Speaker Biographies - Immunogenicity & Bioassay Summit

2019 Archived Content

Immunogenicity and Bioassay Summit Speaker Biographies

Symposium: Immunology for Biotherapeutics
Immunogenicity Assessment & Clinical Relevance
Immunogenicity Prediction and Control
Optimizing Bioassays for Biologics

Symposium: Immunology for Biotherapeutics

Daron Forman, Ph.D., Principal Scientist, Molecular Discovery Technology, Bristol-Myers Squibb
Daron has been at Bristol-Myers Squibb for 10 years focusing on both in silico and in vitro pre-clinical immunogenicity risk assessment and mitigation. He received his Ph.D 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.

Robert Hamilton, PhD, Professor, Medicine and Pathology, Division of Clinical Immunology and Allergy, The Johns Hopkins University School of Medicine
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.

Kristina E. Howard, DVM, PhD, Research Veterinary Medical Officer, Division of Applied Regulatory Science (DARS), OCP/OTS/CDER/FDA
Kristina Howard received her veterinary degree from the Virginia-Maryland Regional College of Veterinary Medicine and her Doctorate in immunology from North Carolina State University. She joined the FDA in 2010 and is currently a principal investigator in the Division of Applied Regulatory Science, Center for Drug Evaluation and Research of the United States Food and Drug Administration. Her research focuses on developing and improving animal models to better predict the safety of small and large molecule drug products in humans.

Michael Lacy, PhD, Lead Scientist, Non-Clinical Development, Emergent BioSolutions
Michael Lacy performed graduate work to dissect a model antibody system, then added a T cell immunology post-doc at the University of Illinois at Urbana-Champaign. Moving to corporate research, he inspected immune responses to monophosphoryl lipid A at Ribi ImmunoChem, then synthetic TLR4 agonists with Corixa Corporation, morphing to emerging diseases with Emergent BioSolutions, including new generation anthrax vaccines, therapeutics and other vaccines.

J. Joseph Melenhorst, Ph.D., Director, Product Development & Correlative Sciences Center for Cellular Immunotherapies University of Pennsylvania
In the past seven years we have shown Dr. J. Joseph Melenhorst is the Director of Product Development & Correlative Sciences (PDCS) at the Center for Cellular Immunotherapies (CCI), and Adjunct Associate Professor of Pathology and Laboratory Medicine, University of Pennsylvania (U Penn). After he obtained is MSc degree at the University of Nijmegen, Netherlands, and PhD degree at the University of Leiden, Netherlands, he did his post-doctoral research at the National Institutes of Health in Bethesda, Maryland, studying the biology of bone marrow failure syndromes, leukemia and graft-versus host immunology, and adoptive cell therapy. Dr. Melenhorst was recruited to the University of Pennsylvania in 2012. The focus of his laboratory is to understand and improve the efficacy and safety of cellular immunotherapy through biomarker, mechanistic, and product development studies. His laboratory has uncovered key biomarkers of a chimeric antigen receptor (CAR) T cell therapy-associated toxicity, cytokine release syndrome (CRS), and developed predictive monitoring tools for CRS in leukemia 1. He furthermore identified the critical parameters determining success in CAR T cell therapies in leukemia 2 (and manuscripts under revision). Lastly, his efforts include the development of a universal, streamlined, cost-effective and potent manufacturing process for T cell engineering and some of his insight has already been translated into clinical practice.

Paul A. Moore, PhD, Vice President, Immunology and Cell Biology, Research, MacroGenics, Inc.
Over 20 years of experience working in biotech, coordinating efforts focused on the discovery and development of novel biologic-based therapies. Began 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.

Kannan Natarajan, PhD, Staff Scientist, National Institute of Allergy and Infectious Diseases, NIH
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.

Bonita (Bonnie) Rup, Ph.D., Biopharmaceutical Consultant, Bonnie Rup Consulting
Bonita Rup is a biopharmaceutical development consultant, providing expert advice on bioanalysis, immunogenicity risk assessment, and related regulatory strategy aspects of biopharmaceutical development. Previously she was Research Fellow and lead for the Immunogenicity Discipline at Pfizer, Assistant Vice President of Protein Bioanalytics in Wyeth, and held various positions directing development and application of immuno-ligand binding assay technologies for PK, immunogenicity and protein impurity analysis, and other aspects of biopharmaceutical development. During her career, she has been involved in multiple regulatory filings during preclinical, clinical development and marketing approval of biopharmaceutical products. She has been a member of AAPS, EIP, European IMI ABIRISK consortium, and Biosafe; with these organizations, she has been a co-author for multiple publications related to monitoring immunogenicity and bioanalysis of therapeutic proteins. Bonnie received her B.S. from University of Massachusetts, Amherst, Ph.D. from University of Texas, Austin, and conducted postdoctoral research at Duke University and University of Rochester, NY.

Simone Nicholson, PhD, DABT, Principal Toxicologist, Clinical Pharmacology and Safety Sciences, AstraZeneca
Simone is a Toxicologist at MedImmune/AstraZeneca, she supports the safety assessment of multiple biologics modalities at all stages of development. Prior to her time at MedImmune, Simone performed in vivo pharmacology and safety studies at Dyax, the antibody library company. She also established a suite of in vitro toxicology assessments to evaluate the toxicity of Epix Pharmaceuticals’ innovative imaging compounds. She came to the field of toxicology, serendipitously, when asked to conduct the studies that were the foundation of the DrugMatrix toxicogenomics database at Iconix Biosciences. She has a Ph.D. in Immunology from Northwestern University and is board certified in Toxicology.

