Notice Number: NOT-NS-14-035
Key Dates
Release Date:
June 16, 2014
Response Date: July 18, 2014
Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
Purpose
The National Institute of Neurological Disorders and Stroke (NINDS), NIH is considering establishing a Phase 1 clinical trials contract program to support advancement of neurotherapeutics. The services provided under this contract program will support that part of NINDS's mission for the development of neurotherapeutics. The design, study population and procedures to be performed will vary from project to project; therefore NINDS would like to determine whether it is possible for a single vendor to provide the full range of services potentially required. NINDS is seeking feedback from potential sources regarding interest, availability, and costs for the desired resources and services.
This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes.
The proposed clinical trial services contract is envisioned as offering a mechanism to support Phase 1 clinical trials for neurotherapeutics, as well as other drugs of direct interest to NINDS. The term neurotherapeutics includes therapies targeted to indications due to dysfunction of the central and/or peripheral nervous system, which fall within the mission of NINDS or the Institutes and Centers that are part of the NIH Blueprint Neurotherapeutics Network (http://neuroscienceblueprint.nih.gov/bpdrugs/). Compounds to be assessed may include small molecules, peptides, proteins or oligonucleotides provided by Contributors (e.g. NINDS grantees) to the program. Phase 1 studies denote clinical trials performed for characterization of safety, pharmacokinetics (PK) and pharmacodynamics (PD), although exploratory efficacy data may be collected in some instances. Pharmacodynamics (PD) is used here to encompass measures to assess target engagement, modulation of biological processes subsequent to target engagement, and modulated processes relevant to disease pathogenesis. It is anticipated that these will all be first-in-human clinical trials. Depending on the project, study populations may be healthy volunteers, demographic subsets of healthy volunteers, or patients with conditions of interest, typically mild forms of the proposed disease indication.
NINDS will maintain frequent, close communication and contact in monitoring and providing oversight of the Phase 1 trials contract. In addition, under such a program the NINDS will provide the Phase 1 clinical trial unit contractor(s) with the following:
The extent of services provided by the Phase 1 clinical trial unit contractor(s) will vary somewhat depending on the specific requirement of each project, though are generally anticipated to be full service from finalization of the clinical protocol through writing of a complete study report.
The following are the requirements envisioned for the Phase 1 clinical trial unit contractor(s):
If your organization would be interested in providing services under such a contract program, please address your interest, qualifications, experience, and capabilities by responding to the following five areas outlined below. It would be appreciated if responses were limited to no more than ten pages. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Generic marketing brochures are not wanted nor will they be considered.
The information collection and recordkeeping requirement associated with publication of the proposed RFI have been approved by OMB Control Number 9000-0037 Exp.Date 11/30/2014, as codified in FAR at 1.106.
Technical Requirements
Experience
Quality
Costs
Business and Organization Information
This 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. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Responses are due by 4:00 PM local time on Friday July 18, 2014.
Please submit responses to:
Annette Carter
Contracting Officer
National Institutes of Health
NINDS R&D Contracts Management Branch
6001 Executive Boulevard, Room 3287
Bethesda, Maryland 20892-9531
(for FedEx or courier, use: Rockville, MD 20852)
Telephone: 301-496-1813
Fax: 301-402-4225
Email responses sent to cartera@mail.nih.gov will also be accepted (please format for printing).
Inquiries
Please submit responses to:
Annette Carter
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1813
Email:cartera@mail.nih.gov