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

Rakesh Dixit, PhD, Vice President, Safety Assessment, Medimmune (A member of AstraZeneca)
Rakesh is a Vice President, R & D and the Global Head of the Biologics Safety Assessment comprising of Toxicology, Pathology and Laboratory Animal Resources functions where he is responsible for overseeing the biologics safety assessment of the entire MedImmune biologics portfolio in all therapeutics areas (2006-todate). Prior to joining MedImmune in 2006, Rakesh served as Senior Director of Toxicology in Johnson and Johnson and Associate Director-Research Fellow in Toxicology in Merck and Co., Inc. (1992-2005). Rakesh has over 25 years of experience in developing pharmaceutical and biotechnology-derived drugs and is the author of over 60 peer-reviewed scientific publications and has been invited to deliver Rakesh is regarded as a Key Opinion Leader in Toxicology community. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and an Associate Editor of Toxicology and Applied Pharmacology and Journal of Toxicology and Environmental Health- all key major toxicology journals.

Jochem Gokemeijer, Ph.D., Associate Director, Molecular Discovery Technology, Bristol-Myers Squibb
Jochem has been at Bristol-Myers Squibb for 14 years in different roles of responsibility focused on biologics drug development. For the last 8 years he has been focused on building a group for pre clinical immunogenicity risk assessment and mitigation. He received his training at the University of Groningen and the Dana Farber Cancer Institute

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 and therapeutics. 

David H. Margulies, MD, PhD, Chief, Molecular Biology, Immunology Lab, NIAID, National Institutes of Health
Dr. Margulies received his AB in analytical biology from Columbia University in 1971 and his MD and PhD degrees from the Albert Einstein College of Medicine in 1978. Following training in Internal Medicine at Columbia-Presbyterian Medical Center from 1978 to 1980, he was a research fellow at the National Institutes of Health (NIH) where he studied the molecular biology of the MHC molecules. Since 1983 he has been an independent investigator in the Laboratory of Immunology at the NIAID of the NIH where his interests in MHC molecule genetics, function, and structure have expanded to understanding MHC interactions with T cell receptors and natural killer (NK) cell receptors. His current research explores the structural basis of peptide loading of MHC molecules, the role of MHC structure in drug hypersensivity, allostery in TCR signaling, and mechanisms of viral immunoevasion.

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.

Bonita (Bonnie) Rup, PhD, 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 at Pfizer, and lead the Immunogenicity Discipline, 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. 

Ethan Shevach, MD, Senior Investigator, Laboratory of Immunology, 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 genome wide transcriptomic and regulomic database in immune cells to map the immunoregulatory networks in autoimmunity and infections.

Immunogenicity Assessment & Clinical Relevance

Mitra Azadeh, PhD, Principal Scientist, Bioanalytical & Biomarker Development, Shire
Mitra Azadeh is a Principal Scientist in the Bioanalytical and Biomarker Development team at Shire.  In her current role, she is responsible for the design, development, and validation of bioanalytical and biomarker methods as well as management of both internal and external PK, ADA, and neutralizing antibody assay projects in support of clinical and non-clinical studies. Prior to Shire, she played a similar role in the Bionalaytical Sciences group of Allergan where she additionally established GLP compliance. She previously served as a Senior Principal Investigator at the Covance Immnunochemistry division where she managed bioanalytical studies for numerous pharmaceutical clients.  Mitra has held positions in GMP and GLP compliant biotechnology, immunodiagnostic, CRO, and pharmaceutical companies and has eighteen years of experience in immunoassay, bioassay, cell-based, neutralizing antibody, immunogenicity and biomarker assay development and validation in a variety of platforms. She received her doctoral degree in Cellular Biology from The Catholic University of America.

Terry P. Combs, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.
In 2016, Dr. Combs joined Pfizer as a Senior Scientist in the bionalytical division for new biological entities. His previous contributions to the bioanalysis of biological material are described in high impact publications on adiponectin, caveolins, toll-like receptors and SOGA (Suppressor Of Glucose form Autophagy), representing a family of genes first characterized in Dr. Combs’ lab at the University of North Carolina at Chapel Hill. He has delivered a total of 160 university classroom lectures and 40 invited presentations, coauthored 42 peer-reviewed articles, been a principal investigator on NIH research awards and an inventor on USPTO issued patents. Dr. Combs is adjunct professor of medicine at McGill University. He resides in the Boston area with his wife and their three daughters.

