J. Javier Aguilera earned his Ph.D. in Chemistry from Rensselaer Polytechnic Institute, where he investigated the distinct effects of glycosaminoglycans on protein folding and aggregation of Serum Amyloid A isotypes. He conducted postdoctoral research in virology at Fred Hutchinson Cancer Research Center, where he studied gp120 variants and engineered pseudoviruses to better understand interactions with CD4 receptors and neutralizing antibodies. At PPD, he gained expertise in GxP principles, later advancing his bioanalytical skills at BioAgilytix in Cambridge, MA. Today, Javier applies his broad experience to clinical research and development at Moderna, supporting ADA, APA, PK- PD and biomarker programs for mRNA-based therapies within the Bioanalytical and Molecular Assays team.

Dr. Kavitha Akula is currently a Principal Scientist at Bristol-Myers Squibb (BMS) in the Non-clinical Disposition and Bioanalysis Group. Kavitha joined BMS in 2019 as Research Investigator-II with about five years of experience in regulated bioanalysis from different contract research organizations (CRO). She received her PhD from Temple University, Philadelphia in Organic Chemistry in 2017. Kavitha has extensive experience in regulate bioanalysis of large molecule drugs and new treatment modalities in support of PK and Immunogenicity. She recently took co-lead position in the Early Career Bioanalytical Scientists (ECBS) sub-team in AAPS.

Jan Amstrup is a Principal Scientist in the department of Bioanalysis, CMC Development at Novo Nordisk. His main responsibilities are on the development of potency and ELISA assays for early-stage projects (Phase I-II). In the department, Jan has been supervising several interns, as well as master students and is involved in both transfer of assays from Research to CMC and from CMC to QC labs prior to launch. Jan has more than 20 years of experience in the pharmaceutical industry and 6 years in academia. Jan has served as a member of a USP expert committee, and as a member of several expert panels. Jan holds a PhD in Molecular Biology from University of Copenhagen and a M.Sc. in Biochemistry from University of Copenhagen.

Nina Blazeska is a Senior Project Manager with over eight years of experience leading cross-functional teams in science research, technology, and financial sectors. At present, Nina leads a portfolio of immunology-based projects at the La Jolla Institute for Immunology with Principal Investigators, Dr. Alessandro Sette and Dr. Bjoern Peters, including the Immune Epitope Database (IEDB - iedb.org) and the Cancer Epitope Database and Analysis Resource (CEDAR - cedar.iedb.org). These databases and bioinformatic tools are used to further our understanding of cancer, autoimmune conditions, infectious diseases, allergies, and transplants. With an MBA in Business Analytics and a strong commitment to continuous improvement, Nina aims to make science accessible to all people by bridging expert and non-expert audiences and fostering community collaborations.

Priya has a PhD in Biochemistry and currently VP and Head of Clinical Bioanalytics & Translational Sciences at Beam Therapeutics. She manages a function within clinical that works across R&D and holds responsibility for bioanalytical, biomarker and forward & reverse translational strategies followed by implementation for a broad pipeline of clinical programs in hematology, immunology, oncology, and rare genetic diseases that leverage base editing technologies, auto, allo cell therapies and novel delivery modalities like LNP. Prior to Beam, she had worked for 20+ years on Translational Medicine, Bioanalytics, Biomarkers & Diagnostics at Wyeth, Pfizer, Takeda and Biogen.

Rakesh Dixit is an accomplished executive, inventor, and scientist with over 35 years of success with top biotechnology and pharmaceutical companies, including Merck, Johnson & Johnson, and Medimmune - AstraZeneca. Currently, he is President and CSO of Regio Biosciences and Bionavigen, LLC. He is a Board Member of Regio Biosciences and a key member of multiple scientific advisory boards. Rakesh is also a chief adviser and consultant for more than 20 companies worldwide. His biopharmaceutical peers selected Rakesh as one of the 100 Most Inspiring People in the Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh received the Most Prestigious Award of Long-Standing Contribution to ADCs by World ADC (Hanson-Wade), 2020. From 2006 to 2019, Rakesh was a Global Vice President of the Biologics R&D at Medimmune - AstraZeneca. Rakesh has unique expertise in developing biologics (e.g., monoclonal antibodies, bispecific biologics, antibody-drug conjugates, fusion proteins, peptides, gene and cell therapies, etc.) and small-molecule biopharmaceuticals. His areas of expertise include discovery, early and late preclinical development, safety assessment, DMPK, and translational sciences. Dr. Dixit conducted extensive graduate and post-graduate training in Pharmacology/Toxicology–Biochemistry with both Indian and USA institutions (e.g., Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is a Diplomate and Board Certified in Toxicology from the American Board of Toxicology, Inc. since 1992.

Felix Feng is a Senior Scientist in the department of Process and Analytical Science, Bioassay Biosafety and Impurities at AstraZeneca. His main responsibilities are the development of cell-based potency and plate-based protein binding potency assays for early-stage projects. In the department, Felix has been supervising a summer intern and is involved in the transfer of methods from CMC to clinical quality control groups. Felix has 9 years of experience in the pharmaceutical industry and holds a M.Sc. in Biotechnology from Johns Hopkins University.

Daron has been at Bristol-Myers Squibb for 16 years focusing on both in silico and in vitro pre-clinical immunogenicity risk assessment and mitigation. He received his PhD training at the University of Massachusetts in Worcester and conducted his post-doctoral studies at Massachusetts General Hospital. Prior to BMS, he worked on understanding mechanism of action of several immune-modulating biologics including anti-CD3 and anti-GITR mAbs.

