Rajiv Mahadevan. Managing Director, Laboratory Services
Eugen (Gene) Koren, MD, PhD. Chief Scientific Officer
Anita Mehta-Damani, PhD. Senior Vice President, R&D
Pamela Lim. Head of Quality Assurance
Paul R. Billings, MD, PhD. Chief Medical Officer, Thermo Fisher Corporation
Robert B. Chess. Chairman, Nektar Therapeutics
David M. Essayan MD, FACP. Former Reviewer, US FDA
Kenneth J. Kelley. Chief Executive Offer, PaxVax
Clay B. Marsh, MD. Chief Innovation Officer, The Ohio State University
Neil McDonnell, PharmD. Senior Vice President, Takeda Pharmaceuticals
Andreas (Andy) Bakker, PhD. Clinical Operations and Quality expert
Mr. Mahadevan brings a broad general management background to the company with experience in sales, business development, strategic planning, operations and program management. He was an early hire at the Google- and Genentech-funded startup 23andMe, where he led business development efforts to implement the company's genetics platform in research and clinical settings. Prior to this he was at the world's largest biotechnology company Amgen, holding various roles of increasing responsibility supporting the development, commercialization, product strategy and partnering of denosumab (Prolia® and XGEVA®), approved in 2010 by the FDA with expected peak annual sales of over $5 billion. He has held roles in licensing at the Danish pharmaceutical firm Novo Nordisk, sales at enterprise software company Aftermind and strategy consulting at Arthur D. Little. He has also served as a global health strategist to the Bill & Melinda Gates Foundation. He received an MBA degree from Stanford University and a BA in Molecular & Cell Biology (emphases in Genetics & Immunology) from the University of California at Berkeley.
Dr. Koren is a nationally and internationally known expert on immunogenicity of therapeutic proteins. He served as a coordinator and senior author in the AAPS committee responsible for the publication of seminal white papers on development, characterization and validation of immunogenicity assays and most recently authored a chapter on immunogenicity published in the United States Pharmacopeia. Dr. Koren holds M.D. and Ph.D. degrees from the University of Zagreb, Croatia. During his clinical and academic career he served as a Director of the Laboratory of Immunology and Immunotherapy at the Clinic of Nuclear Medicine and Oncology at the University Hospital in Zagreb, as well as Associate Member of the Arthritis and Immunology Research Program, Oklahoma Medical Research Foundation and the OMRF Associate Professor of Medicine, Department of Medicine at the University of Oklahoma Health Sciences Center. Dr Koren continued his career in biotechnology industry, with roles of increasing significance at Genentech, CancerVax, Amgen, Scios, Abbott Vascular and BioMarin.
Dr. Mehta-Damani brings over 30 years of academic and industry expertise in cell biology and immunology to deliver novel assays to advance client objectives. She has extensive experience complying with relevant cGxP and CLIA requirements for assay development and clinical testing. She brings strong experience in various bioanalytical methods related to drug development process including assay design, development, validation and analysis for various assay platforms including flow cytometry, ELISA, cell-based assays, receptor-binding assays, ELISPOT, immunoblots, immunoprecipitation, tissue culture and potency assays for biological drug compounds. Dr. MehtaDamani also brings extensive fundamental research and product development experience in cell based immunotherapy for cancer and vaccine therapy for infectious diseases. Seminal research that Dr. Mehta-Damani conducted on dendritic cells as a post-doctoral researcher at Stanford was licensed by Dendreon Corporation and used to develop Provenge®, a novel autologous cellular immunotherapy treatment for advanced prostate cancer. Dr. Mehta-Damani previously held various scientific and management positions at Elan Corporation, Anosys Inc., and Stem Cells Inc. Dr. Mehta-Damani earned her PhD in Cell Biology/Immunology from University of Mumbai, India and did her postdoctoral work at Genentech and Stanford University.
Ms. Lim brings over 30 years of Pharmaceutical, BioPharmaceutical, Diagnostics and Biomedical Device product testing, analytical methods development, and quality management. She has worked with companies including Jennerex, StemCells, Durect, Aronex, Scios, Chiron, and Collagen Corporation, and has expertise in establishing quality laboratories, experienced with GMP/GLP regulations, technical expertise in microbiological, immunological, chemical, and chromatographic assays. She has supported PAI, FDA inspections, and NDA filings. Most recently, she has been providing consulting services managing quality systems and quality control laboratories working with Contract Testing Laboratories and Contract Manufacturing Organizations. Ms. Lim received a BA in Molecular Biology and minor in Chemistry from San Jose State University.
Dr. Billings brings extensive experience as a physician, researcher, and entrepreneur, and is currently Chief Medical Officer of Thermo Fisher Corporation (NYSE: TMO). Previously, he served as President, Chief Executive Officer and Director of Cellpoint Diagnostics (CPD), and as Director and Chief Scientific Officer of the Genomic Medicine Institute at El Camino Hospital. Dr. Billings is also Executive Chairman of Signature Genomics Laboratories, LLC, and serves on the Board of Directors of Cyntellect Inc., Lipomics, Inc., and several not-for-profit public interest organizations. Until September 2007, he was Senior Vice President and Senior Geneticist at Laboratory Corporation of America Holdings, Inc. He has been Professor of Anthropology (adjunct) at the University of California at Berkeley and has published extensively on topics in immunology, genetics and medicine. Dr. Billings, with an M.D from Harvard Medical School and Ph.D. in immunology from Harvard University, also has interest and expertise in diagnostics in medical care and genomic medicine.