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

Theresa J. Goletz, PhD, Global Head, New Biological Entities and Drug Disposition, EMD Serono Research & Development Institute, Inc.
Theresa leads a department responsible for the bioanalytical characterization and immunogenicity assessment of biotherapeutics from discovery through registration. She received her B.A. from the College of Wooster (Wooster, Ohio) and her Ph.D. from Baylor College of Medicine (Houston, Texas).  After post-graduate studies at the National Cancer Institute/National Institutes of Health (Bethesda, Maryland) which focused on vaccines and cellular therapies, Theresa joined the Abramson Family Cancer Research Institute at the University of Pennsylvania.  Dr. Goletz left academia for industry where she has held positions of increasing responsibility at Centocor, a Johnson and Johnson company, and Amgen prior to her current role.

William Hallett, PhD, Biologist, CDER/OPQ/OBP
Will Hallett received his PhD from the University of Nevada, Reno and did postdoctoral work on immunotherapy at the Medical College of Wisconsin and at the University of Wisconsin-Madison. Will joined the FDA in 2012 as a Biologist and CMC reviewer and is now a Team Leader in the Office of Biotechnology Products in CDER. Will’s review responsibilities include CMC reviews of biotechnology products, immunogenicity assays, and inspectional assessment of cGMP facilities. 

Zhihua Jiang, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.
Zhihua Jiang is a group leader in Regulated Bioanalysis of BioMedicine Design at Pfizer Inc. His team is responsible for developing cell based neutralizing antibody assays to support immunogenicity assessment of clinical studies. He is also leading scientific research and development strategies to advance bioanalytical capabilities for assay efficiency and appropriateness, in support for non-clinical and clinical investigations. 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.

Kevin Larimore, PhD, Senior Scientist, Bioanalytical Sciences, BioMarin Pharmaceutical, Inc.
Kevin Larimore is a Sr. Scientist in BioAnalytical assay development at BioMarin. He received a Ph.D. from the University of California, Berkeley in Cell and Molecular Biology with a focus on Immunology. Kevin studied basic B cell biology and T cell-mediated tumor immunotherapy approaches at Berkeley, before pursuing post-doctoral HIV vaccine development in the lab of Phil Greenberg at the University of Washington and Fred Hutchinson Cancer Center, supported by the Bill and Melinda Gates Foundation. Since joining BioMarin in 2012, Kevin has developed BioAnalytical assay methods supporting multiple drug development programs ranging from pre-clinical to post-marketing.

Lilia Macovei, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.
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 Pfizer WRD Large Molecules biotherapeutic portfolio. She worked in in the development and validation of PK and Immunogenicity Assessment Assays (ADA and cell-based neutralizing antibody) for non-clinical GLP IND enabling 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, enzyme replacement therapeutics (ERT) using diverse viral vector platforms and chimeric antigen receptor T-cell (CART) therapies.

Mauricio Maia, PhD, Senior Scientist, BioAnalytical Sciences, Genentech, Inc.
Dr. Maia is a Senior Scientist in the BioAnalyatical Sciences Department at Genentech/Roche.  He has close to twenty-years of experience in biopharmaceutical-drug development, applying his expertise in the design of bioanalytical strategies to support recombinant-protein therapeutic programs. He oversees the development, validation and implementation of immunogenicity, pharmacokinetic, and biomarker assays.  Prior to his current position, Dr. Maia worked in a similar capacity at Protein Design Labs, and served as Assistant-Director of Infectious Diseases Laboratories, at the Massachusetts State Laboratory Institute.  He obtained his Ph.D. degree at UC Davis, and subsequently worked as a postdoctoral research fellow at Massachusetts General Hospital/Harvard Medical School, in Boston.  At Genentech, Dr. Maia leads multiple groups that enable bioanalytical support for drug development projects in the areas of oncology, ophthalmology, and infectious diseases.

Devangi Mehta, PhD, Associate Director, Development Biomarkers and Bioanalytical Sciences, Biogen, Inc.

Dr. Mehta is an Associate Director in the department of Development Biomarkers and Bioanalytical Sciences at Biogen, Cambridge, MA. She received her Bachelors in molecular biology and immunology from University of California, Berkeley in 1998 and earned her Ph.D. in biomedical sciences from Harvard University in 2005. In 2006, she completed a postdoctoral fellowship at the Novartis Institutes for Biomedical Research and then joined Tolerx as a Scientist responsible for preclinical PK/PD studies and implementation of clinical biomarkers to support Tolerx’s immune-modulating monoclonal antibody programs. Dr. Mehta joined Biogen in 2011 where she currently supports clinical programs in immunology and neurology disease areas, including the development of PK, immunogenicity and biomarker assays, as well as establishing biomarker and bioanalytical strategies to support the clinical development pipeline. She has special interest in advancing and implementing industry-wide best practices for assay development and “fit-for-purpose” validation of ligand-binding and flow cytometry assays.

