Senior Vice President, Regulatory Affairs
Steve Sherman brings approximately 30 years of pharmaceutical experience to INSYS.
He started in sales and marketing, spent time at the FDA in OPDP and has been in Regulatory Affairs for the last 20 years. He has successfully filed several INDs and CTAs, filed orphan drug applications and has helped to file several successful NDAs. While at INSYS, his team has successfully written and obtained approval of the Pediatric Study Plan and NDA for SYNDROS® and obtained “rare pediatric disease” status for cannabidiol in Infantile Spasms.
Under Mr. Sherman's leadership, Regulatory Affairs has successfully submitted several INDs and developed and implemented the regulatory strategies for obtaining expanded indications for SUBSYS®, pursuing multiple indications for cannabidiol, buprenorphine, buprenorphine-naloxone, naloxone and others. He has played a substantive role in advancing drug development of numerous clinical projects ranging from our marketed products, SUBSYS and SYNDROS, to investigational products such as cannabidiol and the sublingual sprays.