Ethan Shevach, MD, Senior Investigator, Laboratory of Immune System Biology, National Institute of Allergy and Infectious Diseases, NIH
Dr. Shevach received his A.B. and M.D. degrees from Boston University. He is presently Chief, Cellular Immunology Section, Laboratory of Immunology. Dr. Shevach is the author of over 450 papers in the field of Immunology and his research interests over the years have included antigen presentation and processing, T lymphocyte activation, pathogenesis of autoimmunity, and most recently the role of regulatory T cells in immune responses. He served as Editor-in-Chief of the Journal of Immunology from 1987 to 1992 and as Editor-in-Chief of Cellular Immunology from 1996 to 2007. He is a member of the editorial boards of several journals including Immunity, Journal of Experimental Medicine, and Human Immunology.

Han-Yu Shih, PhD, MS, Research Fellow, National Institute of Arthritis and Musculoskeletal and Skin Disease, (NIAMS), NIH
Dr. Shih is a genomicist with a long-standing interest in fundamental immunology. She started her research career by identifying genetic variants and T cell repertoires associated with drug-induced autoimmune diseases in human, resulting in FDA-approved biomarkers for these diseases. Her doctoral training at Duke University focused on how fine-tuned regulation of T cell receptor loci generates the normal T cell repertoire in mice. Her work provided insights into multi-layered regulation of gene activity and recombination. Realizing the importance of gene regulation in immune responses, she joined NIAMS at NIH in 2013 to study global gene regulation in immune cells. Her studies on regulomes in ILCs argued the distinct routes by which ILCs and their analog Th subsets become epigenetically committed to their effector roles. She is currently working on integration of genomewide transcriptomic and regulomic database in immune cells to map the immunoregulatory networks in autoimmunity and infections.

Immunogenicity Assessment & Clinical Relevance

Shannon Chilewski, PhD, Research Scientist II, Bristol-Myers Squibb
Dr. Chilewski is currently a Research Scientist II in the Department of Bioanalytical Sciences at Bristol-Myers Squibb (BMS). She received a Master’s degree in Biotechnology from the University of Connecticut in 2006 and a Ph.D. in Pharmacology and Toxicology from the University of the Sciences in Philadelphia in 2019. At BMS she is responsible for immunoassay method development and biophysical characterization of reagents. Additionally, she has served as the bioanalytical representative for multiple therapeutic programs. She has over 10 years experience in the bioanalysis of biotherapeutics starting when she joined Merck in 2007, where she developed immunoassays to support pharmacokinetics and immunogenicity.

Shan Chung, PhD, Associate Director and Principal Scientist, Genentech
Dr. Shan Chung is currently an Associate Director and Principal Scientist in the Department of BioAnalytical Sciences (BAS). Shan received his Ph.D. in Molecular Biology from University of Pennsylvania and completed his postdoctoral training in Protein Engineering at Harvard. Shan has more than 20 years’ industry experience in research and development of both small molecule- and protein-based pharmaceutical products. An expert on Fc functions and immunogenicity of biotherapeutics, Shan serves on the USP Fc Function Expert Panel, and is an active member in the AAPS Working Groups on Neutralizing Antibody Assays, Cell-based Assays, and Predictive Immunogenicity Assays. Shan joined Genentech in 2006, and currently leads the Effector Function and Cell Biology group in BAS. He and his group have supported more than 50 successful regulatory filings at Genentech.

Sandra Garces, MD, PhD, Senior Medical Advisor for Immunogenicity, Global Patient Safety, Eli Lilly
Sandra Garces is Rheumatologist with more than a decade of clinical experience, focused on the use of biologic therapies in the treatment of patients with chronic inflammatory diseases. She did her PhD in the Gulbenkian Institute of Science with a thesis entitled “Clinical Relevance of Drug Immunogenicity”. She developed an algorithm that uses information on drug concentrations and immunogenicity to help guide therapeutic decisions towards more cost-effective therapeutic strategies in clinical practice. In 2016 she joined Eli Lilly & Co. where she has worked on the assessment of the clinical relevance of IMG across different programs.

Mohamed Hassanein, PhD, Staff Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals
Mohamed Hassanein has a combined academic and in industry experience of more than 12 years in oncology, translational medicine and regulated bioanalysis. Dr. Hassanein received his Masers in Biological Sciences from Delaware State University and PhD in Molecular Biology and Genetics from University of Delaware. He completed his post-doctoral training at Vanderbilt Ingram Cancer Center where he later became a Research Assistant Professor. At Vanderbilt his research focused on developing and validating blood-based biomarkers for early detection of lung cancer. He then moved to Covance Laboratories where he served as a Principal Investigator, overseeing the bioanalytical development and validation of PK, immunogenicity and biomarker assays in support of preclinical and clinical development of biologics. He currently serves as Staff Scientist/Principal Scientist overseeing the bioanalytical strategy in support of clinical development of therapeutic mAbs at Regeneron Pharmaceuticals.

