Immunogenicity Assessment & Clinical Relevance | Immunogenicity Prediction & Mitigation | Optimizing Bioassays for Biologics
> Immunogenicity Assessment & Clinical Relevance
Francesca Civoli, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.
Isabelle Cludts, Ph.D., Biotherapeutics, National Institute for Biological Standards and Control (MHRA, UK)
Isabelle Cludts gained her PhD in 1994 at the ‘Brussels Free University’ (ULB) in Belgium. She worked in molecular biology and virology, in Belgium and England (Ludwig Institute for Cancer Research). She joined the National Institute for Biological Standards and Control (now part of the Medicines and Healthcare Products Regulatory Agency) to work in the Biotherapeutics department. She is involved in evaluating techniques and developing assays to assess the immunogenicity of biological therapeutics, particularly antibody therapeutics. She is also involved in developing non-cell-based neutralization assays.
Stephen DeWall, Ph.D., Investigator, Clinical Immunology, GlaxoSmithKline
Steve DeWall has been an Investigator in the GSK Clinical Immunology group since September 2010. His main role is providing immunogenicity assessments for biotherapeutics across several therapy areas. This involves overseeing the development and validation of immunogenicity and target-engagement biomarker assays to support all clinical study phases. Prior to joining GSK, Steve worked for Siemens Healthcare developing In Vitro Diagnostic (IVD) assays. He has over 9 years experience developing immunoassays in the pharmaceutical and IVD industries. He received his PhD in Biology and Biomedical Sciences from Washington University Medical School in St. Louis. After completing graduate studies, he was a post-doctoral fellow at Harvard University in the laboratories of Profs. Don C. Wiley and Timothy J. Mitchison.
Martin Gleeson, Ph.D., CSO, Genalyte, Inc.
Martin Gleeson is a biotech veteran. He brings 25 years of management experience in the research, development and launch of innovative products to serve the life sciences market. Dr. Gleeson came to Genalyte from ZyGem Corp., a successful start-up company focused on sample preparation and genetic analysis, where he was a founding director. Prior to this, he gained a wealth of experience at Invitrogen Corp., where he directed R&D, with a focus on evaluation, integration and productization of technologies, obtained through licensing and acquisition. Earlier in his career Dr. Gleeson held research applications and research management positions at Ligand Pharmaceuticals and SIBIA (since acquired by Merck). Dr. Gleeson earned his Ph.D. in Genetics from the University of Sheffield, England. He holds more than 30 pending and issued patents and has written more than 25 peer reviewed scientific publications in journals and books.
Bridget Heelan M.B. Ph.D., V.P. Consulting, Parexel, (ex-MHRA)
Bridget Heelan VP (tech) at PAREXEL Consulting joined Parexel in 2014 after 6 years as a senior clinical assessor in the biological unit at the MHRA. During this time she was also the chair of the Rheumatology Immunology Working Party at the EMA and the UK delegate for the Committee for Advanced Therapies. Dr Heelan worked as a consultant immunologist in the NHS for 8 years with a particular focus on immunodeficiency (primary and secondary) and also autoimmunity and allergy. She has a broad background in general medicine. Her doctorate and her post-doctoral work were on transplantation immunology.
Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, CDER/FDA
Dr. Susan Kirshner received an M.Sc. from University of North Carolina School of Public Health in the field of environmental toxicology. She received a Ph.D. in Immunology from the Weizmann Institute of Science, where she worked on the development of a biological therapeutic. Dr. Kirshner’s post-doctoral training was at the National Cancer Institute in the area of transcriptional regulation of MHC class I genes. Dr. Kirshner worked both in the government and industry before joining the Division of Therapeutic Proteins in the Office of Biotechnology Products at the US FDA over 8 years ago. She is currently the Associate Chief of the Laboratory of Immunology at the FDA.
Mauricio Maia, Ph.D., Bioanalytical Sciences, Genentech, Inc.
