Phase I Clinical Trials for Development of Neurotherapeutics

Added: Jul 07, 2016 10:22 am 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 PPD Development, LP, Wilmington, North Carolina, Contract No. HHSN271201600005I, on July 1, 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 1, 2016 through June 30, 2026. The minimum award amount is $72,325; the maximum award amount under this program is $19,500,000. PPD, Development, LP 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 1, 2016 through June 30, 2017 with an award amount of $72,325. 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 - $48,656
Option No. 2 - Clinical Operations Support for Year 03: 07/1/18- 06/30/19 - $49,614
Option No. 3 - Clinical Operations Support for Year 04: 07/1/19- 06/30/20 - $50,594
Option No. 4 - Clinical Operations Support for Year 05: 07/1/20- 06/30/21 - $51,605
Option No. 5 - Clinical Operations Support for Year 06: 07/1/21- 06/30/22 - $52,649
Option No. 6 - Clinical Operations Support for Year 07: 07/1/22- 06/30/23 - $53,713
Option No. 7 - Clinical Operations Support for Year 08: 07/1/23- 06/30/24 - $54,821
Option No. 8 - Clinical Operations Support for Year 09: 07/1/24- 06/30/25 - $55,954
Option No. 9 - Clinical Operations Support for Year 10: 07/1/25- 06/30/26 - $57,119

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.

Added: Jun 18, 2015 1:40 pm 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.