Michael Partridge, PhD, Senior Staff Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc.
Born and raised in Australia, Michael received his Ph.D. from Sydney University (CSIRO) developing immunoassays to screen for genetic variants in plants. He moved to the US for a post doc at Columbia University where he investigated integrin-mediated cell signaling and motility. He went on to study tumorigenesis and eventually develop immunoassays to detect biomarkers of radiation exposure. Michael left academia to work in industry, and for the last 9 years at Regeneron he has lead a group of scientists developing and validating PK, ADA, Nab and biomarker immunoassays for nonclinical and clinical studies with biologics.

Jack A. Ragheb, M.D. PhD, Senior Medical Fellow, Immunology Global Patient Safety, Eli Lilly & Co
Dr. Ragheb has been with Eli Lilly & Co. for about 3 years. He is based in Indianapolis where he serves as the Senior Medical Fellow for Immunology in Global Patient Safety and Co-Chair of the Immunogenicity/Immunosafety Working Group. He received his MD and PhD degrees from the Johns Hopkins University and is a Diplomate of the American Board of Allergy & Immunology. Formerly, he was a Senior Clinical Investigator at NIH where he conducted clinical and basic research on immune tolerance and a Chief Medical Research Officer in the Office of Biological Products at the FDA where his research group established the BLT humanized mouse model there in an effort to predict the immunogenicity of biotherapeutics. He has published in the areas of immunogenicity, immune tolerance, CD28 and CD40L regulation, retrovirology and gene therapy.

Christian Ruzanski, PhD, Senior Scientist, Bioanalysis, Novo Nordisk A/S
Christian Ruzanski is a Senior Scientist in the Department of Development Bioanalysis at Novo Nordisk (DK). Christian received his PhD in Biochemistry from the University of East Anglia (Norwich, UK) before taking on a PostDoctoral Researcher position at the Carlsberg Laboratory in the Department of Enzymology in Copenhagen, Denmark. Prior to his professional engagement with Novo Nordisk, Christian held the position of Bioassay Scientist at AGC Biologics (Copenhagen, Denmark) where he specialized in the analytical support to the GMP production of biopharmaceuticals. Christian lives with his wife and two kids in Ballerup in the greater Copenhagen area and enjoys a good swim every once in a while. He is also a keen supporter of the German national football team.

Chris Stebbins, PhD, Principal Scientist, Translational Medicine, Biogen, Inc.
Biography unavailable

Lauren Stevenson, Ph.D., Director, Development Biomarkers and Bioanalytical Sciences, Biogen, Inc
Lauren is Director of Development Biomarkers and Bioanalytical Sciences at Biogen, Cambridge, MA. She earned her Ph.D. in Biomedical Sciences from Harvard University and completed a postdoctoral fellowship in molecular oncology at the University of Dundee, Scotland, before joining Therion Biologics where she began to develop her expertise in large molecule bioanalysis. She joined Biogen in 2006 where she leads a group of scientists, setting bioanalytical and biomarker strategies and developing PK, immunogenicity and biomarker assays in support of Biogen’s portfolio, spanning neurology, immunology, fibrosis, multiple sclerosis and rare disease indications. In concert with her scientific role, Lauren is passionate about people development and enjoys providing new scientific and leadership challenges for her team. She also engages the broader industry and regulatory agencies as an invited speaker and course instructor at multiple conferences and workshops.

Joleen T White, PhD, Director, Head of Project Support, NBE Drug Disposition, EMD Serono

Joleen White is Director, Head of Project Support for New Biological Entities in Quantitative Pharmacology and Drug Disposition at EMD Serono, Inc., a business of Merck KGaA, Darmstadt, Germany. She oversees a global scientific staff representing the department across the portfolio of biologics and antibody-drug conjugates. These scientists drive bioanalytical strategy, assess immunogenicity incidence and impact, author summary documents, and discuss scientific approaches with health authorities. Joleen earned a B.S. in Chemistry from Harvey Mudd College in 1997, and a Ph.D. in Biochemistry from The Scripps Research Institute in 2002. Prior to her position with EMD Serono, she worked across bioanalytical, biomarker, and immunogenicity as a Principal Scientist at Biogen, Group Leader at Bristol-Myers Squibb, and Senior Scientist at BioMarin Pharmaceutical Inc. Joleen is active in the international bioanalytical community, including chairing or moderating 8 conferences and sessions and representing EMD Serono on working groups for both AAPS and the International IQ Consortium.