Dr. Maia has over fifteen years’ experience in development, validation and interpretation of immunogenicity, pharmacokinetics, and clinical diagnostic bioanalyses, as well as in vitro characterization of recombinant-protein therapeutics. At Genentech, he is in a multidisciplinary group responsible for bioanalytical support provided at all stages of drug development programs. Prior to his current position, he worked in a similar capacity at Protein Design Labs; and as Assistant-Director in the Infectious Diseases Laboratories Division, at the Massachusetts State Laboratory Institute. Obtained his Doctorate degree at UC Davis, and did postdoctoral research work at Massachusetts General Hospital/Harvard Medical School.
Jim McNally, Ph.D., Senior Principal Scientist, Biotherapeutics Research, Pfizer, Inc.
Jim McNally is the lead of the newly formed Clinical Assay Development, Validation and Testing bioanalytical group at Pfizer. The group, based in Andover, MA, is responsible primarily for developing assays to support pharmacokinetic and immunogenicity analysis of the Pfizer large molecule portfolio. They are also responsible for the scientific oversight of outsourced validations and testing at numerous CROs. Prior to joining Pfizer in 2010, Jim held similar roles in the Clinical Lab Sciences group at Genzyme and Immunobiology group at Repligen. 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.
Reza Mozaffari, Investigator, Clinical Immunology, GlaxoSmithKline
Reza Mozaffari is an Investigator in GlaxoSmithKline’s Clinical Immunology Department. He currently leads part of the clinical immunology efforts in implementing immunogenicity and biomarker assays across multiple therapy areas and clinical study phases. As a clinical team member, he is responsible for the design, development and validation of novel ADA, Nab and biomarker assays in support of clinical studies. He received his BS from Drexel University and has over 10 years of immunoassay development experience in the pharmaceutical industry.
Daniel T. Mytych, Ph.D., Scientific Director, Clinical Immunology, Amgen, Inc.
Dr. Daniel Mytych is currently Scientific Director of Clinical Immunology at Amgen. Prior to joining Amgen, he was a Scientist at Schering Plough (now Merck) for 8 years. He has over 20+ years of experience in development and validation of immunoassays to support basic research and large molecule drug and anti-drug antibody detection. His focus over the past 14 years has been the non-clinical and clinical immunogenicity support throughout the biologic development process, including immunotoxicology assessment and support. He has expertise in numerous assay platform technologies (SPR, ECL, and ELISA), GLP/GMP compliance, regulatory, and clinical characterization and impact assessment of anti-drug antibodies. He received his Bachelor’s degree in Biology from Virginia Commonwealth University, Master’s degree in Microbiology from Seton Hall University and a Ph.D. in Molecular Pathology and Immunology from the University of Medicine and Dentistry of New Jersey.
Michael Partridge, Ph.D., Staff Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc.
Born and raised in Australia, Michael Partridge completed his Ph.D. in 2000 (Sydney University, CSIRO) developing immunoassays to screen for genetic variation in plants. He subsequently moved to the US to complete a post doc at Columbia University where he studied integrin-mediated cell signaling and motility. He went on to study tumorigensis and eventually develop immunoassays to detect biomarkers of radiation exposure. In 2008, Michael left academia to work in biotech, and for the last five years, Michael has been at Regeneron leading a group developing/validating PK and ADA immunoassays for nonclinical and clinical studies.
Gisela Peraus, Ph.D., Lab Head, Pharmacology, Novartis
Dr Gisela Peraus gained her PhD in 1997 at the Ruprecht-Karls University in Heidelberg, Germany. She started her career at Hoechst-Marion-Roussel(now Sanofi-Aventis) where she worked on identification and validation of new drug targets of neurobiological diseases. She subsequently joined a biotechnology company in Munich as a project leader in neurobiology for in-vivo and in-vitro test systems. Prior to her current position at Novartis she gained experience in bioanalyticsat a small company in the Basel area with the focus on development and validation of cell based neutralizingantibody assays. As an investigator at Novartis she is responsible to provide bioanalytical support for pre-clinical and clinical biological projects, in particular by developing and validation of pharmacokinetic, pharmacodynamic and immunological assays.
