Medicinal Chemistry Support Program for Therapeutic Development (MCSP)

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; (2) determine whether they are small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, and women-owned small businesses); (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) the availability of domestically manufactured and commercial services. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is considered a small business under the applicable NAICS code should indicate its small business status in its response.

The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond.

For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule).

Statement of Need and Purpose:

The National Institute on Neurological Disorders and Stroke (NINDS) and the NIH Blueprint Neurotherapeutics Network (BPN) [https://www.nih.gov/neuroscience-blueprint], with participation from the Helping to End Addiction Long-term® Pain Therapeutics Development Program (HEAL-PTDP) [https://www.ninds.nih.gov/current-research/trans-agency-activities/ninds-role-heal-initiative/pain-therapeutics-development-program-ptdp], have established a ‘virtual pharma' network of contract service providers and consultants with extensive industry experience to enable therapeutic (e.g., small molecule, peptide, biologic) development in the NIH research community. This network offers researchers access to a range of industry-style therapeutic development services and expertise, including medicinal chemistry, IND-enabling studies, and Phase 1 clinical trial infrastructure, with the goal of supporting efforts to advance compounds successfully through Phase 1 clinical testing. The Medicinal Chemistry Support Program for Therapeutic Development (MCSP) component has the need to recompete its medicinal chemistry services to support a range of medicinal chemistry activities (exploratory, hit-to-lead and lead optimization phases) including project management and reporting, compound logistics, shipping, synthesis, computational chemistry/Computer Aided Drug Discovery (CADD) and in vitro absorption, distribution, metabolism, excretion and toxicology (ADMET) studies in support of preclinical drug discovery efforts supported by NIH, NINDS and its contributors.

The ultimate goal of the NIH served by this program and of individual projects is to bring new drugs to market. To this end, the NIH has been granted a Determination of Exceptional Circumstances (DEC) to the Federal Acquisition Regulation (FAR) for this contract. The DEC enables the Contributors, Institutes that apply for a Grant, to retain control of the intellectual property for compounds created through the Medicinal Chemistry Support Program for Therapeutic Development (MCSP).

Program Requirement:

The scope of this MCSP program shall be medicinal chemistry services including project management and reporting, compound logistics, synthesis, computational chemistry and in vitro ADMET studies in support of preclinical drug discovery efforts supported by NIH, NINDS and its Contributors. NINDS requires a full service, turn-key medicinal chemistry operation for the development of therapeutics within the mission of NINDS, BPN, HEAL-PTDP and other NIH Institutes. The work may include any individual service or combinations of services including SAR analysis and design, synthesis, in vitro ADMET, computational chemistry/Computer Aided Drug Discovery (CADD) and compound logistics of storage and shipping.

Capable vendors must demonstrate the experience and capability to conduct from 1-10 projects simultaneously in the three chemistry stages: exploratory; hit-to-lead; and lead optimization.  Capable vendors must also demonstrate the professional and technical personnel with appropriate experience and work history, appropriate facilities, resources and equipment, as well as the capability to rapidly scale up or down the number of staff dedicated to the MCSP contract, depending on the number of projects underway at any given time.

Responses To This Notice Must Address/Provide The Following Information:

Businesses who believe that they possess the requisite capabilities, capacity, and personnel with the experience and qualifications to provide the full range of medicinal chemistry services described above are asked to address each of the areas described in the Program Requirement section below and to submit a response. Please ensure that your response is complete and sufficiently detailed to assist in our evaluation as to whether or not this requirement could be set-aside for small business participation only.

(a) Current in-house capability and capacity to perform medicinal chemistry services (exploratory, hit-to-lead and lead optimization phases) including SAR analysis and design, synthesis, in vitro ADMET, computational chemistry/Computer Aided Drug Discovery (CADD) and compound logistics of storage and shipping for 1-10 concurrent projects;

(b) Demonstrated experience and success in providing a flexible medicinal chemistry support program optimizing compounds from hits into pre-clinical lead candidates by addressing a broad range of chemical liabilities, including toxicity, low blood-brain barrier penetrability, and metabolic instability by providing routine in vitro pharmacology and toxicology assays and services;

(c) Demonstrated capability for productive collaborations with organizations and researchers involved in therapeutic development;

(d) Staffing and personnel qualifications, i.e., numbers, availability and type of staff that could be assigned to such a program; their expertise, experience and education, including citation of any formal training;

(e) A discussion of the requirements to be performed in-house versus those performed outside the responding organization; and

(f) Your organization's name, address and Unique Entity Identifier (UEI) number; point of contact, including title, telephone number, and email address; and your current small business size status (e.g., small, small disadvantaged business, HUBZone, women-owned, 8(a), veteran-owned, etc. pursuant to the applicable NAICS code 541715.

GENERIC MARKETING BROCHURES/CAPABILITY STATEMENTS WILL NOT BE EVALUATED.

Please submit one (1) electronic copy of your response via e-mail to Shaun Rostad, at shaun.rostad@nih.gov and one Josh Lazarus, at josh.lazarus@nih.gov in MS Word (doc, docx) or Adobe Portable Document Format (PDF). The e-mail subject line must specify 75N98026R00144SB. You are encouraged to limit your response to fewer than 20 pages.

ALL RESPONSES ARE DUE BY 1:00 PM EASTERN STANDARD TIME ON September 14, 2026.

Commerciality Determination:

The Government has reviewed the requirement described herein and, based on the nature of the work — which includes medicinal chemistry services such as structure activity relationship (SAR) analysis and design, synthesis, in vitro absorption, distribution, metabolism, excretion and toxicology (ADMET) studies, computational chemistry/Computer-Aided Drug Discovery (CADD), and compound logistics in support of preclinical drug discovery — has preliminarily determined that this requirement is not commercial in nature as defined under FAR Part 2.101 and FAR Part 12. Accordingly, the Government does not intend to solicit this requirement using FAR Part 12 procedures for the acquisition of commercial products and commercial services.

The Government's preliminary assessment is that the services required constitute research and development (R&D) and/or non-commercial services that are not customarily provided to the general public and/or the private sector on an unrestricted basis under similar terms and conditions, and therefore do not meet the definition of a "commercial product" or "commercial service" under FAR 2.101.

Request for Vendor Feedback: Notwithstanding the Government's preliminary determination, interested vendors who believe that some or all of the work described in this requirement is, in fact, commercial in nature — including services of a type offered to the general public and/or non-governmental entities under similar terms and conditions — are strongly encouraged to identify this in their response to this Sources Sought Notice. Vendors asserting that the requirement (or any portion thereof) is commercial should provide supporting rationale, including:

1. Identification of the specific portion(s) of the requirement believed to be commercial;
2. Evidence that the services are offered and sold competitively, in substantial quantities, to the general public and/or non-governmental entities, based on established catalog or market prices, in accordance with FAR 2.101;
3. Examples of similar contracts, purchase orders, or engagements with commercial (non-governmental) customers for substantially the same services, including pricing information if available; and
4. Any other information that may assist the Government in making a final determination regarding the commercial nature of this requirement.

This information will assist the Government in determining the appropriate acquisition strategy, including whether FAR Part 12 procedures are applicable to this procurement. All feedback received will be considered in refining the requirement and the resulting solicitation, if issued.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. 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 presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality:

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).”

Closing Statement:

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N98026R00144. Responses must be submitted Shaun Rostad, at shaun.rostad@nih.gov and one Josh Lazarus, at josh.lazarus@nih.gov. Mail and fax responses will not be accepted.