Q&A

Sherry Keramidas, who earned her doctorate in neuroscience and physiological psychology from Purdue University, is executive director of the Maryland-based Regulatory Affairs Professionals Society, which is holding its annual conference Monday and Tuesday at the Indiana Convention Center. The conference attracts 1,500 attendees from as many as 30 countries. Participants work for companies, academic institutions and regulatory agencies on issues affecting the development and use of drugs, medical devices and other health care products. A dozen Indiana firms are participating in the conference, including Eli Lilly and Co., Cook Medical Inc., Zimmer Inc., Indigo BioSystems, Roche Diagnostics and the Baker & Daniels law firm.

IBJ: Can you give us a flavor of what will be going on throughout the conference?

A: It’s a lot of sharing among colleagues things that work as you go through the process of testing the product, as you go through the development cycle or the testing cycle. They’re collegial at this meeting. They are trading stories and best practices and sharing. But they will also talk about broad implications of the regulatory process in overall health economics. They will talk about it in terms of global policy and how things are shifting.

IBJ: What are some of the hot topics you expect to be discussed at this year’s conference?

A: I would suspect that they would be talking about the pluses and minuses of going and getting your product tested and approved in the U.S. versus out of the United States. We do have four or five people coming from the Chinese state food and drug administration. And the Chinese market is a very, very hot topic around the world because of its market size, as well as because China is a source of raw materials. Science is changing the nature of products. [Also], there’s an increasing trend to more personalized products, rather than the traditional blockbuster model, products designed for smaller numbers of patients. The kind of clinical trials, the kind of data, you’re going to present to a regulatory agency is going to be very different than you would for a blockbuster.

IBJ: Has the pace of scientific change quickened in recent years?

A: The nature of the scientific changes right now are changing the system that we’ve put in place. The regulations that we put in place 15-20 years ago, where you had a medical device and pharmaceuticals and then you had biologics, and they were very clear. Science has just taken us into new realms and it’s time to update [the regulatory system].