Laura Salazar-Fontana, Ph.D., Senior Staff Fellow and Immunogenicity Program Coordinator, Therapeutic Proteins, CDER/FDA
Dr. Salazar-Fontana is a Chemistry, Manufacturing, and Controls reviewer and Immunogenicity program coordinator within the Division of Therapeutic Proteins at the Office of Biotechnology Products (OBP, CDER, FDA). She obtained her PhD in Madrid (Spain) and built her scientific career by focusing on the role of co-stimulatory molecules in the activation of helper T cells, especially in the context of the autoimmune diseases, such as Rheumatoid Arthritis and Systemic Lupus Erythematosus. After completing her PhD, she moved to the United States for her postdoctoral training at the National Institutes of Health (NIH), where she studied the signaling pathways derived from the co-stimulatory molecules CD28 and CD43 that contribute to the reorganization of the T cell actin cytoskeleton during antigen recognition. She went on to obtain a faculty position at the Pediatrics Department of the School of Medicine at George Washington University (GWU) where she continued the studies on T cell development and generation of adaptive immune responses. She transitioned to the policy field by collaborating as a Science policy consultant with the University of California at Santa Cruz before joining the FDA.
Steven J. Swanson, Ph.D., Executive Director, Medical Sciences, Clinical Immunology, Amgen, Inc.
Dr. Swanson joined Amgen in 1999 to build the Clinical Immunology Department whose mission was to focus on anti-therapeutic antibody issues. This department supports functions including development, validation, and performance of all immunoassays and bioassays for the detection of antibodies directed against Amgen’s therapeutic proteins. In addition, the cellular immunology group within Clinical Immunology as part of Amgen Medical Sciences investigates cellular interactions through FACS, LSC, confocal microscopy, and other imaging techniques and contributes to biomarker work to support product development.
Harry Yang, Ph.D., Senior Director, Translational Sciences MedImmune, LLC
Harry Yang, Ph.D., is the head of Non-Clinical Biostatistics Group at MedImmune, the Global Biologics Arm of AstraZeneca headquartered in Gaithersburg, Maryland. The group provides statistical support for various functional areas including research, biopharmaceutical development, manufacturing, and regulatory affairs. He is an author of a statistical book and over 70 statistical and scientific manuscript publications. He is also the primary inventor of a patented algorithm used in a marketed DNA probe-based diagnostic system, and a key member of several working CMC working groups. Most recently he was invited to conduct a two-day statistical training course at the FDA, aimed at equipping the reviewers with practical statistical tools so that they can effectively assess statistics-based information in manufacturer’s submission as well as covering issues found during inspections. He received his BS and MS degrees in applied mathematics from Peking University and a Ph.D. in statistics from the University of Pittsburgh.
Surendran Rajendran, Ph.D., Senior Research Investigator II, Bioanalytical Sciences, Biologics, Bristol-Myers Squibb
> Immunogenicity Prediction & Mitigation
Sathy Balu-Iyer, Ph.D., Professor, Pharmaceutical Sciences, SUNY-University at Buffalo
Juliana Bessa, Ph.D., Lab Head, PRED, Immunopathology, Roche Innovation Center Basel
I am a Pharmacist by training. In 2003 I concluded my master thesis in autoimmunity at the Heart Institute, Faculty of Medicine of University of São Paulo. I moved to Switzerland in 2004 to perform my PhD in Immunology at Swiss Federal Institute of Technology Zurich (ETHZ), Switzerland under the supervision of Dr. Martin Bachmann and Prof. Manfred Kopf. During the 4 years PhD I studied the induction of mucosal and systemic antibody responses by virus-like particles. In 2009, I was hired as Scientist by Cytos Biotechnology in Zurich where I continued to explore immunogenic aspects of virus-like particles. In October 2010 I joined F. Hoffmann-La Roche in Basel as Roche Postdoc fellow (RPF) under the supervision of Dr. Antonio Iglesias where my project was to develop a human-IgG transgenic mice for the study of immunogenicity of therapeutic antibody preparations. In 2013 I was hired as Immunopathology Scientist where I am responsible for providing immunosafety support to drug discovery projects in addition to continuing exploratory activities on drug immunogenicity using transgenic mouse models.
