Immunogenicity Assessment & Clinical Relevance | Immunogenicity Prediction & Mitigation
Optimizing Bioassays for Biologics
Immunogenicity Assessment &
Valerie Quarmby, Ph.D., 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.
William Hallett, Ph.D., Product Quality & Immunogenicity Reviewer, CDER/OPQ/OBP FDA
Will Hallett received his PhD in Cellular and Molecular Biology from the University of Nevada, Reno in 2008. His postdoctoral studies on immunotherapy at the Medical College of Wisconsin and the University of Wisconsin-Madison led him to the FDA in 2012. He performs Product Quality and Immunogenicity reviews for the Office of Biotechnology Products in CDER. He is a member of the OBP Immunogenicity Working Group.
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.
Paul Chamberlain, NDA Advisory Board
Paul Chamberlain has over 35 years’ experience as a biopharmaceutical product development specialist, spanning both the R&D and regulatory environments. He started out as a scientist for Beecham Pharmaceuticals, transitioning within SmithKline Beecham to work within the Monoclonal Antibody Unit of its Biotechnology Department. He held the position of European Regulatory Specialist at Amgen, before becoming Head of Quality Control at the start-up biotechnology company, Metris Therapeutics. Paul then worked for the global CRO, MDS Pharma Services, where he was Senior Director, Drug Development Programs. He has been directly involved in the development of biosimilars since 2001.
Bonita Rup, Ph.D., Biotechnology Consultant, Bonnie Rup Consulting LLC
Michael Partridge, Ph.D., Staff Scientist, Bioanalytical Sciences, Regeneron, Inc.
Born and raised in Australia, Michael 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 tumorigenesis and eventually develop immunoassays to detect biomarkers of radiation exposure. In 2008, Michael left academia to work in industry, and for the last six years, he has been at Regeneron leading a group of scientists developing and validating PK, ADA and Nab assays for nonclinical and clinical studies.
Jianyong (Jerry) Wang, Ph.D., Scientist, Biochemical and Cellular Pharmacology, Genentech, Inc.
Jerry Wang is a scientist in the Department of Biochemical and Cellular Pharmacology (used to be Dept of Assay and Automation Technology) at Genentech. The department supports the therapeutic antibody programs during research and early development phases. The main responsibilities include developing and performing biochemical, immunochemical, and cell-based assays to support candidate selection, potency, efficacy, and PK/PD studies as well as immunogenicity evaluations and biomarker measurements. Dr Wang has worked in pharmaceutical industry for more than thirteen years including eight years at Genentech.
Yongchang Qiu, Ph.D., Senior Director, Head, Bioanalytical and Biomarker Development, Research & Nonclinical Development, Shire
Yongchang Qiu is currently a Senior Director and Head of Bioanalytcal and Biomarker Development (BBD) group at Shire. BBD group are responsible for design, development, and implementation of PK, biomarker, and immunogenicity as well as diagnostic testing strategies to support all nonclinical, clinical, and commercial programs within Shire. Prior to joining Shire, he was a director within Transitional Research department at Genzyme for 4.5 years focusing on complex assay development in support of biologics drug development and manufacturing (2008-2012). He also worked for 10 years at Wyeth’s (now Pfizer) Biological Technologies division with increasing responsibilities and directed the Protein Chemistry and Proteomics core group for 5 years (1998-2008). He was initially educated in organic chemistry at New York University (M.S., 1994) and transferred to learn biological sciences in the Department of Pharmaceutical Chemistry at Univ. of California at San Francisco (Ph.D. 1998). He has authored more than 30 peer-reviewed articles with a good range of scientific interests.
Yuling Wu, Ph.D., Principal Scientist, Translational Sciences, MedImmune
Yuling Wu, is a group leader in Clinical Pharmacology & DMPK at MedImmune. She is responsible for development and qualification of PK/PD/ADA and disease biomarkers to support programs from research through clinical development. Her group developed an ECL-based drug specific IgE assay to support mota BLA. That piece of work led to a publication. She was 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.
