Michael Porter to Give Keynote Address at Post-Approval Summit; Leading Harvard Business School Strategist to Shed Light on Impact of Post-Approval Studies on the Healthcare Industry

Business Wire, April 25, 2005

CAMBRIDGE, Mass. -- The Post-Approval Summit at Harvard today announced that Michael Porter, PhD, Bishop William Lawrence University Professor at Harvard Business School will provide a keynote address at the event, scheduled to take place from May 9-10, 2005 in Boston. Dr. Porter will provide the morning keynote titled, "A Strategic View of Post-Approval Research in the Healthcare Marketplace," on Monday, May 9.

The Post-Approval Summit is designed to examine the landscape of programs after regulatory approval, including patient registries, Phase IV studies, risk management programs and quality initiatives. Speakers and attendees representing academia, government, biopharmaceuticals and payors will evaluate the growing impact of these studies on the way health care therapies are marketed, utilized, valued and reimbursed in the U.S. and globally. It was announced last week that Dr. Mark McClellan, Administrator, Centers for Medicare & Medicaid Services and former commissioner of the Food & Drug Administration, will provide the afternoon keynote on the first day of the conference focused on "Post-Approval Programs from an FDA to a CMS Perspective." Honored guests and featured speakers represent organizations including the Agency for Health Care Research and Quality, Novartis, Genzyme and the Harvard School of Public Health, covering topics including:

--The Evolving Role of Safety & Risk Management Programs

--Value and Reimbursement

--Understanding the Rules: OIG, HIPAA, etc.

The Post-Approval Summit at Harvard is co-presented by Outcome and the Massachusetts Eye and Ear Infirmary Clinical Outcomes Research Unit. For more information, visit www.postapproval.com or call 888-526-6700.

About Outcome

Outcome is the leading provider of post-approval strategies and information-based solutions. The Company is focused on helping organizations in life sciences and healthcare develop evidence, demonstrate effectiveness, manage safety and prove product value through registries, Phase IV studies, risk management and coverage under protocol programs. Backed by expertise and experience in over 30 therapeutic areas, Outcome has designed, developed and managed an industry leading number of post-approval studies, including more than 60 registries and many of the largest and most well-recognized programs for disease outcomes and safety/risk management. An Outcome registry received the 2004 Innovation Award from the Department of Health and Human Services. With more than 1 million patients enrolled in studies powered by Outcome and close to 3,000 sites logging on to the Outcome system daily, the Company has by far the most widely used system in the industry. For more information, please visit www.outcome.com.