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Executive 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].
 

 

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  1. Of what value is selling alcoholic beverages to State Fair patrons when there are many families with children attending. Is this the message we want to give children attending and participating in the Fair, another venue with alooholic consumption onsite. Is this to promote beer and wine production in the state which are great for the breweries and wineries, but where does this end up 10-15 years from now, lots more drinkers for the alcoholic contents. If these drinks are so important, why not remove the alcohol content and the flavor and drink itself similar to soft drinks would be the novelty, not the alcoholic content and its affects on the drinker. There is no social or material benefit from drinking alcoholic beverages, mostly people want to get slightly or highly drunk.

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  4. Exciting times in Carmel.

  5. Twenty years ago when we moved to Indy I was a stay at home mom and knew not very many people.WIBC was my family and friends for the most part. It was informative, civil, and humerous with Dave the KING. Terri, Jeff, Stever, Big Joe, Matt, Pat and Crumie. I loved them all, and they seemed to love each other. I didn't mind Greg Garrison, but I was not a Rush fan. NOW I can't stand Chicks and all their giggly opinions. Tony Katz is to abrasive that early in the morning(or really any time). I will tune in on Saturday morning for the usual fun and priceless information from Pat and Crumie, mornings it will be 90.1

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