Merry Christie, Scientist, Pharmaceutical Sciences, University of Colorado
Merry holds a B.S. in Chemistry from Loyola University Chicago where she worked under Dr. Ken Olsen to develop a hemoglobin conjugate for use in phototherapy. She is currently finishing up her last year of graduate school in Dr. John F. Carpenter’s lab at the University of Colorado to obtain a Ph.D. in Pharmaceutical Sciences. Her thesis has focused on investigating the role of various contributors to the immunogenicity of protein therapeutics and the immune mechanisms involved with this phenomenon. This work has allowed her to develop expertise in protein expression and purification, the characterization of protein aggregates and particles, immunoassays and establishment of animal protocols. She is primarily interested in understanding how and why the immune response to proteins occurs in order to improve safety of therapeutics.
Annie S. de Groot, M.D., Research Professor & Director, Immunology and Informatics, University of Rhode Island, Also CEO/CSO: EpiVax, and Professor/Director: iCubed, The University of Rhode Island
Dr. Anne S. De Groot earned her B.S. at Smith College B.S. in 1978, her M.D. at the Pritzker School of Medicine / University of Chicago (1983), worked on field campaigns to vaccinate against measles in Zaire, and then trained in Internal Medicine (New England Medical Center 1986); earned a research (NRSA) fellowship in tropical medicine and vaccinology (NIH, 1986-89), and underwent specialty training in infectious disease at Tufts New England Medical Center (1989-92). She earned board certification in Internal Medicine (1986) and Infectious Disease (1992). Having been awarded her first R01 as a research fellow at NEMC, she moved to Brown University, joined the Medical Faculty (1992-2011), establishing a productive vaccine research laboratory and developing new tools for vaccine design (EpiMatrix, Conservatrix, ClustiMer). Having licensed these tools from her laboratory at Brown, she established EpiVax (1998-present) with business partner Bill Martin. In 2008 she was invited to open the Institute for Immunology and Informatics (iCubed) at the University of Rhode Island. She has served as CEO/CSO at EpiVax from 1998 to present and as Director of the Institute and Research Professor at University of Rhode Island since 2008. Although De Groot is already well established in the fields of immunoinformatics and vaccinology, the co-discovery of Tregitopes resulted in a major shift in her research efforts, to which she has added new explorations in autoimmunity and tolerance.
Daron Forman, Ph.D., Principal Scientist, Immunogenicity Prediction, Bristol-Myers Squibb
Daron Forman, Ph.D. is Principal Scientist for Bristol-Myers Squibb’s Immunogenicity Prediction Core. Dr. Forman holds a B.A. in biology and in psychology from the University of Rochester and a Ph.D. in Virology/Immunology from the University of Massachusetts Medical School in Worcester. Dr. Forman has spent over 18 years working on various therapeutic proteins in both academia and industry. Prior to BMS, Dr. Forman was with Tolerx, where he investigated the mechanism of action and potential biomarkers for several therapeutic Abs, including anti-CD3 and anti-GITR mAbs. Dr. Forman joined BMS in 2009, and his current responsibilities include in silico, in vitro and in vivo evaluation of therapeutic proteins for potential clinical immunogenicity.
Karl E. Griswold, Ph.D., Associate Professor, Thayer
School of Engineering, Dartmouth
Karl Griswold is an Associate Professor of Bioengineering atDartmouth. His work in the field of protein engineering has resulted in the
development of new tools for protein deimmunization, enhanced microbialproduction systems, novel strategies for gene library construction, and new
approaches to high throughput screening of recombinant protein libraries. Atthe Thayer School, his research group is seeking to develop and utilize tools for protein design and engineering while placing a priority on therapeutic applications. Karl studied as a DOW Foundation Scholar at Texas State University,receiving a B.S. in chemistry in 1995. After working two years at Thermo Electron Corporation and two years with Huntsman Corporation, he returned to academia receiving a Ph.D. from the University of Texas at Austin in 2005.
