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OCR for page 207
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.
Representative terms from entire chapter:
clinical trials
