The Development of Medications for the Treatment of Opiate and Cocaine Addictions Issues for the Government and Private Sector (1995) / Chapter Skim
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Appendix E: Model Federal Programs in Pharmaceutical R&D
Appendix E: Model Federal Programs in Pharmaceutical R&D
Pages 227-237
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From page 227... ...
The programs cover a wide array of fields, including drug addiction, cancer, malaria, and contraception. This appendix describes several selected programs that have successfully brought medications to market with the cooperation of commercial sponsors: the Antiepileptic Drug Development Program of the National Institute of Neurological Disorders and Stroke (NINDS)
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The preclinical research primarily supports preclinical screening and toxicity testing to determine target-organ toxicity. The clinical trials are sponsored by contract at academic medical centers.
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229 Cal 4~ V]
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· Medically defned outcome measures. Clinical trials are aided by readily identifiable, medically acceptable outcome measures of drug efficacy.
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NCI's systematic commitment to all aspects of drug development has resulted in the approval of 48 drugs- the majority of commercially available cancer treatments including methotrexate, doxorubicin, and vincristine (Zubrod et al., 1977; Grever et al., 1992~. Today's commercial market for anticancer drugs depends on the incidence of the cancer in question and many other factors.
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Clinical Research Clinical research is supported in two complementary programs: the Cancer Therapy Evaluation Program, which supports extramural research, and the Clinical Oncology Program, which supports intramural research. Together, these programs were budgeted in FY 1993 at about $233 million.
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Almost 75 percent of the new drugs being studied by the groups are provided by industry, 10 percent are provided by university researchers, and about 10 percent come from the Division of Cancer Treatment's preclinical research sponsored by the Developmental Therapeutics Program. Statistical and regulatory support to aid research design and approvals is in the program's Biometrics Research Branch and Regulatory Affairs Branch, respectively.
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Created in 1987, these programs were designed to work with university and private researchers to bring drugs quickly to market to treat both HIV infection and the opportunistic infections afflicting AIDS patients. The commercial market for antiviral and anti-infection drugs for HIV and AIDS-related disease depends on the indication.
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The cooperative agreements supported by the Basic Research and Development Program are the vehicles used to bring university and industry researchers together to work on multidisciplinary preclinical research, both basic and applied. The cooperative agreements fund national cooperative drug discovery groups (NCDDGs)
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Elements of Success NIAID's preclinical and clinical research programs have played a pivotal role in the development of three approved AIDS antiviral drugs and most of the 49 commercially sponsored medications undergoing clinical trials for the treatment of AIDS-related opportunistic infections. Program administrators have attributed their success to the following factors: · Large clinical-trial network.
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From page 237... ...
NIAID staff are staunchly committed to AIDSdrug discovery and development, as evidenced by their track record of success, which is even more impressive considering that this $185 million program is administered by only 90 full-time-equivalent staff.
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