Edward Gomperts, MD- Executive Chairman
Andrew Gomperts- President and Chief Executive Officer
Alison Arter- Chief Commercial Officer
Kevin Bracken - Senior Chemistry, Manufacturing, and Controls Advisor
Bonnie Mills, PhD - Vice President, Clinical Operations
Leo Otterbein, PhD- Principal Scientific Advisor
Brett Skolnick, PhD- Senior Clinical Advisor
Douglas Stockdale - Vice President, Technical Operations
Howard Levy, MD PhD- Senior Medical Advisor
Sandra Cottrell, PhD - Senior Regulatory Advisor
Edward Gomperts, MD
Co-Founder and Executive Chairman
Edward Gomperts MD is a pediatric non-oncologic hematologist and has been on staff at Children’s Hospital of Los Angeles since 1978. He is co-inventor of Hillhurst’s current technology and is a co-founder of the Company. He was Vice President, Medical Affairs and Clinical Development for the Baxter Healthcare Bioscience Division between 1990 and 2005, and was closely associated with the licensure of Baxter’s recombinant Factor VIII therapeutic products. Prior to his recent retirement as Clinical Professor of Pediatrics and Pathology at the University of Southern California Keck School of Medicine, he was Director, Clinical Research at CHLA and co-Director of the USC/CHLA CTSI.
Co-Founder; President and Chief Executive Officer
Before co-founding Hillhurst, Mr. Gomperts was Chief Business Officer at Cerus Corporation, where he was responsible for the global marketing and business development functions and for the commercial organizations in the Americas and Asia-Pacific regions. Prior to Cerus, he led corporate and business development for Sangart, a development stage biopharmaceutical company developing drugs for sickle cell disease and traumatic hemorrhage. Mr. Gomperts also led corporate development for Prometheus Laboratories. He previously spent five years with McKinsey & Company, where he advised corporations on strategic, financial and operational issues. Mr. Gomperts holds an MBA from the Wharton School, a JD from Stanford Law School and a BS in Chemistry and Economics from UCLA.
Chief Commercial Officer
Ms. Arter has over 30 years of experience in pharmaceutical industry, with a focus on commercialization and commercial activities. She has held senior executive positions at Baxter Healthcare, Bayer Pharmaceuticals and Inspiration Biopharmaceuticals. Ms. Arter has led both the commercialization strategy, including marketing strategy, clinical strategy, and product design, as well as operational commercialization activities, including worldwide launch activities and ongoing US and global sales/marketing for numerous therapeutics including several orphan drugs. She has led biopharmaceutical development projects at all stages, from the decision to develop in man through successful global launch and ongoing commercialization. Ms. Arter holds an MBA from the University of Southern California and a BA in Biomedical Engineering from Northwestern University.
Senior Chemistry, Manufacturing, and Controls Advisor
Mr. Bracken has over forty years of executive and operational experience in the development and manufacturing of drug products and formulations. He was previously Vice President of Manufacturing for Verenium, Universal Preservation Technologies, and Vical, where he oversaw production, process development, engineering and quality control for multiple drug products. Mr. Bracken has led both development and commercial stage manufacturing, and has led contract manufacturing and contract research interactions on numerous occasions. He previously oversaw the process engineering function at Vestar/NeXstar and Baxter Bioscience. Mr. Bracken holds a MS in Chemical Engineering from the University of Rochester and a BS in Chemical Engineering from the University of Delaware.
Bonnie Mills, PhD
Vice President, Clinical Operations
Dr. Mills has a multi-national clinical drug development career spanning over 25 years in both the large pharmaceutical and biotech industries. Her broad based experience includes multiple therapeutic areas with development of drugs, biologics and combination products to treat oncology, hematology, immunology and inherited metabolic disorders. In her prior position as Senior Vice President of Clinical and Regulatory Affairs at Inspiration Biopharmaceuticals, she was responsible for strategy, coordination, implementation and oversight of all clinical development and regulatory activities including phase I/II/III clinical development programs, and submission of marketing applications in the US and European Union. Following the relocation of Inspiration headquarters in 2012, Dr. Mills has worked as an independent clinical and regulatory consultant to biotech companies that are initiating clinical development programs and/or preparing marketing applications. Recent projects include gene therapy candidate products, biosimilar development, and novel therapeutics to treat orphan indications. Dr. Mills received her Ph.D. from The University of New Mexico School of Medicine and completed post-doctoral training programs at St. Jude Children’s Research Hospital in Memphis, and Scripps Clinic and Research Foundation in San Diego.