Yuling Wu PhD, Associate Director, Clinical Pharmacology & DMPK, MedImmune

Yuling Wu, is the Head of Clinical Immunology and Bioanalysis (CIB) Group in Clinical Pharmacology & DMPK at MedImmune. She is responsible for Bioanalytical Sciences of PK/PD/ADA/NAb and disease biomarkers to support programs from research through clinical development and BLA. She was a Principal Scientist previously in PKDM at Amgen, where she developed and validated assays for various stages of projects. In particular, she was responsible for the development and validation of bone osteoporoses biomarkers in support of Denosumab commercialization. Prior to Amgen, Yuling was a Stuff Scientist at Life Technology focusing on developing biomarker assays of phospho-protein kinases in the signal transduction used for drug discovery. She completed her post-doctoral work at Stanford University. She received her Ph.D. from St. Bartholomew’s and the Royal London Hospital School of Medicine, University of London, U.K. She has authored or co-authored articles in numerous journals, book chapters and the white papers including validation and applications of biomarkers, an ECL-based drug specific IgE ADA assay, ADCC-based and ligand binding NAb assays etc.

Weifeng Xu, PhD, Senior Research Investigator, Bioanalytical Science, Bristol-Myers Squibb
Weifeng had rich experience in human immunology focusing on the interaction of different immune and non-immune cells. He was recruited to BMS on 2011 as the first dedicated person to develop cell-based neutralizing Ab assay, which is critical to characterize whether the anti-drug antibody developed by clinical patient can neutralize/reduce drug efficacy. This is challenging, since the cells used in the assay needs to be closely related to the Mechanism of Action of the drug, in addition, both patient serum factors and injected drug can interfere with the assay, as Weifeng will discuss later. So far Weifeng has developed and validated multiple cell-based NAb assays for some of the most important pipeline at BMS. Along the way, Weifeng fully utilized his knowledge and critical thinking to overcome the challenging in the field, for example, how residual/carry-over human mAb therapeutics can be measured after ADA extraction and more recently, the alternative ways to overcome drug interference other than acid-dissociation.

Haoheng Yan, PhD, MD, Chemist, OPQ/OBP, CDER/FDA
Dr. Haoheng Yan is a biologics CMC and immunogenicity reviewer in the Office of Biotechnology Products (OBP) in CDER/FDA. Haoheng joined FDA in 2014 as a full-time reviewer. She is the primary reviewer for numerous INDs and several BLAs. Dr. Yan has also gained extensive experience in immunogenicity assay review for monoclonal antibodies, pegylated proteins, fusion proteins, antibody drug conjugates, polypeptides and polynucleotides. She is a member of OBP immunogenicity working group and CDER Center of Excellence in Infectious Disease and Inflammation. Dr. Yan received her M.D. from Peking Union Medical College, Beijing China and her Ph.D in Molecular and Cellular Biology from the University of Massachusetts, Amherst

Immunogenicity Prediction and Control

Steve Bowen, PhD, Team Leader, Chemist, Office of Biotechnology Products, CDER, FDA
Dr. Steven Bowen is a Product Quality and Immunogenicity Reviewer in the Office of Biotechnology Products (OBP) at the U.S Food and Drug Administration. He is a member of the Immunogenicity Working Group within OBP, which focuses on issues related to biotech product immunogenicity including risk assessment, assay development and validation, and clinical outcomes. Dr. Bowen received his Ph.D. in Microbiology and Immunology from University of Maryland, Baltimore in 2012. His post-doctoral research in the Experimental Immunology Branch at the National Cancer Institute (Bethesda, MD) explored the DNA damage response associated with V(D)J recombination in developing T and B lymphocytes.

