SOLICITATION NOTICE
A -- Phase I Clinical Trials for Development of Neurotherapeutics
- Notice Date
- 6/18/2015
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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, Maryland, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- NIH-NINDS-15-01
- Point of Contact
- Annette Carter, Phone: (301) 496-1813, Kirkland L. Davis, Phone: (301) 496-1813
- E-Mail Address
-
cartera@nida.nih.gov, kd17c@nih.gov
(cartera@nida.nih.gov, kd17c@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The NIH has established the "Blueprint Neurotherapeutics Network (BPN)" to bridge the gap in drug development between basic researchers and biopharmaceutical companies ( http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm ). The BPN supports, through grants and contracts, every step of the drug development process from validated hits to Phase I first-in-human clinical trials. The term neurotherapeutics includes novel agents developed by the National Institutes of Health (NIH) and its grantees (henceforth known as the "Contributor (s)") and provided to the NINDS for collaborative development as well as investigational agents supported by and through the NINDS including the Blueprint Neurotherapeutics Network http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm. This proposed contract initiative, under the auspices of the NIH, National Institute of Neurological Disorders and Stroke (NINDS), and as part of the BPN, will support award of contracts that provide a full service, turn-key, Phase I clinical trial operations and facility for the development of novel neurotherapeutic agents. This full service facility would provide a range of services from protocol development/finalization and clinical trial execution through submission of a final clinical study report in support of an IND submission of the tested agent. The emphasis of these Phase I Clinical Trials Facilities will be to perform Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Phase I clinical trials utilizing NINDS-supplied novel agents developed by NINDS, sponsored Investigators or Contributors with an emphasis on first in human testing to determine the tolerated dose range, the dosing regimen, the safety profile and pharmacokinetic (PK) parameters. Assigned Phase I Clinical Trials may also include pharmacodynamics (PD), and evaluation of biological effects and early signs of efficacy. The data generated from these trials will be used by NINDS, its Contributors or sponsored Investigators in support of IND applications and ultimately serve as the basis to advance candidate compounds for further clinical development. THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION NOTICE ONLY, PER FAR 5.204, ANNOUNCING THE EXPECTED AVAILABILITY OF REQUEST FOR PROPOSALS (RFP) NO. NIH-NINDS-15-01, ENTITLED: "PHASE I CLINICAL TRIALS FOR DEVELOPMENT OF NEUROTHERAPEUTICS" ON OR ABOUT JULY 3, 2015. THE RFP WILL BE MADE AVAILABLE ELECTRONICALLY ONLY VIA THE FedBizOpps WEBSITE (URL: http://www.fedbizopps.gov ). PROSPECTIVE OFFERORS WILL BE RESPONSIBLE FOR ROUTINELY CHECKING THE FEDBIZOPPS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. The NINDS anticipates making multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract awards under this solicitation, each with a ten year ordering period. We anticipate that awards may be made either the later part of calendar year 2015 or the first quarter of calendar year 2016. All responsible sources may submit a proposal, which shall be considered by the agency.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NINDS/NIH-NINDS-15-01/listing.html)
- Record
- SN03769038-W 20150620/150618235121-ee6388c05016312504ff50fa758f47d1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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