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

Notice Type:                     Pre-Solicitation

Solicitation Number:        PS75N95023R00037

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

Classification Code:         AN12 - Health R&D  Services; Health care services; Applied Research

NAICS Code:                   325412 -  Pharmaceutical Preparation 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. 75N95023R00037, titled “CHEMISTRY MANUFACTURING AND CONTROLS AND RELATED SERVICES FOR  DEVELOPMENT OF DRUG PRODUCTS,” via SAM.Gov on or about June 14, 2023.

REQUIREMENT AND TYPE OF SERVICE

The Therapeutic Development Branch (TDB) within 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 Products. The objective of these support services is to ensure receipt of formulated Drug Product (DP) of sufficient quality and quantity to support preclinical,  IND-enabling and clinical studies. 

The Contractor shall provide support for a broad range of preclinical services required for the design, development, manufacture, and release of DP, and release of DP as Clinical Trial Material (CTM), including precursors, preliminary states, Reference Standards (RS) and all required testing. Ancillary products (e.g., placebos, diluents, adjuvants, master cell banks, testing standards, reference materials) and other materials manufactured or purchased to support clinical trials or CMC activities may also be required. All activities preliminary to manufacturing in accordance with current Good Manufacturing Practice (cGMP) may be required (e.g., development or engineering lots, formulation studies), even without an associated cGMP manufacturing task. All activities required 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.

Product formats may include small molecules, short oligomeric compounds, biological (large) molecules, quaternary molecular assemblies (homogenous or heterogenous), vectors for gene therapy, nanoparticles, and any  of the above modified genetically, biologically, or chemically. Novel formats  identified after this draft might also be needed. Formats could also include Devices or Combination Products.

The breadth of this Statement of Work (SOW) includes capabilities to support a range of activities differing in size, complexity, and duration.

RELEASE OF SOLICITATION

The Government intends to issue a Request for Proposals on or about June 14, 2023. Proposals will be due 45 calendar days following release of the RFP. 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 FY2024.

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 15 days of this notice.

This advertisement does not commit the Government to award a contract.

ABOUT TDB, DPI AND NCATS

The Therapeutic Development Branch (TDB) within 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, TDB will hand off the drug candidate to external partner(s) to bring the novel therapy to patients.

In addition to developing new candidate drugs, TDB 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 preclinical stage of drug development. The TDB model is to operate as a comprehensive small molecule and biologics drug development organization, moving therapeutic candidates through each phase of the preclinical development process until an Investigational New Drug (IND) application is filed with the US Food and Drug Administration (FDA).

TDB conducts drug development through collaborations, with therapeutic candidates originating from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes. TDB’s operational strategy is to combine the capabilities of in-house staff and collaborative partners, who may be the drug originators, with complementary support from contract research organizations (CROs). Each development program operates in a multi-disciplinary matrix team environment, with a DPI project officer (PO) responsible for overall planning, execution, and reporting.

Contract research organizations (CROs) and contract manufacturing organizations (CMOs) provide TDB 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:

Michelle Cecilia

Contract Specialist

Michelle.Cecilia@nih.gov

Phone: 301-8727-7199

Secondary Point of Contract:

Valerie Whipple

Contracting Officer

valerie.whipple@nih.gov

Phone: 301-827-5218