Dr Christine Grimaldi is an Immunologist with a PhD from SUNY at Stony Brook, Stony Brook, NY. Christine joined Boehringer Ingelheim (BI), Ridgefield CT in 2008 as an immunotoxicologist and immunopharmacologist in the Nonclinical Drug Safety Department. From 2015-2022 she was Director/Distinguished Research Fellow of the Biotherapeutic Bioanalysis Group, in the Drug Metabolism and Pharmacokinetic Department, where she was responsible for nonclinical/clinical PK and ADA assay development, pharmacokinetic/toxicokinetic assessments and immunogenicity risk assessments. In 2022, Dr Grimaldi joined Regeneron, Tarrytown, NY as Director of the Assay Development Group where she is responsible for the development and validation of PK, ADA and biomarker assays for large molecules and novel modalities. Prior to joining the pharmaceutical industry, she held faculty positions at Columbia University and The Feinstein Institute for Medical Research where she studied B cells, autoantibodies and immune tolerance. Dr Grimaldi's expertise includes immunoassays, biotherapeutics drug discovery and development and immunogenicity.

Joanna Grudzinska-Goebel is an Immunogenicity Expert at Bayer AG, where she guides project teams in conducting Immunogenicity Risk Assessments for biotherapeutics incl. peptides and new modalities, and communicating their outcomes to health authorities. Beyond her role at Bayer, Dr. Grudzinska-Goebel currently leads the Immunogenicity Risk Assessment Working Group of the European Immunogenicity Platform (EIP) facilitating cross-industry alignment and collaboration on this topic. She also actively contributes to immunogenicity focused working groups at the IQ Consortium and the AAPS.

Robert G. Hamilton, Ph.D., D.ABMLI is a professor of medicine and pathology and Director of the Dermatology, Allergy, and Clinical Immunology Reference Laboratory at the Johns Hopkins University School of Medicine. He teaches, performs research, and directs a federally licensed clinical immunology laboratory that specializes in the diagnosis of Type-1 hypersensitivity reactions in humans. Over the past 38 years at Johns Hopkins, he has published over 250 peer-reviewed original papers and review articles and 36 chapters in textbooks on the topic of the diagnosis and management of human allergic disease. For the past 15 years, he has served as coordinator for the College of American Pathologist’s Diagnostic Allergy Inter-laboratory Proficiency Survey which monitors ~150 North American laboratories performing diagnostic allergy testing.

Lora Hamuro is the Senior Director of Clinical Pharmacology & Pharmacometrics at Bristol Myers Squibb, with a robust background in clinical oncology drug development. She holds a B.Sc. in Chemistry from Shippensburg University, a Ph.D. in Biochemistry and Molecular Biology from Penn State University College of Medicine, and an M.S. in Pharmacometrics from the University of Maryland. Her career spans roles at Provid Pharmaceuticals and Merck, and she has extensive experience at BMS, contributing to over 15 INDs and leading strategies for multiple regulatory submissions for oncology agents like Opdivo®, Yervoy®, and Augtyro™. Lora has designed numerous clinical pharmacology studies, published 47 peer-reviewed articles, and actively participates in professional societies. She is a member of ASCPT, ISoP, and SITC, and hosted the ISoP Sheiner lecture series podcast "Table Talk". Her interests focus on quantitative methods to understand immunogenicity impact, to enhance drug development and to optimize oncology dosing strategies.

Dr. Han is currently working on developing immunoassays for potency tests of cancer therapeutic-human monoclonal antibodies in early and late phases of the pipeline. He is uniquely qualified with an advanced degree in Biosystems/Biomedical Engineering and Biosensors, has 12 years of experience in research and semi-GLP laboratories for developing immunoassays including: binding ELISAs, lab-on-chips using micro-/nano-fabrication processes for quantifying biologics, DNA-based human proteomic diseases, pathogens, and environmental small toxins.

Tim has 15 years’ experience contributing to immunogenicity risk and mitigation strategies for large molecules and advanced therapies at Roche and Pfizer, from early discovery projects to those in clinical development and post-marketing. During the last ten years he has contributed immunology expertise to the development of an in silico immunogenicity model, with the purpose of improving predictions of clinical immunogenicity for drug candidates. Tim previously worked on vaccine development and holds a PhD in Immunology from the University of Oxford.

Zicheng Hu is a Principal Scientist in the Department of BioAnalytical Sciences (BAS) at Genentech. He studied T cell immunology and received his PhD from the University of Texas at Austin. He received postdoctoral training at the University of California San Francisco and conducted research in computational immunology. Zicheng joined Genentech in 2022. He leads data mining efforts to understand the anti-drug antibody responses and develops predictive models to evaluate the immunogenicity risk of protein-based therapeutics.

Yuri Iozzo, PhD eqv (AKA Egor Svidritskiy) is a structural biologist and machine learning expert whose early research, while at UMass Medical School, on translation termination uncovered foundational insights into ribosome dynamics. He has been at the forefront of advancing cryo-electron microscopy techniques, including the development of Ensemble cryo-EM. He led the charge in applying cryo-EM innovations to biologics drug discovery at Sanofi. As Head of the Digital Biology group at ModeX Therapeutics, Yuri drives the integration of machine learning to de-risk and accelerate therapeutic R&D, combining structural biology and AI to enable next-generation discovery pipelines

Andrew earned his PhD in molecular biology from the University at Albany under the direction of Professor Robert Osuna, identifying and characterizing post translational modifications of the transcription factor DksA in E. coli. He joined ProImmune in 2019 after completing his doctorate and currently works on providing innovative solutions for clients that deeply improve our understanding of both desired and unwanted immune responses.

Vibha brings more than 20+ years of experience in supporting biologics, vaccine development, and gene therapy with contributions to multiple IND, BLA, and MAA filings. She is a recognized leader in the area of Bioanalysis and Immunogenicity with more than 50 peer-reviewed publications. In her current role as an Executive Director for Biotherapeutics Bioanalysis at Bristol Myers Squibb, Vibha is responsible for leading biotherapeutic and cell therapy bioanalytical (BA) functions.

