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Former FDA Head: Complex Drugs Require Closer Collaboration Between Biotechs, Medical Devices Companies

Posted By Administration, Friday, June 20, 2014
Originally posted on 4/12/2013

Former head of the U.S. Food and Drug Administration Dr. Andrew von Eschenbach, who served in this capacity from 2005 to 2009, had some interesting things to say about the changing nature of drug development in early clinical stages. According to the Boston Business Journal, "Von Eschenbach stressed that the medical industry is at an inflection point, due to rapid advancement in recent years in understanding how cells and cell nuclei work. But as the types of medical conditions and diseases that are being targeted are more complex, the solutions needed to address them go beyond a simple drug or medical device. And that means companies working together much more than current intellectual property laws allows.

'You need to be collaborating and sharing intellectual property at the very outset,' he said. 'Today, there are huge barriers to doing that.'”

In the full Boston Business Journal article, von Eschenbach is said to have suggested regulatory changes and an overhaul in funding models to facilitate this type of collaboration. However, one has to wonder whether medical device companies and biotechs have the collaboration skills to execute effectively, even if von Eschenbach's recommendations were implemented.

This week, we put the editorial content for the Q2 2013 issue of Strategic Alliance Magazine to bed. During the course of putting our cover story on big company/small company alliances together, we were reminded that biotechs oftentimes need the larger company to guide them through working with alliance governance processes and such—not always, mind you, but it is common for the smaller entity to follow Big Pharma's lead. When you talk about a biotech–medical device collaboration, now you can conceivably have two alliance novices, which could lead to less-than-optimal execution of combination drug-medical device products.

Is this a real concern? We'd love to hear from the folks from the biopharma side.

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