NIA and NHLBI Entrepreneur Workshop Series: Building Your Regulatory Strategy, Breakout Room 3

The Entrepreneur Workshop Series, co-hosted by the National Institute on Aging (NIA) and the National Heart, Lung, and Blood Institute (NHLBI) Small Business Program, offers research entrepreneurs and biotech small business owners expert guidance on key components of start-up success. The Building Your Regulatory Strategy session provides guidance on how to develop and effectively implement a regulatory plan to obtain approval from the U.S. Food and Drug Administration (FDA). This breakout session provides an opportunity for Q&A and discussion on diagnostic tests, including how to determine if your laboratory-developed test (LDT) / in vitro diagnostic (IVD) test will be regulated by FDA, market deployment of non-FDA regulated tests, and deciding if FDA regulation of your test will be useful, even if it is not required.

Date: October 5, 2021

Speakers: Chris Sasiela, Ph.D., Senior Regulatory Specialist and Innovator Support Team Lead, NIH SEED; Ben Berman, Ph.D., Group Leader for Computational Imaging and Sensing at the MITRE Corporation; Franziska Moeckel, MBA, Principal in Biomedical Innovation at the MITRE Corporation