Immunogenicity Assessment & Clinical Relevance
Tressa Allington, Ph.D., Development Scientist, Bioanalytical Development, Alexion Pharmaceuticals, Inc.
Tressa Allington received her bachelor’s degree from Iowa State University in Chemical Engineering and a Ph.D. in Pharmacology from the University of Colorado. She works on immunogenicity assessment for ultra-rare diseases in preclinical and clinical settings at Alexion Pharmaceuticals based in New Haven, Connecticut. Dr. Allington develops assays and monitors pharmacokinetic, pharmacodynamic and immunogenicity data for a monoclonal antibody in Phase 3 development for the treatment of complement-mediated diseases. Alexion develops therapies to transform the lives of patients living with devastating diseases, including mRNA-based therapeutics, monoclonal antibodies, fusion proteins, enzyme replacement therapies, and small molecules.
Viswanath Devanarayan, Ph.D., Executive Director and Head, Global Statistics, Charles River Labs
Dr. Devanarayan has 21 years of combined pharmaceutical research experience from Eli Lilly, Merck, and AbbVie. He is an elected Fellow of the American Association of Pharmaceutical Scientists (AAPS). His statistical & data-analytic contributions span a wide range of applications across drug discovery and development, such as target identification, high-throughput-screening, genomics, proteomics, bioanalytical methods, biomarker discovery, precision medicine, companion diagnostics, and development of composite clinical endpoints. He has filed 10 patent applications, given over 100 invited talks at scientific meetings, and co-authored over 55 publications. He has published several white-papers with regulatory, academic and industry scientists on immunogenicity, bioanalytical methods, genomics, and biomarker qualification. He has recently been appointed Executive Director, and Head of Global Statistics at Charles River Labs.
Shan Chung, Ph.D., Senior Scientist and Group Leader, BioAnalytical Sciences, Genentech, Inc.
Dr. Shan Chung is a Principal Scientist and Group Leader in the Department of BioAnalytical Sciences (BAS) at Genentech, a Member of the Roche Group. Shan received his Ph.D. in Molecular Biology from University of Pennsylvania and conducted postdoctoral research on Protein Engineering of human T-cell receptors at Harvard University. He joined Genentech in 2006 and currently leads the Effector Function and Cell Biology group in BAS. Shan has more than 20 years industry experience on research and development of pharmaceutical products and specifically development, validation, and implementation of cell-based bioanalytical and potency assays. He is a subject matter expert in the fields of Fc effector functions, neutralizing antibody assays, and immunogenicity prediction/assessment of biotherapeutics. Shan has supported more than 40 successful IND/BLA filings at Genentech.
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.
Robert J Kubiak, Ph.D., Senior Manager R&D, Translational Science, MedImmune LLC
Robert Kubiak heads a research group responsible for development and validation of bioanalytical methods at MedImmune, Gaithersburg. He worked on development and validation of immunoassays at Tandem Labs, PPD and Meso Scale Discovery. He holds a doctorate in medicinal chemistry from University of Illinois at Chicago and a master degree in biotechnology from Johns Hopkins University.
Mauricio Maia, Ph.D., Senior Scientist, BioAnalytical Sciences,Genentech/Roche
Dr. Maia 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.
Jim McNally, Ph.D., Head, Clinical Bioanalysis and QPD Program Rep, Quantitative Pharmacology and Drug Disposition, EMD Serono
Jim McNally is a QPD Program Representative, Head of Clinical Bioanalytics, and Immunogenicity Expert. In this role, he responsible for the immunogenicity strategy, bioanalytical support and scientific oversight of outsourcing of large molecule programs for EMD Serono. Previously, he was the lead of the Clinical Assay Development, Validation and Testing bioanalytical group at Pfizer based in Andover, MA. The group was responsible primarily for developing assays to support pharmacokinetic and immunogenicity analysis of the Pfizer large molecule portfolio. 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.
Keith Merdek, Ph.D., Principal Scientist, Bioanalytical Sciences & Biomarkers, Sanofi
Michael Partridge, Ph.D., Senior Staff Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals
Born and raised in Australia, Michael received his Ph.D. from 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 investigated integrin-mediated cell signaling and motility. He went on to study tumorigenesis and eventually develop immunoassays to detect biomarkers of radiation exposure. Michael then left academia to work in industry, and in his current position at Regeneron he leads a group of scientists developing and validating PK, ADA, Nab and biomarker immunoassays for nonclinical and clinical studies.
