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Making a Difference: Janet Woodcock, FDA

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Guest:

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."

Going Behind the Headlines with Luke Timmerman, National Biotech Editor, Xconomy

Podcast brought to you by: Assay Depot - the world's largest cloud-based marketplace for research services. With Assay Depot, you can easily find the perfect research service provider and manage your project from anywhere in the world. Guest:

Luke Timmerman, Biotech Journalist Bio and Contact Info

Listen (4:41) Xconomy - covering the innovation community

Listen (5:58) Biotech, a calling

Listen (4:59) What makes a good story?

Listen (7:26) At your best, a reporter can do what for the industry?

Listen (1:59) A green guy

What makes a good story? What difference can a good reporter make in the industry? These are some of the questions we pursued in a chat with Luke Timmerman, National Biotech Editor at Xconomy. Luke was a finalist this year for the Gerald Loeb Award, what he says is the Oscar for business reporting. It's a great achievement for Luke and for Xconomy, which has been covering the "innovation" community for five years now. Luke is known for his up-to-date reports on everything biotech and his Monday BioBeat column where he pursues tough questions for the industry. Timmerman is always telling others' stories. Today's interview turns the table and provides a rare glimpse into his own story.

An Ambassador for Art and Science

We keep running into scientists who are artists as well. A few months ago, I wrote a blog, Art and Science, exploring the idea of the renaissance person, someone who is proficient at many different disciplines. If scientists are to become experts in their field, must they proceed at the exclusion of other interests, I asked. Since then we’ve met a few more successful scientists who are proficient as artists as well.

You Can't Google Insight: Up Close with Steve Burrill

Talk to anyone about the history of biotech, and at some point you’ll end up talking about Steven Burrill: venture capitalist, merchant banker, consultant, speaker, mentor, and teacher. On Nov 4, Burrill received the Scrip Lifetime Achievement Award in London's Grosvenor House.

“There’s an incredible number of people and companies who really owe their existence and success to Steve,” says colleague Fred Dorey, special council at the law firm, Cooley Godward Kronish.



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