In a plenary session at the Partnering for Cures conference being held in New York City this week, the Food and Drug Administration's Margaret Hamburg and Janet Woodcock announced the agency's latest draft guidance for industry, which aims, among other things, to enhance collaboration among pharmaceutical firms throughout the drug-development process. The draft form of FDA's "Guidance for industry: Co-development of two or more unmarketed investigational drugs for use in combination" was distributed to conference attendees yesterday. Hamburg, the FDA Commissioner, said that in order "to truly advance medical progress and see the return on our nation's investment in the sciences, we need to seamlessly pass the baton of innovation from one sector to the next."
Woodcock said the agency was committed to evaluating progressive drug-development paradigms to enable the approval of targeted therapies. She used FDA-approved targeted cancer therapies as examples of past success. Cancer therapies that target activated tumor pathways "have potential to significantly improve outcomes — and reduce toxicity," she said. "In order to bring these to market efficiently, we recognize … [that] we're going to have to develop new pathways, new drug development paradigms." Woodcock said that FDA expects that the increased use of drug and diagnostic combinations as well as "adaptive trial designs to evaluate the multiple drug and diagnostic pairings and to ensure ethical treatment [of] enrolled subjects, and increasing attention to the use of novel biomarkers" will move R&D forward. "And, in fact, this isn't just true of cancer," she added. "It's going to be true of many severe diseases, but I think cancer is a good paradigm because we have some early examples of targeted therapy on the market. We have more coming. We're seeing that inflection point."
Comments and suggestions related to the FDA's draft guidance addressed to the agency's Division of Dockets Management will be accepted up to 60 days after the announcement of its release appears in the Federal Register.