Karen Sees, DO

Senior Advisor, Drug Development and Pharmacovigilance


Karen L. Sees joined Pinney Associates as an advisor in 2000. She applies her deep experience in both clinical trial design and interpretation, as well as postmarketing pharmacovigilance surveillance and reporting, to the development of safety summaries for submission to FDA. In this role, Karen:

  • Develops integrated summaries of safety (ISS) in support of NDAs
  • Advises on integration of legacy data into the ISS


With more than 30 years’ experience in substance abuse treatment, research, and pain management, with an emphasis on innovative treatment of opioid and nicotine dependence, Karen has first-hand knowledge of forensic evaluations focusing on the effects of psychoactive drugs and alcohol, and on issues involving the misuse, abuse, and diversion of psychoactive drugs. 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 of the Substance Abuse Treatment Clinic in the Department of Psychiatry at the San Francisco Veteran Affairs Medical Center. She was the 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 the 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 postmarketing ventures. She also has researched and written clinical protocols and abuse liability and benefit-risk 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 helped companies prepare for FDA Advisory Committee meetings, and has provided expert testimony at such meetings.

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.

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.


  • Fellowship, Substance Abuse, VA Medical Center in San Francisco
  • Resident, Internal Medicine, Brentwood Hospital (now Meridia Southpointe Hospital affiliate of the Cleveland Clinic Health Care System)
  • Rotating Internship, Richmond Heights Hospital (now Sinai Medical Center East)
  • DO, Osteopathic Medicine, West Virginia School of Osteopathic Medicine
  • BS magna cum laude, West Virginia Wesleyan College

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