Wojciech Jankowski, Commissioner's Fellow, CBER, FDA
Dr. Jankowski is a research reviewer with the US Food and Drug Administration in the Office of Tissues and Advanced Therapies. He is part of an active research laboratory and his research interests lie in the regulatory-science associated with the licensure of the next generation of therapeutic proteins. A key focus of his research activities has been to understand the immune response to protein therapeutics, which can significantly affect the efficacy and safety of these drugs. He uses a combination of computational, in vitro and ex vivo approaches in his work. Dr. Jankowski received his Ph.D. from Rutgers University, NJ and was subsequently selected for the highly competitive Commissioner’s Fellowship program at the FDA. His research has been published in high impact journals such as Nature and Nature Chemical Biology.

Zhihua Jiang, PhD, Principle Scientist, BioMedicine Design, Pfizer
Zhihua Jiang is a Principal Scientist in Regulated Bioanalysis of BioMedicine Design at Pfizer Inc. He is responsible for ADA and neutralizing antibody assay development and validation, sample testing in support for nonclinical and clinical studies. He is also leading scientific research and development strategies to advance bioanalytical capabilities for assay efficiency and appropriateness. Prior to Pfizer, he completed his postdoctoral study at University of Pittsburgh and Boston University, where he received training in Pulmonary Biology and Hematology. He received his Ph.D. from Jilin University, China.

Leopold Kong, PhD, Biotech Quality and Immunogenicity Reviewer, FDA
Dr. Kong has been a biologics quality and immunogenicity reviewer with the Office of Biotechnology Products, Center for Drugs- FDA since 2017. He received his PhD on Structure-Based Vaccinology in 2010 from the University of Oxford, Oxford, England, UK.
Since joining the FDA, Dr. Kong has accrued regulatory experience in reviewing innovator biologics and serves as an active member of the Immunogenicity Working Group in the Office of Biotechnology Products.

Sheldon Leung, PhD, Director, Bioanalytical Laboratory, Selecta Biosciences
Sheldon Leung is an experienced molecular biologist having managed bioanalytical assay development and analysis for a broad range of large molecule therapeutics including antisense oligonucleotides and gene therapy for pre-clinical and clinical studies. He is currently the director of bioanalytical at Selecta Biosciences, an immune tolerance based company, overseeing assay development and analysis covering discovery to phase 3 preparations for their lead program. His research interests include data and lab automation and biomarker discovery. Prior to Selecta Biosciences, he held positions at Wyeth and Pfizer.

Thomas Little, PhD, President and CEO, Bioassay Sciences, Thomas A. Little Consulting
Dr. Little is President of BioAssay Sciences (BAS) a globally recognized bioassay consulting company for biologicals and vaccines. BAS specializes in the design, calculation and control of potency and relative potency for bioassays. BAS specializes in In-Vivo and In-Vitro bioassays. BAS works with international companies and health authorities globally to achieve product development goals aligned to ICH and USP guidance. BAS is a strategic partner of SAS/JMP and a division of Thomas A. Little Consulting. Dr. Little has developed specific content courses in statistical methods and data analysis, Bioassay Design and Validation, Quality Risk Management, design of experiments, Robust Optimization, Design Space and Tolerance Design, Assay Development and Method Validation, statistical process control, mixture design of experiments, Stability Analysis and Nonlinear Modeling. These courses are used by a variety of fortune 100+ companies to train their chemists, engineers and scientists.

Lilia Macovei, PhD, Bioanalytical Principal Investigator, Senior Scientist, Pfizer
Lilia Macovei is a Principal Bioanalytical Investigator/Senior Scientist in BioMedicine Design Department, Pfizer. Lilia earned Ph.D. in Molecular Biology from the University of Agricultural Sciences and Veterinary Medicine, Cluj-Napoca, Romania and later completed postdoctoral research studies in Microbiology, Infectious Diseases and Immunology at The Forsyth Institute/Harvard Medical School. Lilia’s expertise includes non-regulated and regulated bioanalytical support for the Pfizers biotherapeutic portfolio. She worked in the development and validation of PK and Immunogenicity Assessment Assays (ADA and cell-based neutralizing antibody) for non-clinical and clinical studies. She is experienced with a broad range of biotherapeutic modalities and diseases, including monoclonal antibodies, fusion proteins, bi-specifics, antibody drug conjugates, diverse viral vector platforms and chimeric antigen receptor T-cell (CART) therapies.

Jim McNally, PhD, Executive Director, Head of Research and Clinical Assays, Program Lead, CRISPR Therapeutics
Jim McNally is the Head of Research and Clinical Assays at CRISPR Therapeutics in Cambridge, MA. His group is responsible for assays to support the entire continuum of the drug development process. Prior to this role he has held similar roles at Shire, EMD Serono and Pfizer. A graduate of the Microbiology and Virology Ph.D. program at LSU Medical Center in 1998, Jim has a special interest in immunomodulation and immunogenicity of biotherapeutics. Jim co-leads two AAPS Discussion Groups on Immunogenicity Assessment and Neutralizing Antibodies.

Hongmei Niu, PhD, Senior Scientist, EMD Serono
Currently Hongmei Niu is working in clinical assay development group at EMD Serono in Billerica, MA as senior scientist where she is responsible for bioanalytical support and scientific oversight of outsourcing of large molecule programs for EMD Serono. Prior to joining EMD Serono, Hongmei held a similar role in the Bioanalytical and Biomarker Development group at Shire in Lexington, MA and Bioanalytical Science group at Immunogen in Waltham, MA. Hongmei obtained her Ph.D. degree and her medical training in China and has around eight years of experience in PK, ADA and biomarker ligand binding assay development, validation and oversight of outsourced assays supporting a wide range of therapeutic modalities including recombinant proteins, monoclonal antibodies, bispecific antibodies, Fc fusion proteins and antibody drug conjugates.

