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This Government Contract opportunity was posted on July 8, 2016. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Phase I Clinical Trials for Development of Neurotherapeutics

Awarded
NIH-NINDS-15-01Federal

Contract Overview

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The National Institute of Neurological Diseases and Stroke has awarded an Indefinite Delivery/Indefinite Quantity contract to Duke University for the performance of Phase I first-in-human clinical trials. The primary objective of this agreement is to evaluate new potential therapeutics by determining tolerated dose ranges, dosing regimens, safety profiles, pharmacokinetic and pharmacodynamic parameters, and early signs of efficacy. The contract spans a ten year ordering period from July 8, 2016, through June 30, 2026, with a minimum award of 51,910 dollars and a maximum ceiling of 19,500,000 dollars. Concurrent with the parent contract, Duke University was granted an initial task order for Administrative and Overall Clinical Operations Support covering the first year of performance. This specific support component includes nine additional twelve month options extending through June 2026, with annual funding incrementally increasing from 43,951 dollars to 57,164 dollars. Beyond these administrative services, the agency intends to compete and award separate task orders for specific Phase 1 clinical trials to the ID/IQ awardees.

General Info

Agency

N/A

Contract Value

$0

NAICS

541712 - Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)

Place of Performance

USA

Set-Aside

NONE

Award Issued Date

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

PhaseAwarded
Posted

Presolicitation

Type Changed

Presolicitation → Solicitation

Awarded

Contract was awarded

Submission Closed

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Organization & Contact Information

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AgencyN/A
Contacts2 people available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
Contacts
Annette CarterContracting Officer
Kirkland L. DavisChief, Contracts Management Branch

Full Description

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The National Institute of Neurological Diseases and Stroke (NINDS), National Institute of Health (NIH), has made an Indefinite Delivery/Indefinite Quantity (ID/IQ) contract award under RFP No. NIH-NINDS-15-01. An ID/IQ contract has been awarded to Duke University, Durham, North Carolina, Contract No. HHSN271201600004I, on July 8, 2016. This contract is for performance of Phase I first in human clinical trials to determine the tolerated dose range, the dosing regimen, the safety profile and pharmacokinetic (PK) parameters and may include pharmacodynamics (PD), and evaluation of biological effects and early signs of efficacy in new potential therapeutics. The ID/IQ contract has been awarded with a ten (10) year ordering period of July 8, 2016 through June 30, 2026. The minimum award amount is $51,910; the maximum award amount under this program is $19,500,000. Duke University has also been awarded a task order concurrent with the parent ID/IQ contract. This task order covers the first year of performance under the "Administrative and Overall Clinical Operations Support" component of the program. The period of performance of this task order award is July 8, 2016 through June 30, 2017 with an award amount of $51,910. The task order award also contains nine (9) additional 12-month term options which have been negotiated as follows: Option No. 1 - Clinical Operations Support for Year 02 07/1/17- 06/30/18 - $43,951 Option No. 2 - Clinical Operations Support for Year 03 07/1/18- 06/30/19 - $49,447 Option No. 3 - Clinical Operations Support for Year 04 07/1/19- 06/30/20 - $50,829 Option No. 4 - Clinical Operations Support for Year 05 07/1/20- 06/30/21 - $51,808 Option No. 5 - Clinical Operations Support for Year 06 07/1/21- 06/30/22 - $52,816 Option No. 6 - Clinical Operations Support for Year 07 07/1/22- 06/30/23 - $53,855 Option No. 7 - Clinical Operations Support for Year 08 07/1/23- 06/30/24 - $54,925 Option No. 8 - Clinical Operations Support for Year 09 07/1/24- 06/30/25 - $56,028 Option No. 9 - Clinical Operations Support for Year 10 07/1/25- 06/30/26 - $57,164 Separate and distinct from the annual "Administrative and Overall Clinical Operations Support" task order, the NINDS will compete and award future Phase 1 clinical trial Task Orders from the ID/IQ awardees under the RFP.

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