Following a postdoctoral fellowship with George Georgiou, he joined the Dartmouth Thayer School of Engineering faculty, where he continues to teach and
maintain an interdisciplinary research group. In September of 2013, he co-founded the biotechnology startup Stealth Biologics LLC, where he serves as
CEO. Working with partners in the biopharmaceutical industry, Stealth Biologics is pursuing development of novel, immunotolerant, protein therapeutic
Tim Hickling, Ph.D., Associate Research Fellow, Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.
Dr. Tim Hickling is currently investigating the immunogenicity of biotherapeutics at Pfizer. He obtained his Biochemistry degree and Immunology Doctorate 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.
Vibha Jawa, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.
Dr. Vibha Jawa is a Principal Scientist at Amgen in the Department of Clinical Immunology. She obtained her Ph.D. in Biochemistry and Immunology with a thesis work studying the immune mechanisms behind autoimmune diseases. This was followed by a postdoctoral fellowship at University of Pennsylvania where she did extensive work on assay development for monitoring the immune response to viral vectors. She then moved to the Bay area where she worked with a gene therapy company evaluating viral vectors for hemophilia therapy. She then moved to Southern California where she worked for City of Hope Cancer Centre Stem Cell and Gene Therapy group prior to moving to Amgen in 2002. As a Principal Investigator and Clinical Immunology representative on several of Amgen’s drug development teams for the past 12 years, she is responsible for developing and validating immunoassays capable of detecting anti-drug antibodies. Her current research interests include evaluating immune cells as biomarkers for early drug development and efficacy, immunogenicity prediction using in silico technologies, modeling impact of immunogenicity on PK and PD , antigen processing and presentation and the role of T cells in immune response to drug products.
Kei Kishimoto, Ph.D., 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.
Mads Kjelgaard-Hansen, Ph.D., Principal Scientist, Translational Haemophilia Pharmacology, Novo Nordisk A/S
Sophia Levitskaya, Ph.D., Scientist, Analytical Biotechnology, MedImmune
Ronit Mazor, Ph.D., Post Doctoral Fellow, Laboratory of Molecular Biology, National Cancer Institute, NIH
Ronit Mazor is a member of the Laboratory of Molecular Biology at the National Cancer Institute. She received a B.S. and M.S. from Tel-Aviv University and after working in industry for several years in Luminex Corporation is now completing her PhD with Ira Pastan. The topic of her thesis is the identification and removal of T cell epitopes in non-human proteins.
Jack Ragheb, Ph.D., Principal Investigator, Therapeutic Proteins, FDA/CDER
Jack A. Ragheb, M.D. Ph.D. is a Senior Regulatory Research Officer and Principal Investigator in the Division of Therapeutic Proteins/OBP/OPS/CDER/FDA and an Attending Physician on the Allergy Immunology Service, NIAID, National Institutes of Health, Bethesda, MD. A graduate of the Johns Hopkins University and School of Medicine, he performed his clinical training at the Johns Hopkins Hospital and National Institutes of Health. A recipient of numerous research awards, his work and publications has spanned the fields of retrovirology, gene therapy, immune activation, and clinical trials in immune tolerance. He is actively investigating the use of humanized mouse models to predict the immunogenicity of therapeutic proteins.
Amy Rosenberg, Ph.D., Director, Therapeutic Proteins, FDA CDER
Noel Smith, Ph.D., Senior Group Leader, Lonza Biologics, Lonza Applied Protein Services, Lonza
Noel Smith completed his PhD and subsequent post-doctoral studies at the University of Cambridge (UK) before moving to Lonza. Dr Smith currently leads an immunology group in Lonza’s Applied Protein Services Department where his work focuses on developing human in vitro tools to assess the immunogenicity of therapeutic proteins and vaccines.
