Myers Squibb. Vibha leads the biotherapeutic and cell/gene therapy supporting DMPK and bioanalysis. She also provides strategic and scientific oversight for the BMS developmental portfolio for clinical trial-related submissions and regulatory approvals. Vibha was part of the PPDM organization at Merck for four years before joining BMS. She was responsible for developing a risk-based strategy from discovery to development for vaccines and biologics. Prior to that, as part of translational medicine/early development at Amgen-14 years, she supported preclinical and clinical development-related activities, including early developability efforts around candidate selection and lead optimization, de-risking critical quality attributes during process development and designing risk-based bioanalytical strategies for support of preclinical and clinical studies. Vibha has extensive experience with diverse modalities, including monoclonal antibodies, fusion, and recombinant proteins, multi-domain biologics including bispecific, BiTEs, and antibody-drug conjugates, and novel biologics like cell, gene, and nucleic acid-based therapies.
Dr. Jawa completed her Master’s degree and Ph.D. in Biochemistry and Immunology from the All India Institute of Medical Sciences with her thesis work evaluating the role of complement and macrophages in Rheumatoid arthritis. Postdoctoral training followed her graduation, where she worked on gene therapy for retinal degenerative diseases at the University of Pennsylvania Institute of Human Gene Therapy. Vibha is a recognized leader in Bioanalysis and Immunogenicity with 75+ peer-reviewed publications and serves as a Reviewer and Editor for The AAPS Journal and J. Pharm Sci. She was nominated as an AAPS Fellow in 2022 and serves as Chair for Women in the Pharmaceutical Sciences Community. She leads the Gene and Cell therapy bioanalytical and biomarker team within the GCTP community and has served as the past chair of the AAPS Personalized Medicine community. She leads the IQ-Consortium for Cell/Viral/Gene therapies and is an advisory board member for the Europe-based Advanced Therapies initiative. Vibha also serves as a President for STEAM Park, a NJ non-profit providing STEM opportunities to low-income communities. She also mentors high-school students and early career scientists on STEM-related projects in her free time.

Senior Immunology Sales Specialist, ProImmune

Dr. Emilee Knowlton gained her Ph.D. in Infectious Diseases and Microbiology from the University of Pittsburgh under the direction of Professor Charles Rinaldo, identifying immune responses to lytic infection with Human Herpes Virus-8 and the role of cytokines in the pathogenesis of Kaposi’s Sarcoma. She joined ProImmune in 2013 after completing her postdoc in Dr. Rinaldo’s lab. She works on the ProImmune team to provide innovative solutions for clients that radically improve our understanding of both desired and unwanted immune responses.

Senior Global Toxicologist, Sandoz Global Development Center, Ljubljana, Slovenia

Mr. Filip Kolenc joined Sandoz in 2023 as a Senior Global Toxicologist at the Sandoz Development Center in Ljubljana, Slovenia. Based within the Global Toxicology/Preclinical Research department, he is dedicated to ensuring the robust safety evaluation of complex generic products. His primary focus lies in assessing immunogenicity risk of peptide-related and oligonucleotide-related impurities and their safety qualification (general toxicity). Additionally, he contributes to the safety evaluation of the small molecule components in antibody-drug conjugates (ADCs). With eight years of experience in the generic pharmaceutical industry, Kolenc possesses a broad toxicological expertise, ranging from safety evaluation of humans to veterinary medicinal products, ensuring their timely regulatory approval. His interests extend beyond his core responsibilities to include Health Hazard Assessments (HHA), Environmental Risk Assessments (ERA), and the evaluation of mutagenicity of small molecule impurities. Previously, he also served as a study director for in vitro mutagenicity studies conducted under Good Laboratory Practice (GLP). He earned his Bachelor’s and his Master’s Degrees in Biochemistry at the University of Ljubljana, Slovenia.

Director, OPQA III, OPQ, CDER, FDA

Dr. Steven Kozlowski is the Director of the Office of Product Quality Assessment III (OPQA III), Office of Pharmaceutical Science, at the Center for Drugs Evaluation and Research, FDA. OPQA III is responsible for the quality of all the active ingredients and substances in the Center for Drug Evaluation and Research from, OTC acetaminophen to complex biological products.
He received his medical degree from Northwestern University and trained in pediatrics at the University of Illinois. Prior to joining the FDA, Dr. Kozlowski worked as a staff fellow in the Molecular Biology Section of the Laboratory of Immunology, NIAID, NIH. He studied the immune responses to proteins and peptides during his fellowship.
Dr. Kozlowski joined the Division of Monoclonal Antibodies in 1993 and was tenured as a Senior Investigator in 2000. He has been involved in all phases of the regulatory process as a reviewer, from pre-IND product development through inspections, licensing, and post-approval supplements. Dr. Kozlowski served as the acting Director of the Division of Monoclonal Antibodies from 2004 to 2005. He was the Director of the Office of Biotechnology Products from 2006 to 2024. Dr. Kozlowski’s research interests included the effects of drugs on the immune system. He has been very involved in promoting advances in the manufacture of biopharmaceutical products and enabling the development of biosimilar biological products.

