Marion Coe, PhD
Director, Clinical Development and Postmarketing Surveillance
Helping plan optimal pathways for the clinical development and postmarketing surveillance of unique and challenging classes of drugs
A clinical pharmacologist skilled in clinical development of CNS-active drugs and postmarketing surveillance programs, with a focus on psychedelic compounds such as MDMA and psilocybin, Marion advises clients on:
- Clinical development plans and trial design
- Regulatory strategy
- Target product profiles
- Postmarketing strategy, surveillance reporting, and Risk Evaluation and Mitigation Strategies
- Scientific due diligence
Marion has worked in clinical drug development for biotech, big pharma, academia, government, non-profit, and CRO partners.
Before joining Pinney Associates in 2019, she spent eight years designing and operationalizing clinical trials with unique and challenging drugs for the treatment of substance use disorders.
At NIH, she utilized innovative clinical-trial design elements, such as intravenous ethanol self-administration in humans, to assess the efficacy of medications for alcohol use disorder. As part of her doctorate, Marion supported clinical trial design, start-up, and management. Her dissertation, funded by the National Institute on Drug Abuse, utilized a driving simulator to characterize the time course and severity of benzodiazepine- and hypnotic-induced psychomotor impairment.
In the Office of Technology Commercialization at the University of Kentucky, Marion performed strategic patent analyses and competitive analyses of competitor products, and synthesized market trends to further client commercialization goals.
Her numerous publications include a review of all marketed buprenorphine products; results from a survey of kratom users; and an inpatient study examining pain responses during an oxycodone maintenance procedure.
- PhD, Pharmacology, University of Kentucky
- BA, Psychology, University of Wisconsin–Madison