Michael Partridge, PhD, Associate Director, Bioanalytical Sciences, Regeneron Pharmaceuticals
Born and raised in Australia, Michael received his Ph.D. from Sydney University (CSIRO). He moved to the US for a post doc at Columbia University where he investigated integrin-mediated cell signaling, tumorigenesis and biomarkers of radiation exposure. Michael left academia to work at Regeneron where he led a group of scientists developing and validating PK, ADA, NAb and biomarker immunoassays. He has subsequently taken a role interacting with clinical teams as the bioanalytical strategic lead for multiple therapeutic areas.

Carley Tasker, PhD, Associate Scientist, Merck Research Laboratories
Carley completed her PhD at Rutgers University – New Jersey Medical School in Infection, Immunity, and Inflammation. Her thesis work focused on the impact of hormones on innate immune responses and impact on HIV infection and transmission. She discovered a novel role of type I interferon-epsilon in protecting against HIV infection of target cells and headed a longitudinal clinical study analyzing the impact of the hormonal contraceptive Depo-Provera on the HIV infectivity and mucosal immune responses. Carley is currently a member of the Predictive and Clinical Immunogenicity Group at Merck Research Laboratories and is currently focused on developing high-throughput in vitro methods to predict immunogenicity and risk assessment.

Sir Michael Tovey, Managing Director, Paris Management, Svar Life Science

Michael brings an extensive knowledge and expertise in molecular genetics, signal transduction, and cell engineering and is the inventor of the iLite™ reporter gene technology. Michael is the author of more than 200 articles on cytokines, biotechnology, and immunogenicity.

Yuling Wu, PhD, Associate Director, Clinical Pharmacology Biologics and Bioanalysis, AstraZeneca
Dr. Yuling Wu heads the Clinical Immunology and Bioanalysis (CIB) Group in Clinical Pharmacology and Safety Sciences at AstraZeneca in Gaithersburg, MD. There she is responsible for Bioanalytical Sciences and covers PK/PD/ADA/NAb assessment and disease biomarker development in support of oncology, respiratory, inflammation, infectious disease programs from research through clinical development and BLA. Previously Dr. Wu was a Principal Scientist in PKDM at Amgen, where she developed and validated assays for programs at various stages of development. A highlight of her contributions at Amgen was bone osteoporosis biomarker development and validation in support of denosumab commercialization. Prior to Amgen, Yuling was a staff scientist at Life Technologies where she focused on developing phospho-protein kinase biomarker assays that were used in signal transduction drug discovery research. She completed her post-doctoral work at Stanford University after she received her Ph.D. from St. Bartholomew’s and the Royal London Hospital School of Medicine, University of London, U.K. Dr. Wu has authored numerous peer reviewed articles, book chapters and white papers covering validation and applications of biomarkers in drug development, IgE ADA, ADCC-based and ligand binding NAb assays Yuling is a frequent invited reviewer for multiple journals in the bioanalytical field.

Yuhong Xiang, Senior Scientist and Manager, Jounce Therapeutics
Yuhong Xiang, M.S., Senior scientist at Jounce Therapeutic. Her role is to lead vendor management of clinical and pre-clinical bioanalytical work for Jounce’s programs. She possesses over 10 years of experiences in the large molecule immunoassay field, specializing in PK/immunogenicity method development and validation. Prior to joining Jounce, she was a Bioanalytical Scientist at BioMedicine Design, Pfizer to develop and validate regulated bioanalytical assays in PK, ADA and NAb for preclinical and clinical studies in various therapeutic areas. She also worked at Biogen supporting numerous bioanalytical method development and optimization of Biomarker, Target Engagement, PK and ADA assays with various technologies. She has published several manuscripts in major journals and presented scientific posters/talks at various scientific conferences. She received the M.S. degree in Computer Science from Boston University and the M.S. degree in Molecular Biology from Xi’an Jiaotong University.

Weifeng Xu, PhD, Principal Scientist, Merck
Dr. Xu was leading the cell-assay group at BMS and have developed, validated and transferred about half-dozen cell-based neutralizing antibody (NAb) assays, including blockbusters such as Opdivo and Yervoy. Over these projects, Weifeng has encountered numerous challenged and was able to address them innovatively. Most recently, Weifeng has been focusing on 1) how to overcome drug interference, which is particularly challenging for cell-based NAb assays. One of the innovative ideas is to use heating to destroy excessive amount of small biologic therapeutics such as domain Ab or nanobody in the sample; 2) to simplify and improve cell-based NAb assay, for example, using MSD-based cell binding assay. This will dramatically simplify the assay development, transfer, as well as sample testing. Weifeng is currently Principal Scientist and Group Leader of Cell Assay Group at PPDM BA, Merck, to develop neutralization assays for both biologics and vaccines.

Immunogenicity Prediction & Control

Daniel L. Adams, Director of Clinical R&D, Creatv MicroTech, Inc.
Daniel L. Adams is Director of Clinical R&D at Creatv MicroTech’s facility in NJ, focusing on development of custom assays and analysis of patient samples. He is credited with the discovery and phenotyping of circulating cancer associated macrophage-like cells (CAMLs). He has written extensively on the isolation, identification and clinical utility of CTCs, CAMLs, EMTs and circulating endothelial cells.

