Edison is a world leader in the discovery and development of redox drugs. The company has obtained orphan designation in both the United States and Europe for its first drug candidate, EPI-743 (Vincerinone®). Vincerinone® is now in phase 2 clinical development. It is being evaluated in multiple clinical indications where defects in the mitochondrial proteins and redox control have been well characterized.
Edison Pharmaceuticals’ research efforts are focused on the science of cellular energy and the development of drugs targeting the control of metabolism. Our first clinical indications are a group of diseases collectively known as “mitochondrial disease.” These diseases are frequently inherited and primarily affect children. They commonly result in severe neurological impairment and death. At present, there are no FDA- or EMA-approved treatments. Mitochondrial diseases share a common feature: defects in DNA that encode for proteins critical to the proper handling of electrons. The process of regulating the flow of electrons is known as redox control, and it is essential to the generation and regulation of energy. Thus, mitochondrial diseases are diseases of redox control.
The Company’s strategy is to first gain approval for EPI-743 for orphan mitochondrial disease. It is already applying what it has learned from the study of these diseases to developing potential treatments for other neurological diseases with shared (redox) disease mechanisms.
Guy Miller, MD, PhD
Chairman & CEO
Guy Miller, MD, PhD is the co-founder of Edison Pharmaceuticals, and has served as Chairman and Chief Executive Officer of the Board since 2005. Prior to founding Edison, he founded Galileo Pharmaceuticals, a biopharmaceutical company, and was its Chairman and CEO from 1995-2005. Dr. Miller holds an MD from the Medical College of Pennsylvania and a PhD in chemistry from the University of Virginia. He completed his surgical internship at the University of Chicago, and a residency in anesthesiology and critical care medicine at Johns Hopkins. Dr. Miller completed a fellowship in multidisciplinary critical care medicine at Johns Hopkins, where he was on the faculty as an Assistant Professor until 1996. He is currently an attending physician in medical-surgical critical care medicine at Stanford University-PAVAMC.
Matthew B. Klein, MD, MS, FACS
Chief Medical Officer
Matthew B. Klein, MD, MS, FACS is Chief Medical Officer of Edison Pharmaceuticals. He received his MD degree from Yale University and completed his surgical training at Stanford University. He also holds a Masters degree in Epidemiology. Dr. Klein most recently held the David and Nancy Auth-Washington Research Foundation Endowed Chair for Restorative Burn Surgery at the University of Washington where he was a professor of surgery and epidemiology. His clinical and research expertise spans several fields, including skin biology, wound healing, systemic inflammatory disorders, clinical trials, and nutrition. Dr. Klein has authored or co-authored over 80 peer-reviewed manuscripts and 15 book chapters related to these areas, and sits on the editorial review boards of several prominent biomedical journals. He is currently a clinical associate professor at Stanford University.
Martin Thoolen, PhD
Chief Drug Development Officer
Martin J. Thoolen, PhD has served as Edison’s Chief Drug Development Officer since 2009. Prior to joining Edison, Dr. Thoolen held positions with increasing responsibilities at Amgen and Tularik. He has over 25 years in pharmaceutical R&D. Other companies he has been employed at include DuPont Biopharmaceuticals, DuPont-Merck, and Nuvelo. He was co-founder of Cerulean Biosciences. Dr. Thoolen’s pharmaceutical R&D expertise includes non-clinical and clinical development of small molecules, proteins, oligonucleotides, and radiopharmaceuticals in cardiovascular disease, neurology, oncology, thrombosis, immunology and inflammation, metabolic diseases, and anti-bacterial. He contributed to many successful regulatory submissions including more than 15 IND/CTXs and two NDAs, has authored or co-authored more than 100 papers published in peer-reviewed journals and served on the Editorial Board of the Journal of Pharmacology and Experimental Therapeutics for 15 years. He earned his PhD in Pharmacology (cum laude) in 1982 at the University of Amsterdam.