Daniela Verthelyi, Ph.D., 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 Immunology Interest Group and NIH-FDA Cytokine Interest Group, and has received of the FDA's ‘Excellence in Laboratory Sciences Award, among other honors.
David C. Wraith, Ph.D., Professor, Experimental Pathology, University of Bristol, & CSO, Apitope International NV
David Wraith is a research immunologist and Professor of Experimental Pathology at the University of Bristol. He is also founder and CSO of Apitope NV, a University of Bristol spinout company that designs and develops peptides for antigen-specific immunotherapy of allergic and autoimmune diseases. David began his career at NIMR, London, working on the immune response to viruses. He received MRC funding to work at Stanford University in California where he developed his interest in autoimmune diseases. This led to him establishing a Wellcome Trust funded research laboratory at the University of Cambridge and, in 1995, he took up the Chair in Experimental Pathology in Bristol. His group is principally supported by the Wellcome Trust, MRC and MS Society UK.
> Optimizing Bioassays for Biologics
Carl Apgar, Ph.D., Field Application Scientist, PerkinElmer
Shawn Fernando, Senior Researcher, Morphotek, Inc.
Senior Researcher Shawn Fernando is responsible for bioanalytical assay development at Morphotek Inc., a biopharmaceutical company in Exton, PA. Shawn is the lead scientist for method development/troubleshooting biochemical and immunological assays under GLP conditions to evaluate pharmacokinetics and immunogenicity analysis in support of preclinical and clinical studies of biologics. He then assumed the role of Principal Scientist in order to take responsibility of the technical conduct of a bioanalytical study as well as for the interpretation and analysis, documentation , and reporting of results in support of preclinical and clinical studies.
Jaya Goyal, Ph.D., Director, Translational Sciences, Biogen Idec
Dr. Jaya Goyal is a Director in the Translational Sciences department at Biogen Idec, Inc., Cambridge Massachusetts and a member of Value Based Medicine team. Dr. Goyal has been involved in developing translational biomarker strategies and has been leading the personalized medicine initiative at Biogen Idec. Her research interests also include the study of pharmacogenomics.
Dr. Goyal has been at Biogen Idec for past 13 years, she received her Ph.D. degree in Biochemistry from Central Drug Research Institute, India in 1993 and did her post-doctoral training at the Rush Presbyterian St. Luke’s Medical Center, Chicago and New England Medical Center, Boston in the Department of radiation biology.
Lichun Huang, Ph.D., Senior Scientist, Genentech
Dr. Lichun Huang has over fifteen years of assay development experience in the diagnostic and pharmaceutical industry, particularly in potency assay development for protein therapeutics and novel gene and cell therapy products. Currently, Dr. Huang is leading a group of 8 scientists and specialists, with expertise ranging from clinical assays (clinical chemistry, immunoassays, hematology and histology/IHC) to activity assays (cell based or enzymatic), to support translational needs in early phase of drug development. Dr. Hunag's achievements include overseeing successful validation and transfer of potency assays and obtaining FDA approval for a release/stability assay used for a commercial product.
Palanisamy Kanakaraj, Ph.D., Associate Director, Pharmacology, Zyngenia, Inc.
Dr. Palanisamy Kanakaraj is presently an Associate Directory of Pharmacology at Zyngenia, Inc, a biotech company specialized in developing multi-specific antibodies. Kanakaraj’s research interests include receptor-ligand interactions, cell signaling, in vitro and in vivo studies to support development of biologics and developing bioassays for lot release and stability testing. Previously, he held scientific positions at various biotechnology and pharmaceutical companies including RW Johnson Pharmaceutical Research Institute, centaur pharmaceutical, Inc, Human genome Sciences, Inc, CoGenesys, Inc. and Teva pharmaceuticals. He obtained his M.S in biochemistry from University of Madras and Ph.D from Indian Institute of Technology, Madras.