Sivan Cohen, PhD, Scientist, BioAnalytical Sciences, Genentech, Inc.
Dr. Sivan Cohen is a scientist in the Department of BioAnalytical Sciences (BAS) at Genentech. A trained immunologist, She received her Ph.D. in Immunology from the Weizmann Institute of Science and conducted her post-doctoral training in the laboratory of Dr. Jeffrey Rathmell in Duke University.  Sivan joined Genentech in 2017, and currently leads the development and implementation of in silico and in vitro bioanalytical assays to support evaluation of immunogenicity potential of Genentech’s biotherapeutic products.

Mark Fogg, PhD, Head, Immunology, Biology, Abzena
Dr. Mark Fogg is the head of immunology at Abzena and an Innovative immunologist with more than 10 years of experience in T cell and B cell immunology, cancer immunology and immunotherapy.

Timothy Hickling, PhD, Immunogenicity Sciences Lead, Biomedicine Design, Pfizer, Inc.
Dr Tim Hickling is Discipline Lead for Immunogenicity Sciences at Pfizer. He obtained his Biochemistry degree and Immunology Ph.D. from the University of Oxford. He carried out post-doctoral training at Glaxo and the MRC’s National Institute for Medical Research before taking up a lectureship at the University of Nottingham. Tim has worked on various aspects of innate and adaptive immunology in infectious and inflammatory diseases. Tim joined Pfizer in 2007 and has worked on early stage vaccines and from early discover to late stage development of biotherapeutics. He is passionate about applying our growing knowledge of the immune system to the development of safe and effect therapies.

Indigo King, PhD, Scientist, Immunology, Cyrus Biotechnology
Indigo works with computers to solve problems in protein engineering, developing predictive models, optimization algorithms, automation tools, and data analysis workflows for prediction of drug immunogenicity and high-throughput design of protein biologics. Currently a scientist/developer at Cyrus Biotechnology, they lead teams in vaccine and antibody engineering and develop cloud-based tools for molecular modeling and design. Previously a senior fellow and project leader with David Baker at the Institute for Protein Design, they worked on translating these computational solutions into novel therapeutics for immuno-oncology and infectious disease.

Kei Kishimoto, PhD, CSO, Selecta Biosciences
Dr. Kishimoto is the Chief Scientific Officer of Selecta Biosciences, a biotechnology company developing synthetic vaccines based on a novel self-assembling nanoparticle technology.  Prior to joining Selecta, Dr. Kishimoto was Vice President of Research at Momenta Pharmaceuticals where he led multidisciplinary teams in inflammation, oncology, and cardiovascular disease.  Previously he was Senior Director of Inflammation Research at Millennium Pharmaceuticals, where he provided the scientific leadership for four programs in clinical development, and an Associate Director of Immunology at Boehringer Ingelheim.  Dr. Kishimoto received his doctoral degree in Immunology from Harvard University and his post-doctoral training at Stanford University.

Karen Liao, MD, Investigator, GSK Associate Fellow, Immunogenicity and Clinical Immunology, GlaxoSmithKline
Karen Liao is an Investigator and Associate Fellow at GSK working in the department of Immunogenicity and Clinical 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, and 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. Her current research focuses on immunogenicity prediction using ex vivo PBMC derived assays.

Jad Maamary, PhD, Senior Scientist, Merck and Co., Inc.
Jad Maamary is an Associate Principal Scientist at Merck. He obtained his Ph.D. in Virology from Mount Sinai School of Medicine working on developing novel viral vaccine vectors. He conducted his post-doctoral training at The Rockefeller University in Molecular Genetics and Immunology where he investigated the immunomodulatory and effector function of antibodies. At Merck, Jad is working on immunogenicity prediction of biologics.

Ronit Mazor, PhD, Scientist, Antibody Discovery & Protein Engineering (ADPE), MedImmune, Inc.
Ronit Mazor joined Medimmune as a scientist at the end of 2017 where she focuses on minimizing the on immunogenicity of therapeutic proteins. Before joining Medimmune, Ronit was a post-doctoral fellow in the lab for Molecular Biology in NCI, working with Ira Pastan on recombinant immunotoxins. Her talk will focus on methods to reduce the immunogenicity of recombinant therapeutic proteins in cancer therapy.

