How can the FDA help speed up the drug discovery process?
If necessity is indeed the mother of invention, then our current drug development model is ripe for change. “If we want health care and medical products to be accessible, they have to be available at a price that is affordable,” says Frank F. Weichold M.D., Ph.D., the Director of Critical Path and Regulatory Science Initiatives at the FDA. “And as such, we have to rethink how we develop drugs, how we develop products, and how we approve them.”
But do regulatory agencies such as the FDA stifle or advance innovation? According to Weichold, it’s clearly the latter. The essential goal of regulatory science, he says, is to speed development and move products from bench to bedside faster and more efficiently. The mission of the FDA’s regulatory science program is to “develop new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products.” That includes a whopping 30% of all products purchased in the United States. “We understand the problems, gaps and shortcomings, very well,” says Weichold. Now what we need is innovation.
Weichold believes that a more robust partnership between academia and the regulatory agency could be just the tactic a new drug development model needs to succeed. Academic medicine “is a vital source of innovation and drives many of the product development processes,” says Weichold. If the FDA can direct and stimulate research and academia can react quickly enough to variable priorities, the entire process will move more quickly. He believes that this model for partnership is both achievable and promising.
Twenty years ago, Weichold, left the clinic to contribute to drug development and improve therapies for patients. “Today for me, it would be much easier to treat people because I have options and diagnostics that were unthinkable 20 years ago,” says Weichold, an immunologist, who practiced in Berlin, Germany. While Weichold thinks we’ve come a long way, he agrees that there’s still a lot of work ahead. The question now is: how long will it take to develop and implement these new tools to expedite bringing viable treatment options to patients?