Veerle Snoeck, Ph.D., Principal Scientist, Pharmacology / Immunogenicity, Ablynx nv
Veerle Snoeck is working as a Principle Scientist in the Pharmacology Department of Ablynx (Belgium) where she is responsible for the immunogenicity risk assessment and immunogenicity testing across projects. She is an Immunologist by training and obtained her PhD in 2004 in the Laboratory of Veterinary Immunology at the University of Ghent (Belgium) on vaccine development. She previously worked at the VIB (Ghent) as post-doctoral researcher and as Project Leader at ActoGenix on projects focused on immunotherapy development for several autoimmune and allergic indications. Since 2010 she joined Ablynx nv, a pioneer in the discovery and development of Nanobodies®, a novel class of antibody-derived therapeutic proteins.
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.
Junxia Wang, Ph.D., Associate Director, Immunosafety and Bioanalytical development, Editas Medicine
Junxia Wang, is an Associate Director of Immunosafety and Bioanalytical development at Editas Medicine, responsible for the development and implementation of strategies for safety evaluation CRISPR/Cas9 programs across portfolio with a focus on immunogenicity. Prior to Editas, Junxia worked at Novartis, where she was a Fellow in Cell and Gene Therapy, Oncology Business Unit. She was a project leader in Technical Research and Development spearheaded exploratory analytical activities for biomarker discovery, led functional assay design and development to support process development, manufacturing and clinical development of CAR T-Cell immunotherapy. Before Novartis, Junxia was an Instructor and Associate Immunologist in Division of Rheumatology, Immunology and Allergy at Brigham and Women’s, where she conducted research on biomarkers/targets for Inflammatory Arthritis in human using CyTOF, human T cell immuno-phenotyping, classification of T cell effector and memory subsets with PD1 expression. Junxia received her Ph.D. in Pharmacology at Shanghai Institute of Materia Medica, Chinese Academy of Sciences.
Yuanxin Xu, Ph.D., Senior Scientific Director, Clinical Assay Development, Clinical Lab Sciences, Alnylam Pharmaceuticals
Yuanxin Xu joined Alnylam Pharmaceuticals in April 2015 as Sr. Director managing Bioanalytical Sciences group. Her responsibilities included management of method development/validation and sample analysis (done by Alnylam labs and CROs) to support RNAi therapeutic development from pre-clinical to clinical stages. Multiple platforms (such as mass spec, HPLC, qPCR, LBA, and clinical IVD methods) have been in use to evaluate drug mechanism of action, PK/TK/metabolites, PD/biomarkers, and immunogenicity (ADA), etc. From 2002-2015, she was Pr. Scientist to Sr. Scientific Director at Genzyme/Sanofi, her responsibilities included clinical assay development/validation to support drug development and NDA/BLA filings (protein and small molecule drugs, cell/gene therapies, peptides and an antisense oligonucleotide). She was also Scientific Liaison for Sanofi-CRO strategic alliance. Prior to Genzyme, she studied transplantation and induction of immune tolerance at BioTransplant. Yuanxin received her Ph.D. in Biochemistry, 1990 from Iowa State University in Biochemistry as a CUSBEA scholar (China-US government program) and Bachelor of Medicine from Beijing Medical University (now Peking University). She is an active contributor to AAPS LBABFG, journal reviewer, and invited speaker.
Rong Zeng, Ph.D., Director, Bioanalytical Sciences, OncoMed Pharmaceuticals
Dr. Rong Zeng is the Director of Bioanalytical Sciences at OncoMed Pharmaceuticals. He oversees the bioanalytical methods development, validation, and technology transfer activities to support preclinical and clinical development of biotherapeutics for the treatment of cancer. Prior to joining OncoMed in 2015, Dr. Zeng worked for the National Institutes of Health (NIH), Amplimmune, and AstraZeneca/MedImmune with increasing responsibilities. Dr. Zeng has over 15 years of experience in in vitro/ex vivo assay development, in vivo pharmacology, and biomarker discovery and development. His research in cytokine receptor signaling and immunoregulation results in a number of well-cited publications. Dr. Zeng received his PhD degree in Molecular and Cell Biology from the University of Tokyo (Japan), and BS /MS degrees in Biochemistry from Tsinghua University (China).
