Archives: Speakers

Ken is the Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, and Chairman of the Center for Information and Study on Clinical Research Participation, a non-profit organization that he founded to raise public and patient awareness of the clinical research enterprise. He is founder and owner of CenterWatch, and an owner and board member of the Metrics Champion Consortium. A well-known speaker at symposia, universities, and corporations, Ken has published extensively in peer-reviewed journals, books and in the trade press.  He has been an active DIA member for 25 years and has held board appointments in the private and public sectors.  Ken earned his MBA from Northwestern University.

John has 15+ years of experience in the medical device and pharmaceutical industry with responsibility for people management/development, global clinical trial management, regulatory strategy, and leading product development processes with emphasis on comprehensive regulatory and clinical strategy and product risk management. John’s experience in clinical and regulatory includes leading multiple Investigational Device Exemption IDE Trials, regulatory submissions, and FDA communications in a variety of indications including spine, neurosurgical, cranial, pulmonology, gastroenterology, diagnostics (IVDs), women’s health, and vascular surgery devices.

Gabrielle DeBartolomeo is the clinical trial scientist at Alkeus Pharmaceuticals, a Boston-based biotech focused on developing treatments for rare and common forms of currently untreatable blindness including age-related macular degeneration and Stargardt disease. Wearing multiple hats in the company, she is responsible for clinical operations activities and coordinates operational and regulatory activities with private practice and academic sites, in addition to leading patient outreach and support. Through this role, she has witnessed firsthand the multidimensional impact of COVID-19 on clinical trials.