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FDA – 101 for Biotech Entrepreneurs

June 26

12:00 pm - 1:00 pm

If you’re just starting to learn about how and why the FDA regulates biomedical products, then join us for this one-hour session. We will review what products are regulated, how they are regulated, and how you can learn more. The authority of the FDA stems from Acts of Congress, which ultimately are codified into federal regulations, and we’ll review how this process occurs. The FDA generally wants to assure the safety, efficacy and quality of the products it regulates, but it provides very specific recommendations to industry on how to achieve those goals. We’ll review how to find this information, and provide some general information on the likely timelines and costs to bring biomedical products to market.


Molly Schmid, Ph.D.

Molly Schmid, Ph.D. currently serves as an SBDC consultant focusing on providing customized solutions for life science businesses facing growth challenges.

Dr. Schmid brings more than 20 years of experience in the life science and small business technology industries and has held a variety of impressive leadership roles in bioinformatics, pharmaceuticals and health technologies, as well as the entrepreneurial space. She has also published several patents and publications. She was Vice President of Life and Health Technologies at ieCrowd, a global community of innovators where she coached Olfactor Laboratories, Inc. staff to transform novel vector control products into commercially viable technologies.

She was also Senior Vice President of Preclinical Programs at Affinium Pharmaceuticals, Inc. in Toronto, Canada, where she managed several multi-million dollar technical projects, including a three-year $15 million discovery-stage collaboration with Pfizer.

In addition to Applied Innovation’s successful SBDC program, Dr. Schmid currently serves as an Entrepreneur-in-Residence for Alfred Mann Institute of Bioengineering at USC. She also has been an adjunct professor for USC Marshall School of Business’s Lloyd Greif Center for Entrepreneurial Studies, and UCLA’s Anderson School of Management.

Dr. Schmid earned her Ph.D. in Biology at the University of Utah and worked as a research fellow at the University of Oregon.