Immunogenicity Prediction & Control
Xiaoying Chen, Ph.D., Senior Manager, Early Oncology Development & Clinical Research, Pfizer
Xiaoying Chen is currently a clinical pharmacology lead in the Early Oncology Development & Clinical Research Department at Pfizer. Xiaoying received her Ph.D. degree (Pharmaceutical Sciences) from the University of Southern California, in 2011. She started her career at Pfizer PDM since 2011, working on mathematical modeling and simulation approaches to immunogenicity prediction for therapeutic proteins. She currently works on modeling and simulation supporting early Oncology clinical projects. Her research interests include mathematical modeling, such as empirical PK/PD modeling and system pharmacology modeling, immunogenicity prediction, drug delivery, bio-analysis, and design of recombinant fusion proteins.
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
Vibha Jawa, Ph.D., Director, Biologics and Vaccines Bioanalytics, Merck and Co. Inc.
Dr. Vibha Jawa 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. Subsequently, she 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 2003. Until recently she was a Principal Investigator and Clinical Immunology representative on several of Amgen’s drug development teams where she provided input to develop appropriate immunogenicity risk assessment strategies. Her current research interests include evaluating immune response biomarkers for early drug development and efficacy, immunogenicity prediction using in silico, in vitro and in vivo technologies, modeling impact of immunogenicity on PK and PD, antigen processing and presentation and the role of T cells in immune response to drug products.
Marisa Joubert, Ph.D., Principal Scientist, Process Development, Amgen, Inc.
Marisa Joubert is a Principal Scientist and Group Leader of the Attribute Impact Group in the department of Process Development at Amgen Inc (Thousand Oaks, CA). She has been at Amgen since 2008 as a pharmaceutical scientist in drug product development. Her group evaluates the impact of biotherapeutic attributes on the safety and efficacy of drug products. She is also the team lead of a multi-department cross-functional working group that assesses the risk of immunogenicity of key product quality attributes. She has received several awards for this work including the 2015 Ebert Prize from the American Pharmacists Association. 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. She received her PhD in 2006 from the University of California, Los Angeles, in Biochemistry and Molecular Biology.
Kei Kishimoto, Ph.D., Chief Scientific Officer, 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.
Ronit Mazor, Ph.D., Post Doctoral Fellow, Molecular Biology, National Cancer Institute
Dr Mazor is a post-doctoral fellow in the lab for Molecular Biology in NCI, working with Ira Pastan on recombinant immunotoxins. She holds a Bachelor, Master and PhD degrees from Tel Aviv University, in Israel. In 2016 she also became an instructor in the NIH graduate school “Foundation of Advanced Education in Science (FAES)” teaching Immunotherapy of cancer. Ronit has been focusing on methods to reduce the immunogenicity of recombinant therapeutic proteins in cancer therapy. She is a co-inventor of US and European patents pertaining protein engineering of recombinant immunotoxins with low immunogenicity or longer half-life.
Joao Pedras-Vasconcelos, Ph.D., Biotech Quality and Immunogenicity Reviewer, Office of Biotechnology Products, CDER-FDA
Dr. Pedras-Vasconcelos has been a biologics quality and immunogenicity reviewer with the Office of Biotechnology Products, Center for Drugs- FDA for 15 years, first as a researcher-reviewer (7 years) and then as a full time reviewer (8 years). He received his B. Sc. Honours in Microbiology in 1990, and an M. Sc. in Microbiology in 1993 from The University of Saskatchewan, Canada. He received his Ph. D. in Immunology in 1999 from Cornell University, Ithaca NY. Afterwards he completed a post-doctoral research fellowship at the Institute of Biological Sciences, National Research Council of Canada, and had a position as a term-Research Scientist at the Canadian Food Inspection Agency, both in Ottawa Canada. He joined the FDA in 2002, first with CBER and then CDER and has extensive regulatory experience in reviewing cytokines, fusion proteins, therapeutic toxins, hormones, immunomodulatory extracts, and enzyme replacement therapies. Joao is a standing member of the OBP immunogenicity working group and the coordinating committee for CDER Office of Pharmaceutical Quality Infectious Disease and Inflammation Center of Excellence. He was is also a member of the AAPS NAb assay working group.
