Medicinal Chemistry Support Program for Therapeutic Development

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541715 with a small business size standard of 1,000 employees

REGULATORY AUTHORITY

The resultant modification will include all applicable provisions and clauses of the Revolutionary FAR Overhaul (RFO) Initiative, in accordance with Executive Order 14275 and OMB Memorandum M-25-26.

STATUTORY AUTHORITY

This modification is conducted under the authority of 41 U.S.C. 3304(a)(1) and in accordance with RFO 6.103-1 Only one responsible source and no other supplies or services will satisfy agency requirements..

DESCRIPTION

Background
Since 2011, The National Institute on Neurological Disorders and Stroke (NINDS) and the NIH Blueprint Neurotherapeutics Network (BPN) https://www.ninds.nih.gov/current-research/trans-agency-activities/nih-blueprint-neuroscience-research/bpn-small-molecules has established a virtual pharma network of contract service providers and consultants with extensive industry experience to enable small molecule, peptide and biologic therapeutics discovery and development in the NIH community. The contract is primary objective is for the development of therapeutics within the mission of NINDS, BPN and other NIH Institutes. This full-service facility and staff supports a range of medicinal chemistry services including SAR analysis and design, synthesis, in vitro ADMET, computational chemistry/Computer Aided Drug Discovery (CADD) and compound logistics of storage and shipping. The Network, similar NINDS and NIH programs offer researchers access to a range of industry-standard services and expertise including full service medicinal chemistry services, Pharmacokinetics/toxicology, drug manufacturing and formulation and Phase I clinical testing.

The term neurotherapeutics includes therapies targeted to indications due to disorders of the central and/or peripheral nervous system, and shall include 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 through the NINDS including the Blueprint Neurotherapeutics Network (BPN) and other Institutes or Centers (ICs). Although the NINDS focus is on neurotherapeutics, it is envisioned the other ICs may on occasion access this contract for small molecule therapeutics other than neurotherapeutics. The data generated from this contract will be used by NINDS, contributors or sponsored investigators in support of IND directed preclinical activities. The results of the efforts of this contract will be the basis to advance preclinical candidate compounds for further development i.e., advanced PK and toxicological evaluation in preparation of IND filings.

Goals and Objectives

The scope of this contract is for 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, NINOS and its contributors. The work may include any individual service or combinations of services described (e.g. Synthesis, CADD, ADMET individually or in combination).

The Contractor must have the capacity to continue its work on existing and ongoing projects simultaneously in the three chemistry stages as outlined below (exploratory, hit-to-lead, lead optimization). The Contractor must also be able to rapidly scale up or down the number of staff dedicated to the contract, depending on the number of projects underway at any given time. The contract includes two performance areas:

1. Performance Area 1: Tech Transfer, Storage Handling and Distribution, Access Training and IT Security Relevant to Existing Compound Repository. Under this Performance Area, the Contractor shall perform all activities related to the overall administration and implementation of the medicinal chemistry support services including but not limited to the setup for project management, overall contract management, technical preparedness and support, communications and submission of deliverables under the contract and the ongoing delivery of project reports and compound management logistics.
2. Performance Area 2: Medicinal Chemistry Support. Under this Performance Area 2, independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed for Medicinal Chemistry Planning, Synthesis, Isolation, Characterization which may include:
   1. Project planning
   2. Project management
   3. Design, procurement, and milligram-scale synthesis of chemical analogs
   4. Multi-gram and scale-up synthesis for testing in animal models
   5. In vitro ADME and toxicology testing for lead optimization
   6. Compound registration and data entry
   7. Communication (teleconferences, minutes, written updates)

Period of Performance

The IDIQ contract proposed for modification has an ordering period of March 16, 2018 to March 15, 2028 which remains unchanged.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals and the Government is not committed to award a contract pursuant to this announcement.  However, interested parties may respond by identifying their interest, submitting capability statements, and or submitting objections to the proposed contract modification.  The Government will consider responses; however, a determination by the Government to proceed with the proposed contract modification is solely within the discretion of the Government.

Any potential offeror must have an active registration in the System for Award Management (SAM) www.sam.gov. In addition, the Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response.

A determination by the Government not to compete this proposed modification based upon responses to this notice is solely within the discretion of the Government.  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.

Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.

All responses must be received by 1:00 p.m. Eastern Daylight Time, Thursday, June 4, 2026, and reference notice number HHSN271201800001I.  Responses must be submitted electronically to Shaun Rostad, Contract Specialist, at [email protected].  Fax responses will not be accepted.

Contracting Office Address:
National Institutes of Health

Office of Acquisitions and Logistics Management (OALM)

6701 Rockledge Dr, RK2 RM 409-K

Bethesda, MD 20817-7786

All responsible sources may submit a capability statement which shall be considered by the agency.