Jeffrey Fetterman, as President of ParagonRx, has solidified the company's status as a leader in the field of REMS (Risk Evaluation and Mitigation Strategies) and benefit-risk management for pharmaceutical, biotech, and medical device industries. He draws upon his engineering experience to give clients a unique set of tools that help to keep them on trend within the ever-changing regulatory environment.
As coauthor of two pharmaceutical risk management books and consultant for numerous risk management programs, he is a proven pioneer in applying risk management principles to the pharmaceutical industry. Having led the pre-startup safety assessment of the only nuclear reactor to be reactivated following deactivation, Jeff is familiar with the cross-industry implications of risk management techniques.
Prior to cofounding ParagonRx, Jeff cofounded Empower Health, a business that integrated care management tools and services to improve clinical health outcomes of people with chronic illness. Fetterman has extensive pharmaceutical industry experience, having led marketing, medical education, strategic planning, and business development organizations at DuPont Pharmaceuticals and DuPont Consumer Health.
He is an Adjunct Instructor in the Lehigh University Healthcare Systems Engineering Program that applies industrial systems improvement methods to the complex healthcare system. He is also a board member for First State Innovation which fosters entrepreneurial businesses in Delaware. He holds a BS in Chemical Engineering from Lehigh University and an MBA from Katz School of Business at University of Pittsburgh.
Dr. Stephen Sun is the Chief Medical Officer at ParagonRx. Dr. Sun earned his Bachelors of Science in Chemistry, Food, and Nutrition from Rutgers University, his medical degree from UMDNJ-New Jersey Medical School, and his Masters in Public Health from the Johns Hopkins Bloomberg School of Public Health. While training in general surgery at Beth Israel Medical Center in New York City, he dedicated his off-hours to developing a medical internet start-up. He eventually left residency to work full-time on his medical knowledge company, Medtower, which delivered relevant late-breaking news to research scientists in the life sciences.
Dr. Sun then transitioned to work for the pharmaceutical industry, first at Organon in Drug Safety and Medical Knowledge Management. He next joined Alpharma as Director of Drug Safety for all US generic and branded drugs. He was soon promoted to Senior Director of Medical Affairs, where he oversaw Phase I, II and IV clinical studies, risk management plans, pharmacovigilance, medical education, scientific publications, government affairs, health outcomes, and supported sales and marketing teams as well as working with medical science liaisons.
After King Pharmaceuticals', Dr. Sun moved on to further expand his industry experience in over-the-counter medications at Reckitt-Benckiser. With an interest in public health, Dr. Sun joined the FDA as a Medical Officer. He has served in the CDER Division of Risk Management and most recently in the Controlled Substances Staff. Highlights of his tenure at the FDA include the TIRF class REMS, the abuse potential assessment decision tree, the proposed standardization of abuse-related adverse event MedDRA terms, and the development of a surveillance system using mobile technology called Realtime Application for Portable Interactive Devices (RAPID).
He now joins ParagonRx (Parent: InVentiv Health) as Chief Medical Officer to provide science-based, systems-level expertise on the management of risks throughout the various stages of product development and launch.
Kris Srinivasan, MD, MBA, M.Eng.HSE is the Clinical Consulting Director at ParagonRx and his role is to provide strategic plans for both the regulatory and commercial needs of clients. As a physician and engineer by training, with years of experience working in many different types of healthcare systems, Kris provides clinical innovations and analytics to the unique, systematic approach ParagonRx has for guiding risk management strategies in the pharmaceutical industry. Kris founded Gold Standard Solutions, LLC, which provides quality improvement and clinical practice optimization solutions to various types of medical practices. He has successfully optimized over a dozen medical facilities to ensure positive patient outcomes by maximizing practice efficiency and ensuring continuous quality improvements. Kris’s experiences in the healthcare industry are now being used in the pharmaceutical industry to ensure medication safe use for positive patient outcomes and optimizing regulatory and commercial strategies.
Kris completed his medical training in New York City and received a degree in medicine from the American University of Antigua School of Medicine. He concurrently earned a Master’s in Business Administration from Davenport University and most recently graduated with a Master’s degree in Healthcare Systems Engineering from Lehigh University.