William D. Shrader, PhD
Senior Vice President of Innovation at Edison Pharmaceuticals, Inc
William D. Shrader, PhD is the Senior Vice President of Innovation at Edison Pharmaceuticals, Inc. Dr. Shrader obtained his BS in chemistry from the University of Illinois at Urbana and his PhD in organic chemistry from the University of California at Berkeley. Following his doctoral studies, Dr. Shrader was a National Institute of Health (NIH) postdoctoral fellow at the California Institute of Technology. He has previously held positions at Abbott Laboratories, Celera Genomics, and Ampere Life Sciences, where he directed programs in thrombosis, oncology, and inflammation. His research expertise spans several fields, including medicinal chemistry, structure-based drug discovery, and enzymology. Dr. Shrader is the author on more than 25 peer-reviewed journal articles in these fields.
Peter P. Giannousis, PhD
Vice President, Pharmaceutical Development and Manufacturing
Peter P. Giannousis, PhD consulted on CMC Development for over two years prior to joining Edison. Prior to consulting, he was Senior Director of CMC Development at The Vaccine Company, where he was responsible for the development and outsourcing of manufacturing processes and analytical methods to supply drug substance, drug product, and drug kits for clinical trials. He has over 20 years of experience in the pharmaceutical industry including process research and development, Quality Assurance, CMC project management, analytical, and pharmaceutical development. Dr. Giannousis has previously held positions of increasing responsibility at Novartis Pharmaceuticals, Sugen (a Pharmacia company), and Scios (a J&J company). He received a BS in chemistry from MIT, and a PhD in bioorganic chemistry from the University of California at Berkeley.
Sandy Mohan, PhD
Vice President, Quality Assurance
Sandy Mohan, PhD is Edison’s Vice President of Quality. Prior to joining Edison, Dr. Mohan was the Vice President of Quality at Intermune Pharmaceuticals. She has over 20 years of experience in the pharmaceutical industry. Her areas of expertise include drug development, commercialization, and GxP (GMP, GLP, GCP, GPvP) Quality and Compliance. She has extensive experience in the oversight of domestic and international clinical trials as well as contract GMP manufacturing. Her experience includes regulatory submissions (NDA, MAA, NDS) leading to product approvals and launches in the US, European Union, and Canada, as well as several successful FDA, MHRA and other European (SwissMedic and Swedish) regulatory inspections. Other companies for which Dr. Mohan has worked include CV Therapeutics (acquired by Gilead), Alexza, Purdue Pharma, Immunomedics, and Merck. She holds an MS and PhD in Microbiology from New York University.
Kerstin K. Leuther, PhD
Vice President, R&D Operations/Alliance Management
Kerstin K. Leuther, PhD is Edison’s Vice President of R&D Operations/Alliance Management. Before joining Edison, Dr. Leuther was the Executive Director of Alliance and Project Management at Affymax, Inc., having joined Affymax as a staff scientist. At Affymax, she was responsible for the central coordination of cross-functional activities for Affymax’s lead investigational drug candidate, and managed cross-functional project teams in R&D, commercial, and medical affairs departments at Affymax. Previously, she held various scientific positions in the Molecular Genetics and Cell Biology groups at Affymax Research Institute where she made key contributions in technology development and drug discovery. Dr. Leuther received her PhD in Biochemistry from the University of Texas, Southwestern Medical Center in Dallas, TX, and a BA in Biology (summa cum laude) from Jamestown College in Jamestown, ND. She pursued postdoctoral studies in structural biology and biochemistry at Stanford University in Stanford, CA.
Jeff K. Trimmer, PhD
Vice President, Discovery
Jeff K. Trimmer, PhD is Edison’s Vice President, Discovery, and has 20+ years of scientific experience in metabolic and cardiovascular disease areas, systems biology/computational modeling, and business development. Prior to joining Edison, Dr. Trimmer was Executive Director and Head of Diabetes Prevention & Remission and Systems Biology in Pfizer’s Cardiovascular, Metabolic and Endocrine Disease (CVMED) Research Unit. In that position, he was responsible for the determination and implementation of the Research Unit’s near and long-term drug discovery and development strategy, and led a group of >30 scientists working on preclinical and clinical projects. Before joining Pfizer, Dr. Trimmer was at Entelos, Inc. for ten years in increasingly responsible positions, ending as the Chief Scientific Officer. Dr. Trimmer holds a PhD in Integrative Biology; with a concentration in Human Physiology and Metabolism from the University of California Berkeley.