Hello, I’m Janet Woodcock, and I’m Director of the Center for Drug Evaluation and Research at the US Food and Drug Administration. I’ve been coming to Austin to the International Conference on Drug Development for many years and I have found it one of the most impactful conferences that I attend. There is the opportunity for really in-depth discussion and interchange between members of industry, members of the bar, members of Congress, members of the regulators, and others that is very meaningful, and I hope to keep attending this conference because I learn something new every year that I come.
Hi, my name is Jerry Yakatan. I’ve been attending what’s now called the International Conference on Drug Development since 1972. If there’s any person who’s involved in any way with or wants to know about regulatory issues that are facing the industry, they ought to be at this meeting because it’s the one meeting that I wouldn’t miss. The smallness of the meeting, the limit to around 100-125 people, allows for some very significant interaction both with other people in the industry and with the FDA representatives that are in attendance.
The industry and the regulatory authorities today are confronting a host of very challenging issues and I think the only way to find a good way to deal with some of these issues is to bring all of the major parties together and one of the tremendous strengths of the ICD2 is the fact that you have top people from the FDA, top people from industry, top people from other organizations, the legal groups, academic institutions all getting together and really trying to hash out some of the major challenges that the industry and the environment is dealing with and find ways to move forward. This is an invaluable opportunity to hear from experts in the area, people who are the decision makers and the problem solvers and this is a unique opportunity and I think it’s not something that should be ignored.
So I would say that as someone who’s responsible for both informing and guiding regulatory strategy for development and marketing products in the portfolio for the company that I work for, the ICD2 is an incredibly intimate setting which allows dialogue on cutting edge topics with not only senior scientists and policy makers at the FDA, but academicians and other senior scientists and executives from industry, the opportunity to exchange that dialogue and discuss those topics in not only a small, intimate conference setting, but also over three meals a day, is really a unique opportunity. It’s not a typical conference. It’s something that really is almost more like a think-tank, almost more like a working-group setting, and it’s a privilege. It’s a privilege to be able to have that exchange with colleagues in that fashion.