B_Sources Sought Notice.pdf

Sources Sought notice # 75N95023Q00329

Therapeutic Oligonucleotide Platform Biologics Chemistry, Manufacturing and Controls (CMC) Subject Matter Expert Consultant

This is a Small Business Sources Sought notice. THIS IS NOT A REQUEST FOR PROPOSALS, ABSTRACTS, OR QUOTATIONS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement.

The purpose of this notice is to obtain information regarding:

1. The availability and capability of qualified small business sources.

2. Whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and

3. Their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

The applicable NAICS code for this acquisition is 541690. An organization that is not considered a small business under this NAICS code should not submit a response to this notice.

PROJECT REQUIREMENTS

The National Institute of Neurological Disorders and Stroke (NINDS) mission is to seek fundamental knowledge about the brain and nervous system and use that knowledge to reduce the burden of neurological disease. Consequently, the NINDS seeks to support translational development of novel therapeutics, including biologics, that can provide health benefits to patients.

The NINDS has established the URGenT program to support the development and clinical evaluation of therapeutics to address ultra-rare genetically based neurological disorders (https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research/urgent-network).

The program will provide neuroscience researchers with funding and access to a full range of industry-style biologics development services and expertise and in the future may expand to include other NIH institutes. The program is intended to rapidly advance patient-customized therapeutics through manufacturing, preclinical toxicology testing, and evaluation in Phase 1 clinical studies.

The NIH Blueprint Neurotherapeutics (BPN) network (https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-neurotherapeutics-bpn- network) is a consortium comprised of the NIH Office of the Director and 14 NIH Institutes and Centers (ICs) that support neuroscience research. BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise.

The program, originally focused on small molecules, was launched for projects requiring medicinal chemistry optimization, pharmacokinetics (PK), pharmacodynamics (PD), drug manufacturing and formulation, investigational new drug (IND)-enabling toxicological studies support through Phase I https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research/urgent-network https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research/urgent-network clinical testing and it is now being expanded to include the development of biological therapeutics for neurological diseases (BPN-Biologics). https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics.

The NINDS anticipates needing 1-3 consultants to cover all projects. These individuals would be expected to provide guidance and advice on biologics development processes for the National Institute of Neurological Disorders and Stroke (NINDS) Ultra-Rare Gene Therapy (URGenT) program, the NIH Blueprint Neurotherapeutics (BPN) Biologics program, and other NINDS and trans-NIH programs where therapeutic oligonucleotide CMC expertise is required.

Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner.

Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc.

All capability statements must provide the following: 1) company name, address and UEI number; 2) point of contact, 3) phone/email; 4) NAICS Codes; 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as.

Electronic capability statements will be accepted by the primary point of contact at polina.klimenkova@nih.gov in the form of a single PDF file with the subject line: “Capability Statement 75N95023Q00329” NO LATER THAN 30 May 2023 at 12:00 PM EST.

THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not obligate the Government to award a contract or otherwise pay for the information provided in this response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. 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). Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in SAM. However, responses to this notice will not be considered adequate responses to the subsequent solicitation.

https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics mailto:polina.klimenkova@nih.gov