Brandon DeKosky, PhD, Assistant Professor, The University of Kansas
Dr. Brandon DeKosky is an Assistant Professor at the University of Kansas Departments of Chemical Engineering and Pharmaceutical Chemistry, where his laboratory leverages recent advances in next-generation DNA sequencing technologies to achieve a more comprehensive understanding of immune function and accelerate the development of new vaccines and therapeutics. During his graduate research, Dr. DeKosky invented the very first technology for sequencing the antibody proteins encoded by B cells at the single-cell level, at a massive scale (for example, over 5 million single B cells in a one-day experiment), which reduced cost and enhanced throughput for antibody sequencing by multiple orders of magnitude compared to traditional antibody discovery platforms. Dr. DeKosky also pioneered the associated bioinformatic methods for rapid statistical analysis of the very large datasets generated by this approach. Ongoing efforts in the DeKosky lab, supported by an NIH Director’s Early Independence Award and a United States Department of Defense Career Development Award, and focus on expanding our ability to determine the mechanisms of protection for human vaccines and to develop novel and improved targeted human therapeutics.

Jochem Gokemeijer, PhD, Associate Director, Molecular Discovery Technology, Bristol-Myers Squibb
Jochem Gokemeijer has been working at Bristol Myers Squibb for 15 years in Immunogenicity and biologics drug discovery. Before that he was involved in two alternative scaffold biotech companies Phylos and Adnexus Therapeutics. Jochem did his undergraduate work in the Netherlands and graduate work at the Dana Farber Cancer Institute.

Timothy Hickling, PhD, Immunogenicity Sciences Lead, Pfizer
Tim leads the Immunogenicity Sciences group in Pfizer that is responsible for immunogenicity risk assessments, screening biomolecules for improved immunogenicity profiles and developing predictive methods for immune responses. Tim joined Pfizer in the UK in 2007 to develop Vaccines before switching to unwanted immunogenicity, and the USA, in 2011. He had previously obtained his Biochemistry degree and Immunology Doctorate from the University of Oxford, U.K. and was a Lecturer in Virology at the University of Nottingham, U.K.

Vibha Jawa, PhD, Director, Predictive and Clinical Immunogenicity, Pharmacokinetics, Pharmacometrics and Drug Modeling Group, Merck
Dr. Vibha Jawa is currently a Director, Predictive and Clinical Immunogenicity group within Preclinical Development at Merck. She is responsible for developing a strategy and provides oversight and management of scientific programs for discovery, development and optimization of biologics and vaccines. In this role, she is partnering with discovery and development groups to design better molecules. Dr Jawa received her bachelors in Biochemistry (1991) from Delhi University and her doctorate in Biochemistry/Immunology (1998) from All India Institute of Medical Sciences, New Delhi, India with a thesis work studying the immune mechanisms behind autoimmune diseases followed by a postdoctoral fellowship at University of Pennsylvania on monitoring the immune response to viral vectors. She continued to work in the field of gene therapy company evaluating viral vectors for hemophilia therapy in the Bay area followed by City of Hope Cancer Centre Stem Cell and Gene Therapy group and at Amgen from 2003-2016. Her current research interests include evaluating immune response biomarkers for early drug development and efficacy, immunogenicity prediction using in silico, in vitro and in vivo technologies, modeling impact of immunogenicity on PK and PD and their application to a systems based approach, antigen processing and presentation and the role of T cells in immune response to drug products. Vibha is a member of multiple professional organizations like American Association of Pharmaceutical Scientists (AAPS), American Association of Immunology (AAI) , European Immunogenicity Platform and Federation of Clinical Immunology Society (FOCIS). Within AAPS, Vibha has been actively involved as a Steering Committee member of the Therapeutic Protein Immunogenicity Focus Group (TPIFG) and is currently leading the Immunogenicity Risk Assessment and Mitigation Working Group (IRAM). She is also a co-lead of the Industry Innovation and Quality consortium for Cell/viral/gene therapies. Dr. Jawa also serves as a manuscript reviewer for The AAPS Journal , Clinical Experimental Immunology and J.Pharm Sci Journal. Dr. Jawa has published over 50 papers and her articles in the Nature Genetics, Annals of Hematology and Clinical Immunology journals have been cited over 2500 times. She is the recipient of the 2015 Ebert Prize from the American Pharmacists Association for her work on assessing risk of critical quality attributes in a humanized mouse model system.

Yong Chan Kim, PhD, Vice President for Research, TeraImmune
Dr. Yong Chan Kim has been dedicated to developing platforms to generate antigen-specific therapeutic human regulatory T cells using the antigenic receptor technology over 12 years. Dr. Kim is the inventor of the TeraImmune technology and developed the specific engineered Tregs, and currently a Vice President for Research at TeraImmune.

Emilee Knowlton, PhD, Immunology Sales Specialist, Sales, ProImmune Inc.
Emilee gained her PhD in Infectious Diseases and Microbiology from the University of Pittsburgh under the direction of Prof. Charles Rinaldo, identifying immune responses to lytic infection with Human Herpes Virus-8. She joined ProImmune in 2013 after completing her Post Doc in Rinaldo’s lab. She works on the ProImmune team providing innovative solutions for clients that radically improve our understanding of both desired and unwanted immune responses.

