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Janet Woodcock, MD, Director, CDER, FDA Bio and Contact Info
Listen (6:48) Is the FDA changing their approach?
Listen (4:34) Message to pharma: work together
Listen (5:08) How does a submission get breakthrough status?
Listen (2:29) It's a privilege to work somewhere you can really make a difference
Listen (2:47) What feedback lets you know you're doing a good job?
Recently named one of Fierce's 25 most influential people in biopharma, Janet Woodcock is changing things at the FDA. With her influential position as Director of CDER (Center for Drug Evaluation and Research) she is pushing for the use of more biomarkers and combination therapies. With targeted therapies, "it's easier to see that they work, and they require a smaller number of people in trials to demonstrate they're effective." This is not just talk from Woodcock. Last year the agency approved more drugs than in any of the previous 15 years. Woodcock speaks in the interview about her role as prod to the bio-pharma industry. She regularly urges them to work together and share more of their pre competitive work.
A couple weeks ago, Janet made headlines announcing the FDA's new "Breakthrough Status" program, a process for streamlining submissions with a special potential to make a big difference. In today's show, Janet explains what it take to get this designation, saying that potentially a drug could be approved after a Phase I trial. Woodcock has spent many years at the FDA and talks about the secrets to her success. "I have to use my own individual judgement about what is right for the people who are my customers, the patients."