Marion Coe is a clinical pharmacologist with experience working across the drug development pipeline with small and big pharma, academic, government, non-profit, and contract research organization partners and clients. She has expertise in clinical development and operations, development and management of postmarketing surveillance programs, and strategic analysis supporting due diligence for potential pharmaceutical in-licensing and/or acquisitions. She spent eight years working on clinical trials for various substance use disorders and specializes in clinical development for unique and challenging classes of drugs. Marion advises clients on:
- Clinical development, commercialization, and postmarketing strategy for psychedelic compounds (e.g., MDMA and psilocybin)
- Clinical development plans and trial design
- Regulatory strategy and agency interaction
- Strategic Target Product Profile development
- Postmarketing surveillance and Risk Evaluation and Mitigation Strategies (REMS)
Marion joined PinneyAssociates in 2019. Before joining, Marion worked in a clinical pharmacology unit at the National Institutes of Health utilizing innovative clinical trial design elements (e.g., intravenous ethanol self-administration in humans) to assess efficacy of medications for alcohol use disorder. She continued to support clinical trials design, start-up, and management during her doctoral work, including for a pivotal Phase 2 trial assessing a novel formulation of buprenorphine. Her dissertation, which was funded by a National Institute on Drug Abuse (NIDA) grant, utilized a driving simulator to characterize the time course and severity of benzodiazepine-and hypnotic-induced psychomotor impairment.
Working in the Office of Technology Commercialization at the University of Kentucky, Marion performed strategic analyses of patent literature, competitive analysis of existing and pipeline pharmaceutical products, and synthesis of market trends related to key stakeholder activity and profitability further client commercialization goals.
Marion’s 15 plus publications include, among others, 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.
In addition, Marion also serves as Head of Clinical Operations for Harm Reduction Therapeutics, a non-profit organization working to bring a low-cost, naloxone product to the OTC market to reduce opioid overdose deaths by reducing barriers to access.
- Received her doctorate in pharmacology from the University of Kentucky
- Earned her bachelor of arts in psychology from the University of Wisconsin at Madison