MICHAEL KLEIN PhD
CONSULTANT
About CSSS
Since its inception, Controlled Substance Scientific Solutions has provided strategic support and expertise to drug companies with developmental controlled substances in the works.
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Argonne National Laboratory
Postdoctoral, Organic Synthesis, Mass Spectrometry, Radiactive Analysis
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University of Illinois at Chicago
Doctor of Philosophy in Medicinal Chemistry
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University of Illinois College of Pharmacy
Bachelor of Science in Pharmacy
During more than 40 years of federal service, pharmacologist Michael Klein, PhD, amassed extensive experience with issues related to drug regulation, abuse, misuse, and addiction.
Dr. Klein served as the Director of the Controlled Substance Staff (CSS) in the Food and Drug Administration, Department of Health and Human Services (FDA/HHS) from 2008 to 2017. Since leaving the FDA, he has provided consultation as the Principal of Controlled Substance Scientific Solutions LLC. He has more than forty years of experience in drug regulation and research in pharmacology and chemistry. This includes 27 years with the FDA Center for Drug Evaluation and Research (CDER) and 15 years prior regulatory and scientific experience with the Drug Enforcement Administration (DEA) in evaluation of new substances with abuse potential.
In New Drug Application review, Dr. Klein was responsible for directing the assessment of abuse liability of new drug products and providing advice to the Industry and the medical review divisions on numerous public health-related concerns. Dr. Klein has been a leader in the development of several FDA Guidelines in the area of abuse potential assessment and new abuse deterrent drug products. In addition, Dr. Klein has provided expertise in the area of premarketing review of controlled substances and coordinated activities with other USG agencies, including the National Institutes of Health, National Institute on Drug Abuse (NIH/NIDA) and the DEA. He provided technical assistance to the World Health Organization evaluation of new drugs of abuse.
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Since leaving the federal government in early 2017, Dr. Klein has worked with a variety of consulting and pharmaceutical companies. He recently served as the Director of Controlled Substances for Coté Orphan, a QuintilesIMS Company--now Iqvia--developing strategic plans and advice for the pharmaceutical industry on nonclinical and clinical studies to assess the abuse potential and dependence liability of drugs. This includes advice on the study of abuse deterrence of opioid drug products.
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Dr. Klein is a member of the College on Problems of Drug Dependence (CPDD), the International Society for CNS Clinical Trial Methodology (ISCTM), and a 50 year member of the American Chemical Society (ACS).
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