Friday, November 27, 2015

Innovation plans from FDA, venture capital group

The FDA and venture capitalists roll out plans for more biomedical innovation.

Innovation plans from FDA, venture capital group


Innovation, innovation, innovation.

Everybody loves innovation.

We can't get enough people to wash their hands in hospitals to reduce infections, but we always need more biomedical innovation.

On Wednesday, the U.S. Food and Drug Administration rolled out a plan and on Thursday Sen. Michael Bennet (D.-Col) and the National Venture Capitals Association gave their version of how to fix the situation.

FDA Commissioner Margaret Hamburg offered a new plan called, "Driving Biomedical Innovation: Initiatives for Improving Products for Patients.”

Hamburg said in a statement, “America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public. Our innovation blueprint highlights some of the initiatives FDA will be implementing to ensure that these opportunities are translated into safe and effective treatments that can help keep both American patients and American industry healthy and strong.”

The bullet points of the plan are:

• rebuilding FDA’s small business outreach services

• building the infrastructure to drive and support personalized medicine

• creating a rapid drug development pathway for important targeted therapies

• harnessing the potential of data mining and information sharing while protecting patient privacy

• improving consistency and clarity in the medical device review process

• training the next generation of innovators

• streamlining and reforming FDA regulations.

The FDA plan is here.

On Thursday, Bennett (D-Colo.) and the National Venture Capital Association Medical Innovation Coalition (MedIC) held a news conference to discuss a report on declining venture capital investment in medical innovation.

The complaint is that the FDA impedes the process of selling drugs and devices, though the mission was originally to safeguard the food and medicine going into patients.

“For decades, the U.S. has been the leader in delivering medical innovations to our citizens due to the thousands of startup healthcare companies that have been brought to life with venture capital funding. Millions of high quality jobs have been created, and iconic companies such as Genentech, Amgen, Medtronic, Biogen-Idec and Lifescan have been built. But our leadership is now at risk,” Dr. Beth Seidenberg, partner at Kleiner Perkins Caufield & Byers and chairwoman of the MedIC Coalition, said in a statement.

The MedIC press release is here.

Vital Signs Press Conference Deck PPoint 10 =6 11

Inquirer Staff Writer
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About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at or 215-854-4506.

David Sell Inquirer Staff Writer
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