SOLICITATION NOTICE
A -- Efficacy Testing of Anticonvulsants and Neuroprotectants as Medical Countermeasures Against Chemical Threats
- Notice Date
- 9/23/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, MD, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- Reference-Number-NIH-NINDS-06-02
- Response Due
- 11/7/2005
- Archive Date
- 11/22/2005
- Description
- The National Institute of Neurological Disorders and Stroke (NINDS) intend to negotiate on a sole source basis with the University of Utah, under contract number N01-NS-4-2359 new requirements to the existing Anticonvulsant Screening Program (ASP) Statement of Work. These new requirements are for screening compounds for therapeutic activity against convulsions and seizures caused by acute exposure to organophosphorus nerve agent chemical weapons and cyanide. In addition, there will be new requirements to screen compounds for activity against the neurodegeneration associated with acute exposures to these chemicals. The existing ASP contract routinely conducts an extensive drug discovery and translational science effort aimed at identifying new therapies for advanced development and eventual marketing to treat human epilepsy disorders and modulation of axonal neurotransmission. Promising compounds are tested through a series of pharmacological and pharmacokinetic evaluations (both in vivo and in vitro screening) that help define a candidate?s anticonvulsant profile including activity, neurotoxicity, and effect on hepatic microsomal metabolizing enzymes, drug resistance and pharmacodynamic interactions. These efforts have been carried out under the contract mechanism since 1975 with the University of Utah. Approximately 800 compounds are evaluated for therapeutic usefulness each year. Overall testing requirements in the existing ASP include, but are not limited to, anticonvulsant identification, associated neurotoxicity, anticonvulsant quantitation including establishment of effective doses for a panel of relevant tests, pharmacologic differentiation from prototype drugs, evaluation of proconvulsant potential, studies directed toward elucidating anticonvulsant mechanism(s) of action, drug interaction studies, mutagenicity tests, drug resistance and a variety of other standardized tests to determine relevant activity in candidate compounds. During the past 30 years, the University of Utah has been able to successfully adopt specialized techniques, methods of evaluation and accumulation of extensive pharmacodynamic and pharmacokinetic profiles for all the current therapeutic agents and new investigational drugs. This accumulation of data and experiences is the basis by which all new test compounds are pharmacologically compared. This new work will include in vitro screens and animal models to test a candidate drug?s potential therapeutic value against convulsions and seizures caused by exposure to nerve agents and/or cyanide. Requirements will include the development, validation, and use of models that utilize relevant exposure scenarios to chemical agents, or models that simulate such exposures. Examples of models that may simulate nerve agent-induced seizures include the pilocarpine - and kainite-induced epilepsy models. Requirements will also include the testing of new or existing candidate neuroprotectant compounds for efficacy against neurodegeneration and neuronal/glial damage caused by exposure to chemical threat agents. For example, neurodegeneration may be assessed via quantitative stereological analysis and the relationship between seizure activity and neuronal damage. Finally, the new work will include the development of specialized in vivo and/or in vitro models to assess the effectiveness of candidate therapies, e.g. pediatric pharmacotherapy models, drug interactions, for use with pre-existing medical conditions, and efficacy in the elderly. The ultimate goal of these programs will be to develop new therapies that are fast acting (<10 min), have intermediate duration of action, i.e., effective for a few hours or more, have minimal respiratory depressant effect, can be delivered through non-IV route (IM, IN) appropriate for field conditions, are suitable for a wide demographic range, are stable at room temperature, and can be administered in combination with other appropriate therapies. The NINDS believes that the University of Utah is the only known source for performing comprehensive evaluations by virtue of their 30 years of experience, demonstrated expertise, availability of required staff, laboratory and animal facilities, other requisite resources already in existence within the core program, and validated control data on numerous marketed therapies. NINDS' requirement for consistency and compatibility of data derived from these screening procedures is paramount to the success of this program. For the 30 years of the ongoing anticonvulsant screening work performed by the University of Utah, the NINDS is not aware of or doesn?t believe that any other organization possesses the capability or has developed a comparable database upon which work for the new screening objectives will be based exists. Inability to produce compatible evaluation results to our existing data base would lead to delays in screening new compounds and incurrence of duplicate costs, both of which would be unacceptable to the Government. A determination for use of other than full and open competition has been made in accordance with 41 U.S.C. 253 ?(1), as set forth in FAR 6.302 . The University of Utah is considered the only source capable of performing the additional screening analyses and has the prerequisite knowledge and expertise to continue the contract work based on their current experience and work under the contract to date. See Numbered Note 22.
- Place of Performance
- Address: University of Utah, Salt Lake City, Utah
- Zip Code: 84112
- Zip Code: 84112
- Record
- SN00902546-W 20050925/050923211937 (fbodaily.com)
- Source
-
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