Pharmaceutical Scientist, DPQR IV, OPQR, OPQ, CDER, FDA

Dr. Ha-Na Lee is currently working as a Pharmaceutical Scientist at the Office of Pharmaceutical Quality Research (OPQR), Office of Pharmaceutical Quality (OPQ), CDER/FDA. She obtained her Ph.D. in 2013 in the College of Pharmacy at Seoul National University in the Republic of Korea. In 2018, before joining the FDA, she completed her postdoctoral fellowship at NIAID/NIH. Dr. Lee is currently a researcher-reviewer in OPQR, and her role involves working in the lab to develop systems that assess the impact of innate immune response modulating impurities and providing immunogenicity consultations for therapeutic peptides and oligonucleotide drugs. Based on her research, Dr. Lee has published a total of 16 first-authored and 30 co-authored peer-reviewed papers.

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.

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

Dr. Markham C. Luke serves as FDA Supervisory Physician (Dermatology) and Director of the Division of Therapeutic Performance 1 (DTP I) in the Office of Research and Standards, Office of Generic Drugs at FDA. DTP I 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. He is an Associate Professor at the Uniformed Services University of the Health Sciences, Bethesda, MD with research interests in dermatopharmacology, clinical pharmacology, clinical study design and endpoints assessment (including patient-reported outcomes) for medical, surgical, and aesthetic products. 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.

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

Dr. Mohanraj Manangeeswaran received his Ph.D. from the University of Madras, India, and completed his joint post-doctoral fellowship with Boston Children’s Hospital (Harvard Medical School) and the FDA. Dr. Manangeeswaran is currently a Senior Research Scientist at the United States Food and Drug Administration and has more than 20 years of research experience in the areas of infectious disease and immunology and over 12 years of regulatory experience in dealing with product quality and immunogenicity assessments of therapeutic proteins and complex peptide drugs. He serves as a Subject Matter Expert in FDA working groups, facilitating the development of guidance documents and FDA policy related to immunogenicity risk assessment and potency of anti-viral therapeutics. Dr. Manangeeswaran has extensive experience developing and validating bioassays, which are needed to monitor and control processes and product-related impurities in peptide drug products. He has also received multiple awards from the FDA, recognizing his research and regulatory excellence. He is a peer reviewer for intramural and extramural grants, a scientific reviewer for reputed scientific journals, and has represented the FDA in multiple research and regulatory workshops.

Director, OGD, CDER, FDA

Dr. Iilun Murphy is the Director for Office of Generic Drugs since June 2023. Dr. Murphy began her FDA career in 2007, joining CDER’s Office of New Drugs, Division of Gastroenterology and Inborn Errors of Metabolism Products as a Medical Officer. In 2011, Dr. Murphy transitioned to the Center for Tobacco Products serving in various leadership roles within the Office of Science until she returned to CDER in 2020 as the Deputy Director for Clinical and Regulatory Affairs in the Office of Generic Drugs.
Dr. Murphy holds a Bachelor of Arts from Cornell University and a Doctor of Medicine from Stanford University, School of Medicine. She completed the Harvard University and Boston University Combined Residency Program in Pediatrics and is board certified in pediatric medicine. Dr. Murphy practiced pediatrics in both the private practice and inpatient hospital settings prior to joining the FDA. Dr. Murphy continues to be involved in clinical teaching as an Assistant Clinical Professor of Pediatrics at George Washington University School of Medicine.

Acting Team Lead, DTP I, ORS, OGD, CDER, FDA

Dr. Eric Pang specializes in the analyses of peptide and large-molecule drugs. He currently leads the Complex API and Formulation Team in the Division of Therapeutic Performance I, Office of Research Standards in the Office of Generic Drugs. Dr. Pang also serves as the subject matter expert in policy development and reviews various aspects of peptide products, including immunogenicity. He drafted and developed product-specific guidances on complex drug products, responded to questions through controlled correspondences and pre-ANDA meeting requests, and supported the Agency’s responses to citizen petitions. He manages several regulatory science projects regarding generic complex drug substances and products. Dr. Pang has over eleven years of experience in the Agency as a research chemist, CMC reviewer, and policy lead.

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 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).

