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Regulatory and Clinical Trial Considerations Critical to Development Partners and Investors (Atlanta)

hosted by the Georgia Bioscience Commercialization Center and Baker Donelson
November 8, 2011
7:30 AM - 9:00 AM


Baker Donelson
3414 Peachtree Road N.E.
1600 Monarch Plaza
Atlanta, Georgia


November 8, 2011
7:30 AM - 9:00 AM

Clinical development and the conduct of human trials are a pivotal phase in medical device development. Investors play a critical role in advancing early stage therapeutics, however investment dollars are a finite resource with significant market competition from other medical device companies. Often the key determinant and differentiator for investors when choosing is a company to finance is the management of risk. This program will focus on key considerations that a new company should entertain if it is to be successful in convincing investors that it has a viable regulatory plan to achieve FDA clearance for the medical device. We will also examine the common pitfalls that companies encounter in clinical trials.


Steven Caras, MD, Ph. D.
Senior Medical Director, PAREXEL International Adjunct Professor,
University of Georgia College of Pharmacy, BioPharma Regulatory Affairs Graduate Education Program

David W. Mullis Jr., Ph.D., RAC
President, Mullis & Associates, Inc.
Director, University of Georgia College of Pharmacy, BioPharma Regulatory Affairs Graduate Education Program


Robert Derricotte
President, Medical Marketing Insights
Co-Founder, Georgia Bioscience Commercialization Center
CEO, Ketal Biomedical Inc.

Events Contact

Heather Stripling
T: 205.250.8332
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