Lynn Kamen is a Scientific Officer at BioAgilytix. She earned her PhD in Immunology at the University of Michigan and completed a postdoctoral fellowship in immunology at the University of California, San Francisco. Lynn has over a decade of experience working in drug development, from early target discovery through clinical development for both large and small molecules at several companies including Portola Pharmaceuticals, and Alector. More recently, Lynn was a principal scientist at Genentech where she supported the in vitro biological characterization of large molecules and lead the development of immunogenicity assays including ADA, NAb and immunogenicity risk ranking assays. She is co-lead of the AAPS NAber working group and member of the AAPS NAb drug tolerance sub-team.

Dr. Zeynep Kosaloglu-Yalçin is an Instructor and computational cancer immunologist at the La Jolla Institute for Immunology. She develops advanced machine learning methods and bioinformatics tools to predict T cell recognition of epitopes and support the development of personalized immunotherapies. As the tools lead for the Cancer Epitope Database and Analysis Resource (CEDAR), she designs user-friendly, accessible resources that empower researchers across disciplines to explore cancer immunity at scale. Her work bridges computational immunology and clinical oncology by integrating large-scale patient data with a focus on translational applications. Dr. Kosaloglu-Yalçin works closely with clinicians, immunologists, and data scientists to perform multidisciplinary, integrated analyses with the goal of advancing precision cancer immunology.

PhD. Head of Bioassay Department at Biocad, Russian Leading Innovative Biotechnology Company. The department is responsible for selection the bioassay strategies and development, validation and transfer bioassays including potency assays in support of drug development pipeline.

Kunal Kundu, PhD is a Principal Scientist specializing in Bioinformatics at Regeneron Pharmaceuticals, New York. With over ten years of experience spanning both industry and academia, Dr. Kundu has made impactful contributions to genomics, protein design, and machine learning. He earned his Ph.D. in Bioinformatics from the University of Maryland, College Park. Dr. Kundu has authored more than 25 peer-reviewed publications, showcasing his work on collaborative and independent projects. His areas of expertise include next-generation sequencing (NGS) data analysis for clinical diagnosis of rare and complex trait diseases, cancer genomics, immunopeptidomics, protein design, deep learning applications in genetic data, and the development and visualization of biological knowledge graphs. Throughout his career, Dr. Kundu has held positions, including Bioinformatics Engineer at TCS Research & Innovation in India, Visiting Scholar at UC Berkeley, and Graduate Research Assistant at the Institute for Bioscience and Biotechnology Research. Beyond his professional achievements, he is also a passionate drummer.

Daniel Leventhal, Ph.D. has over 6 years of experience working at the intersection of immunology and machine learning to predict and mitigate unwanted immunogenicity. Daniel has led teams at Xaira Therapeutics and Generate Biomedicines developing machine learning models and experimental systems to understand and control key immunological processes underpinning the immunogenicity of biotherapeutics. Prior to entering the immunogenicity field, he worked in immune oncology, advancing T-cell receptor therapies and immune-engineered bacteria for cancer treatment. Daniel holds a Ph.D. in Cancer Biology and an M.S. in Translational Sciences from the University of Chicago, where he studied tumor-associated regulatory T-cell development and antigen specificity.

Chuying has been at Merck for about three years, focusing on the development of regulated bioanalytical assays for both biologic therapeutics and vaccines in support of preclinical and clinical studies. Since joining Merck, she has quickly built her expertise in multiple bioassays, including the most complicated opsonophagocytic bacterial killing assay for the pneumococcal vaccine, as well as critical reagents, and is passionate about leveraging cutting-edge AI/ML tools in the bioanalytical field, also for both biologics and vaccines. She received her PhD degree in Bioengineering from Pennsylvania State University and previously studied the interaction of biomaterials with stem cells and immune cells.

Dr. Ronit Mazor is a Principal Investigator and Lab Chief in the Gene Transfer Immunogenicity Branch at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), where she leads a multi-disciplinary research team focused on evaluating and mitigating immunogenicity of gene therapy products. She serves as a primary CMC reviewer and BLA chair for first-in-class gene therapy products. Dr. Mazor's scientific contributions include high-impact publications, patents, and several FDA awards including the prestigious CBER Center Director Awards. Her research encompasses T cell immunology, algorithm-based HLA binding predictions, investigation of sex-based immunological differences in gene therapy outcomes, and development of tolerogenic approaches to enhance therapeutic efficacy. Prior to joining FDA, she conducted research at the National Cancer Institute developing immune tolerance strategies for cancer immunotoxins and served as a Research Lead at AstraZeneca focusing on immunogenicity prediction for therapeutic proteins. Dr. Mazor holds a Ph.D. in Molecular Immunology from Tel Aviv University through the NIH Graduate Partnership Program and completed her postdoctoral training at the National Cancer Institute.

Dr. McNally has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry. Prior to joining Sword Bio, Dr. McNally was Chief Scientific Officer for BioAgilytix for 5 years leading scientific innovation and strategy. He has also previously held roles at Genzyme, Pfizer, EMD Serono, Shire and CRISPR Therapeutics which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics. Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance. Dr. McNally obtained his B.S. in Biology from Mississippi State University, his Ph.D. Viral Immunology from Louisiana State University School of Medicine in Shreveport, and his Post-Doc in Viral Immunology from University of Massachusetts Medical School.