Lakshmi Amaravadi, Ph.D., Senior Director, Translational Medicine, Biogen Idec
Dr. Lakshmi Amaravadi is currently Senior Director of Translational Medicine, at BiogenIdec. In this role she provides leadership and strategic guidance to the team of senior level scientists to develop and implement biomarker and bioanalytical (PK, Immunogenicity) strategies and assays in support of multiple therapeutic areas including Neurology, Immunology, and Fibrosis/Tissue Repair. She has extensive experience in the area of translational biomarkers, PK and Immunogenicity assessments in support of drug candidates from pre-clinical and clinical development phase including post-marketing phase as applicable. Dr. Amaravadi is the past-Chair of the Ligand Binding Assay Focus Group of AAPS, and currently leading the Biomarker Sub-team that comprises members from across the industry. She has over 20 years of experience in the Pharmaceutical Research & Development. She received her Ph.D. in Molecular and Cell Biology at Indiana State University, followed by a post-doctoral fellowship at Walther Oncology Center, IU School of Medicine. Her industry career spanned both drug Discovery and Development phases at small and large pharma including Eli Lilly and Millennium Pharmaceuticals.
Amy Loercher, Ph.D., Manager, Clinical Immunology, GlaxoSmithKline
Dr. Amy Loercher is a manager in the GSK Clinical Immunology group with almost 10 years of experience in immunogenicity assay development and validation. She obtained her Ph.D. in Immunology from the M.D. Anderson Cancer Center, doing her thesis work in cancer immunotherapy with an emphasis on T-cell activation and the tumor environment, before going on to complete a post-doctoral research appointment at the National Institutes of Health in Bethesda, MD, where her studies focused on the contribution of inflammatory cytokines to the progression of head and neck cancers. Amy also spent 2 years as a Research Fellow and Instructor at the Washington University School of Medicine in St. Louis before moving on to gain experience in the pharmaceutical industry; firstly in a CRO setting, now at GSK where she leads a team of 15 scientists in the assessment of the immunogenicity of biotherapeutics and the analysis of target-engagement biomarkers in clinical studies.
Theo Rispens, Ph.D., Senior Scientist, Immunopathology, Sanquin
Theo Rispens (Dokkum, 1976) studied chemistry in Groningen, The Netherlands. He received his PhD in 2004 following research of chemical reactivity in biological models systems. Since 2006 he has worked at Sanquin, where is staff member at the department of Immunopathology of Sanquin Research. Current research activities focus on the structure and function of immunoglobulins and the mutual interactions between the immune system and therapeutic antibodies. One research line involves mechanisms of humoral tolerance, in particuular the biology of IgG4 antibody responses in health and disease. Furthermore, he studies the immune response to biologicals in autoimmune patients, primarily in rheumatology and neurology, and is responsible for the development of novel immunoassays to support this research line, and to implement for world-wide service testing at Sanquin Diagnostics, to support the optimization of treatment strategies with biologicals.
Rebecca Elliott, MSc, Manager, BioAnalytical Sciences, Genentech, Inc.
I completed my undergraduate degree at the University of Illinois, Champaign-Urbana in 1985 with a Bachelor of Science. Following undergraduate school, I graduated from the Florida Institute of Technology in 1993 with a Master of Science in Cell and Molecular Biology. I worked for 17 years at Novartis (formerly Chiron Corportion) in the Analytical Sciences department. At Chiron, I learned to develop, validate, and implement bioanalytical assays supporting the oncology large molecule products in GLP/GCP studies as well as GMP clinical product release assays. For the last 6 years, I have been at Genentech in the BioAnalytical Sciences Department overseeing the validation and implementation of pharmacokinetic and anti-drug antibody assays supporting the large molecule portfolio in oncology
Per Holse Mygind, Ph.D., Senior Scientist, Immunogenicity Assessment, Novo Nordisk
Per Holse Mygind has been working for the last fourteen years in industry within drug development of biologics. He has a background in natural sciences (Chemistry and Biotechnology). Later he obtained a PhD in Medical Microbiology and Immunology from University of Aarhus, Denmark. In 2001, he joined Novozymes, discovering and developing antimicrobial peptides as novel human therapeutics. Working in a highly dedicated team as a project leader, this work resulted in both high ranking publications and a joint collaboration with a larger pharmaceutical company. In 2009 he joined Novo Nordisk in Department of Immunogenicity Assessment. He has developed, validated and implemented novel immunoassays for a diversity of drug candidates through early non-clinical stages until supporting post-approval commitments. Appropriate immunogenicity assessments and clear communication to both internal and external stakeholders is a key driver in his work.