Valerie Quarmby, PhD, Staff Scientist, BioAnalytical Sciences, Genentech, Inc.
Dr. Valerie Quarmby is a Staff Scientist in the Department of BioAnalytical Sciences at Genentech. At Genentech, Dr. Quarmby has developed bioanalytical methods & strategies to enable IND, BLA and related filings for: Nutropin, Xolair, Raptiva, Rituxan, Avastin, Lucentis, Perjeta and Kadcyla. She has also created bioanalytical methods, platforms and strategies for therapeutic proteins in the gRED Drug development pipeline. Dr. Quarmby currently chairs the internal group that establishes bioanalytical strategies for all protein therapeutics in the gRED drug development pipeline. She is the past Chair of the AAPS Therapeutic Product Immunogenicity Focus Group and a member of the 2010-2015 USP Immunogenicity Testing Expert Panel. Dr. Quarmby is co-author of several AAPS sponsored industry guidance documents and many publications in peer-reviewed journals.
Dr. Quarmby holds a Ph.D. in Hormone Physiology from the Imperial Cancer Research Fund and the University of London, England.  Prior to joining Genentech, Dr. Quarmby did postdoctoral work at NIH and UNC-CH followed by work in the clinical diagnostics industry.  In 2014, in recognition of her many contributions to the pharmaceutical industry, Dr. Quarmby was selected to be an AAPS Fellow.

Zuben E. Sauna, PhD, Principal Investigator, Plasma Protein Therapeutics, CBER/FDA
Zuben Sauna is a Principal Investigator and a Reviewer at the US Food and Drug Administration. His research interests lie in understanding the pharmacogenetic basis of the immune response to proteins used in therapeutic interventions as these affect efficacy and safety. His laboratory exploits a combination of computational, in vitro and ex vivo approaches to understand why some individuals and/or sub-populations develop immune responses while others do not. His work has published extensively in high impact journals such as Nature Biotechnology, Nature Medicine, Science, Science Translational Medicine and Nature Reviews Genetics. He received his Ph.D. from Poona University, India with subsequent training at the National Cancer Institute, Bethesda, USA.

Renu Singh-Dhanikula, PhD, Senior Research Investigator, Metabolism & Pharmacokinetics, Bristol Myers Squibb

Dr. Renu Singh Dhanikula, PhD is a Senior Research investigator at Bristol-Myers Squibb. Dr. Singh received her PhD from University of Montreal, Canada.  She has over 6 years of experience in pharmaceutical industry in the field of drug metabolism and pharmacokinetics, with emphasis on application of PK/PD modelling to enable translation of preclinical efficacy and safety to clinic. She is a member of American Association for Pharmaceutical Scientists and International Society of Pharmacometrics. She has several publications in the peer-reviewed journals and presentations in the scientific conferences.

Noel Smith, PhD, Senior Group Leader, Applied Protein Services, Lonza Pharma & Biotech
As a Senior Group Leader in Lonza’s Applied Protein Services Group, Noel Smith is responsible for developing human in vitro assay platforms to optimize the potency and safety of therapeutic proteins, vaccines and immunotherapies during the early stages of development. He studied Medical Biochemistry at the University of Wales and completed a PhD and subsequent post-doctoral studies at the University of Cambridge. Noel is also a board member of the European Immunogenicity Platform (EIP).

Daniela Verthelyi, PhD, Chief, Immunology Lab, Therapeutic Proteins, FDA/CDER
Dr. Verthelyi received her MD from the University of Buenos Aires and a PhD from the Virginia Tech in USA, and then completed a fellowship training in Immunology at the Section in Retroviral Immunology of the Center for Biologics Evaluation and Research of the FDA before joining the Laboratory of Immunology of Division of Therapeutic Proteins and eventually becoming its Chief. She has authored over 60 peer reviewed articles and several patents, serves on the NIH Human Immunology advisory board, The NIH Immunology Interest Group and NIH-FDA Cytokine Interest Group, and has received of the FDA's ‘Excellence in Laboratory Sciences Award, among other honors.

Joleen T White, PhD, Director, Head of Project Support, NBE Drug Disposition, EMD Serono
Joleen White is Director, Head of Project Support for New Biological Entities in Quantitative Pharmacology and Drug Disposition at EMD Serono, Inc., a business of Merck KGaA, Darmstadt, Germany. She oversees a global scientific staff representing the department across the portfolio of biologics and antibody-drug conjugates. These scientists drive bioanalytical strategy, assess immunogenicity incidence and impact, author summary documents, and discuss scientific approaches with health authorities.
Joleen earned a B.S. in Chemistry from Harvey Mudd College in 1997, and a Ph.D. in Biochemistry from The Scripps Research Institute in 2002. Prior to her position with EMD Serono, she worked across bioanalytical, biomarker, and immunogenicity as a Principal Scientist at Biogen, Group Leader at Bristol-Myers Squibb, and Senior Scientist at BioMarin Pharmaceutical Inc.
Joleen is active in the international bioanalytical community, including chairing or moderating 8 conferences and sessions and representing EMD Serono on working groups for both AAPS and the International IQ Consortium.