Dr. Stephen Miller is the Judy E. Gugenheim Research Professor of Microbiology-Immunology at Northwestern University Feinberg School of Medicine in Chicago. He received his Ph.D. in 1975 from the Pennsylvania State University and did postdoctoral training at the University of Colorado Health Sciences Center before joining the faculty at Northwestern in 1981 where he currently serves as Director of the Northwestern University Interdepartmental Immunobiology Center. Dr. Miller is internationally recognized for his research on pathogenesis and regulation of autoimmune diseases. He has published over 410 journal articles, reviews and book chapters and has trained multiple generations of scientists. His work has significantly enhanced understanding of immune inflammatory processes underlying chronic autoimmune disease employing animal models of multiple sclerosis (MS), Type 1 diabetes (T1D) and celiac disease (CD). His work has focused on the study of the cellular and molecular mechanisms underlying treatment of established T cell-mediated autoimmune diseases using antigen-specific immune tolerance. His current work is geared to translating the use of antigen-encapsulating biodegradable PLG nanoparticles for the treatment of human immune-mediated diseases including autoimmunity, allergy, anti-drug antibody responses and tissue/organ transplantation. Dr. Miller is also co-founder of Cour Pharmaceutical Development Company which is partnering with Takeda Pharmaceuticals in testing tolerance therapy of CD using gliadin-encapsulating tolerogenic immune-modifying nanoparticles (TIMPs).

Over 20 years of experience working in biotech, coordinating efforts focused on the discovery and development of novel biologic-based therapies. I began my biotechnology career at Human Genome Sciences, where directed genomic-based target discovery programs and the preclinical development of various protein and mAb-based therapeutics for the treatment of cancer, metabolic, and autoimmune diseases. Notably, these efforts led to the discovery of BLyS as a B-cell survival factor providing the basis for the development of Benlysta for the treatment for lupus. At MacroGenics, leads a research group dedicated to the discovery, preclinical development, and clinical translational biology of antibody-based therapeutics including Fc-optimized mAbs and bispecifics for cancer or autoimmune disease through harnessing of the host immune system. Obtained PhD from University of Glasgow and performed post-doctoral work at the Roche Institute of Molecular Biology; co-authored over 70 peer-reviewed manuscripts and 40 issued US patents.

Ashley (Arthur) Moore is a cell biologist with expertise in assay development and biologics research. Currently, Ashley works in Discovery Biology as Scientist II at Alexion, where she is pivotal in derisking new biologics and advancing therapeutics through key development stages. She is also working to develop new therapeutic candidates using targeted immune checkpoints. Before working for Alexion, Ashley worked at Abcam developing and validating antibodies against difficult targets. Ashley obtained her Ph.D. at the University of Minnesota, Genetics, Cell Biology and Development working in cell migration and did a postdoctoral fellowship at Yale University studying neuronal polarity.

Kamalika Mukherjee is a Principal Scientist in the Bioanalytical Strategy Group at Regeneron Pharmaceuticals Inc. where she serves as the Principal Investigator supporting the bioanalysis of PK, ADA, and biomarker samples for clinical studies in oncology. Kamalika received her PhD in Pharmaceutical Sciences from University of Kentucky, Lexington followed by post-doctoral fellowships focusing on Pharmacology in varied therapeutic areas. Before joining Regeneron, Kamalika worked as a Scientist in Pharmaceutical Sciences at St. Jude Children’s Research Hospital.

Dr Kannan Natarajan obtained his Ph.D. in Immunology from India and trained as a postdoctoral fellow at the Biozentrum, University of Basel, Switzerland, and at the University of Rochester, New York. Following a 2-year stint on the faculty of the Forsyth Research Institute in Boston, he joined the Laboratory of Immunology at the NIAID/NIH. Kannan’s research interests are the structural basis of ligand recognition by receptors of the immune system, especially receptors found on T cells and natural killer cells, and the molecular aspects of antigen presentation.

Uche works as a Senior Scientist in the Bioassay, Biosafety, and Impurities (BB&I) team within Biopharmaceutical Development at AstraZeneca leading various assay development teams and developing Bioassay and Impurities methods to support various types of biologics (including mAbs , bispecifics, peptides, ADCs, Tcell engagers). She is part of Chemistry Manufacturing and Control (CMC) teams for various biologic projects, contributing towards the analytical activities of the projects as well as regulatory submissions. Prior to joining AZ, Uche did her PhD investigating small molecules, synthetic and natural compounds targeting inflammatory signalling pathways in microglial and neuronal cells. She also worked at LGC developing assay for Pharmacokinetics and Neutralization assays for biologics.

Sofie Pattyn, CTO and founder of ImmunXperts, has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development with a focus on functional assays for immunogenicity, immune oncology, and cell and gene therapy products. She has extensive hands-on lab experience and has managed and coached several in vitro teams over the last decade. From 2008 until 2013, she was Head of the in vitro Immunogenicity group at AlgoNomics (Ghent, Belgium) and Lonza Applied Protein Services (Cambridge, UK). Prior to that, she worked at Innogenetics in Belgium for over 15 years.

Kelly Pham leads the development of neutralizing antibodies assays to support late phase trials at Merck. She possesses a rare fusion of deep scientific expertise, regulatory insight, and commercial strategy which allow her to contribute to the full cycle of bringing innovative therapeutics to patients - not just in theory but in practice. She has a successful track record of leading research projects, managing tech transfer, cross-functional cross-national collaborations and teaching. Kelly earned a PhD degree in Pharmaceutical Sciences at Duquesne University (Pittsburgh, PA) and completed an ORISE Fellowship at the FDA CDER/OCP.

Dr. Montserrat Puig earned her PhD in Microbiology from the University of Barcelona and subsequently moved to the U.S. for postdoctoral studies at the Food and Drug Administration. There, she developed immunization strategies to combat HCV infections and to enhance innate immunity against Leishmania. Later, as a Lead Biologist, she focused on assessing the immunogenicity of therapeutic products and immune-mediated drug hypersensitivity reactions. Dr. Puig also took on review responsibilities to help bring new drugs and biologics to patients faster and more safely. She has served on various Agency and Center-wide committees addressing complex scientific and regulatory issues to support multidisciplinary teams in advancing regulatory policy. Recently, Dr. Puig has joined Merck as a Senior Principal Scientist.

