Gary Pasternack, MD, PhD
Chief Executive Officer (C.E.O.)
Gary Pasternack, MD, PhD is a seasoned biotech executive with a history of identifying opportunities for challenging, innovative technologies and driving them to product stage and commercialization. As one example, he is a co-founder of Intralytix where he identified food safety opportunities for bacteriophages, obtained initial funding for the company, and helped the company obtain FDA approval for its initial products involving the application of bacteriophages (live viruses) to food to eliminate food-borne bacterial pathogens. Most recently, after joining Asklepion in 2008, he led Asklepion’s successful efforts to obtain FDA and EMA approval for Cholbam® (cholic acid) in the US and Kolbam® (cholic acid) in the EU based principally upon retrospective studies of patients with inborn errors of bile acid metabolism, earning a Rare Pediatric Disease Priority Review Voucher from the FDA. Forming a team with Jeff Courtney, Asklepion’s C.O.O., the pair successfully negotiated the sale of Cholbam/Kolbam to Retrophin. Dr. Pasternack is a board-certified pathologist who maintains an adjunct academic appointment at his alma mater, Johns Hopkins. He is an inventor on 29 issued US patents.
Jeff Courtney, EMBA
Managing Director and Chief Operating Officer
Mr. Courtney has over 30 years of experience in business and finance with Ernst & Young, Village Roadshow Limited, Mayne Pharma Group, Sanitarium Health and Wellbeing, Ausio Pharmaceuticals and Asklepion Pharmaceuticals. As Managing Director and COO of Asklepion, he and Dr. Pasternack helped drive 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, 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.
Keith Ryan
Director of Regulatory Affairs
Mr. Ryan brings more than 25 years of pharmaceutical regulatory affairs experience to Asklepion Pharmaceuticals, LLC. His regulatory experience covers multiple therapeutic areas and orphan drugs. He has worked primarily on the brand side of the pharmaceutical industry with Eximias, Sanofi-Aventis, Grunenthal, USA and Cote Orphan Consulting. Mr. Ryan also has extensive experience from the CRO side of the regulatory business, with time spent at IBRD-Rostrum and Omnicare. Mr. Ryan holds a B.S. in Microbiology with graduate course work in toxicology, biostatistics, epidemiology, virology and biochemistry at the National Institutes of Health.