David Lansky, Ph.D., President, Statistics, Precision Bioassay, Inc.
David Lansky’s education includes a year of Electrical and Computer Engineering (University of Michigan), a gap, a BS in Botany (San Francisco State), an MS in Entomology (Cornell) then an MS and Ph.D. in Biometry (both Cornell). David has 25 years experience with bioassay development, analysis, and validation, including 10 years at Searle/Monsanto/Pharmacia and 12 years as the owner of Precision Bioassay, Inc. David had a substantial role in the recent major revision of the USP bioassay chapters.
Janet Lathey, Ph.D., Consultant, Product and Assay Development and Evaluation
Dr. Janet L. Lathey is currently a consultant specializing in Bioassay Development, Validation, and Standardization. Previously, she was Director of Immunology and Assay Validation at Emergent BioSolutions in Gaithersburg, MD. Primary work areas were Toxin Neutralization assays, ELISA, and ELIspot for Anthrax vaccine evaluations for potency, and clinical and animal trial assessments. She was Deputy Director for Global Clinical Immunology at Sanofi Pasteur, Swiftwater, PA. As a Project Representative and Manager, she was involved with standardizing assays for influenza clinical trials and efficacy studies, supporting the licensure of seasonal and pandemic influenza vaccines. Before moving to Sanofi, Janet was director of Virology and Immunology at SeraCare in Gaithersburg, MD. Here she was responsible for developing an ELIspot kit for market and setting up proficiency testing using ELIspot for HIV and Cancer programs. In addition, two new products were developed: PBMC cell bank for use in assay development and standardization and a cellular assay control for the Digene HPV screening assay. At ZYCOS in Lexington, MA, Janet was group leader for clinical immunology and developed bioassays for the evaluation of Phase I and II cancer clinical trials.
Before moving to industry, Dr. Lathey was an Associate Research Scientist and co-director of the retro-virology laboratory at University of California, San Diego in the department of Pediatrics. She was heavily involved in developing assays for evaluating anti-retroviral clinical trials for treatment of HIV. She was the leader of nationwide assay working groups for both virological and immunological assays for the AIDS Clinical Trial Group (ACTG). Janet completed a post doctorial fellowship in Viral pathogenesis at Scripps Clinic and Research Foundation, La Jolla, CA. after receiving her Ph.D. in Viral Immunology from the University of Tennessee in Knoxville, TN.
Shihua Lin, Ph.D., Analytical Biotechnology Development, MedImmune, Inc.
Shihua Lin received his PhD in neuroscience and cell biology from Kyoto Institute of Technology, and postdoctoral training at Wayne State University School of Medicine. He has over 12 years of experience in pharmaceutical companies specializing in biomarker discovery, translational sciences and bioassay development in a number of fields. Before joining MedImmune, he was a bioassay scientist at Teva Pharmaceuticals responsible for cell-based assay development and validation as well as GMP sample testing. During 2002 to 2011, Shihua was a scientist and senior manager at Otsuka America Pharmaceuticals, where he was responsible for target screening, assay development and drug evaluation.
Tina S. Morris, Ph.D., Vice President, Biologics & Biotechnology, United States Pharmacopeial Convention, Global Science & Standards Division
Dr. Tina Morris is Vice President, Biologics and Biotechnology, USP-NF in the Global Science and Standards Division at USP, which she joined in 2003. She coordinates all standard-setting activities in the division related to biologics and biotechnology for the US-based compendia and manages the scientific staff responsible for the relevant Expert Committees, the development of biological reference materials, and the biologics laboratory at USP Headquarters.
Before joining USP, Dr. Morris’ industrial experience includes major biotech companies in the areas of analytical development, especially mass spectrometry, and recombinant protein characterization. Dr. Morris is the holder of several United States patents in the areas of virology and mass spectrometry assay development. She is the author of many publications in peer-reviewed journals and a frequent invited speaker at national and international scientific conferences.