Mohsen Rajabi is the Scientific Director in the Translational Medicine, Pharmacokinetic Sciences Group at Novartis. Before joining Novartis, Mohsen worked at the FDA where he provided scientific expertise on clinical pharmacology and immunogenicity issues related to biosimilar and therapeutic biologics. He led collaborative initiatives to develop and establish clinical pharmacology and immunogenicity guidance and policies. Mohsen also conducted inspection of bioanalytical and clinical studies in support of regulatory submissions. Mohsen received his Ph.D. in Peptide Chemistry from the Department of Chemistry and Biochemistry, University of Maryland. He researched the role of defensins in innate and adaptive immune responses to microbial infection. This work was the basis of several publication about the multifaceted biological activity of defensins.

Krupa Ramani is a Manager in the department of Bioanalytical Discovery and Development Sciences at Johnson and Johnson (J&J). Krupa has been in the field of immunogenicity for over 20 years. She joined J&J in 2015 as an Associate Scientist and assumed progressively greater responsibilities supporting biologics therapeutics from preclinical through post-market studies. She oversees the immunogenicity validation and laboratory bioanalysis teams, managing a group of five scientists. Prior to joining J&J, Krupa worked at Strategic Diagnostics, Inc (SDIX). She earned a B.S. degree from M.G Science Institute and Medical Tech degree from The Gujarat Cancer & Research Institute in India.

Sue Richards has a record of sustained contributions to the biopharmaceutical sciences with over 30 years’ experience in the biotechnology/biopharmaceutical industry. Dr. Richards currently is Principal and immunogenicity consultant at Biopharma Immunogenicity Consulting LLC. Previously she was a member of Translational Medicine and Early Development in Sanofi R&D where she contributed as global scientific expert in immunogenicity. She also was the Head of the Clinical Laboratory Sciences Department in Sanofi/Genzyme Biologics R&D, responsible for Clinical Assay Development, Clinical Specialty Lab and Investigative Clinical Immunology. The department supported assay development and bioanalysis of PK, biomarkers and immunogenicity of biologics in clinical development and post approval for replacement enzymes, monoclonal antibodies, fusion proteins and gene therapy programs. Dr. Richards has contributed to the approval of 15 biologic drugs. Her research interests included immune tolerance induction (ITI) for replacement enzymes, and her lab pioneered nonclinical studies for prophylactic use of short-term methotrexate for ITI. She is an active member and Fellow of the American Association of Pharmaceutical Scientists.

Amy Rosenberg is a physician-immunologist who, for 33 years regulated biologics including cellular and protein therapeutics and cell-device combination products at FDA. She had oversight over the approval of numerous protein therapeutic products. She recently moved to EpiVax, Inc as Senior Director of Immunology and Protein Therapeutics. During her time at FDA, she served as FDA consultant to the NIAID Immune Tolerance Network Steering Committee and was FDA representative to the ABIRISK Consortium. She is the principal author of “Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products,” published in 2014.

Nancy Sajjadi, M.Sc. is Founder and Principal Consultant of Sajjadi Consulting. She has over 30 years of experience in biopharmaceutical product development. She began her career as a bench scientist doing malaria vaccine research then joined a start-up company developing cell and gene-using therapies for infectious disease, cancer, and cell therapy applications. Her responsibilities included research, assay development, and quality control. In 2000, she left her position as Director of QC at Chiron Technologies Center for Gene Therapy to start her own consulting business. For over 20 years, Ms. Sajjadi has provided services to biopharmaceutical companies, contract laboratories, non-profit organizations, universities, and US government agencies. She has assisted clients in the development, implementation, and improvement of quality programs for a range of cutting-edge products and provides technical expertise in assay development, qualification, and validation. Ms. Sajjadi has authored several articles pertaining to bioassays and viral gene therapy and has served on 5 advisory panels for the United States Pharmacopeia (USP). She enjoys teaching introductory courses in bioassay design, development, and validation for non-statisticians. Her company has recently expanded services to include leadership development and executive coaching to guide organizations toward sustaining a culture of quality.

Laura is a former US FDA professional with over 20 years of merged experience in research, translational medicine and regulatory affairs. During her years at the FDA, Laura specialized in the regulatory aspects of the Chemistry, Manufacturing and Controls (CMC) section of biotherapeutics, while acting as immunogenicity lead, and participated in numerous FDA official meetings including an Advisory Meeting. She was the primary CMC reviewer and immunogenicity reviewer/lead of multiple INDs, (A)NDAs, BLAs, and post-approval supplements. Laura consolidated her regulatory career holding several regulatory affairs (RA) and translational medicine leadership positions at well-established pharmaceutical companies headquartered both in the US and Europe. Laura has vast experience defining the regulatory quality and immunogenicity strategies of biopharmaceuticals, e.g., fusion proteins, monoclonal antibodies and biosimilars, from early development all the way to commercialization. Her combined experience as quality RA professional, translational medicine lead and human immunology, have steered her to apply her RA strategic skills into cell & gene therapies (CAR-Ts, AAV-vector based gene therapies) for various pre-clinical and clinical stage companies both in Europe and across the Atlantic. She is now one of the co-founders of the Immununogenicity Integrated platform and member of the NDA Group Advisory Board Expert.Laura holds a Ph.D. in Biochemistry and Molecular Biology by Universidad Autónoma de Madrid (Spain), and conducted her postdoctoral training in human immunology as visiting fellow in the US National Institute of Allergy and Infectious Diseases (NIAID) and National Heart, Lung and Blood Institute (NHLBI) (Bethesda, USA). She held an assistant professorship position at George Washing University (GWU, US) prior serving for the FDA. Laura has co-authored multiple regulatory and scientific peer-reviewed publications, including two FDA Guidance for Industry, and has been the invited speaker at several regulatory conferences.

