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Cognitive Research Corporation names Alison Taber SVP Data Management

CRC partnered with BioXcel Therapeutics on FDA approval of IGALMI™ (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. This program was from first-in-human trials through NDA approval. With this approval, BioXcel becomes the first and only FDA-approved orally dissolving sublingual film for mild, moderate, or severe agitation in patients with schizophrenia or bipolar disorder. Tom Hochadel, President of CRC, commented, “It is very rare for a clinical service company to work with a sponsor from first-in-human to NDA approval of a new drug. CRC and BioXcel have been collaborating on this program since 2018 and have worked cohesively and rapidly to move this innovative new therapy to approval. CRC is proud of their ability to deliver scientific and clinical development expertise to this program.”

Cognitive Research Corporation (CRC), a leading neuroscience clinical services company, announced that C. Gordon “Chip” Gillooly has been named Chief Executive Officer. Mr. Gillooly succeeds Dr. Tom Hochadel, Co-Founder, who will now serve as President and will continue to play an integral role in the company’s growth and delivery of exceptional CRO services to our clients. Dr. Gary Kay, Co-Founder and Head of Psychometric Assessments, will remain Chief Science Officer. CRC has been supporting clinical development for CNS-focused small to mid-size pharma, biotech, and medical device companies for over 16 years. The company has experienced explosive growth over the past five years as the CNS market has accelerated.

Cognitive Research Corporation (CRC), a leading neuroscience clinical services company, announced that Patrick Simms has been named Chief Operating Officer, reporting to Dr. Tom Hochadel, Co-Founder and Chief Executive Officer. CRC has been supporting clinical development for CNS-focused small to mid-size pharma, biotech, and medical device companies for over 16 years. The company has experienced explosive growth over the past five years as the CNS market has accelerated.

The purpose of this guidance is to assist pharmaceutical sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle. Specifically, this guidance addresses the FDA’s current thinking regarding the FDA-regulated drugs for which such evaluation may be needed, and the types of studies that such an evaluation entails.