Judy B. Ashworth came to PinneyAssociates with nearly two decades of experience in pharmaceutical drug development. Since joining the company in 2018, Judy primarily supports our clients who are developing CNS-active drugs, from traditional pharmaceuticals to psychedelics and cannabinoids, across a range of neurologic and psychiatric indications with:
- Clinical development plans and trial design
- Regulatory strategies including agency interactions
- Strategic target product profile development with attention to potential market access challenges
- Strategies for assessing abuse potential of novel compounds as well as new formulations of marketed compounds
Judy began her pharmaceutical career in 2001 as a clinical pharmacologist at Grunenthal GmbH. In 2003, Judy took on the project leadership of Gruenenthal’s abuse deterrent formulations (ADFs) program and an internal working group tasked with developing expertise in abuse potential assessment as well as monitoring the rapidly evolving regulatory landscape surrounding the development of these new products.
From 2006-2008, Judy served as a visiting lecturer in Columbia University’s Department of Substance Abuse Research where she worked on the development of novel clinical trial designs for assessing the relative abuse potential of ADFs. During this time, she participated in the Tufts Health Care Institute’s Program on Opioid Risk Management – a series of summits which brought together major stakeholders including FDA, DEA, academia, and industry to work on potential solutions to the rising abuse of prescription opioids. In parallel, she established the Center of Excellence for Abuse Liability at Gruenenthal USA, Inc, supporting the company’s commitment to help develop safer alternatives for pain management.
Upon returning to Germany, Judy was the clinical lead for tapentadol during its marketing registration process in the US and EU, then set up a partnering intelligence department to support business development, with asset search and evaluation and scientific due diligences, and later helped establish the Innovative Medicines Unit at Gruenenthal’s headquarters before opening its first external hub in the Leiden BioScience Park in the Netherlands.
Judy has published on clinical development and abuse potential assessment of CNS-active drugs.
Along with her work at PinneyAssociates, Judy also serves as the Chief Medical Officer 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.
Education and Training
- Completed the Internal Medicine residency program at Santa Barbara Cottage Hospital, serving as chief resident in her final year of training
- Graduated as a Dean’s Scholar from UCLA School of Medicine, in recognition of research in geriatric medicine
- Graduated with high honors from the University of California Santa Barbara with a bachelor’s in biology