Daniel Lagasse, PhD, Research-Regulator, FDA
Daniel Lagassé conducts research and CMC review as a Biologist in the Division of Plasma Protein Therapeutics within the Center of Biologics Evaluation and Research at the U.S. Food and Drug Administration. Dr. Lagassé received his PhD in Molecular Microbiology and Immunology from Johns Hopkins Bloomberg School of Public Health.

Karen Liao, MD, Investigator, GSK Associate Fellow, GlaxoSmithKline
Karen Liao is an Investigator and Associate Fellow at GSK working in the department of Immunogenicity for nearly 10 years. Karen has developed and implemented ADA and neutralization assays for broad biological modalities, including therapeutic monoclonal antibodies, enzyme therapies, immune modulators, antibody-drug conjugates (ADC). She has published several papers on developing neutralization assays, resolving target-induced false ADA positives for clinical ADA assays, and reporting the detection of memory B activity for pre-existing ADA against a domain antibody. In the past few years, Karen has been focused on immunogenicity prediction for biologics using ex vivo T cell activation and proliferation assays and she has gained extensive first-hand experience in this field.

Emma Liu, PhD, Scientist, Genentech
Emma (Yanqiu) Liu, Ph.D. is a Scientist in Bioanalytical Sciences Department at Genentech. She joined Genentech in 2014, leading bioanalytical strategy and assay development to support drug development in ophthalmology and cancer immunotherapy. Prior to Genentech, she worked at a private biotech company after receiving her PhD from Harvard University.

Bernard Maillere, PhD, Research Director, Immunology, CEA
Benrard holds a master degree in biochemistry in 1987 and a PhD in immunology in 1992 from AgroParisTech, Paris, France. He is currently director of research and head of the laboratory of immunochemistry of the cellular immune response at CEA, a French Governmental research Institute. He is head of the pole of immunology of the doctoral school “therapeutic innovation” of the university of Paris-Saclay. His current research focuses on the prediction of immunogenicity and the identification of T cell epitopes in humans with the perspectives of developing safe therapeutic proteins and new vaccines. He was co-leader of the work package dealing with immunogenicity prediction of the European IMI project ABIRISK.

Ronit Mazor, PhD, Scientist II, Antibody Discovery & Protein Engineering (ADPE), MedImmune
Ronit Mazor joined Medimmune as a scientist on 2017 where she leads the efforts to minimize the immunogenicity of therapeutic proteins during early development. Before joining Medimmune, was a post-doctoral fellow in the lab for Molecular Biology in NCI, working with Ira Pastan on recombinant immunotoxins.

Stephen Miller, PhD, Professor of Microbiology-Immunology, Feinberg School of Medicine, Northwestern University
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).

Horacio Plotkin, MD, SVP and Head, Clinical Development, Selecta Biosciences
Dr. Plotkin is SVP and Head, Clinical Development at Selecta Biosciences and Adjunct Associate Professor of Pediatrics and Orthopedic Surgery at the University of Nebraska School of Medicine. Dr. Plotkin has 12 years of experience in drug development having held positions at Genzyme, Enobia Pharma, Alexion Pharmaceuticals, Retrophin, Shire, PPD and Moderna. During this period, he was involved in developing treatments for rare metabolic conditions including the regulatory approval for treatments for Pompe Disease (US) and Hypophosphatasia (Japan, US, EU). He is also the Founder and first Medical Director of the Pediatric Bone Diseases Program at Omaha Children’s Hospital. Dr. Plotkin is a member of the scientific advisory board for several rare disease patient advocacy organizations and a member of the Advances in Therapeutics and Technology section at the American Academy of Pediatrics. He has authored eight chapters in medical textbooks and more than 50 scientific papers, and he’s presented more than 70 abstracts in national and international scientific meetings.

Laura Santambrogio, MD, PhD, Associate Director, Precision Immunology, Englander Institute of Precision Medicine, Weill-Cornell
Dr. Laura Santambrogio is the Associate Director for Precision Immunology at the Englander Institute of Precision Medicine at Weill-Cornell Medical, and Professor of of Radiation Oncology, Physiology and Biophysics. Dr. Santambrogio received her PhD from Padua University and trained as post-doctoral fellow at NYU and Harvard Medical School in the laboratory of Jack Strominger. 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 and integrated approach that combine cell biology, biochemistry and biophysics. Important questions addressed by her laboratory relates 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.

Katherine Seidl, PhD, Vice President Immunology, SQZ Biotech
Since February 2019, Dr. Seidl has served as VP Immunology,Research and Development, at SQZ Biotech, Watertown, MA. Dr. Katherine Seidl earned a Ph.D. in Genetics from Stanford University, under the supervision of Drs. Len and Lee Herzenberg studying B cell development and immunoglobulin repertoire. After postdoctoral training at Harvard Medical School under the guidance of Dr. Frederick Alt studying B cell immunoglobulin VDJ and class switch recombination, Dr. Seidl embarked on a 15+ year career in drug discovery and development. Dr. Seidl worked at bluebird bio, Cambridge, MA as Director of Immunotherapy leading Preclinical teams developing CAR and TCR cell therapeutics for oncology indications. Prior, she worked at Novartis Institute of Biomedical Research in Basel, Switzerland and Cambridge, MA , USA where she held several positions with increasing responsibility over a nearly 6 year tenure. Dr. Seidl served as a Group Leader in the department of Oncology in Cambridge, MA driving the strategy for biologics in Immuno-oncology and in the department of Autoimmune, Transplantation and Inflammation developing therapeutics against early drug discovery targets in autoimmune disease with a focus on Type I Diabetes, Celiac Disease and Transplantation indications. Additional previous experience in pre-clinical and translational research include Daiamed, Wyeth, and Pfizer.