Leo Otterbein, PhD
Principal Scientific Advisor
Dr. Otterbein has over twenty years of experience in heme oxygenase-1 (HO-1) and carbon monoxide (CO) research, including seminal preclinical and clinical research expertise on the therapeutic use of CO in a number of indications including organ transplantation, sepsis, vascular-proliferative disease and acute lung injury, among others. His current research is focused on the mechanisms by which HO-1 and CO modulate innate immunity, host defense and tissue repair. Dr. Otterbein brings more than ten years of experience advising companies on CO-focused drug development programs. Dr. Otterbein earned his PhD in Physiology at Johns Hopkins University with graduate and postdoctoral training at Yale University and the University of Pittsburgh. He joined the Department of Surgery and the Transplant Institute at the Beth Israel Deaconess Medical Center in 2004 and currently has an appointment as an Associate Professor at Harvard Medical School.
Brett Skolnick, PhD
Senior Clinical Advisor
Dr. Skolnick has over 16 years experience in academic medicine followed by 15 years experience in clinical drug development. His clinical development work started as Head of Office for Quintiles’ Neurology division and then for the last 12 years he has held positions of increasing responsibility at Novo Nordisk. He has a broad based experience with development responsibilities in neurology that include Intracerebral hemorrhage, traumatic brain injury and stroke as well as more recently in the area of inflammation having worked on the development of multiple monoclonal antibodies in Psoriasis, Rheumatoid Arthritis, Crohn’s disease and Ulcerative Colitis. Dr. Skolnick now works as an independent clinical development consultant to pharmaceutical companies with a focus on early development. Dr. Skolnick received his Ph.D. from Washington University and completed a post-doctoral fellowship at the University of Pennsylvania in Neuropsychopharmacology. He remained at the University of Pennsylvania in roles of increasing responsibility and is currently an Adjunct Associate Professor of Neurology in the Perlman School of Medicine while also serving as a Clinical Associate Professor of Neurosurgery at the Hofstra North Shore-LIJ School of Medicine.
Vice President, Technical Operations
Mr. Stockdale has over thirty years of broad operational and technical experience in the Life Science Industry and was previously head of European Contract Manufacturing for Inspiration Biopharmaceuticals, Inc., a late stage company focused on the development of recombinant proteins for the treatment of hemophilia. Prior to Inspiration, he was the CEO of Stockdale Associates, Inc. a boutique consulting group providing technical operational professional services to the life science industry. Mr. Stockdale spent over twenty years with Baxter Healthcare in various operational and technical leadership roles with four Baxter business units; Diagnostics, Biologics, Medical Devices and Biopharmaceuticals. Mr. Stockdale holds an MBA from the University of La Verne and a BS in engineering from Michigan State University.
Targeting Debilitating and Life Threatening Inflammation
Howard Levy, MD PhD
Senior Medical Advisor
Dr. Levy has over 25 years’ experience in the pharmaceutical industry with a focus on critical care and benign hematology therapeutic areas. He was the Senior Vice President and Chief Medical Officer at Inspiration Biopharmaceuticals, a company solely focused on innovation in hemophilia. He served as Chief Medical Officer at Sangart, Inc., which was developing pegylated hemoglobin as an oxygen therapeutic agent, and a treatment for sickle cell crisis. Prior to Sangart, he was Associate Vice President, Clinical Research, Medical and Regulatory Affairs, at Novo Nordisk and was responsible for a number of clinical research programs, including hemostasis agents, recombinant factor VIIa for trauma and intracerebral hemorrhage, and anti-inflammatory biological compounds. Earlier, Dr. Levy was Clinical Research Physician and Medical Director Acute Care in the U.S. Medical Division of Eli Lilly and Company supporting postmarketing clinical trials and medical affairs for recombinant Activated Protein C (Xigris) in severe sepsis and antiplatelet agents ReoPro and prasugrel. He was Chief of Critical Care Medicine at the University of New Mexico in Albuquerque for 11 years.
Sandra Cottrell, PhD
Senior Regulatory Advisor
Dr. Cottrell’s career has span roles in small, mid-size and large pharmaceutical company settings, including serving as Vice President of Regulatory Affairs at Insmed, Mylan Specialty, LP, NPS Pharmaceuticals, B&H Consulting Services and INO Therapeutics LLC; as Head of Regulatory Affairs at Chugai, US; as franchise and therapeutic area head in Regulatory Affairs at the US affiliate of Novo Nordisk Inc; and has over 25 years of experience within Johnson & Johnson's pharmaceutical sector. She has established company GCP compliance, pharmacovigilance processes, and target and company core data sheets; she has worked within risk management, global project management, and medical affairs, and has achieved successful negotiations with the FDA, successful Advisory Committee hearings, and NDA/BLA approvalsWith over 30 years’ experience working globally in the biopharmaceutical industry across multiple therapeutic areas, she has an in-depth knowledge of small-molecule and biological product development with a specialty in Regulatory Affairs across products’ life cycle (pre-IND to post approval). Dr. Cottrell is an adjunct professor at Temple University teaching in their graduate QA/RA program and guest lectures for the Danish Medicademy's degree program. She received her Bachelor and Master degrees in Chemistry and Doctorate degree in Pharmaceutics with an emphasis on Regulatory Affairs from Temple University. Dr. Cottrell founded Regulatory Gap Services, LLC. in 2014.