Kathleen P. Pratt, Ph.D., Associate Professor, Medicine, Uniformed Services University of the Health Sciences
Kathleen Pratt received her PhD in Biophysical Chemistry from Cornell University. As a postdoctoral fellow she determined the crystal structures of blood coagulation proteins, including the C2 domain of factor VIII (FVIII), which is essential for normal hemostasis. Her laboratory has utilized mutagenesis plus surface plasmon resonance to comprehensively map the B-cell epitopes on this important region of the FVIII protein. Over the past decade, they have also mapped immunodominant T-cell epitopes in FVIII and characterized human CD4 T-cell responses using blood samples from hemophilia A patients who develop neutralizing anti-drug antibodies to therapeutically administered FVIII. She joined the Uniformed Services University of the Health Sciences (Bethesda, MD) in 2013, where her laboratory continues to pursue studies of protein engineering and immunologic approaches to investigate clinically important anti-drug antibodies.
Amy S. Rosenberg, M.D., Division Director, Office of Biotechnology Products, FDA
Amy Rosenberg received her medical degree 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, CBER/CDER in 2000. Her division (now DBRR3 in the Office of Biotechnology Products, CDER) regulates diverse protein therapeutics, including monoclonal antibodies and fusion proteins, enzyme replacement therapies, hematologic and somatic cell growth factors, and immunomodulatory agents. She has been a driving force in risk evaluation and mitigation pertaining to the immunogenicity of therapeutic proteins (Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products) and in the elucidation and implementation of immune tolerance induction protocols in clinical settings. Most recently, she co-edited the AAPS/Springer Book “Biobetters: Protein Engineering to Approach the Curative”.
Laura I. Salazar-Fontana, Ph.D., Ph.D., Associate Director, Biomarkers and Clinical Bioanalysis, Translational Medicine and Early Development, Sanofi
Dr. Laura Salazar-Fontana has extensive experience in human immunology applied to autoimmunity, inflammation, cancer and infectious diseases. She joined Sanofi as Associate Director for Immunology and Biomarkers, within Sanofi Translational Medicine and Early Development, after working as Chemistry, Manufacturing and Controls (CMC) and immunogenicity reviewer at the Food and Drug Administration (FDA), Center for Drug evaluation and Research (CDER). Prior to this, she held an academic appointment at George Washington University (GWU) after finishing her postdoctoral training at the National Institutes of Health (NIH). Laura currently supports the development of strategies for immunogenicity and biomarkers selection during product development life cycle. Laura is experienced in the implementation of risk assessment approaches to the manufacturing of biotherapeutics, in particular to the contribution of product quality attributes to the immunogenicity potential of this kind of therapeutics. Laura is also a member of the AAPS Therapeutic Product Immunogenicity Focus Group where she led a sub-team involved in the review of immune mitigation approaches to control unwanted anti-drug antibody responses to therapeutic proteins within the Immune Mitigation Action Program Area (IMAPA).
Becky Schweighardt, Ph.D., Senior Director, Immunogenicity Assessment, BioMarin Pharmaceutical Inc.
Becky Schweighardt, PhD leads the Immunogenicity Assessment group at BioMarin Pharmaceutical in San Rafael, CA. The main focus of her team is to develop and implement strategic risk-based approaches for monitoring the impact of drug-related immunogenicity on the pharmacokinetics, pharmacodynamics, clinical safety, and efficacy of novel protein therapeutics. BioMarin is a leader in the field of enzyme-replacement therapy for orphan indications.
Priya Sriraman, Pd.D., Principal Investigator Non Clinical Development, Celgene Corp
Priya Sriraman is a Principal investigator at Celgene in NJ. Her group is responsible for immunogenicity, bioanalytical and pharmacokinetic support for biotherapeutic and cell therapy programs, from discovery through preclinical and clinical development. Prior to Celgene, Priya was at Roche Pharmaceuticals.
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.
Optimizing Bioassays for Biologics
Tim Allison, Ph.D., Field Applications Manager, North America, Labcyte Inc.
Tim Allison is the Field Applications Manager – North America for Labcyte Inc. He received training as a PhD at the University of Virginia and as a post-doc at NIH. He then worked at Merck for several years as a protein crystallographer. He has been serving Labcyte customers for over six years, in areas including compound screening, genomics, and synthetic biology.
Robyn Beckwith, Ph.D., Associate Scientist, Analytical Development and Quality Control, Product Technical Development, Genentech
Dr. Robyn Beckwith is an Associate Scientist in Analytical Development and Quality Control at Genentech. She obtained her Ph.D. in biochemistry and chemical biology from UC Berkeley researching the mechano-chemical principles of ATP-dependent protein unfolding, then transitioned to industry as a scientist at Theranos designing microscale clinical diagnostic assays. She joined Genentech with a principle role in bioassay development/validation for QC environments and has subsequently pursued keen interests in the advancement and implementation of automation technologies.