Dr. Laura Santambrogio received her PhD from Padua University and trained as a post-doctoral fellow at NYU and Harvard Medical School with Jack Strominger. She was recruited at Albert Einstein College of Medicine with an Irene Diamond Professorship in Immunology and recently moved to Weill Cornell where she held the position of Associate Director of Precision Immunology in the Englander Institute of Precision Medicine, Professor of Radiation Oncology, Physiology and Biophysics. Current efforts in her laboratory are focused on the mechanisms of antigen processing and presentation, peptide binding to MHC class II molecules and the overall role of dendritic cells in innate and adaptive immune responses. She is tackling these questions using an integrated approach that combines cell biology, biochemistry and biophysics. Important questions addressed by her laboratory relate to the different cellular pathways utilized for antigen processing and presentation which include autophagy, endosomal processing and surface MHC II loading. Additionally, she is interested in understanding how changes in the cellular transcriptome and metabolome translate in the plasticity of the MHC II immunopeptidome.

Sumona Sarkar is a Biomedical Engineer at the National Institute of Standards and Technology in Gaithersburg MD. She has been at NIST for 8 years with a focus on cell material interactions for tissue engineering and regenerative medicine, and analytical methods for cell and gene therapy. She serves as a subject matter expert and project leader in ISO TC 276: Biotechnology with particular expertise in cell count, viability, and characterization. Prior to joining NIST Sumona received her Ph.D in biomedical engineering from Drexel University, and her M.S. from Boston University.

I have devoted more than 30 years to understanding basic mechanisms of antigen recognition and immune responses, measuring and predicting immune activity, and developing disease intervention strategies against cancer, infectious diseases, autoimmune diseases and allergies. My early work, in the mid-80s to mid-90s, related to the demonstration that the main biological function of MHC is to bind epitopes. From those studies we further developed the notion that different MHCs have distinct binding specificities that can be used to predict epitopes. Since then, our group has defined motifs for over one hundred different class I and class II MHC variants expressed in from humans, and several other species. Throughout the last fifteen years I have been the PI of the Immune Epitope Database and Analysis Resource, freely available to the scientific community, which host immune reactivity data, and a series of bioinformatics algorithms to assist in the prediction and evaluation of immune responses. Our group also discovered and characterized how MHC variants can be grouped according to broad functional specificities (MHC supertypes), greatly facilitating epitope classification, characterization and understanding the basic rules of epitope-MHC interactions. Over the last 32 years, I have been continuously involved in hundreds of epitope identification studies, in cancer, autoimmunity, allergy, and infectious disease. By probing the IEDB, it can be established that I have been involved in identifying over 6,500 different epitopes.

Anurag Sharma joined CBER/FDA in 2018, and currently oversees review of the CMC aspects of diverse gene therapy products as Branch Chief at Office of Therapeutic Products. Earlier, Anurag earned his bachelor’s degree in veterinary sciences and master’s in animal biotechnology from India before moving to the United States to pursue PhD in Molecular Virology from Purdue University at West Lafayette, IN. His doctoral research primarily focused on the development and characterization of novel adenoviral vectors for gene delivery applications. After his PhD, Anurag worked at Weill Cornell Medicine (WCM) at New York City as a postdoctoral associate and subsequently as an Assistant Professor of Research. At WCM, he continued his research to design innovative strategies to further improve adenoviral vectors and to develop vaccines against some of the pediatric respiratory infections with no approved vaccines. He also holds Regulatory Affairs Certification (RAC US) offered by Regulatory Affairs Professional Society (RAPS).

Dr. Shih received her Ph.D. from Duke University and Postdoctoral training at the NIH. Her PhD dissertation studied the role of three-dimensional chromatin looping and the key looping factor, CTCF, in gene regulation during thymocyte development. As a postdoctoral fellow, she investigated lymphocyte regulomes by integrating cutting-edge techniques and computational approaches. She found that the regulomes in innate lymphoid cells were generated early in their development and in this manner differed from adaptive lymphocytes. Dr. Shih is currently a Stadtman Investigator jointly appointed with the National Eye Institute and National Institute of Neurological Disorders and Stroke at NIH. Her research focuses on understanding the regulation of cytokine loci and immune regulomes in health and neurodegenerative diseases in the eye and brain, with an ultimate goal of developing more specific and efficacious therapies.

Accomplished scientist and mentor with nearly 2 decades of industrial experience developing protein therapeutics who leads a multi-disciplinary laboratory composed of diverse talents and educational backgrounds. Extensive experience in antibody discovery/engineering and proteomics who has worked across all phases of drug development from target identification to registration. Rob received his Ph.D. in Microbiology and Biochemistry from Indiana University Bloomington and postdoctoral training at Los Alamos National Laboratory where he began his antibody engineering career that includes extensive work with both phage and yeast in vitro display systems. He has been with Eli Lilly and Company since 2007 and most recently has collaboratively devised and implemented the large molecule portfolio preclinical immunogenicity risk assessment strategy.

Noel completed his PhD and subsequent post-doctoral studies at the University of Cambridge in the field of metabolic disease. Noel joined Lonza in 2009 and was involved in the setup of the human primary cell-based assay platform and is now Head of Immunology overseeing teams in Cambridge, UK and Cambridge, Massachusetts. The Immunology group is responsible for the human in vitro platforms that support the pre-clinical developability/immunosafety assessment of a wide range of products during drug development. Working across multiple business units to support immunology programs for therapeutic proteins/peptides, mRNA therapies, vaccines and cell & gene therapies. Contribution to several working groups in the field of immunosafety and support for regulatory filings, including the design and execution of studies to support IND and ANDA filings.