Leader Biologist, DPQR IV, OPQR, OPQ, CDER, FDA

Dr. Montserrat Puig is a Staff Scientist at the Center for Drug Evaluation and Research (CDER), FDA. She earned her Ph.D. in Microbiology from the University of Barcelona, Spain, then moved to the U.S. for postdoctoral studies. At the Center for Biologics Evaluation and Research (FDA), Dr. Puig developed immunization strategies to combat hepatitis C virus infections. Later, at CDER, she worked on enhancing innate immunity to prevent Leishmania cutaneous infections. Her current position at the Office of Pharmaceutical Quality Research focuses on developing methods to assess the immunogenicity of therapeutic products and immune-mediated drug hypersensitivity reactions. Dr. Puig’s scientific background is critical to performing her daily review and research responsibilities, knowing that this will help bring new drugs and biologics to patients faster and make these products safer. Her interest in research at the FDA expands beyond lab work. She is a member of Agency and Center-wide Committees focused on addressing complex scientific and regulatory questions to aid the work of multidisciplinary teams and to guide the advancement of regulatory policy.

Lead Immunogenicity, Global Clinical Management, IPDO, Dr. Reddy’s Laboratories Limited

Mr. Narasimha Rao is currently working as Lead Immunogenicity in the Global Clinical Management group, IPDO at Dr. Reddy’s Laboratories Limited (DRL), Hyderabad, India. He is responsible for non-clinical immunogenicity assessment of generic complex peptide products at DRL and ensure that the evaluation meet regulators expectations. He has extensive experience in outsourcing preclinical studies to CROs both in and outside of India. Prior to joining DRL, Mr. Narasimha Rao was Research Officer in Virology R&D at Indian Immunologicals Ltd. (IIL), Hyderabad, India. He obtained Masters in Biotechnology from University of Madras, Chennai, Tamil Nadu, India. Overall Mr. Narasimha has an experience of 17+ years in the field of drug discovery, development, pre-clinical assessments, and drug repurposing programs. His research interest includes identifying orthogonal assays for immunogenicity risk assessment and usage of relevant digital tools.

Research Officer and Reviewer, DTPM, OCP, OTS, CDER, FDA

Dr. Hobart ‘Bart’ Rogers is a reviewer in the Division of Translational and Precision Medicine in the Office of Clinical Pharmacology (OCP) at the FDA. He serves as a pharmacogenomics reviewer for various non-oncologic therapeutic areas. He also serves as the lead for OCP’s review of all RNA-therapeutics. His research interests focus on the pharmacology of synthetic oligonucleotides, N=1 individualized drug development, and pharmacogenomics. Prior to joining the FDA, Bart received his Pharm.D. and Ph.D. from the University of Maryland, School of Pharmacy. His thesis work focused on the pharmacogenomics of beta-blockers in heart failure.

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

Dr. Anna Schwendeman is the Larry and Ann Hsu 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 Biologist, OCP, OTS, CDER, FDA

Dr. Sophie Shubow is a Senior Biologist in the Office of Clinical Pharmacology (OCP) in FDA’s Center for Drug Evaluation and Research (CDER). She leads the CDER-level Immunogenicity Review Committee, a forum for defining integrated multidisciplinary approaches to immunogenicity risk assessments. As such, she is actively involved in the development of guidance and policy for therapeutic biologics. Dr. Shubow holds a Ph.D. in Cell and Molecular Biology from the University of Bordeaux, France, and a degree in management from ESCP Business School in Paris, France.

Associate Vice President, Laboratory for Experimental Medicine, Eli Lilly and Company

Dr. Robert (Rob) Siegel is Associate Vice President of Laboratory for Experimental Medicine at Eli Lilly and Company. He received his B.S. in Life Sciences from Indiana State University and his Ph.D. in Microbiology with a minor in Biochemistry from Indiana University in Bloomington. Rob completed postdoctoral training at the Los Alamos National Laboratory where he began his antibody engineering career that includes extensive work with both phage and yeast in vitro display systems. Rob joined Eli Lilly and Company in 2007 and most recently has collaboratively devised and implemented the large molecule portfolio preclinical immunogenicity risk assessment strategy. His laboratory focuses on antibody discovery / engineering and proteomics while working across all phases of drug development from target identification to registration. He is the author of > 50 peer-reviewed publications and holds nine granted patents. His latest publications investigate the immunopeptidome of SARS-CoV-2 glycoprotein and AAV-mediate gene delivery vehicles and advances in our understanding of triglyceride metabolism.

