John J. Orloff, M.D., is a global R&D/business leader with 20 years of experience in the bio-pharmaceutical industry at leading organizations. His expertise in research, non-clinical and clinical development, medical affairs, health economics & outcomes research, and regulatory affairs has informed all his work. Dr. Orloff recently joined Novelion Therapeutics as EVP and Head of R&D, overseeing a portfolio in metabolic disease and ophthalmic disorders. Previously he was EVP, Global Head of R&D, and Chief Scientific Officer at Baxalta, where he and his team advanced its pipeline by employing an external innovation model; led ~1300 people spanning discovery research to LCM; and served as a Section 16 Officer, representing R&D at all Executive Committee meetings, Board interactions, and investor/external community engagements. During a span of 2 years, Dr. Orloff oversaw regulatory approval of 10 unique products and 2 devices in the US and Europe. Dr. Orloff left following the acquisition of Baxalta by Shire. Before Baxalta was spun-off from its parent, Baxter International, in 2015, Dr. Orloff served as Executive VP, Global Head of R&D, BioSciences International at Baxter, and as a member of the Division’s Senior Management Team, reporting to the President. During his tenure, he advanced the BioScience pipeline; led all R&D functions, enhanced the R&D operating model; and pursued additional innovative opportunities. He also represented Baxter BioSciences externally in fora interfacing with scientific/academic communities, payer organizations, HTAs, health authorities, health care policy makers, and scientific congresses. Before joining Baxter in 2014, Dr. Orloff served as SVP, Global Head of Clinical Development at Merck Serono Pharmaceuticals (2014), leading design and execution of global clinical development programs and projects, and oversaw pipeline management and development. Dr. Orloff joined Novartis Pharma in 2003 in a leadership role, quickly rising to positions of greater responsibility. As SVP, Head, US Medical & Regulatory Affairs at Novartis Pharmaceuticals, a US subsidiary, he provided executive leadership of U.S. Clinical Development, Medical Affairs, and Evidence-based Medicine, and for North America Regulatory Affairs. He oversaw the successful development of/received regulatory approval for a wide range of products, often for multiple indications. From 2010 to 2013, Dr. Orloff served as SVP, Chief Medical Officer for Novartis Pharma’s Pharmaceutical Division, where he provided strategic and scientific leadership for all Global Development processes, continuous process improvement, clinical training and education, oversight of protocol and CDP reviews, and setting clinical policy. He led an overhaul of the quality organization and all R&D SOPs; established company policy for data sharing, aligned with Sandoz on a corporate position for biosimilars development, and drove implementation of innovative approaches to clinical development across key projects. From 1997 to 2003, Dr. Orloff served in several leadership roles with Merck Research Laboratories, supporting clinical development of products for osteoporosis, bone-related disorders, and arthritis, leading a Fosamax clinical program and efforts for clinical development of new compounds (novel MOAs) for osteoporosis and other bone- and arthritis-related conditions. Earlier, Dr. Orloff taught at Yale University School of Medicine as an Instructor, Assistant Professor, and Associate Professor of Medicine. He has been a member of industry Advisory Boards, and is a member of numerous professional societies and associations. Dr. Orloff is Board Certified in Endocrinology & Metabolism and Internal Medicine, and is a Diplomate, National Board of Medical Examiners. Dr. Orloff earned an M.D. from the University of Vermont’s College of Medicine, and an AB in Chemistry from Dartmouth College. He completed his Internal Medicine Internship, Residency, and Chief Residency at the University of Pittsburgh Medical Center, and, from 1987 to 1989, he held an Endocrinology & Metabolism Fellowship at Yale University School of Medicine.