United BioSource Expands Risk Management and Drug Safety Capabilities

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Applied Clinical Trials

Top Biopharmaceutical Safety Expert Dr. Annette Stemhagen Joins UBC: Former FDA Official Dr. Gerald Faich to Lead New Epidemiology and Risk Management Group

BETHESDA, Md., June 13 /PRNewswire/ -- United BioSource Corporation (UBC) today announced the launch of a new Epidemiology and Risk Management group led by former FDA official Gerald Faich. In addition, the company announced that biopharmaceutical safety expert Annette Stemhagen has joined UBC as Vice President for this group. The launch of this new risk management and safety consulting practice is part of the UBC strategy of building integrated capabilities to meet growing demand from the pharmaceutical and biotech sectors for evidence-based product support in the areas of product effectiveness, safety, and economic value.

UBC delivers evidence-based services to enhance the medical and commercial potential of pharmaceuticals, biologics, medical devices and diagnostics. The company leverages a unique suite of scientific capabilities to demonstrate product effectiveness and safety, manage and minimize risk, document economic value, and secure appropriate third-party payment for prescription medicines and other medical technology.

The new group will be led by Gerald Faich, UBC's Senior Vice President of Epidemiology and Risk Management and a pharmaceutical safety veteran. The group will focus on assessing safety issues and minimizing risk associated with prescription medicines and other medical technology. The team will leverage its expertise to help clients design and implement appropriate post- marketing registries, safety surveillance programs, large simplified clinical trials, and risk management programs, and will support for other epidemiological and product development activities. Faich and Stemhagen will provide ongoing advice and support for UBC project teams as they assist our clients in the design and management of large peri-approval trials and registries. In addition, they will provide strategic advice on regulatory matters in these areas.

"UBC is building the industry's finest roster of drug safety and risk minimization experts," said UBC Founder and CEO Ethan Leder, "We intend to be a global leader in helping pharmaceutical and biotech companies deliver scientific evidence to support the safe use of prescription medicines."

"Management of drug risk is one of the critical challenges facing the biopharmaceutical industry," said Dr. Faich. "We can help our clients quantify the benefits and risks associated with their products, enhance their management of product safety, and deliver scientific information to enable informed therapeutic decisions by the health care community."

The launch of this new risk management and drug safety group is the latest in a series of actions announced since UBC raised $153 million in equity capital from a syndicate of leading private equity firms.


About Gerald Faich, MD, MPH, FISPE
Dr. Faich is the former President and Chief Executive Officer of Corning Pharmaceutical Services (now Covance). Prior to his career in the private sector, Dr. Faich served in a series of positions of increasing responsibility within state and federal public health institutions. Dr. Faich was Director of the U.S. Food and Drug Administration (FDA) Office of Biostatistics, Epidemiology, and Post-Marketing Surveillance and Deputy Director of the Office of International Health for the Office of the U.S. Surgeon General. Dr. Faich has held academic positions at several prestigious universities, has published over 90 articles, and is a reviewer for several medical journals. Dr. Faich received his medical degree from the University of Wisconsin and his master's degree in Public Health from Harvard. He is board certified in Internal Medicine and Preventative Medicine and is a Fellow of the American Colleges of Physicians and the American College of Preventative Medicine. He currently is the President of the International Society of Pharmacoepidemiology.

About Annette Stemhagen, DrPH, FISPE
Dr. Annette Stemhagen is a pharmacoepidemiologist. Prior to joining UBC, Dr. Stemhagen was the Vice President of Strategic Development Services for the Periapproval Services unit of Covance, Inc. Much of her work has focused on developing epidemiologic strategies for research on drugs and biologics during late stage development, including new initiatives in risk management. She has also held positions within the pharmaceutical industry and in academia.

In 2004 Dr. Stemhagen was appointed to the FDA Drug Safety and Risk Management Advisory Committee as the industry representative. She served as an industry representative to the PhRMA Clinical Safety Surveillance Committee for more than 10 years, chairing both the Epidemiology subcommittee, and the Ethics subcommittee. Dr. Stemhagen is a Fellow and past Vice President of the International Society of Pharmacoepidemiology, as well as a former member of the Board of Directors of the Drug Information Association. She also holds an adjunct faculty appointment at the University of Pennsylvania School of Medicine. Dr. Stemhagen received a Bachelor of Arts degree in Biology from the University of Pennsylvania and both Masters and Doctoral degrees in Public Health (Epidemiology) from the University of Pittsburgh Graduate School of Public Health.

About UBC
United BioSource Corporation (UBC) delivers evidence-based solutions to optimize the medical and commercial potential of pharmaceuticals, biotechnology, medical devices, and diagnostics. UBC is based in Bethesda, Maryland. For more information about UBC, visit www.unitedbiosource.com or call 240-644-0420.