Li Xue, PhD, Senior Principal Scientist, BioMedicine Design, Pfizer, Inc.
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 a as a principal investigator for the regulated and non-regulated bioanalytical support of clinical and non-clinical studies. In 2009, Dr. Xue transitioned to the founding member of the immunogenicity sciences group focusing on the predictive immunogenicity. Dr. Xue is one of the key developers of the immunogenicity risk assessment concepts and strategies at Pfizer. Dr. Xue has provided the immunogenicity risk assessment and mitigation planning for numerous biologic projects at all stages of development. She also oversees the internal lab for immunogenicity risk assessment tool development and portfolio support.
Dr. Xue led the AAPS pre-existing antibody team to the development of the white paper on pre-existing antibody assessment and management (AAPS J, 2017).
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

Mitra Azadeh, PhD, Principal Scientist, Bioanalytical & Biomarker Development, Nonclinical Development, R&D, Shire
Mitra Azadeh is a Principal Scientist in the Bioanalytical and Biomarker Development team at Shire.  In her current role, she is responsible for the design, development, and validation of bioanalytical and biomarker methods as well as management of both internal and external PK, ADA, and neutralizing antibody assay projects in support of clinical and non-clinical studies. Prior to Shire, she played a similar role in the Bionalaytical Sciences group of Allergan where she additionally established GLP compliance. Before Allergan, she served as a Senior Principal Investigator at the Covance Immnunochemistry division where she managed bioanalytical studies for numerous pharmaceutical clients.  She has held positions in GMP and GLP compliant biotechnology, immunodiagnostic, CRO, and pharmaceutical companies and has eighteen years of experience in immunoassay, bioassay, cell-based, neutralizing antibody, immunogenicity and biomarker assay development and validation in a variety of platforms. She received her doctoral degree in Cellular Biology from The Catholic University of America.

Robyn Beckwith, PhD, Technical Development Scientist, Analytical Development and Quality Control, Genentech
Dr. Robyn Beckwith is a Scientist in Analytical Development and Quality Control at Genentech, a Member of the Roche Group.  She received her Ph.D. in Molecular and Cell Biology from the University of California, Berkeley, researching principles of mechano-chemical protein unfolding by the eukaryotic proteasome.  She transitioned to industry working at Theranos, where she developed a variety of microscale clinical diagnostic assays for integration onto a unique automated platform.   Robyn joined Genentech in 2016 with a principle role in the technical development and validation of analytical bioassays to support biological characterization of large molecule therapeutics.  She continues to keenly pursue research interests in the advancement and implementation of automation technologies for complex assay systems.

Keith M. Bower, Principal CMC Statistician, Process Sciences, Seattle Genetics
Keith M. Bower is Principal CMC Statistician at Seattle Genetics, and an Affiliate Assistant Professor at the University of Washington. He received a Bachelor of Science degree in Mathematics with Economics from Strathclyde University (UK) and a Master of Science degree in Quality Management & Productivity from the University of Iowa (USA).

Stephen Hartman, PhD, Principal Scientist, AbbVie
Steve Hartman leads the Bioassay Development group at the AbbVie site in Redwood City, CA. He received his Ph.D. in Cellular and Molecular Biology from Yale University. He then joined the bioassay group at PDL BioPharma, which created the spin-off company Facet Biotech, which was acquired by Abbott Laboratories, which then founded AbbVie as a separate biopharmaceutical company. Steve’s group specializes in the development, qualification, transfer, and maintenance of cell-based and non-cell-based binding and functional potency assays for product release, stability, and characterization testing. He has worked in the bioassay field for over 10 years.

Samantha Jeshonek, PhD, Research Informatics Analyst, Research Informatics, Collaborative Drug Discovery
Jeshonek holds a BA in Biology/Chemistry from New College of Florida, M.A. and Ph.D in MoleBio/Cell Bio/Biochem from Brown.  Samantha focused on RNA localization in Xenopus laevis oocytes, with an emphasis on proteomic and transcriptomic characterization of large RNA-protein transport complexes. At CDD Samantha is working in biologics in the Research Informatics Team.

