Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances

Notice Type:                       Presolicitation

Pre-Solicitation Number:      PS75N95024R00094

Project Title:                      Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances

Classification Code:         A – Research & Development

NAICS Code:                       325411 Medicinal and Botanical Manufacturing

SUMMARY:

This is a notice of a proposed contract action issued in accordance with FAR 5.203(a). The Government intends to issue RFP No. 75N95024R00094, titled “Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances via SAM.Gov on or about October 4, 2024.

REQUIREMENT AND TYPE OF SERVICE

The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research in the area of human therapeutics development.

The scope of this contract is for Chemistry, Manufacturing, and Control (CMC) services for drug substances. The objective of these support services is to ensure DPI receives Drug Substance (DS) of sufficient quality and quantity to support preclinical and IND-enabling studies.  For detailed information, see Attachment 1-Statement of Work.

The Contractor shall provide support for a broad range of preclinical services required for the design, development, manufacture, and release of DS, including precursors, preliminary states, Reference Standards (RS) and all required testing. All activities preliminary to manufacturing in accordance with current Good Manufacturing Practice (cGMP) may be required, even without an associated cGMP manufacturing task. These include, but are not limited to, process development and process robustness studies, development or engineering lots, and formulation studies. All activities necessary to maintain material in a usable state, including storage, shipping, testing (in process, release, stability, and quality actions), and preparation of documents to support regulatory submissions may also be required.

While this contract will be primarily in support of the DPI drug development programs, this contract may include support for a range of NCATS activities differing in size, complexity, and duration.

RELEASE OF SOLICITATION

The Government intends to issue a Request for Proposals on or about October 4, 2024. All information required for the submission of a proposal will be contained in or accessible through the RFP package.

The Government anticipates making multiple, seven-year, Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract awards —with the eventual contracts being administered and funded via Task Orders (TO). The Government may award either cost reimbursement and/or fixed price task orders under this contract.  The Government anticipates that at least one task order will be awarded at the time of award. The Government also anticipates the use of Options to Extend the Period of Performance and Options for Increased Quantities negotiated and established at the individual task order level.  Each task order shall be individually negotiated at the time of evaluation, prior to award.

The ultimate goal of DPI and this planned project is to bring new drugs to market.  To this end, the Government has issued a Determination of Exceptional Circumstances (DEC) to deviate from the Federal Acquisition Regulation clauses at 52.227-11 Patent Rights and 52.227-14 Rights in Data.  The deviated language enables DPI contributors to retain control of their intellectual property and will be included in the RFP and incorporated in any resultant contract.  Prospective Offerors are advised that agreement to the terms of these FAR clause deviations will be a condition for contract award.

The Government will select the proposal that is most advantageous to the Government in accordance with the basis of award included in the solicitation.

The Government anticipates awards will be made in the second quarter of FY2025.

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 or organizations may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 30 days of this notice.

THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. This advertisement does not commit the Government to award a contract.

ABOUT DPI AND NCATS

The Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Sciences (NCATS) conducts translational research in human therapeutics development and aims to move small molecule and biologic drug candidates forward in the drug development pipeline to predetermined milestones, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients.

In addition to developing new candidate drugs, DPI seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial pre-clinical stage of drug development. DPI’s model is to operate as a full range small molecule and biologics drug development organization, moving drug candidates through each phase of the pre-clinical drug development process until an IND is filed with the US Food and Drug Administration (FDA).

DPI conducts drug development as collaborations through programs such as the Therapeutics for Rare and Neglected Diseases (TRND) and the Bridging Interventional Development Gaps (BrIDGs) programs. DPI drug development programs originate from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes, and its R&D operational strategy is to combine the capabilities of DPI in-house staff and DPI partners, who may be the drug originators. Each drug program operates in a multi-disciplinary, multi-partnership matrix team environment, and a DPI program officer (PO) is responsible for the overall planning, execution, and reporting of the program.

Contract research organizations (CROs) and contract manufacturing organizations (CMOs) provide DPI with manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to assist with drug development. Planning and execution of each individual drug development program includes identification of scientific areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program.

CONTRACTING OFFICE ADDRESS:

National Institutes of Health

National Institute on Drug Abuse (NIDA), Office of Acquisition

C/O NIH Mail Center

NIDA 3WFN MSC 6023

16071 Industrial Drive

Gaithersburg, MD  20877 (20892 for USPS)

Primary Point of Contact:

Samson Shifaraw

Contract Specialist

Samson.shifaraw@nih.gov

Phone: 301-480-7153

Secondary Point of Contract:

Valerie Whipple

Contracting Officer

valerie.whipple@nih.gov

phone: 301-827-5218