FDA

Q&A with Janet Woodcock, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)

innspotlight janet
Q. How would you describe the purpose and goals of biomedical research consortia to your mom?

A: Biomedical research consortia are partnerships made up of different groups that share the same underlying goal of getting new treatments or cures to people more efficiently. Many of these consortia are focused on a particular disease or condition, like Alzheimer’s disease. Others focus on issues that apply to multiple therapeutic areas, for instance, modernizing clinical trials. Although all of these groups share in the same goal, no one group is strictly in charge of getting there. Each group brings its own strengths to the consortium. Patient groups provide a unique perspective for what the “need” is, advise on risk trade-offs they’re willing to make in exchange for treatment benefits, and often contribute funding. Drug development industry members bring expertise and frequently contribute funding and research resources. Academic and research groups have deep technical knowledge to help guide studies. Regulators, like the FDA, bring knowledge and experience gained from seeing across all the different development programs. FDA knows the pitfalls and can really counsel partners on what needs to be done to make reaching their goals easier. By working together, consortium partners accomplish things that cannot be accomplished by any one group alone.

Q. Your role as CDER’s director goes beyond the scope of what most people consider a regular day-job. What keeps you motivated to stay at it?

A: At the end of the day, it’s the chance to make a difference in people's lives, a desire that I think many people can relate to. The work I do, the work that CDER does, to affect how drugs are developed, tested, and manufactured, really makes a difference in helping to keep people safe and healthy. That alone would be enough, but I’m also a person who is very stimulated by intellectual challenges, and there’s just one challenge after another here, with each challenge more complicated than the last. My training, as an analytical chemist and then as a physician in immunology and rheumatology, has served me well in that every day I use everything I’ve learned to tackle these challenges. The bottom line is that I’m an optimist. These challenges don’t discourage me, I get excited about them and I always look on the bright side – we’ll solve this problem and move on to the next.

Q. What has surprised you the most about these multi-stakeholder collaborations?  What weren’t you expecting?

A: I’ve been surprised by the enthusiasm that consortium partners are bringing to the table and their willingness to come together and work toward a common goal. When these partnerships begin, there is often a 6-month period of bewilderment because the stakeholder groups aren’t used to working in this collaborative way together, and they can’t picture how it’s all going to work. But once they grasp the potential for what a consortium can achieve and they can see the way forward, these folks become tenaciously devoted to the work and pick up the ball and run with it. In particular, it’s very exciting for me to see patient groups and academic partners feeling empowered by their work in consortia to really make a difference and be a part of something big.

Q. If you could trade places with anyone in the world for one week, who would it be? 

A: I recently heard a story about the Million Orchid Project at the Fairchild Tropical Botanic Garden in South Florida. Volunteer researchers there are cultivating seeds of three orchid species with the aim of getting orchids back out into the community. Many people already know about my love of gardening and my passion for orchids in particular. I think it might be nice to trade places with one of the volunteers for a week to help nurture newly “hatched” orchids and in some small way help the group to re-establish these beauties in their natural home.

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