Judy Ashworth, MD
Vice President, Rx Strategic Services and Chief Medical Officer
Guiding the clinical development of CNS-active drugs in a challenging and rapidly evolving regulatory environment
Judy collaborates with clients developing CNS-active drugs, from traditional pharmaceuticals to psychedelics and cannabinoids, for neurologic and psychiatric indications.
She specializes in:
• Clinical development plans and trial design
• Regulatory strategy
• Target product profiles
• Abuse potential assessment
Judy had spent nearly two decades in drug development when she joined Pinney Associates in 2018. Launching her pharmaceutical career as a clinical pharmacologist at Grünenthal GmbH in 2001, she soon assumed project leadership of Grünenthal’s abuse-deterrent formulations program; spearheaded efforts to develop in-house abuse potential assessment expertise; and began to monitor the rapidly evolving regulatory landscape.
From 2006 to 2008, Judy was a visiting lecturer in Columbia University’s Department of Substance Abuse Research, concurrently participating in the innovative Tufts Health Care Institute Program on Opioid Risk Management. In parallel, she fostered the development of safer pain management alternatives by establishing Grünenthal’s U.S.A.’s Center of Excellence for Abuse Liability.
Returning to Germany in 2009, Judy was Grünenthal’s clinical lead for the U.S. and EU marketing registration of the analgesic drug tapentadol; set up a partnering intelligence department to support business development; and helped establish Grünenthal’s Innovative Medicines Unit.
Judy frequently presents at scientific conferences on the development and abuse potential assessment of CNS-active drugs.
Along with her work at Pinney Associates, she is the Chief Medical Officer for Harm Reduction Therapeutics, a nonprofit devoted to saving lives from opioid overdose by making low-cost naloxone available as an OTC product.
- Resident, Internal Medicine, Santa Barbara Cottage Hospital
- MD, UCLA School of Medicine, Dean’s Scholar
- BA with high honors, Biology, University of California Santa Barbara