Martin Kane, MS, CRE, Managing Data Scientist, Statistical and Data Sciences Practice, Exponent
Mr. Kane is Managing Data Scientist in the Statistical and Data Sciences Practice of Exponent. In his more than five years with Exponent, he has provided proactive (R&D and Quality) consulting services in the fields of biopharmaceuticals, pharmaceuticals, medical devices, and industrial design and manufacturing for many clients.  Prior to joining Exponent, Mr. Kane spent nearly 11 years at GlaxoSmithKline (previously Human Genome Sciences) where he ended his tenure as Director of Process Statistics. At Human Genome Sciences, Mr. Kane was responsible for all statistical analyses of PK, immunogenicity, neutralization, and potency assays, and he has implemented Design of Experiments across cell culture, purification, formulation, and analytical development processes.  He also enjoys applying Measurement System Capability analyses and Statistical Process Control in lab and industrial settings. Mr. Kane is also an active Senior Member in the American Society for Quality, and is a Certified Reliability Engineer.

David Lansky, PhD, President, Precision Bioassay, Inc.
David Lansky’s training includes both biology (BS in Botany from San Francisco State and MS in Entomology from Cornell) and statistics (MS and PhD in Biometry from Cornell). David has been practicing statistical design and analysis of biological assays for over 30 years. He had a substantial role in the development of the USP bioassay chapters (<103X>) and currently leads a subcommittee that is working on revisions to those chapters.

Thomas Little, Ph.D., 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.

Steven Novick, PhD, Director, Statistical Sciences, Medimmune
Steven Novick currently holds the title of Director of Statistical Sciences with MedImmune.  He spent the bulk of his statistics career with GlaxoSmithKline, consulting and collaborating on CMC and Discovery problems and dabbling in clinical trial simulation.  Steve received his Ph.D. in statistics from North Carolina State University in 2000 and regularly publishes articles in peer-reviewed statistics journals.  In addition, he has co-authored several book chapters in various areas of non-clinical statistics.  At home in Raleigh, North Carolina, Steve lives with his wife, two teenage children, and a Lhasa Apso dog named Morgan.  In his spare time, Steve enjoys spending time with his family, playing piano, jogging, and practicing martial arts.

Brian R. Peterson, President, Bioassay Solutions LLC
Biography Unavailable

Timothy Schofield, Senior Advisor, Technical Research & Development, GSK
Timothy Schofield is a Senior Advisor in the Vaccines Technical Research & Development department at GSK. Prior to joining GSK Tim worked at MedImmune as a Senior Fellow in Analytical Biotechnology, at Arlenda, Inc. as Managing Director and Head of Nonclinical Statistics, at GSK in US Regulatory Affairs, and at the Merck Research Laboratories heading the Nonclinical Statistics unit. Tim is a member of the USP Statistics Expert Committee and has participated in industry initiatives related to Quality by Design, analytical method development and validation, stability and specifications. Tim received a Master of Arts degree in Statistics and Operations Research in 1976 from the Wharton School of the University of Pennsylvania in Philadelphia.

Mingfang Shen, Principal Development Associate, Translational Research, ImmunoGen, Inc.
Biography Unavailable

Perceval Sondag, Senior Manager, Statistics, PharmaLex
Perceval Sondag holds a Bachelor Degree in Physical Therapy and a Master’s Degree in Biostatistics, both obtained from the Catholic University of Louvain-la-Neuve in Belgium. He then began his career by implementing statistical thinking in the newly created Operational Excellence department of the Brussels Saint-Luc University Hospital.
He joined Arlenda in 2013 as a Statistician consultant, and moved to the US based team in 2015. He specializes in Bayesian modelling and statistics applied to bioassays and process manufacturing. In addition to his job at Arlenda, providing statistical support for small and big pharmaceutical companies across the globe, he currently works on a PhD thesis about Similarity Testing for Bioassays. He is a member of the USP Expert Panel for Bioassays and has authored or co-authored multiple publications, including a book chapter on assay validation.

Dr. Ralf Stegmann, Stegmann Systems

Ralf Stegmann earned his PhD in Computational Chemistry from the Philipps-University Marburg Germany in 1999. Already during the work on his thesis, he entered the field of biological assay analysis as a software developer. Ralf now serves as CEO, founder and owner of Stegmann Systems and leads a team of over 30 biostatisticians, (bio-) chemists and software developers that are constantly improving the well-known biological assay software “PLA 3.0”. The software is currently used by over 500 companies worldwide, giving him and his biological assay team a deep insight into the evaluation of biological assays.