BURLINGTON, Mass., Aug. 19, 2013 /PRNewswire/ -- ParagonRx, an inVentiv Health company offering product safety risk management and healthcare systems consulting to pharmaceutical and medical device companies, announced today the appointment of Stephen W. Sun, MD, MPH, as Chief Medical Officer advising clients on regulatory and safety issues.
Dr. Sun, formerly with the U.S. Food and Drug Administration (FDA), will be reporting directly to ParagonRx President Jeffrey Fetterman.
His appointment comes at a time of dramatic regulatory change in both the United States and globally. Regulators are under pressure to speed review of new medical products while simultaneously improving safety. As a consequence, drug developers and device makers planning for a successful review must be proactive in assuring optimal and safe use of products before the products come up for review.
"The focus today is on enhanced pharmacovigilance, putting preventions in place before any regulatory body requires it," Fetterman said. "Dr. Sun's FDA experience will enrich the guidance we offer clients to assure that active risk management is at the core of developing all new products and services."
ParagonRx clients will have access to a savvy regulatory strategist in Dr. Sun, who understands the escalating scientific rigor regulators expect to see in filings. His public health experience also will benefit clients seeking counsel on the appropriate use of medications and devices designed to improve the well-being of large populations.
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, managing the team responsible for adverse events, product complaints and medical information for all U.S. 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' acquisition of Alpharma, Dr. Sun served as King's Senior Director of Pharmacovigilance and Risk Management before moving 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 proposed standardization of abuse-related adverse event MedDRA terms and the development of a surveillance system using mobile technology.
"Dr. Sun's experience and know-how, combined with ParagonRx's systematic approach to minimizing risks, enable us to define pathways for optimal utilization of products and ease the path for our clients," Fetterman said.
ParagonRx, an inVentiv Health company, is a leading provider of risk and benefit consulting services to the pharmaceutical and medical device industries. The company guides clients through proactive planning across the life cycle of products with REMS, RMPs, and post-marketing commitments. Its benefit-risk management expertise, systematic methodologies, and standardized tools, coupled with the unique suite of services available through our affiliates at inVentiv Health, provide end-to-end support for our clients to improve patient safety and enable commercial success. For more information, visit http://ParagonRx.com.
About inVentiv Health
inVentiv Health, Inc. is a leading global provider of best-in-class clinical, commercial and consulting services to companies seeking to accelerate performance. inVentiv offers convergent services that deliver extraordinary outcomes to clients whose goal is improving human life. In 40 countries around the world, inVentiv's 13,000 employees help clients rapidly transform promising ideas into commercial reality. inVentiv clients include more than 550 pharmaceutical, biotech and life sciences companies, as well as companies that now see health as part of their mission. inVentiv Health, Inc. is privately owned by inVentiv Group Holdings, Inc., an organization sponsored by affiliates of Thomas H. Lee Partners, L.P., Liberty Lane Partners and members of the inVentiv management team. For more information, visit http://www.inVentivHealth.com.
SOURCE inVentiv Health, Inc.