Alessandro Sette, Dr Biol Sci, Professor, Head and Member, La Jolla Institute for Immunology
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.

Li Xue, PhD, Senior Principal Scientist, Pfizer
Dr. Li Xue is a senior principal scientist and the laboratory lead of the Immunogenicity Sciences group in Biomedicine Design, Pfizer Inc. Dr. Xue joined Pfizer in 2007, where she initially served as a principal investigator for the regulated and non-regulated bioanalytical support of clinical and non-clinical studies. In 2009, Dr. Xue was transitioned to the founding member of the immunogenicity sciences group focusing on the predictive immunogenicity. She has provided the immunogenicity risk assessment and mitigation planning for numerous biologic projects of various modalities at all stages of product development. Dr. Xue led the AAPS pre-existing antibody team and developed the white paper for the assessment and management of pre-existing drug-reactive antibodies. Prior to Pfizer, Dr. Xue was a research fellow at Harvard Medical School. Her research work was published in PNAS and Immunity. Dr. Xue holds a Ph.D. degree in Immunology from Chinese Academy of Medical Sciences.

Optimizing Bioassays for Biologics

Adriana Bajardi-Taccioli, Scientist II, Analytical Development, Biogen
Adriana Bajardi-Taccioli is currently a Scientist in Analytical Development Department at Biogen, Cambridge, MA where she focuses on the development and qualification of bioassays to support the release and characterization of biologics drug candidates. Adriana received her Master of Science degree in Biochemistry from the University of Buenos Aires, Argentina. In the past, she held positions at Albert Einstein College of Medicine, Children’s Hospital Boston, Harvard School of Public Health, and Abbott Bioresearch Center.

Alex Gurka, Scientist III, DMPK, Boeringer Ingelheim
Alex Gurka is a Scientist III in the Biotherapeutics Bioanalysis group supporting Drug Metabolism and Pharmacokinetics at Boehringer Ingelheim (BI). She graduated from University of Miami with a B.S. in Neurobiology & received her M.S. in Biotechnology from Rush University. After graduate school, she worked as a bioanalytical scientist at WIL Research (acquired by Charles River). Alex’s main focus while at BI has been clinical immunogenicity assay development with strong interests in automation and statistics.

Daniel Harding, Principal Consultant, Bioassay Sciences
Dan Harding is a principal consultant at BioAssay Sciences (BAS), a globally recognized bioassay consulting company for biologicals and vaccines. BAS specializes in the design, calculation and control of potency and relative potency for bioassays. BAS works with international companies and health authorities globally to achieve product development goals aligned to ICH and USP guidance. BAS is a strategic partner of SAS/JMP and a division of Thomas A. Little Consulting. Dan has trained a variety of scientist and engineers using courses in statistical methods and data analysis, Bioassay Design and Validation, design of experiments (DOE), Assay Development and Method Validation, and statistical process control. Dan is passionate about helping CMC teams and others improve the results of bioassays by establishing robust acceptance criteria, improving outlier identification and removal, choosing the right statistical model, and other tools key to understanding bioassays.

Walter W. Hauck, PhD, Former Senior Scientific Fellow, USP

Dr. Hauck received a B.S. in Mathematics and Economics from Carnegie-Mellon University and his M.S. and Ph.D. in Statistics from Harvard University. He has authored or co-authored 236 peer-reviewed papers and has served as a statistical consultant to working groups within FDA’s Office of Pharmaceutical Sciences, US Pharmacopeia (USP), and to pharmaceutical companies. Within the pharmaceutical industry he is best know for his work on bioequivalence and equivalence studies and for work on the USP bioassay chapters.
Most recently, he worked for USP as their statistician. Prior to USP, he worked at Thomas Jefferson University, Philadelphia, where he was Professor and Director, Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics. Dr. Hauck has also worked at the Harvard Medical School, Worcester Polytechnic Institute, Illinois Cancer Council, Northwestern University Cancer Center, and the University of California at San Francisco.

David Lansky, PhD, President, Precision Bioassay, Inc.
David Lansky has been practicing statistics on bioassays (and other non-clinical applications in Pharma) for 30 years. This includes 10 years at Searle/Monsanto/Pharmacia and 16 years as the owner of Precision Bioassay, Inc. David has been and is still an active participant in the work to revise the USP bioassay chapters. His education includes a year of Electrical and Computer Engineering (University of Michigan), a BS in Botany (San Francisco State), an MS in Entomology (Cornell) and finally both an MS and Ph.D. in Biometry (both Cornell).

Kathryn Lindley, Vice President, Operations, BioAgilytix
Kathie has a MS in Microbiology and Immunology from UNC Chapel Hill and 20+ years of experience in academia and industry. She has experience in cell-based and immunoassay development utilizing platforms: Hybridoma Generation, ELISA, ELISpot, MSD, DELFIA and RIA. She is an expert in the use/interpretation of BIAcore technology having developed high primary antibody screens. She holds patents on several monoclonal antibodies being progressed as therapeutic agents for sarcopenia, breast cancer, and osteoarthritis.

