Judy Ashworth draws on nearly two decades of experience in pharmaceutical drug development to provide clients with strategic input on target product profile development, clinical development plans, regulatory pathways (US and EU) and unmet medical need analyses with attention to potential market access challenges. Given her vast experience in the development of analgesics, including abuse deterrent formulations, Judy is particularly adept in advising clients on the development of CNS-active drugs with an emphasis on strategies for assessing abuse liability of novel compounds as well as new formulations of marketed compounds.
Trained in internal medicine, Judy began her pharmaceutical career in 2001 as a clinical pharmacologist at Gruenenthal GmbH, a German pharmaceutical company primarily focused on the development of innovative pain medications. In 2003, Judy took on the project leadership of Gruenenthal’s development of abuse deterrent formulations (ADFs) and an internal working group tasked with developing Gruenenthal’s expertise in abuse liability 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 and Professors Sandra Comer and Herbert Kleber worked to develop new 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.
Judy established the Center of Excellence for Abuse Liability at Gruenenthal USA, Inc, a unit which supported the company’s commitment to help develop safer alternatives for the management of pain. In addition, Judy was the clinical lead for tapentadol during its registration process in the US and EU, set up a partnering intelligence department to support business development, helped establish the Innovative Medicines Unit at Gruenenthal’s headquarters and opened its first hub, and performed the search for and evaluation of novel analgesics to help enrich the company’s internal pipeline with external innovation from academia and biotech.
Judy graduated as a Dean’s Scholar from UCLA School of Medicine in 1993 and then completed the Internal Medicine residency program at Santa Barbara Cottage Hospital in 1996, serving as chief resident in her final year of training.