Anne Benoit, Ph.D., Expert Biostatistician, Biostatistics and Statistical Programming, Non-Clinical R&D Statistics – CLS, Clinical Evidence Generation, GSK Vaccines
Anne Benoit is currently working at GSK Vaccines as a Non Clinical R&D expert biostatistician, supporting the methodological aspects of the development of clinical assays. She obtained a PhD in Statistics from the Catholic University of Louvain-La-Neuve in 2015, working under the co-supervision of GSK Vaccines and aiming to identify new approaches to assess the clinical efficacy of influenza vaccine. Before starting this research, she spent two years at UCB Pharma in the Exploratory Statistics group, contributing to the design and analysis of pharmacometrics and early phases clinical trials.
Erica Bortolotto, Ph.D., Senior Scientist, Bioassay Development, Analytical Sciences for Biologicals, UCB PHARMA
Dr Erica Bortolotto joined UCB Pharma SA (Belgium) in September 2011 as Bioassay Development Scientist in the Analytical Sciences for Biologicals department. She is working on potency assays method development, validation and transfer as well as release of products from preclinical phase to phase 3 in a GMP environment.
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 four years at 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.
Maura Kibbey, Ph.D., Director, Global Biologics, U.S. Pharmacopeia
Dr. Maura Kibbey is a Director of Science & Standards in USP’s Global Biologics Department. Maura and her team work with the four USP Expert Committees and multiple Expert Panels for biologics to develop documentary standards (chapters and monographs) and Reference Standards that support biopharmaceutical quality assessment. Before joining USP, Dr. Kibbey worked for several biotechnology 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. She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.
Natalia Kozhemyakina, Ph.D., Head, Bioassay Laboratory, Analytical Development Department, BIOCAD
PhD. Head of Bioassay Laboratory at Biocad, Russian leading innovative biotechnology company. The lab is responsible for selection the bioassay strategy and development, optimization, automation and validation/qualification bioassays including potency assays for Biologics and Small molecules in support of manufacturing and product development, stability and characterization studies.
David Lansky, Ph.D., 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, Bioassay Sciences, Thomas A. Little Consulting
Dr. Little is the president and founder of Thomas A. Little Consulting (TLC), a globally recognized biologics, vaccine, and pharmaceutical consulting firm specializing in CMC product, process and method development, and QbD approaches to product quality. He has extensive experience in the design, support, and validation of bioassays, and works with industry professionals to achieve results in bioassay design and validation. Dr. Little received his PhD from Purdue University, and was a professor at San Jose State University. He has extensive experience in applying analytical methods to biologics and pharmaceuticals. Dr. Little has published over 25 articles and has presented papers on many aspects of QbD, statistical modeling, analytical thinking, and process/method validation. Dr. Little and his organization have trained over 100,000 engineers, scientists, pharmaceutical and regulatory professionals during his career.
Rachid Marhaba, Ph.D., Senior Scientist, Clinical Laboratory Sciences, GSK Vaccines GmbH
Rachid is a Technical Excellence Senior Manager at the Clinical Laboratory Sciences (CLS) department in GSK Vaccines, Marburg (Germany). In this role, he is part of a team (of 2) responsible for the oversight of assay development and validation activities to ensure that assays are scientifically sound and compliant to the latest guidelines. Prior to this, he was leading the Assay Development group for early projects at Novartis Vaccines (that became GSK Vaccines in 2015). Rachid studied Biochemistry and holds a PhD in Immunology from the university of Nice, France.
Ravish Patel, Ph.D., Manager, Quality Control, Epygen Biotech
Dr. Ravish Patel completed a Ph.D. in biotechnology from Niram University and a Master’s degree in Microbiology from University of Mysore, Dr. Ravish Patel started his career at the Intas pharmaceutical, Ahmedabad as Research associate in 2007. He quickly advanced from a Research associate to his current position as Manager- Quality at Epygen, Mumbai. The company is engaged in development and manufacturing of Bio-therapeutics. He is responsible for biological assay development and analytical techniques on biosimilar. Furthermore, his background in biological assay development and validation helped to provide him to best lead a key team of scientists within the global discovery services group at Epygen.
Perceval Sondag, Principal Statistician, Non-Clinical Statistics, Arlenda
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. After starting 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 has authored or co-authored multiple publications, including a book chapter on assay validation.