Greg received his Ph.D. in Statistics from Virginia Tech and has over 25-years experience as a nonclinical statistician all across the drug development timeline: From early molecular discovery to compound development to regulatory submission to manufacturing. Greg champions the use of experimental design and innovative modeling for data-driven decision making, plays a role in his team's internal education initiatives, and greets every project and interaction with enthusiasm and vigor.

Ralf Stegmann is an expert in biological assay analysis and software development. With a background in Computational Chemistry from the University of Marburg, he combines a strong scientific foundation with more than two decades of experience in assay analysis. As the founder of Stegmann Systems, Ralf has been instrumental in developing PLA 3.0, a modular software platform widely used for the management and analysis of biological assays. Today, PLA 3.0 supports more than 1,000 organizations and regulatory agencies across over 80 countries, including all of the top 100 pharmaceutical companies. Ralf focuses on advancing methods and tools that make biostatistical analysis more accessible and reliable. His work centers on bridging scientific rigor with practical application to meet the evolving needs of the bioassay community. Since 2017, he has served as a member of the U.S. Pharmacopeia Bioassay Expert Panel.

Matthew Stephenson is a Director of Statistics at Quantics Biostatistics where he has been advising clients on the statistical analysis of bioassays since 2019. He completed an undergraduate degree in Biology (2012) and a MSc (2015) and PhD (2019) in Statistics. He was awarded the 2020 Canadian Journal of Statistics Award for his PhD research on leveraging the graphical structure among predictors to improve outcome prediction. Following a stint as Assistant Professor in Statistics at the University of New Brunswick from 2020-2022, he resumed a full-time role at Quantics in 2023.

Lauren is currently Chief Scientific Officer at Immunologix Laboratories where she also co-founded and leads the Translational Sciences organization. Prior to joining Immunologix in 2019, Lauren accrued 20+ years of drug development experience in small and large biotech and pharma where her teams were responsible for developing bioanalytical and biomarker strategies and execution thereof in support of a diverse portfolio of therapeutics spanning all stages of drug development from late research to post-market. Lauren is a globally recognized thought leader in large molecule bioanalysis and biomarkers who has authored multiple white papers and frequently presents at national and international conferences. In addition to her scientific interests, Lauren is equally passionate about strengths-based people development and fostering a culture of collaboration and interdependence that leads to collective success.

Jiangbo Tang is a Principal Scientist in the Department of Clinical Pharmacology, Pharmacometrics & Bioanalysis at Bristol Myers Squibb (BMS). He leads regulated PK and immunogenicity bioanalytical development to support programs in CAR T, ADC, and antibody therapeutics. Prior to joining BMS, for several years he led a team at a CRO and provided regulated bioanalytical support for clinical programs. He also worked as a Staff Scientist in the QC Department at Regeneron, where he automated potency assays in support of stability, and lot release of drug products. Jiangbo received his PhD in Human Genetics from the University of Pittsburgh and completed his postdoc training at the University of Pennsylvania, where his published research in cancer biology and immunology has been widely cited with over 1,500 citations.

After graduating with a degree in Biochemistry, I went into industry. I started at ABC Laboratories (now Eurofins) developing ligand binding assays to assess the effects of chemicals on aquatic life. From there, I moved to working on the pharmaceutical side and added other assay types to my repertoire. Eight years later, I moved to KCAS to help build their ligand binding assay group. After 12 years in CROs, I moved to Moderna and am developing neutralizing antibody methods.

Henrik Toft-Hansen holds a PhD in immunology from McGill University, Canada, and works as immunogenicity specialist at Novo Nordisk, Denmark. Henrik was associate professor in Clinical immunology at University of Southern Denmark with primary focus on autoimmunity research before joining Novo Nordisk in 2016. At Novo Nordisk he has worked extensively with non-clinical and clinical immunogenicity assessment of peptide-based drugs. This work has involved early immunogenicity potential assessment, anti-drug antibody assay validation, sample analysis, outsourcing and writing of integrated summary of immunogenicity for submissions.

Sophie received her PhD 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 acts as Director of Scientific Affairs for the European Immunogenicity Platform.

Jenny Valentine currently works in the Bioanalytical Strategy Group at Regeneron, where she leads bioanalytical strategy for multiple clinical programs, primarily in oncology, that utilize both traditional and emerging drug modalities. She has ten years of experience in large molecule bioanalysis, with previous roles in immunogenicity assay development, validation, and sample testing. Jenny earned her Ph.D. in Chemistry from Yale University and is an active participant in several AAPS working groups.

Faye is currently Executive Director of the Regulated PK&ADA Bioanalysis Group of Merck Research Laboratories, West Point, PA, USA. In this role, Faye is responsible for the strategic and scientific oversight for method development, validation, and implementation of regulated bioanalytical assays to support quantification of drugs and metabolites as well as bioanalytical characterization of anti-drug antibodies, supporting a diversity of modalities including small molecules, peptides, and biologics utilizing chromatographic-mass spectrometry and ligand binding assays. Prior to joining Merck in April 2019, Faye was with Roche for seventeen years and held several positions, rising from Lab Head to Global Head of Bioanalytical Outsourcing, and Bioanalytical Oncology Group Head in the Department of Clinical Pharmacology and Bioanalytical R&D. Faye is highly engaged within the global bioanalytical community through various organizations including AAPS and IQ. She also serves on the International Council of Harmonization Bioanalytical Method Validation and Sample Analysis (ICH M10) Expert Working Group as the BIO organization representative.

