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Appendix B Organization and Mission Statements of NIDA's Medications Development Division and Its Branches MEDICATIONS DEVELOPMENT DIVISION MISSION STATEMENT (1) Plans and directs studies necessary to identify, evaluate, develop and obtain FDA marketing approval for new medications for the treatment of drug dependence and addiction and other brain and behavioral disorders; (2) develops and administers a national program of basic and clinical pharmaceutical research to develop innovative biological and pharmacological treatment approaches; (3) supports training in the fundamental sciences and clinical disciplines related to the pharmacotherapeutic treatment of drug abuse; (4) collaborates with: (a) the pharmaceutical and chemical industry in the United States and other Nations and, (b) the Federal medications development programs; and (5) works closely with FDA in assuring that research designed to show the clinical efficacy of new compounds is evaluated and approved in the most expeditious manner possible. Biometrics Branch Mission Statement (1) Provides consultation and advice on study design and analysis issues involved in pharmacology, toxicology, pharmacokinetics, and clinical trials for intramural and extramural projects of interest to the Division; (2) provides consultation on design and analysis issues regarding medications being developed by the pharmaceutical industry for clinical indications subsumed under the Division's responsibilities; and (3) analyzes preclinical and clinical data for medications development projects, using established methodologies as appropriate 207

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208 DEVELOPMENT OF MEDICATIONS and developing new analysis methods when current methods are judged inappropriate. Chemistry and Pharmaceutics Branch Mission Statement (1) Administers a national program of research and development in the following areas: (a) medicinal and synthetic chemistry, and discovery of new chemicals of therapeutic value; (b) bioavailability, pharmacokinetics and drug metabolism studies and studies on the interactions of these compounds with known drugs of abuse, including fetal exposure; and (c) bulk chemical preparation and dosage form preparation of medications under development carried out in compliance with the FDA Good Manufacturing Practice regula- tions; (2) develops and manages: (a) an SAR database for data on compounds of interest to the Medications Development Division; and (b) new rapid screening projects which generate pharmacological activity and storage of such data in a computer database and coordination of screening programs with other sources of data of potential interest to the Division; (3) provides analytical chemistry development and services including development of assay methods for applications of drug characterization, bioavailability and kinetic studies in the Division, and centralized analysis of biological specimens (e.g., urine for cocaine use detection); (4) manages the distribution of controlled substances and related compounds, research chemicals, bulk pharmaceuticals, dosage forms which are used in programs associated with medications development; (5) provides documentation of testing of new drug substances and dosage forms for Investigational New Drug application and New Drug Application reports for drugs developed in the Division; and (6) provides consultation and technical support for urine testing of drugs of abuse in clinical trials being conducted for the Division. Clinical Trials Branch Mission Statement (1) Plans, designs, and implements a comprehensive program of extramural clinical studies, in coordination with intramural projects, evaluating new and marketed drugs for their potential value in treating substance abuse disorders; (2) provides consultation to the other ADAMHA Institutes regarding medications development, patient recruitment, investigator and site selection, and other administrative clinical issues; (3) files Investigation New Drug applications for clinical projects in conjunction with the Regulatory Affairs Branch; (4) designs and monitors clinical trials for safety and efficacy of new and currently marketed drugs in the treatment of substance abuse disorders;

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APPENDIX B 209 (5) provides consultation and collaboration with the pharmaceutical industry regarding projects of mutual interest; and (6) supports research training of clinicians to increase the skills, quantity, quality, and utilization of research in medications development. Pharmacology and Toxicology Branch Mission Statement (1) Plans, designs, implements, and coordinates a comprehensive program of extramural studies, in coordination with intramural projects, evaluating the efficacy of potential medications in preclinical pharmacological models; (2) plans, designs, and implements a comprehensive program of preclinical toxicological studies conducted under Good Laboratory Practices regulations for the purpose of determining the safety of potential medications; (3) evaluates the interactive effects of potential medications with drugs of abuse in preclinical models; (4) recommends compounds for further testing in animal models and coordinated testing of compounds under development with the other branches of the Division; (5) recommends compounds for human testing for potential efficacy in substance abuse disorders; (6) develops data storage capacities for preclinical pharmacological and toxicological data; and (7) provides liaison, consultation, and collaboration with the Food and Drug Administration and the pharmaceutical industry on matters related to preclinical models of drug abuse and drug dependence. Regulatory Affairs Branch Mission Statement (1) Provides legal and regulatory advice and support to the Division's medication development activities; (2) coordinates the Division's activities in technology transfer and development, including the development and negotiation of Cooperative Research and Development Agreements, Material Transfer Agreements, interagency agreements and contracts; (3) maintains liaison with the Office of the General Counsel, Office of the Secretary, the Patent Branch of the Office of General Counsel,NIH and the Office of Technology Transfer, NIH; (4) maintains liaison with the Food and Drug Administration, and files Investigation- al New Drug applications and New Drug Applications as necessary; (5) develops and maintains a management information database and library functions, assuring that proprietary and confidential information are appropriately safeguarded; (6) serves as project managers coordinating a variety of patent, regulatory, business and data functions, including electronic filing and storage of data, marketing surveys, access to consultants and new systems to keep the program current;

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210 DEVELOPMENT OF MEDICATIONS (7) provides briefings, reports, and congressional testimony as required; and (8) serves the executive secretary Unction for the Agency's Medications Develop- ment Workgroup. 1 Office of the | Director Clinical Trials Branch | Pharmacology/ Toxicology Branch Regulatory Affairs Branch L Screening Evaluation Toxicology studies (Through contracts) - Liaisons with: - FDA NIH Office of Technology Transfer Chemistryl Biometrics Pharmaceutics Branch Rr~n~h Clinical Trial Capability (Pharmacokinetic studies and phases 1, 11, and 111) through: Veterans Affairs medical centers Treatment research units University medical centers NIDA Addiction Research Center Product development Protocol design Bulk synthesis Clinical data management Pharmacokinetic studies Statistical anaysis (~rough contracts) In vitro screening Medicinal chemistry research FIGURE B.1 Organizational structure of MDD. SOURCE: Federal Register 57(220): 53907. November 13, 1992.