“Pharma is not wanted—they just want our money or our drugs, but they don’t want us at the table because they claim it taints the collaboration or the investigation and we have to get around that. Pharma does have something to offer, both intellectually and also scientifically to the discussion and collaborations. If we really want to level the playing field between the U.S. and Europe, we have to think about the cultural barriers that exist in the U.S. that don’t in Europe.”

The FDA draft guidance is mainly for small molecules and not for vaccines and other products. But Dr. Dagher pointed out that there are a lot of good principles in the guidance that could apply to other kinds of products such as antibodies combined with drugs or vaccines. Dr. Sherman responded that the guidance was directed toward small molecules used in combination because that was what industry asked FDA to address, but the same principles could be applied to other types of treatments used in combination.



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