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Panel Detail:

Tuesday, April 24, 2007
10:50 AM - 12:05 PM

The Globalization of Medical Discoveries

Moderator:

Greg Simon, President, FasterCures / The Center for Accelerating Medical Solutions

Panelists, including G. Stephen Burrill, left, and Seth Berkley, describe the great hopes and concerns accompanying today’s globalization of medical discoveries.

Carol Cruickshank of A.T. Kearney pointed out that globalization presents "opportunities to accelerate, to move drugs to market more quickly and bring more to patients faster." The challenge, she said, will be to ensure that the benefits of globalization are spread ethically, and that quality is ensured across the board. G. Stephen Burrill of Burrill & Co. added that one of the challenges in globalization is harmonization from a regulatory and patent standpoint.

The health-care industry is now able to use a global perspective to view differences in persons with disease. According to Andrew von Eschenbach of the U.S. Food and Drug Administration, we are more aware than ever of the molecular processes and needs of individuals. "The personalization of treatments will move us into a world of 'predictiveness' and ultimately in a world of 'preventiveness,' where we will treat the well, not only the sick." He sees challenge is in the need for a higher degree of global interoperability and knowledge sharing among nations.

In a discussion of overseas clinical trials, Cruickshank noted that 48 percent of the trials conducted by the top 12 pharmaceuticals have been located outside the United States. Offshore clinical trial activity has increased by 20 percent in the last year alone. For the most part, these trials are moving to emerging markets; the top countries making ground are China, India and Russia, all attractive to pharma because of the large potential patient pools, developed infrastructures, low costs, available expertise and good regulatory environments.

Eschenbach noted that there are no inherent barriers to the FDA using data generated from offshore trials so long as the entire research continuum -- such as using the appropriate patient pool and collecting reliable raw data -- is acceptable. The FDA judges all trials on a case-by-case and study-by-study basis. And while the agency lacks the resources to check every country's infrastructure, it has sufficient strategic alliances to ensure that proper procedures are being followed. He also pointed out that when using overseas populations for studies, the obligation exists to care for them.

The panel also stressed the importance of globalizing innovation in medical discoveries. Burrill stated that the increased use of generic medications to temper rising health-care costs is a large disincentive for innovation. On average, a new drug costs $1.2 billion to $1.8 billion to bring to market, he said, and only one-third of drugs that make it to the market recover their initial investments. An additional disincentive, said Berkley, is the regulatory uncertainty in the industry. He supports rationalizing a differential pricing strategy for drug sales and concentrating less on blockbuster drugs. Essentially, by charging the most to those who can pay the most and charging the least to the disadvantaged, drug companies could increase their overall profitability while improving access.

The panelist agreed that there will never be an "international FDA" that globalizes medical discoveries, but that we can globalize the processes each country follows. In some views, the FDA process may be superior to other countries' regulatory bodies, but it depends on the type of disease and drug.

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