Piyush Vyas, PhD is a Director in Bioassay development group at Eli Lilly and Company. He joined Eli Lilly in 2011 as Research Scientist and have led bioassay development of many therapeutic molecules such as monoclonal antibodies, bispecific antibodies, fusion proteins and novel modalities such as AAV, ARCs and peptide conjugates. Prior to Eli Lilly, Piyush contributed for PK/PD bioassay development group at Bristol Myers Squibb. He did his post-doctoral fellowship at School of Medicine at Indiana University focusing on transduction peptides for protein delivery and obtained his PhD in Biochemical Pharmacology in the department of pharmaceutical sciences from University of Iowa. In his current role in bioassay group with Eli Lilly, he has networked with Discovery side of the organization to transfer the projects and led those projects for bioassay deliverables in CMC space. He manages these projects from Phase 1 to Phase 3 and beyond. He has delivered mechanistic relevant cell-based assays and other bioassays for more than ~60 projects under his 14 years tenure at Eli Lilly. He supervises these bioassays internally as well as manages transfer of these assays to third party organizations for successful Validation and GMP testing of API and DP. In this pursuit, visiting and determining the capabilities of third parties and resolve the issues/deviations at external partners is also a stapled part of his responsibilities. He has networked with several contract manufacturing organization to obtain supplies of critical reagents in cost effective manner. He is also responsible for authoring bioassay sections of regulatory submissions of INDs, BLA and providing responses to questions from variety of Regulatory agencies across the globe. Even in commercial stage of the projects beyond Phase 3, he supports the commercial group for technical resolution on bioassay related activities. He leads a group of contract scientist at Eli Lilly and manages development of plethora of bioassays for bioproducts in Lilly portfolio. He has also implemented innovative ideas for bioassays at Eli Lilly and presented his work and led panel discussions at various bioassay conferences.

Mr. Walfish is Principal Science & Standards Liaison at United States Pharmacopeia (USP) responsible for the Statistics Expert Committee. Prior to this role Mr. Walfish was Principal Statistician at Becton Dickinson in Franklin Lakes, NJ responsible for supporting continuous improvement efforts and process development for worldwide operations. Mr. Walfish has held roles at GE Healthcare, Human Genome Sciences and Chiron. Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries. Mr. Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification and validation and stability analysis. Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

Dr. Yow-Ming Wang is currently the Associate Director for Biosimilars and Therapeutic Biologics as well as Director of Therapeutic Biologics Program in the Office of Clinical Pharmacology at the FDA. From 2011 to September 2017, Dr. Wang served as the team leader of Biologics Team in Division of Clinical Pharmacology III; her team was responsible for reviewing submissions of biological products in three clinical divisions. Prior to joining the FDA, she worked in the pharmaceutical industry with experience in small molecules and large molecules. From 2004 to 2011, she worked at Amgen where she supported multiple biologic products in clinical development, in registration phase, and in post-marketing phase. Before Amgen, she supported small molecule drug discovery and development for 11 years at Vertex Pharmaceuticals and at Parke-Davis Pharmaceutical Research. She received her PhD degree from The Ohio State University College of Pharmacy with a research focus on Pharmacokinetics and Biopharmaceutics.

Erin West is an Associate Scientist in the Complement and Inflammation Research Section of the National Heart, Lung, and Blood Institute (NHLBI) at the NIH. She earned her doctorate in Immunology from Emory University in 2011, where her research in Dr. Rafi Ahmed’s lab explored the mechanisms of T cell exhaustion and therapeutic strategies in chronic infection. Following her PhD, she completed postdoctoral training at the NIH, initiating her work on the complement system in collaboration with Dr. Claudia Kemper’s group. Dr. West’s current research sits at the interface of infection and complement biology, with a focus on delineating how systemic (liver-derived) and cell-intrinsic (intracellular, also known as the complosome) complement pathways shape immune cell responses during homeostasis, infection, and autoimmunity. Her work aims to uncover new insights into the regulatory roles of complement in immunity, with the goal of informing the development of novel therapeutic approaches.

Weifeng has been in the field of immunogenicity for biologics for about 10 years. He had developed cell-based neutralization Ab assays for multiple key product at BMS including Opdivo and Yervoy. He is an active member in AAPS NAb work group as well as EBA NAb team; he is also co-leading the NAb assay drug tolerance subteam at AAPS. After join Merck at the end of 2018, Weifeng is now leading Cell Assay group within PPDM Regulated Immunogenicity to develop neutralizing assays for both biologics and vaccines.

Khaled Yamout is a thought leader in Analytical Sciences, Quality and Manufacturing. Previously held a position as a Senior Director, Analytical Services and Quality Control at TriLink Biotechnologies where he oversaw the Analytical Sciences Center of Excellence and all analytical aspects of method development and validation to product release and stability to support regulatory filings for both small and large molecules. Prior to TriLink, Khaled held various positions in Quality Control, Research and Development, and Manufacturing where he supported several Drug substances and Drug products (both small molecules and biologics) from clinical phase to commercial. These include diverse experience and expertise ranging from discovery to manufacturing with Fortune 500 firms, as well as small entrepreneurial businesses in the areas of synthetic, analytical, colloidal, surface modification, protein, and antibody modification and purification covering both manufacturing and analytical testing and characterization.

Zhaojun Yin is a principal scientist at Genentech where he supports the in vitro biological characterization of large molecules and leads the development of immunogenicity assays including NAb and immunogenicity risk ranking assays.

Josh Zylstra is an Associate Director in the Assay Development Group at Regeneron, where he leads the development of Ligand Binding Assay to support clinical and nonclinical programs. He brings over a decade in regulated bioanalysis, focusing on immunogenicity, PK and biomarker development. Josh earned his Ph.D. in Chemistry from Syracuse University.