Division of Controlled Substances

Coté Orphan's newest regulatory and consulting services division delivers the expertise of the FDA's former Director of Controlled Substances, Dr. Michael Klein, to provide strategic support to drug companies with development of controlled substances within the pipeline. 

 

Michael Klein, Ph.D.

Dr. Klein previously 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 2007 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 prior regulatory and scientific experience with the Drug Enforcement Administration (DEA) in evaluation of new psychoactive substances.  

At the FDA, he led an interdisciplinary scientific team of pharmacologists, physicians, pharmacists, biological and physical scientists.  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 coordinates 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.  

Dr. Klein has recently joined  Coté Orphan and will be providing strategic consulting services as the Director of Controlled Substances.

Dr. Klein received a B.S. in Pharmacy (1967) and Ph.D. in Medicinal Chemistry (1971) from the University of Illinois, Medical Center, Chicago, and performed postdoctoral research at Argonne National Laboratory in organic research, mass spectrometry and analysis of radioactive elements.


 

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Our Services

 

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- Provide advice on strategies for abuse and dependence assessments in drug development.

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    - Assess Product Development Plan, identify the appropriate pathway for approval for marketing, define all applicable regulatory requirements and craft a customized product development strategy that minimizes time to clinical trials and regulatory approval.

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    - Provide advice on the design and development of nonclinical and clinical protocols for the study of controlled substances, abuse potential and dependence liability assessment, and abuse deterrence assessments, consistent with Agency guidance.

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    - Review nonclinical and clinical study reports, including interpretation of results, for controlled substances and drugs with abuse potential.

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-Once IND application has been submitted to the FDA, support client’s Product Development Team with advice every step of the way through the IND review process.

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    - Provide consultation on Pre-IND submissions and meetings, IND’s, clinical trials and product development.

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    - Prepare NDA submissions on drug scheduling proposals based on abuse potential and dependence liability studies.

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    - Collaborate with client’s product development team to manage study and data evaluation.

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    - Review and prepare applications and provide advice for research with Schedule I substances.

    - Prepare meeting requests and briefing packages for Agency meetings.

- Maintain currency with the Agency’s public viewpoint and guidance to position client’s new product for successful outcome.

Provide advice on possible regulatory outcomes for the new drug product, including product labeling, drug scheduling, and the need for a Medication Guide or Risk Evaluation and Mitigation Strategy (REMS).