What CMOs Need to Know About Medical Affairs

Dr Daniel Chung is the Chief Medical Officer for SparingVision, an ocular genomic medicine company, focusing on gene agnostic gene therapy and CRISPR gene editing approaches to combat blinding diseases. Prior to his recruitment to SparingVision, Dr. Chung was the Ophthalmology Therapeutic Leader for Spark Therapeutics, Where he led the medical affair group and contributed to areas of clinical development and operations, marketing, commercial, patient advocacy, pre-clinical research and development and business development. Dr. Chung was intimately involved with the development of Luxturna, the first gene therapy approved by the FDA and EMA for use in a blinding genetic disease.Prior to joining Spark Therapeutics, at the Scheie Eye Institute, University of Pennsylvania, working in retinal gene therapy. Also serving as a sub-PI on the RPE65 gene therapy clinical trial at the Children’s Hospital of Philadelphia (CHOP), and made major contribution to the development of the Phase 3 MLMT novel endpoint, was PI of the MLMT study, and the RPE65 Natural History Study. He completed his ophthalmology residency at Summa Health Systems in Akron, Ohio. He then completed fellowships in pediatric ophthalmology and ocular genetics research at the Cole Eye Institute at the Cleveland Clinic, and in retinal gene therapy at the National Eye Institute/NIH in Bethesda, MD.

Peg Crowley-Nowick is a well-respected expert in the pharmaceutical industry, bringing nearly 30 years of experience in medical affairs and clinical research. She has successfully led late-stage biotech and pharmaceutical companies through multiple product launches across several therapeutic areas, such as oncology, cardiovascular and diabetes. Dr Crowley-Nowick's patient-centric view and drive for improved patient care and outcomes have propelled her to shape Lumanity Medical Affairs based on not only scientific integrity but also continual collaboration with emerging medical stakeholders. Earlier in her career, Dr Crowley-Nowick held academic appointments, establishing her scientific credibility in the research and medical communities. Later she joined industry and gained valuable experience at all levels of responsibility within Medical Affairs, first at Berlex Laboratories, and then Bayer Healthcare Pharmaceuticals. Dr Crowley-Nowick founded Zipher Medical Affairs which was acquired by Lumanity in 2021. Dr Crowley-Nowick received a PhD from the University of Alabama at Birmingham in the field of immunology and an MBA from Simmons School of Management.

Joseph Elassal, MD is Chief Medical Officer of Ankyra Therapeutics. He has over a 15 year career in the pharmaceutical industry with his most recent position serving as a Senior Director for Medical Affairs at Regeneron where he was leading efforts on cemiplimab and other immunotherapy approaches for patients with cervical and non-melanoma skin cancer. He has also served as Senior Medical Director at Replimune overseeing early stage clinical development of oncolytic viruses in a variety of solid tumors. Prior to that, he served as Deputy Vice-President at the Pharmaceutical Research and Manufacturers of America (PhRMA) where he lead regulatory policy efforts for biosimilars as well as cell and gene therapies including implementation of the Biosimilars User Fee Act (BsUFA II). Dr Elassal earned his MD from Eastern Virginia Medical School and MBA from Columbia Business School. He completed his internship and residency at Columbia University/New York Presbyterian Hospital and is certified by the American Board of Internal Medicine.

John Yee MD, MPH, currently serves as Senior Vice President, Medical Affairs, at Apnimed, Inc., a company developing oral drugs for the treatment of obstructive sleep apnea. He has more than 25 years of leadership experience at leading biotechnology, pharmaceutical, and health care technology companies, and at a major academic medical center. Dr. Yee has expertise in all aspects of drug development and commercialization, including clinical development, medical affairs, pharmacovigilance, regulatory affairs, and patient advocacy. He has provided medical leadership for more than 10 new product launches and label expansions. Dr. Yee has served in senior medical leadership roles at Genzyme Corporation, AstraZeneca Pharmaceuticals, Intarcia Therapeutics, Vertex Pharmaceuticals, Flexion Therapeutics, and Sobi North America. Dr. Yee serves on the scientific advisory board for Comera Life Sciences, and previously served as a non-executive director on the board of directors. Dr. Yee earned an M.D. from Harvard Medical School, an M.P.H. in Health Care Management from the Harvard T.H. Chan School of Public Health, and an A.B. in History and Science from Harvard College. He completed his pediatric residency and fellowship training in rheumatology, immunology and health services research at Boston Children’s Hospital. Prior to joining the industry, Dr. Yee held leadership roles at Boston Children’s Hospital and served as a faculty member at Harvard Medical School.