Immunogenicity Prediction &
Marisa Joubert, Ph.D., Senior Scientist, Process Development, Amgen, Inc.
Marisa Joubert is currently in the department of Process Development in Operations at Amgen Inc (Thousand Oaks, CA). She has been at Amgen since 2008 as a pharmaceutical scientist in drug product development. She is the team lead of a multi-department cross-functional working group that assesses the risk of immunogenicity of molecular attributes of biotherapeutics. Prior to joining Amgen, she was a Senior Researcher at the Council for Scientific and Industrial Research in Pretoria, South Africa, where she evaluated novel therapeutic agents for treating HIV-1. Marisa received her PhD in 2006 from the University of California, Los Angeles, in Biochemistry and Molecular Biology.
Tim Hickling, Ph.D., Associate Research Fellow, Pharmacokinetics, Dynamics and Metabolism, 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.
Jack Ragheb, Ph.D., Principal Investigator, Therapeutic Proteins, CDER/FDA
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.
Daniela Verthelyi, M.D., Ph.D., Chief, Immunology Lab, CDER/OBP/FDA
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
Naren Chirmule, Ph.D., Senior Vice President, R&D, Biocon, Bangalore, India
Dr. Chirmule is an Immunologist and has responsibility for development of novel Biologics and Biosimilars at Biocon. He has held senior leadership positions at Amgen (Thousand Oaks, CA) and Merck (Philadelphia, PA). His expertise is in the area of immune responses to biologics and vaccines. In Biologics, he has published extensively on the topics of immunogenicity prediction and assessment, predictive toxicology and quality-by-design. In vaccines, his experience spans development of assays for various viruses and bacteria to supporting operations of very large clinical trials. He has a PhD from University of Mumbai, post-doctoral training at Cornell University Medical College, and teaching and research experience as Assistant Professor in the Human Gene Therapy Group of University of Pennsylvania.
Atanas Koulov, Ph.D., Group Head, Pharma Technical Development Europe (Biologics), Analytics, F. Hoffmann-La Roche Ltd.
Atanas Koulov holds a doctorate in Biochemistry from the University of Notre Dame, IN, U.S.A. After postdoctoral work at The Scripps Research Institute CA, U.S.A. he focused his scientific interests on understanding protein aggregation and the interaction of protein aggregates and particles with the immune system. First as a Laboratory Head at the Analytical R&D Department of Novartis Biologics and currently as a Group Head at the Analytical Development and QC Department of Roche Pharma Technical Development Europe (Biologics) Atanas Koulov has overseen dynamic and interdisciplinary research programs in the field of aggregation of protein biopharmaceuticals and the biological effects of protein aggregates. He is the current Chair of the AAPS Protein Aggregation & Biological Consequences Focus Group.
Zoheb Kazi, MBBS, Postdoctoral Research Associate, Pediatrics/Medical Genetics, Duke University Medical Center
Zoheb Kazi, MBBS received his medical education at Government Medical College Bhavnagar, India. He is a member of the Southeastern Regional Genetics Group (SERGG) American College of Medical Genetics (ACMG), and Lysosomal Disease Network (LDN). He is actively involved in research on Pompe disease at Duke University Medical Center, North Carolina. His research focus is mitigating the challenges faced with immunogenicity with enzyme replacement therapy (ERT) in infantile Pompe disease. He received a LDN fellowship for a project that involves identifying the subset of Pompe patients most likely to mount an immune response to enzyme replacement therapy. Identifying such patients would help optimal implementation of immune modulation in the ERT-naïve setting.
Amy S. Rosenberg, M.D., Division Director, Office of Biotechnology Products, FDA
Amy Rosenberg received her M.D. from Albert Einstein College of Medicine and is Board Certified in Internal Medicine. She was a post-doctoral fellow in Al Singer’s Laboratory in the NCI before coming to CBER, FDA in 1988. She became Director of the Division of Therapeutic Proteins in 2000. Her division regulates diverse protein therapeutics, including Enzyme Replacement Therapies, hematologic and somatic cell growth factors, and immunomodulatory agents including interferons and interleukins. Her particular interests are in tolerance induction in diverse clinical settings including autoimmunity, therapeutic protein immunogenicity and transplantation.