Sandra Thiemann, Ph.D., Scientist, Bio-Immunoassay Group, Attribute Sciences, Amgen
Dr. Thiemann is a Senior Scientist at Amgen in Thousand Oaks where she heads the Attribute Sciences Pre-Pivotal Release and Stability Testing Bio-Immunoassay group. Although her team runs a large number of routine bioassays, they find time to venture into technology development projects that improve speed and accuracy of their work.
Sandra holds a PhD in Immunology from the University of Colorado and worked on the role of sugar-binding proteins on immune cell migration during her postdoc at the University of California Los Angeles. At Amgen, she employs her scientific knowledge to develop and improve bioassays for various modalities. In particular, she is interested in the utilization of automation in regulated environments.
Bioassays for Immuno-Oncology
Ulrike Herbrand, Ph.D., Scientific Supervisor, Research & Development, Biosafety & Bioassay Services, Charles River Labs
Ulrike Herbrand joined Charles River Biopharmaceutical Services in 2007. She works as scientific supervisor for research and development and her focus are mechanism of action reflecting bioassays for protein therapeutics. She gained a PhD in biological sciences during her time at the Max-Planck-Institute for Molecular Physiology in Dortmund (Germany) and worked five years at post-doctoral positions at medical research centers in the field of cancer research.
Steven J. Kussick, M.D., Ph.D., CMO, Director, Contract Research and Flow Cytometry, PhenoPath Laboratories; Clinical Assistant Professor, Laboratory Medicine, University of Washington
In addition to Associate Medical Director, Steven J. Kussick, MD, PhD, is Director of Contract Research, and Director of Flow Cytometry at PhenoPath Laboratories. He has extensive experience in the use of morphologic, immunophenotypic, and molecular methods in the diagnosis of hematolymphoid neoplasms. Dr. Kussick received his M.D. and Ph.D. from the Medical Scientist Training Program at the University of Washington, where he also completed his Anatomic Pathology Residency and Hematopathology Fellowship. He is board-certified in Anatomic Pathology and Hematopathology. Prior to joining PhenoPath, he was Attending Hematopathologist and Associate Director of Hematopathology in the Department of Laboratory Medicine at the University of Washington. At PhenoPath, Dr. Kussick established our 9-color flow cytometry laboratory in 2005, and transitioned the methodology to 10-color analysis in 2010. He has overseen the validation of numerous new IHC assays related to hematopathology. In addition to 19 years of attending experience in diagnostic hematopathology, Dr. Kussick has a broad research background, with over 36 peer-reviewed research publications in areas including flow cytometry, hematopathology, basic cancer biology and chronic disease epidemiology.
LeeAnn Machiesky, Scientist, MedImmune
LeeAnn Machiesky is currently a Scientist in the Analytical Bioassay Development Team at Medimmune, Gaithersburg MD. She has a Master’s Degree and 13 years of experience, including 8 years in Pharmaceutical development at Medimmune and previous, experience performing bio-physical research at USAMRIID. LeeAnn has performed a wide range of biological characterization assays, specializing in Fc effector function assays using SPR technology. She has contributed data to numerous regulatory filings including INDs and BLAs in the oncology, neurology, and respiratory therapeutic areas. She is also a member of the USP Panel which is authoring a new chapter for Fc Function Assays.
Tony Navas, Ph.D., Senior Scientist, Clinical Pharmacodynamic Biomarkers Program, Applied/Developmental Research Directorate, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research
Tony Navas, Ph.D has over 20 years of biotech and pharmaceutical industry experience in preclinical and translational research as well as in development of PD assays for clinical drug development. He obtained his Ph.D in Zoology from the National University of Singapore and second Ph.D. in Biochemistry from Baylor College of Medicine. He did his postdoc at Genentech Inc and then went on to work in various capacities at different biotech companies including Scios Inc (JNJ), Amgen and Agensys (Astellas). He is currently working as a senior translational scientist at Leidos Biomedical Research at the Frederick National Laboratories, developing PD assays that support Ph1 oncology clinical trials at NCI-DCTD.
Sofie Pattijn, CTO, ImmunXperts
Sofie Pattijn (CTO and founder, ImmunXperts) has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development. She has extensive hands-on lab experience and has managed and coached several In Vitro teams over the last decade. From 2008 till 2013 she was Head of the In Vitro Immunogenicity group at AlgoNomics (Ghent, Belgium) and Lonza Applied Protein Services (Cambridge, UK). Prior to that, she worked at Innogenetics, Belgium for over 15 years.