Medical Research in the New World
A discussion of the global research market in the “Medical Research Goes Global” panel began with Steve Burrill, CEO of Burrill & Co pointing out that even the smallest player in the biotech and research arena is now global. The challenges of global medical research are increasingly complex. One challenge is that one size doesn’t fit all, and currently medicines are not yet differentiated for individuals.
According to Art Caplan from the University of Pennsylvania, the ethical issues have exploded as research goes global. He described four basic areas of protection:
• informed consent – where there has been a tremendous move to outsource overseas, but each place is doing consent differently;
• peer review by scientists – not much has been done to build infrastructure for local peer review;
• well designed trials – currently there is not harmonization; and
• minimized conflict of interest.
“There is a cultural context for this research that needs to be addressed,” said Seth Berkley of the International AIDS Vaccine Initiative. Countries are asking: who are these drugs are for? Will a drug be used locally? Where will it be manufactured? He added, "You have a real problem when you are running trials that are not applicable locally.”
Panel moderator Maria Livanos Cattaui asked how the world is changing. One trend is that countries have an amazing amount of talent and many scientists are staying home instead of coming to the U.S. Berkley pointed out one challenge is how to get countries that are now beginning to engage in medical research to focus on diseases of the developing world and orphan diseases. Furthermore, how do we work with them to accelerate that process? Countries like China and India have populations that are aging and battling chronic diseases at higher rates. Burrill pointed out that China’s pharma market will be #5 worldwide by 2010.
“One of the things about speeding innovation is the presence of a market and getting drugs into markets,“ asserted Lynn Margherio of the Clinton Foundation. Aggregating demand and assisting countries rationalize procurement practices is part of the Clinton Foundation agenda.
For session details and speaker biographies, click here.
According to Art Caplan from the University of Pennsylvania, the ethical issues have exploded as research goes global. He described four basic areas of protection:
• informed consent – where there has been a tremendous move to outsource overseas, but each place is doing consent differently;
• peer review by scientists – not much has been done to build infrastructure for local peer review;
• well designed trials – currently there is not harmonization; and
• minimized conflict of interest.
“There is a cultural context for this research that needs to be addressed,” said Seth Berkley of the International AIDS Vaccine Initiative. Countries are asking: who are these drugs are for? Will a drug be used locally? Where will it be manufactured? He added, "You have a real problem when you are running trials that are not applicable locally.”
Panel moderator Maria Livanos Cattaui asked how the world is changing. One trend is that countries have an amazing amount of talent and many scientists are staying home instead of coming to the U.S. Berkley pointed out one challenge is how to get countries that are now beginning to engage in medical research to focus on diseases of the developing world and orphan diseases. Furthermore, how do we work with them to accelerate that process? Countries like China and India have populations that are aging and battling chronic diseases at higher rates. Burrill pointed out that China’s pharma market will be #5 worldwide by 2010.
“One of the things about speeding innovation is the presence of a market and getting drugs into markets,“ asserted Lynn Margherio of the Clinton Foundation. Aggregating demand and assisting countries rationalize procurement practices is part of the Clinton Foundation agenda.
For session details and speaker biographies, click here.
posted by Margaret at 4:36 PM
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