Ira Pastan, M.D., Co-Chief, Molecular Biology, National Cancer Institute, National Institutes of Health
Dr. Ira Pastan was educated at the Boston Public Latin School, Tufts College, and Tufts Medical School. He did his residency at the Yale School of Medicine (1957-1959) and came to NIH in 1959. 1970, he was appointed chief of the Laboratory of Molecular Biology. Society memberships: American Society of Clinical Investigation, Association of American Physicians, American Society of Biological Chemists, American Society of Microbiology, American Society of Cell Biology, American Association for Cancer Research, Antibody Society. Honorary Member, Japanese Cancer Association, 2005.
Karl Griswold, Ph.D., Associate Professor, Thayer School of Engineering, Dartmouth
Karl Griswold is an Associate Professor of Bioengineering at Dartmouth. At the Thayer School of Engineering, 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, deimmunized, protein therapeutics.
Matthew Macauley, Ph.D., Assistant Professor, Chemical Physiology, Scripps Research Institute
Trained as a biochemist, my interests are in glycan-mediated function began in my graduate research at Simon Fraser University where I studied the role of the O-GlcNAc modification in the etiology of diabetes and neurodegeneration. This work involved the rational design and in vivo implementation of an enzyme inhibitor to interrogate the function of O-GlcNAc. In my post-doctoral research at The Scripps Research Institute, I continued to study the role of glycans in health and disease, but in the context of the immune system. During this time, I developed a method for inducing antigen-specific B cell tolerance through the B cell siglecs that exploits their natural function on naïve follicular B cells. Rooted in a biochemical understanding of how glycosylation is involved in immune cell recognition of ‘self’, my laboratory is studying roles of Siglecs in immune cell function and using this information to design approaches for controlling immune responses.
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.
David W. Scott, Ph.D., Professor and Vice Chair for Research, Department of Medicine (MED), Uniformed Services University of Health Sciences
David W. Scott, Ph.D. is Vice Chair for Research in the Department of Medicine at the Uniformed Services School of Health Sciences (USUHS) in Bethesda, MD. An alumnus of Antioch College, Dr. Scott received his M.S. degree from the University of Chicago and Ph.D. from Yale University in 1969. Following a post-doctoral fellowship at Oxford University, UK, he joined the faculty at Duke University in 1971, where he initiated his NIH-funded studies on immune tolerance mechanisms. In 1983, he was named Dean's Professor of Immunology at the University of Rochester, a post he held for 11 winters. Dr. Scott thereafter became Head of the newly formed Immunology Department at the Holland Lab of the American Red Cross, and moved to the University of Maryland School of Medicine in 2004. He assumed his current position at USUHS in September 2010. Dr. Scott has contributed to over 200 research papers on several subjects in immunology, focusing on immunologic tolerance, and its application in autoimmune diseases, hemophilia and gene therapy. He is the author of two textbooks, including a monograph entitled, The Nature of Immunologic Tolerance, and recipient of a number of awards, including the Distinguished Service Award, from the American Association of Immunologists (2004), a Boerhaave Professorship at Leiden University Medical School, The Netherlands (2006) and the 2009 Scientific Achievement Award from the AAPS. Active in science education, Dr. Scott has been chair of Education committees at the ASM and AAI. He has also served on the editorial boards of major immunologic journals, and as a member of both foundation and NIH Study Sections.
Stephan Kontos, Ph.D., Co-Founder, Director, Research, Anokion
Stephan is a Co-founder and the Director of Research at Anokion, driving the technology forward from our research unit at the EPFL Innovation Park in Lausanne, Switzerland. He received his B.Sc. in Chemical Engineering from the University of Texas at Austin and moved to the EPFL for his doctorate in Bioengineering. During his thesis work in Prof. Jeffrey Hubbell’s group, he co-invented and developed the erythrocyte-binding tolerance technology that led to the founding of Anokion. Following completion of his PhD in Bioengineering, Stephan further advanced several design aspects of our core technology as a post-doctoral researcher.
Optimizing Bioassays for Biologics
Camille Dycke, Ph.D., F. Hoffmann-La Roche Ltd. / Genentech; Associate Director, Method Management and Technologies, Bioassay, Global Biologics QC
No bio available.
Laura Geagan, Principal Research Associate, Bioanalytical Development, Genzyme
No bio available.
