Jeff Courtney
Chief Executive Officer
Mr. Courtney has over 30 years of experience in pharmaceuticals, business and finance with Ernst & Young, Village Roadshow Limited, Mayne Pharma Group, Sanitarium Health and Wellbeing, Ausio Pharmaceuticals and Asklepion Pharmaceuticals. As Managing Director of Asklepion, he drove successful efforts to obtain FDA approval for Cholbam in the US and EMA approval for Kolbam in the EU. Mr. Courtney has held numerous board positions on companies in the United States, Australia, New Zealand, Canada, the United Kingdom, India and Hong Kong.
Gurdyal Kalsi, M.D.
Chief Medical Officer
Dr Kalsi brings more than 20 years of experience in global clinical development, medical affairs, investment strategy and regulatory affairs to Asklepion Pharmaceuticals, LLC. Most recently, Dr. Kalsi served as the SVP/CMO of Tissue Gene, where he headed medical, clinical and regulatory development functions in cell and gene therapeutics and helped IPO its lead asset in Knee OA on the KOSDAQ. Prior to his time with Tissue Gene, Dr. Kalsi served as Corporate Vice President for Clinical Development & Medical Affairs at Emergent BioSolutions Inc. At MDS Pharma, he was the head of Medical Affairs and Regulatory Affairs. Dr. Kalsi held executive leadership positions with ICON plc in clinical development and medical affairs. He began his pharmaceutical career at Lundbeck A/S in Copenhagen, Denmark. Dr. Kalsi received his medical degrees in surgery and medicine from Glancy Medical College (GMC), followed by postgraduate training courses in public health medicine at St George’s Hospital in London and Pharmaceutical Medicine postgraduate training at Cardiff University, UK. He is a member of the British Association of Pharmaceutical Physicians and Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians.
Richard Schwen, PhD
Consultant, Regulatory Affairs
Dr. Schwen has over 30 years of experience in the areas of drug development, toxicology and regulatory affairs. His career began at Procter and Gamble Pharmaceuticals, with research and management experience in both OTC and prescription product categories. He subsequently guided regulatory approval programs for many innovative technologies while VP of Regulatory Affairs at Kendle International, PAREXEL International, and Ausio Pharmaceuticals (analgesic, anti-inflammatory, oncology, antipsychotic, CNS, and women’s health). Educational background includes chemistry (Hamline U.), pharmacology (PhD, U. Minnesota), and prior board certifications in toxicology (DABT) and regulatory affairs (RAC). Recent regulatory expertise includes Rare Pediatric Disease, Orphan Drug, and FDA’s Expedited Programs. Dr. Schwen continues as a consultant and as an Adjunct Professor at the University of Cincinnati College of Pharmacy. Prior board positions include the Cincinnati Board of Health (past chair), and the Ohio Association of Boards of Health (OABH).
Heather Hill
QA Director
Ms. Hill has over 20 years of experience in the biotech and pharmaceutical industry, specializing in GxP compliance and quality systems. At Asklepion, she oversees the management of quality systems, audit readiness, CAPA, and ensures product safety compliance. She has a proven track record of supporting regulatory inspections and driving continuous improvement activities for various product types including small molecules, vaccines, and human tissue products. Ms. Hill received here degree in chemistry from Michigan State University.
