CRO Support for NCATS Animal Model Development and In Vivo Pharmacology Studies and Related Services

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. N01TR-19-2005, titled "CRO Support for NCATS Animal Model Development and In Vivo Pharmacology Studies and Related Services," via FedBizOpps on or about March 30, 2018.

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 objective of this contract is to support the DPI drug development programs by providing services related to the development of animal models and the execution of in vivo pharmacology and related studies, including the use of relevant supporting services needed to accomplish requested tasks.
The DPI program requires confirmation and verification of the efficacy of development compounds in an acceptable animal model of the disease. To accomplish this endeavor, DPI has a need for novel, re-developed, optimized, or use of existing, validated animal models to conduct in vivo pharmacology studies for rare disorders and neglected diseases. These models are not able to be pre-determined as needs change depending on the disease; as such, access to both small (e.g., mice, rat) and large (e.g., dog, cat, monkey, pig) models are needed. In addition, therapies can cover a wide range of modalities, small molecules, and biologics (e.g. antibody, proteins, and cell and gene therapy).
While this contract will be primarily in support of the DPI drug development programs. The Government reserves the right to allow other drug development programs at NIH to solicit task order proposals. As such, this contract is not limited to rare or neglected disorders.
RELEASE OF SOLICITATION

The Government intends to issue a Request for Proposals on or about March 30, 2018. Proposals will be due 45 calendar days following release of the RFP.

The Government anticipates making single Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract awards -with the eventual contract being administered and funded via Task Orders (TO).
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 clauses deviations will be a condition for contract award.

This is a new requirement; therefore, no incumbent information is provided. 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 first quarter of FY2019.

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 Center for Advancing Translational Sciences
NINDS R&D Contracts Management Branch
6001 Executive Blvd
Suite 3287, MSC 9531
Bethesda, MD 20892-9531*
*Use Rockville, MD 20852 for FedEx/USPS/Courier/Hand Delivery

Primary Point of Contact:

Jessica Adams
Contract Specialist
jessica.adams@nih.gov
Phone: 301-443-8761

Secondary Point of Contract:

Jeffrey R. Schmidt
Contracting Officer
schmidtjr@mail.nih.gov
phone: 301-402-1488