Melody Sauerborn, Senior Expert, Immunogenicity and Bioanalysis, TNO, a Netherlands Applied Research Center
Dr. Sauerborn spent most of her undergrad years in well-known institutes such as the Centers for Disease Control and Prevention in Atlanta to widen her knowledge in immunology. After acquiring her Masters in Science she joined the lab of Prof. Schellekens and Prof. Jiskoot, two experts in immunogenicity of protein drugs, to shed more light on the immunological aspects of antibody formation against aggregated protein therapeutics. After obtaining her PhD she started a spin-off, ADA InVivo BV, a biotech CRO in the field of drug safety. Besides her work as a trainer and senior expert in immunogenicity, she is also a project leader and innovation manager at the bioanalysis and immunogenicity department at TNO Triskelion.
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.
Lieselot Bontinck, Scientist, Immunogenicity, Pharmacology, Ablynx BV
Lieselot holds a degree from Ghent University as a Master of Bioscience Engineering, Cell and Gene Biotechnology. As a first step in her career, she was active at the Scientific Institute of Public Health as a researcher responsible for diagnostic assay development and verification as well as working on her own research projects. In 2009 she joined Ablynx as a scientist in the bioanalytical team where she has held positions with increasing responsibility. Lieselot has extensive experience in ligand binding assays with a focus on assay development and validation of immunogenicity assays in support of both preclinical and clinical studies for various Nanobody® programs in development. Ablynx is a pioneer in the discovery and development of Nanobodies®, a novel class of antibody-derived therapeutic proteins.
Martin Schwickart, Ph.D., Scientist, Clinical Pharmacology and DMPK, MedImmune, Inc.
Dr. Martin Schwickart is a Scientist in Clinical Pharmacology and DMPK at MedImmune. Martin leads a group that provides both clinical and preclinical study support with bioanalytical strategy, assay development and sample testing. Martin oversees assay development and sample testing using ligand binding assays, cell-based assays and flow cytometry. He also provides PHC strategy and inputs into clinical study design. Previously, Martin worked at Genentech in target discovery. He performed his doctoral studies at the Max-Planck Institute for Molecular Cell Biology and Genetics in Dresden, Germany. Martin has published a number of research articles, many in high impact journals describing seminal work.
Kyra Cowan, Ph.D., Scientist, Development Sciences, Genentech, Inc.
Dr. Kyra J. Cowan is a scientist in the BioAnalytical Sciences department at Genentech, focusing on clinical and nonclinical pharmacokinetic and anti-therapeutic antibody assay method development and validation, as well as fit-for-purpose biomarker assay and novel technology development, in support of Genentech’s drug pipeline. She received her Ph.D. in Chemistry from the Ottawa-Carleton Chemistry Institute, Carleton University, in Ottawa, Canada, focusing on the regulation of metabolism through the reversible phosphorylation control of enzymes. She then completed two postdoctoral fellowships, her first at COR Therapeutics (now Millennium Pharmaceuticals), identifying signaling proteins critical to platelet aggregation, and her second at the University of California, San Francisco, focusing on neurodegenerative disorders and the involvement of molecular chaperones in disease. After working at two startup companies, Dr. Cowan joined Genentech in 2006 and since that time has led and been a team member on several pharmacology teams and bioanalytical subteams for molecules that target oncology, immunology, ophthalmology, metabolism, and cardiovascular disease areas.
Francesca Civoli, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.
Jill B. Conner, Ph.D., Director, Global Specialty Medicines, Teva Pharmaceuticals
Dr. Jill Conner joined Teva Pharmaceuticals in 2006 in the Medical Affairs department, where she was Director of Medical Operations, before she took her current position as Director of Life Cycle Initiatives. She currently is responsible for the life cycle management for innovative products. Prior to joining Teva, Dr. Conner spent several years as a medical technologist before focusing her work in drug approval research with management positions in CRL-Medinet, followed by director positions in Clinical Operations/Project Management at United BioSource Corporation.
Deborah Finco, Ph.D., Senior Principal Scientist, Immunotoxicology COE, Pfizer, Inc.
Deborah Finco is a senior principal scientist in the Immunotoxicology lab in Drug Safety Research and Development at Pfizer Inc. in Groton CT. Her more recent work has focused on the development of immunoassays and bioassays to meet regulatory guidelines with respect to immunogenicity of biological therapeutics. She has authored/co-authored numerous publications dealing with immunogenicity in recent years.
Marta Starcevic Manning, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.
Marta Starcevic Manning is a Principal Scientist in the Clinical Immunology department at Amgen. Marta received her B.S. in Cell and Molecular Biology from Tulane University in New Orleans, and her PhD in Human Genetics at the University of California, Los Angeles. Since joining Amgen in 2005, Marta has supported immunogenicity testing efforts for various types of protein therapeutics, including antibody-drug conjugates. She is experienced in the development of risk-based immunogenicity testing strategies, assay optimization and validation, and interpretation of anti-drug antibody results.
Laura Salazar-Fontana, Ph.D., Reviewer, Quality & Immunogenicity, 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 costimulatory 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 costimulatory 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.
Becky Schweighardt, Ph.D., Principal Scientist, Immunogenicity Assessment, BioAnalytical Sciences, BioMarin, Inc.
Claire Holland, Ph.D., Senior Manager, Biopharm R&D, Clinical Immunology, GlaxoSmithKline
Robin Thorpe, Ph.D., FRCPath, Head, Biotherapeutics Group, National Institute for Biological Standards and Control
Kathleen Clouse, Ph.D., Director, Division of Monoclonal Antibodies, CDER/FDA