Karen L. Sees, D.O.

Drug Development and Pharmacovigilance

Karen L. Sees, D.O., began consulting with PinneyAssociates in 2000. She has over 29 years’ experience in substance abuse treatment, research, and pain management, with a particular emphasis on innovative treatment of opioid and nicotine dependence.

Previously, Karen served as a clinical instructor in the Department of Psychiatry at the University of California in San Francisco from 1987 to 1998. From 1989 to 1996, she served as Assistant Chief and then Chief for the Substance Abuse Treatment Clinic in the Department of Psychiatry at the San Francisco Veteran Affairs Medical Center. She was Associate Director of Clinical Research & Development at the ALZA Corporation from 1996 to 1997.

Through her extensive research and development experience, Karen has served as principal investigator for nationally funded R01 grants and as Clinical Program Management/Medical Monitor on Phase I through Phase IV clinical trials. Her responsibilities have included managing Phase I-IV clinical studies and various post-marketing ventures, researching and writing clinical protocols, and the abuse liability and risk/benefit sections for INDs and NDAs. Karen has served as a consultant on new drug development including those with novel delivery systems for pharmaceutical and biotechnology companies since 1998. She has worked extensively on medications for the treatment of acute and chronic pain, opioid and nicotine addiction, ADD/ADHD, urinary urge incontinence, osteoporosis, and post-operative bowel dysfunction. Karen has also helped companies prepare for FDA Advisory Committee meetings, and has provided expert testimony at such meetings. Karen has extensive experience in post-marketing pharmacovigilance surveillance and reporting, and has been involved in forensic evaluations focusing on the effects of psychoactive drugs and alcohol, and issues involving the misuse, abuse, and diversion of psychoactive drugs.

Karen’s research has resulted in the writing of numerous book chapters, as well as articles, letters, and abstracts for prominent peer-reviewed medical journals on topics in substance abuse and pain management. She is on the editorial review board of several substance abuse journals.

Having graduated magna cum laude from West Virginia Wesleyan College in 1976 with a bachelor’s in science, Karen received her doctorate in osteopathic medicine from the West Virginia School of Osteopathic Medicine in 1983. Karen’s post-doctoral training included a rotating internship at Richmond Heights Hospital (now Sinai Medical Center East) from 1983 to 1984, an internal medicine residency at Brentwood Hospital (now Meridia Southpointe Hospital affiliate of the Cleveland Clinic Health Care System) from 1984 to 1987, and a substance abuse fellowship at the VA Medical Center in San Francisco from 1987 to 1989.

Karen is Board Certified by the American Osteopathic Board of Internal Medicine, holds a Certificate of Added Qualifications in Addiction Medicine and a Certificate of Added Qualifications in Pain Medicine, both from the American Osteopathic Board of Internal Medicine, and is certified by examination by the American Society of Addiction Medicine. She is a fellow in the American Osteopathic Academy of Addiction Medicine.