On Wednesday, July 1, join Potomac Law partner Dr. Jur Strobos for an in-depth discussion with a former FDA official and clinical trial investigator regarding the likely structural changes to come at the FDA and their implications for regulatory processes.
- Resource reallocation at the FDA – Infectious Disease is back (it really never left) and its here to stay for FDA, but what’s left for non-Infectious Disease companies?
- Potential reorganization of the FDA – As we head into November, how will the medical need, the funds and the politics factor into structural changes at the FDA?
- New models for drug development – Hospital systems have the monopoly on clinical trials and drug development, but is that about to change?
- Implications on development timelines and trial design for established and emerging biotech companies – How could regulatory flexibility spread to non-Infectious Disease indications?
Dr. Strobos is an attorney specializing in medical product development. He provides life sciences companies with legal, regulatory, and policy advice on drug, biologics, tissue, cell, and medical device development. He has served as a senior policy official at the U.S. Food and Drug Administration, and credentialed investigator, which gives him insight into the internal workings of the agency in both policy development, regulatory procedures, and approaches to new scientific issues. He has also had the opportunity to serve as a senior executive in charge of drug, medical device, and biological product development in a variety of start-ups and mid-cap specialty pharma. In those positions, his responsibilities included managing the development of multiple products from University to marketing authorization including management of clinical trials, regulatory filings, clinical, nonclinical, manufacturing vendor contracting and oversight, and licensing. His scope of work included strategic policy and evaluation of in-licensing or sale of products or assets from out licensing to acquisition and merger.
Dr. Strobos is currently working on a number of COVID-19 related products, including personal protective equipment, laboratory testing, telemedicine, sanitizers, and in-licensing of promising products.