Before working in industry, Dr. Morris was a Young Investigator Award Fellow for the German Cancer Research Center at the National Institute of Allergy and Infectious Diseases in Bethesda, working on the Virology of Hepatitis A with Dr. Robert H. Purcell.
Dr. Morris earned her Ph.D. degree in molecular virology at the Medical University of Lübeck, Germany and her MS and BA degrees in biology at the University of Oldenburg, Germany.
Natko Nuber, Ph.D., Biologics R&D, Novartis
Dr. Natko Nuber is a Principal Scientist in Novartis Biologics R&D in Basel, Switzerland. He originates in Croatia where he received his M.Sc. in Molecular Biology at the University of Zagreb. Realizing his interest in applied science and especially immunology he moved to Switzerland where he obtained a Ph.D. in Immunology from the University of Zurich. Hisprimary scientific interests arecancer immunotherapy and the mechanisms underlying the establishment of immune tolerance, which he further pursued at the University of Basel. After joining Novartis he became responsible forthe development of potency assays for several early and late phase projects includingmonoclonal antibodies as well as novel cellular therapies.
Gillian Payne, Senior Director, Bioanalytical Science, ImmunoGen, Inc.
Gillian Payne is currently the Senior Directorof the department of BioAnalytical Science at ImmunoGen, Inc. Dr. Payne joined ImmunoGen’s subsidiary, Apoptosis Technology Inc., in 1993. There she conducted research in apoptosis target identification and high throughput screen assay development. Since 2001 Dr. Payne led a team at ImmunoGen focusing on the preclinical evaluation of new conjugate antibodies and more recently has taken on roles in ADC CMC specializing in bioassay development . In addition her group supports clinical pharmacology assay development and critical reagents.Prior to Immunogen, Dr. Payne was a Postdoctoral Fellow at HarvardMedicalSchoolin the laboratory ofProfessorChristopher T. Walsh. She received her doctorate in 1990 from the Department of Biochemistry,University of North Carolina at Chapel Hill in the laboratory of Professor Aziz Sancar.
William Roach, Ph.D., Scientist, Antibody Engineering and Platform Transfer Manager, Adimab, LLC
William Roach's work at Adimab is focused on performing antibody discovery campaigns against targets of therapeutic interest. His group has also been actively engaged in understanding antibody specificity and developability. He came to Adimab after graduate and post-doctoral studies within the field of glucose transporter structure, function and regulation.
LaKenya Williams, Ph.D., Senior Research Investigator I, Bioanalytical Sciences - Biologics, Bristol-Myers Squibb
LaKenya received her Ph.D. in Chemistry from Texas A&M University, College Station in 2007. She has been with Bristol-Myers Squibb in the Bioanalytical Science - Biologics department since 2011. LaKenya’s prior experience includes 4 years at a contract research organization developing immunoassays and as a project manager.
Baolin Zhang, Ph.D., Senior Investigator, Division of Therapeutic Proteins, Office of Biotechnology Products, Food and Drug Administration
Baolin Zhang is a Senior Investigator and a Product Quality Reviewer at the Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). He has 13 years of FDA regulatory experience in the quality review (Chemistry, Manufacturing and Control) of therapeutic protein product applications s under investigational new drug applications (INDs) and biologic license applications (BLAs). He also leads a research team in the conduct of FDA mission-related research aimed at improving drug safety and efficacy. His scientific expertise lies in the areas of protein biochemistry, cell death and growth regulation, cancer drug development, and quality control of protein therapeutics. He has published over 70 original studies in prestigious journals, and presented at numerous scientific and regulatory conferences on the development of protein therapeutics. He serves as an Editorial Board member or reviewer for numerous scientific journals. He has supervised and mentored many research fellows and product reviewers. He earned his Ph.D. in chemistry from Peking University, China. He is a recipient of FDA/CDER Scientific Achievement Award, FDA/CDER Excellence in Leadership Award and FDA/CDER Excellence in Mentoring Award.