Notice Number: NOT-NS-05-008
Release Date: April 20, 2005
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
The National Institute of Neurological Disorders and Stroke (NINDS) is exploring the market interest and capabilities relating to the development of a contract facility with the ability to conduct preclinical animal drug studies in different models of Parkinson's Disease. The contract facility would have 3 functions: 1) conduct efficacy and pharmacokinetic studies in a range of rodent models of Parkinson's disease; 2) conduct some toxicology studies; 3) provide research support for the neuroprotection drug selection process (CINAPS), such as literature reviews and assembling drug dossiers.
In 2001, the NINDS established the Committee to Identify Neuroprotective Agents for Parkinson's (CINAPS), the process whereby drugs and doses are selected for ongoing Neuroprotection Exploratory Trials in Parkinson's disease (NET-PD). Using an evidence based-approach, CINAPS utilizes the published literature to select the most promising drugs for Parkinson's clinical trials. This process was well received and the CINAPS results were published (Neurology 60(8):1234-40, 2003). While the CINAPS process is sound, the quality of preclinical information used for planning future NET-PD trials could be greatly enhanced by having a contract facility with the ability to conduct preclinical animal drug studies in different models of PD.
The main limitation is the quality and thoroughness of the preclinical animal testing data found in the literature. When planning trials, there is often insufficient information in the published preclinical literature. The models chosen, route of administration, dose and other features may not fully answer some of the questions needed for bringing drugs into clinical trials, or there may simply be no replication of the study results demonstrating efficacy in a particular model. For example, insufficient preclinical toxicology (chronic) data on compounds may permit short-term but not chronic use of a drug, thus limiting the types of trials that can be conducted.
Therefore, the NINDS has identified a need to establish a contract facility that would conduct the needed preclinical animal drug studies.
Goals of the Proposed Initiative
This contract would allow the CINAPS process to augment information about potential neuroprotective compounds by performing the necessary additional experiments and would increase the likelihood of success for agents entering human trials. It can be expected that a range of lesion and transgenic models will be included. This is not a drug development program in the sense of looking for new chemical entities or developing agents with medicinal chemistry. Rather, the testing performed under this contract would be used to optimize information about compounds that are already of some established interest in PD but need independent verification or refinement before entering clinical studies. Specific goals include:
1) Replicate published findings, and utilize different doses or routes of administration to strengthen the case for using a particular agent in human trials.
2) Obtain important pharmacological information such as brain concentrations necessary for neuroprotection, to improve the planning and dose selection for human trials.
3) Test potential agents in different PD models to help select agents for human clinical trials and narrow the field of potential agents.
4) Perform standardized assessments and characterization in different PD models (particularly newer transgenic models) and determine the predictive value of different models and phenotypes.
5) Conduct some of the toxicology studies for select agents that appear promising.
6) Provide research support for the CINAPS process.
Information in the following areas could aid in the design of a possible future solicitation. We ask that interested organizations help identify critical criteria that would be germane to any such solicitation. The information supplied in any response to this request should address, but not be limited to, the following:
In addition, we seek information as to the capabilities, experience, and expertise needed for an organization to implement the goals outlined above.
This Request for Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked.
All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization.
Responses should be limited to a maximum of 10 pages and should be identified with NINDS RFI No. NOT-NS-05-008. Responses are due by May 18, 2005. Please submit three (3) copies of your response to:
Contracts Management Branch
National Institute of Neurological Disorders and Stroke, NIH
6001 Executive Boulevard, Room 3287 MSC 9531
Bethesda, Maryland 20892-9531.
(for FedEx or courier, use: Rockville, MD 20852)
E-mail responses, sent to firstname.lastname@example.org, will also be accepted.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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