Florence Guilhot, Ph.D., Head, Translational Pharmacology Lab, NovImmune SA
Florence Guilhot is currently a Project Coordinator and Outsourcing Manager at NovImmune SA, a privately-held biotech company based in Geneva, Switzerland. Florence leads outsourcing work to develop, optimize and validate in vitro assays to support pre-clinical and clinical development of monoclonal and bispecific antibody programs. In her previous role, Florence worked as Head of Translational Pharmacology Laboratory where she was responsible for development, transfer, validation and troubleshooting of a range of in vitro assays formats. In 2002, Florence received a M.Sc. in Protein engineering and a M.Sc. in Molecular Physiology & Genetics in France. Then she obtained in 2007 a Ph.D. in Pharmacology from the University of Montreal, Canada.
Darshana Jani, Ph.D., Senior Manager, Pfizer
No bio available.
Brenna Kelley-Clark, Ph.D., Scientist II, Assay Development, Immune Design
Brenna received her B.S. in Biochemistry from the University of Washington and a Ph.D. in Virology from Harvard University. She continued her training as a post-doctoral fellow at the University of Washington, where she was awarded a Ruth L. Kirschstein National Research Service Award. Brenna’s academic work focused on viral replication and assembly and included work with herpes-, lenti-, alpha- and filoviruses. Since joining Immune Design in 2010, Brenna has led the Assay Development group and been responsible for designing and implementing characterization and release assays for the company’s lentiviral vector platform (ZVex), which is currently being evaluated in the field of cancer immunotherapy.
Maura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics & Biotechnology, United States Pharmacopeia
Dr. Maura Kibbey is a Senior Scientific Liaison in the Biologics and Biotechnology (B&B) Department in the Global Science & Standards Division at USP. Maura’s primary focus is to work with the General Chapters-Biological Analysis Expert Committee to develop documentary standards that support biopharmaceutical quality assessment. Maura also assists with development of B&B monographs. Before joining USP, Dr. Kibbey worked for several biotech and diagnostic companies in the Washington DC area as well as at the National Institutes of Health. Her scientific expertise includes development and validation of many different assay types for measurement of individual molecules, their activities, or binding interactions (e.g., ligand-binding methods with multiple technology platforms, immunogenicity assays, nucleic acid quantitation, transcription factor binding assays, receptor-ligand interactions, etc.). She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.
Seema Kumar, Ph.D., Principal Scientist, Pfizer, Inc.
Dr. Kumar is a Principal Scientist in the Pharmacokinetics Pharmacodynamics and Metabolism (PDM) department at Pfizer Inc. She leads a group that provides regulated bioanalytical support including assay development, validation and sample analysis for the assessment of pharmacokinetics and immunogenicity in pre-clinical and clinical development of Pfizer’s biotherapeutics portfolio. Dr. Kumar is also responsible for scientific oversight of GLP and clinical studies outsourced at CROs. Prior to Pfizer, Dr. Kumar held similar role as Director of CLIA certified Clinical Bioanalytical Lab at XBiotech USA Inc. Dr. Kumar holds a Ph.D. in Biophysical Chemistry from Johns Hopkins University, and has published several publications in peer-reviewed journals, and contributed to book chapters.
John M. Lehrach, Research Scientist II, Bristol-Meyers Squibb
John Lehrach is a contributor to the success of the BioPharmaceutial Industry for over 15 years. He developed a broad skill-set in functional cell-based assay optimization, miniaturization, and automation throughout the drug discovery landscape. He is currently working at Bristol-Myers Squib in the Leads Discovery and Optimization (LDO) Department focusing on BioAssay Development and Biologic Screening.
Shihua Lin, Ph.D., Analytical Biotechnology Development, MedImmune LLC
No bio available.
LiNa Loo, Ph.D., Senior Scientist, Bioanalytical Development, Merck
Dr. Loo received her PhD from North Carolina State University in Chemistry where her doctoral thesis was on developing a plant virus as a drug delivery tool. After graduating, she joined Fox Chase Cancer center (FCCC) to become a post-doctoral researcher. The focus of her research at FCCC was to develop a biosensor to detect cancer biomarkers. She is currently a Senior Scientist at the Bioanalytical Development, Merck, focusing on developing and validating immunogenicity assays in preclinical and clinical samples.