Supervisory Chemist, DPQA IV, OPQA I, OPQ, CDER, FDA

Dr. Cameron Smith is a Supervisory Chemist in the Office of Product Quality Assessment I/Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration in Silver Spring, MD. He has expertise in the assessment of complex generic drug products such as peptides, iron colloids, long-acting release injectables, and other liquid and semi-solid dosage forms. Prior to his Agency tenure, he spent 15 years in the pharmaceutical industry as a medicinal chemist, primarily at Merck Research Laboratories in Rahway, NJ, and before that at OSI Pharmaceuticals in Durham, NC. Cameron completed his Ph.D. studies in chemistry at the University of Cambridge in Cambridge, UK. He followed this up with postdoctoral studies at the University of Utah in Salt Lake City, UT. He obtained his undergraduate degree at Monash University in Melbourne, Australia.

Director, Head of Immunology, Early Development Services, Lonza Biologics

Dr. Noel Smith joined Lonza in 2009 and was involved in the set-up of the human primary cell-based assay platform. He is the current Director and Head of the Immunology group developing assays to screen products for immunogenicity and immunotoxicity risk. The Immunology services are part of Lonza’s Early Development Services (EDS) group and have labs in Cambridge, UK, and Cambridge, MA. The EDS group focuses on supporting the development of new therapies with a particular focus on immunogenicity, immunotoxicity, manufacturability, and protein expression.

Biologist, Researcher/ Immunogenicity Reviewer, DPQR IV, OPQR, OPQ, CDER, FDA

Dr. Seth Thacker received his Ph.D. at the University of Michigan in Immunology. He completed a post-doctoral fellowship at the NIH and the FDA. Dr. Thacker currently works as a Research Scientist at the US Food and Drug Administration and has over 15 years of experience in innate immunity and autoimmunity. He also has five years of regulatory experience with product quality and immunogenicity assessments of therapeutic proteins and peptides. Dr. Thacker has extensive experience developing and validating bioassays to monitor and control process and product-related impurities. He has received multiple awards from the FDA, recognizing his research excellence.

Immunogenicity Sciences Lead, Pfizer

Dr. Sophie Tourdot received her Ph.D. in Immunology from the Université Paris Cité, France. She has over 20 years of experience in vaccine, immunotherapy and biologics research and development. She joined Pfizer in 2017 where she leads a group focused on immunogenicity risk assessment and mitigation of Pfizer’s biologics and is co-chair of the Immunogenicity Advisory Council. Sophie is the Director of Scientific Affairs of the European Immunogenicity Platform.

Chief Supervisory Biologist, Laboratory of Immunology, DPQR IV, OPQR, OPQ, CDER, FDA

Dr. Daniela Verthelyi leads the Laboratory of Innate Immunity in OPQR which is focused on developing tools to monitor and control innate immune and inflammatory responses, including potential impurities in therapeutic products that may foster unwanted immune responses and therapeutic proteins, reducing their life-saving potential. She has been a driving force in developing new strategies and tools for immunogenicity risk evaluation and mitigation for therapeutic proteins, peptides, and oligonucleotides. She has contributed to writing multiple immunogenicity-related FDA Guidance for Industry documents. She currently chairs the Center for Excellence in Infectious Diseases and Inflammation in OPQ, CDER, and FDA. She is on the advisory board of the FDA-NIH Immunology Interest Group and the NIH-FDA Cytokine Interest Group. She has authored over 100 scientific papers, holds multiple patents, and received the Excellence in Laboratory Sciences award from the FDA, CBER, and CDER, among other honors.

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

Dr. Kui Yang is a Senior Research Scientist in the Office of Pharmaceutical Quality Research within the Office of Pharmaceutical Quality at FDA. She specializes in mass spectrometry-based analytical method development. Her research in regulatory science centers on the characterization and impurity analysis of complex drug products to provide scientific inputs on drug quality questions. She leads an oligonucleotide research team and cross-office working group and serves as a subject matter expert in oligonucleotide product specific guidance development at FDA. Prior to joining FDA in 2016, Dr. Yang held the position of Instructor in Medicine at Washington University School of Medicine, where she accumulated over ten years of experience in mass spectrometry-based lipidomics and biomarker research related to diabetes, heart disease and Alzheimer’s disease. She received a Ph.D. degree in Chemical Engineering from Tianjin University in China and has published over 70 peer-reviewed papers.

Senior Chemist, DTP I, ORS, OGD, CDER, FDA

Dr. Deyi Zhang is a senior chemist in the Office of Research and Standards (ORS), Office of Generic Drugs (OGD) at FDA specializing in complex active ingredients, including peptides, oligonucleotides and complex mixtures. He provides scientific inputs for regulatory policy and actively involves in pre-ANDA meetings, product-specific guidance development of such products, and manages related research activities. Dr. Zhang received his Ph.D. in organic chemistry from the University of Notre Dame. He had a two-year NIH postdoctoral fellowship training at the University of Pennsylvania before joining Eli Lilly in 2000. After 15 years in the pharmaceutical industry, he joined FDA. He has over 50 publications and presentations.