Jia Liu, PhD, Manager, Pharm Science & PGS Statistics, Pfizer
Jia got her PhD degree in statistics from Iowa State University in 2013. She started her career at Pfizer as CMC statistician to support small molecular projects and switched to large molecular supports since 2016.

Sofie Pattijn, CTO, ImmunXperts
Sofie Pattijn (CTO and founder, ImmunXperts) has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development of therapeutics. She has extensive hands-on lab experience and has managed and coached several In Vitro teams over the last decade. From 2008 till 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, Belgium for over 15 years.

Sandra Prior, PhD, Senior Scientist, Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)
Sandra Prior joined the National Institute for Biological Standards and Control (NIBSC, Potters Bar, UK) as a Senior Scientist in 2015. She works on the development of bioassay standards for therapeutic monoclonal antibodies and the investigation of structure-function in relation to the safety and efficacy of monoclonal antibody products. She is also currently a member of the European Directorate for the Quality of Medicines and HealthCare (EDQM) monoclonal antibody expert committee. Formerly she obtained her PhD from the University of Navarra (Spain) and then moved to the UK where she initially worked in NIBSC investigating safety and protective mechanisms of bacterial combination vaccines. In 2010 she joined Lonza Biologics (Cambridge, UK) working on bioactivity and immunogenicity assessment of biotherapeutics. Sandra has over 15 years’ experience in applied immunology and in vitro cell-based assay development.

Nancy Sajjadi, MSc, Independent Quality Consultant
Nancy Sajjadi, M.Sc. is an independent quality consultant with over 30 years of experience in biopharmaceutical product development. She began her career as a bench scientist at a small cell and gene therapy company developing retroviral vectors for infectious disease, cancer and cell therapy applications. Her responsibilities included research, development, and quality control. Five years after the company was acquired, she left her position as Director of QC at Chiron Technologies Center for Gene Therapy to start a consulting business.

Over the last 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 biopharmaceutical products in early phase development. She also has provided technical expertise in assay development, qualification and validation. Ms. Sajjadi has authored several articles pertaining to bioassays and viral gene therapy, has served on 5 advisory panels for the United States Pharmacopeia (USP) and teaches introductory courses in bioassay design, development, validation and fundamental concepts in biostatistics for non-statisticians.

Jeanette Villarreal-Kinney, Senior Research Associate, Technical Development, Biological Technologies, Genentech, Inc.
Jeanette Villarreal-Kinney is a Technical Development Senior Research Associate in Analytical Development and Quality Control at Genentech, a Member of the Roche Group. She received her BS in Biochemistry and BA in Chemistry from San Francisco State University. She immediately began industry work at Tularik, Inc , later acquired by Amgen, Inc., working as an Associate Scientist in the Drug Discovery group. She developed a variety of High-Throughput Screening assays for DMPK support, siRNA knockdown and cell based target discovery incorporating high content imaging.

Jeanette joined Genentech in 2015, joining the technical development and validation group supporting biological characterization of large molecule therapeutics, developing analytical binding/bioassays. Her enthusiasm for implementation of automation technologies for intricate assay systems challenges her to shift automation advancement into a QC environment.

Steven Walfish, MBA, Principal Scientific Liaison, USP
Mr. Walfish brings over 30 years of industrial expertise in the application of statistical methods for assay development and validation. Steven has experience applying statistical methods to all facets of the CMC process. Mr. Walfish is Principal Science & Standards Liaison in the Global Science and Standards Division at United States Pharmacopeia (USP). 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.

Ryan Yamagata, US Function Head, CMC Statistical Sciences, Vaccines Technical Research & Development, GSK
Ryan Yamagata is the US Function Head of CMC Statistical Sciences, Technical R&D for GSK Vaccines in Rockville, MD. Prior to joining GSK, Ryan was a consultant working with small biotech and medical device companies, and has also worked for MedImmune, Shire, and Wyeth. He has extensive experience supporting preclinical and clinical studies, translational science, and CMC activities. Ryan has an MS in Statistics from Brigham Young University.

Harry Yang, PhD, Senior Director, Statistical Sciences, AstraZeneca
Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at MedImmune. He is also the Membe of USP Statistics Expert Committee. Harry has published 5 statistical books, 14 book chapters, and over 90 peer-reviewed papers over diverse statistical and scientific subjects. He is a frequent invited speaker at national and international conferences and workshops. He was also invited to develop statistical courses and conduct the training at the FDA, Chinese FDA, and USP. He received his BS and MS degrees in Applied Mathematics from Peking University and Ph.D. in Statistics from the University of Pittsburgh.

Jun Xu, PhD, Associate Director, Product Development, Cellular Immunotherapies, University of Pennsylvania
Dr. Xu earned her B.S. in Bioscience from Zhejiang University, China. She completed her Ph.D. study at Lewis Katz School of medicine, Temple University in 2014, where she investigated the regulation of type I interferons in dendritic cells in viral infection, systemic lupus erythematosus and melanoma. In 2014, she joined Product Development Laboratory at Center for Cellular Immunotherapies, University of Pennsylvania. She has been investigating the novel predictive and prognostic biomarkers for immune-gene therapies to understand and improve the in vivo potency of immune-gene therapies. Since 2018, she serves as Associate Director focusing on establishing and evaluating the new platforms to improve the quality of cellular products.

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