Xiaobin (Victor) Lu, Ph.D., Biologist, Virology Interest Group, CBER-FDA
Dr. Xiaobin Victor Lu received his Bachelor’s degree in Biochemistry from Fudan University in Shanghai China and his Ph.D. in molecular virology from State University of New York at Buffalo. His Ph.D. thesis work was focused on HIV molecular biology related to mechanisms of HIV-1 Rev and Tat regulation of post transcriptional RNA processing. He was a post-doctoral fellow at UCSF where he studied HIV transcriptional regulation and HIV-1 Nef protein and Nef associated proteins. He worked at ONYX Pharmaceutical as a research scientist and continued work on HIV-Nef-associated kinases. At VIRxSYS Corporation, he served as a senior scientist and later a senior director for development of HIV and SIV based lentiviral vectors for clinical studies. He played an important role in the development of the first HIV-1 based lentiviral vector for human clinical studies for HIV infected individuals. Later, he served as a senior scientific liaison at the United State Pharmacopeia in charge of the Vaccines and Virology expert committee. Currently Dr. Lu is a product reviewer in the Office of Cellular, Tissues and Gene Therapies, in the Center for Biologics Evaluation and Research, of the FDA.
Jane Robinson, Scientific Liaison, Biopharmaceutical Emerging Best Practices Association (BEBPA)
Jane has more than 25 years’ experience in biopharmaceuticals, specializing in in vitro bioassays and reference standards, from 1989 to 2015 at the National Institute for Biological Standards and Control (NIBSC), UK. Jane has advised regulatory authorities and other organizations on bioassay design and analysis, led collaborative projects to develop World Health Organization international standards and participated in the European Directorate for the Quality of Medicines and Healthcare (EDQM) testing of Centrally Approved Products. Jane has been involved with the Biopharmaceutical Emerging Best Practices Association (BEBPA) since its foundation in 2008. She lectures and provides training for regulatory, professional, academic and commercial organizations.
Liming Shi, MS, MA, Senior Research Scientist, Bioassay Development, Eli Lilly and Company
Liming has more than 16 years’ experience in biopharmaceutical industry. He specializes in bioanalytical method development, qualification, transfer, and validation. He has lots of GMP and compliance experience and he has been deeply involved in IND and BLA activities. With thorough statistical knowledge, GMP experience and bioanalytical expertise, he has successfully developed many bioassays, addressed numerous GMP/regulatory issues and performed a lot of trouble shootings. He also has experience in immunogenicity evaluation and Pharmacokinetics, drug metabolism, and toxicology studies. Liming holds a Master degree in Biophysics and a second Master degree in Biochemistry. Liming also holds an UCSD Certificate of ADMET Process (Absorption, Distribution, Metabolism, Excretion and Toxicology).
Piyush M. Vyas, Ph.D., Research Scientist, Bioassay Development, Eli Lilly and Company
Dr. Piyush Vyas is a Research Scientist in Eli Lilly Bioassay group for the last 4 years. He has led numerous Bioassay projects for the Lilly Antibodies portfolio. Prior to Lilly, he was a Contract Research Scientist at Bristol Myers Squibb in the area of Bioassay development for PK/PD. Before joining BMS, he was a Research Associate at Wells research center and led projects for developing fusion proteins for delivering protein therapeutics inside cellular targets. Prior to Wells research center, he had obtained a Ph.D. in Biochemical Pharmacology from University of Iowa.
Ray Zhang, Ph.D., Research Investigator, Bristol-Meyers Squibb
Ray Zhang received his Ph.D. from the Medical College of Wisconsin, where he majored in Microbiology and Immunology. He did his postdoctoral training at Yale University School of Medicine, Department of Cell Biology, and studied intracellular membrane trafficking. Later he became a Howard Hughes Medical Institute postdoctoral fellow, where he studied vector borne diseases and host immune responses. In 2011, he joined Bristol-Myers Squibb in New Jersey and had been working on phenotypic screening on regulatory T cells, T-cell target validation and antibody combination studies. His current role at Bioassay Core Group of Department of Lead Discovery and Optimization is to design, develop and validate bioassays for pre-clinical stage biologic product lot release and stability assay, neutralizing antibody assay, cell line generation, immunoassay, T-cell signaling assay and assay platform development.
Immunogenicity Assessment & Clinical Relevance | Immunogenicity Prediction & Mitigation
Optimizing Bioassays for Biologics