Jeff Courtney, EMBA
Chief Executive 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 of Asklepion, he 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.
Lu Anne Novello
Executive Director, Clinical Operations
Ms. Novello has over 40 years of experience across the industry and has held positions of increasing responsibility in Clinical Operations, Project Management and Regulatory Affairs at various biotech and biopharma companies and has also worked on the CRO side of the business. She has a wide array of therapeutic experience with a heavy concentration in hematology and oncology including TILs, CAR T (allo and auto), personalized cancer vaccines, and targeted therapies in multiple tumor types. She served as Vice President of Clinical Operations at Aravive and was one of the first development employees hired at Human Genome Sciences where she led the clinical operations group for two BLA enabling programs in Hepatits C and a biodefense program for Anthrax poisoning. During her time at PPD she was responsible for the creation and management of the Early Phase Oncology Group which targeted best operational practices for delivering complex early phase oncology programs. Her regulatory background includes being the responsible head for delivery of an NDA for post-menopausal osteoporosis. She is a graduate of the University of Connecticut, School of Pharmacy.
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.
