Edward Cone, Ph.D.

Drug Delivery and Abuse Deterrent Drug Products

Expertise

Edward (Ed) J. Cone is recognized world-wide for his expertise on the chemistry and pharmacology of drugs of abuse. At PinneyAssociates, based on his expert knowledge of pharmacokinetics and drug testing methodologies, he consults with clients on the:

  • Evaluation of abuse-deterrent formulations
  • Development of novel drug delivery systems

Experience

Throughout his career, Ed has emphasized the value of applying real-world experience to solving problems in the laboratory. Doing just that, his practical model for in vitro laboratory assessment of abuse-deterrence predicted much of what appears in the 2015 FDA Guidance on Abuse-Deterrent Opioids — Evaluation and Labeling. He has presented in meetings with the FDA reviewing divisions and Advisory Committees on behalf of numerous pharmaceutical clients.

At the Addiction Research Center of the National Institute on Drug Abuse, Ed completed a series of seminal studies on the metabolism and excretion of opioid agonists and antagonists. As Chief of the Chemistry Section, he was responsible for executing a variety of clinical studies concerning the pharmacokinetics and pharmacodynamics of psychoactive drugs. He has extensive experience in the design and execution of clinical research studies and has trained many doctoral candidates.

Ed has published over 250 research and review articles and chapters on a broad array of topics concerning human drug administration. In 2020 he was cited as the most highly cited scientist worldwide in forensic toxicology and he was cited by ScienceWatch as the most highly cited author in forensic science over the period of 1981-1993. He was additionally recognized with the Scientist Professional Advisory Committee Career Scientist of the Year Award granted by the US Public Health Service Commissioned Officer’s Association (1996), was awarded the Irvine Sunshine Award in Clinical Toxicology (1995), received the Rolla Harger Award from the American Academy of Forensic Sciences for “Outstanding Contributions to Forensic Toxicology” (2000), and won the Irvine Alan Curry Award for his extensive research in Clinical Toxicology from the International Association of Forensic Toxicologists (2006).

Ed has been a member of the Johns Hopkins University School of Medicine faculty since 1998 and is presently also Adjunct Associate Professor in the Department of Psychiatry and Behavioral Sciences.

Education

  • Served as a postdoctoral Fellow, Department of Chemistry, University of Kentucky, Lexington, KY
  • Earned his doctorate in organic chemistry from the University of Alabama
  • Graduated with a bachelor’s in chemistry from Mobile College, Mobile, Alabama