Mr. Chess is Chairman of Nektar Therapeutics, a public biotechnology company (NASDAQ:NKTR) and Chairman of OPX Biotechnologies, a private company in the renewable fuels and chemicals field. He joined Nektar as its first non-founder employee in 1991 and led the company as CEO through 1999 and as Chairman since then. He was previously the co-founder and president of Penederm, Inc., a publicly traded dermatological pharmaceutical company that was sold to Mylan Laboratories. He has held management positions at Intel Corporation and Metaphor Computer Systems (now part of IBM), and was a member of the first President Bush's White House staff. He is chairman of Bio Venture for Global Health and a member of the Board of Directors of Metabolex, and is on the Board of Trustees of the California Institute of Technology and the Committee for Economic Development. He is a member of the faculty of the Stanford Graduate School of Business, where he teaches courses in entrepreneurship and management of health care innovation, and is an adjunct fellow at Stanford's Center for Health Policy. Mr. Chess received his B.S. degree in engineering from the California Institute of Technology and an M.B.A. from Harvard.
Dr. Essayan is a noted regulatory expert and serves as Executive Vice President for ONCORD, Inc. Prior to joining ONCORD, Dr. Essayan served as Executive Director of Regulatory Affairs at Amgen, Inc., where he held global responsibility for both pipeline and marketed products in the inflammation and general medicine therapeutic areas. Prior to Amgen, he was a Supervisory Medical Officer in the Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) and a Principle Investigator in the Laboratory of Tumor Molecular Biology, CBER/FDA. He received his B.S. in Chemistry from Yale University and his M.D. from the University of Pennsylvania. He completed his Residency in Internal Medicine at Temple University Hospital and his Fellowship in Allergy and Clinical Immunology at the Johns Hopkins University School of Medicine, where he held a faculty appointment for 12 years. He is Board Certified in both Internal Medicine and Allergy and Clinical Immunology.
Mr. Kelley brings thirty years of experience in biotechnology (IntraBiotics, Integrated Genetics, PaxVax), venture capital (K2 BioVentures, Latterell Venture Partners, Institutional Venture Partners), and strategic management (McKinsey & Company). During his career, Mr. Kelley has funded over 36 early stage biotechnology and medical device companies of which 15 became public. As founder/CEO and Chairman of IntraBiotics Pharmaceuticals, Inc., he raised over $200M and took the company public in 2000 (NASDAQ: IBPI). Mr. Kelley co-founded PaxVax in early 2007 and currently serves as the Company's Chief Executive Officer and Executive Chairman. Currently, Mr. Kelley also serves as Chairman of the Board for Halozyme (NASDAQ: HALO) and Fluxion Biosystems. Mr. Kelley earned an M.B.A. from Stanford University and a B.A. in Biochemical Sciences from Harvard University.
Dr. Marsh is currently Professor of Medicine in the College of Medicine and Director of the Center for Critical Care; Vice Chair, Research, Department of Internal Medicine, and Chief Innovation Officer at The Ohio State University. He is a physician-scientist where his laboratory focuses on intracellular signaling in mononuclear phagocytes and their role in angiogenesis, organ injury, remodeling and repair and systems biology applications to human health and disease. He has a specific interest in the biology of prediction and prevention of human disease. Dr. Marsh trained in internal medicine and pulmonary and critical care medicine at The Ohio State University, where he remained as faculty. He serves as a member of the national advisory board for Battelle Industries in the area of lung disease research and is currently the Chair of the Board of the Sarnoff Foundation for Cardiovascular Research. He reviews grants for the NIH, ALA, and the Wellcome Foundation and past member of the NIH Lung Injury, Repair and Remodeling study section. Currently, his research focuses upon how innate inflammation is regulated in advanced lung disease and in applications of systems biology to preventive, predictive, and personalized health care.
Dr. McDonnell, is Senior Vice President, Cardiovascular and Metabolic Diseases Therapeutic Area at Takeda Pharmaceuticals. Prior to this he was Deputy Director of Strategy for Global Health at the Bill and Melinda Gates Foundation, where he provided strategy and portfolio planning advice to the President of Global Health on a complex and diverse product development pipeline, an array of global health partnerships, and implementation projects in developing countries. Previously, he was Chief of Staff for Global Health at the foundation. He was formerly vice president of program management at the biotechnology firm ZymoGenetics, overseeing its portfolio of products in development. Prior to that, he spent 9 years in development and commercial operations at Immunex Corporation. He began his career in healthcare as a clinical pharmacist in hematology/oncology and gynecologic oncology at the University of Washington Medical Center. He has product development experience in a variety of therapeutic areas, including medical and surgical hemostasis, oncology, rheumatology, and asthma. Dr. McDonnell received both his Pharm.D and B.S. Pharm from the University of Washington. He completed a general residency in hospital pharmacy at the University of Washington and Harborview medical centers.
Dr. Bakker has established and managed several GxP and CLIA laboratories during his career. He is currently Vice President of Operations at Cynvenio Biosystems. Previously he served as vice president of molecular diagnostics and clinical trials at Solstas Lab Partners. At Amgen Inc., he developed a novel outsourcing and management organization as director of Technical Services that provides laboratory and imaging support to clinical studies worldwide. Prior to Amgen, Dr. Bakker was the vice president of clinical programs at Pathway Diagnostics where he established and managed the clinical trials organization. Before joining Pathway Diagnostics, Dr. Bakker directed several organizations at Specialty Laboratories (now Quest Diagnostics), including the genotyping laboratory, molecular technology development, and clinical trials. Dr. Bakker received his Ph.D. from the University of California, Los Angeles and a B.S. from the University of California, San Diego.