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-19-2006, titled "CRO Support for NCATS Medicinal Chemistry for Lead Optimization," via FedBizOpps on or about November 21, 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 identifying preclinical drug candidates with improved efficacy, optimized ADME properties, and minimal predicted toxicity.

One of the DPI program requirements is to efficiently identify preclinical development candidates for rare and neglected diseases. To accomplish this endeavor, DPI has a need for a team of chemists; pharmacologists; absorption, distribution, metabolism, and excretion (ADME)/pharmacokinetics (PK) experts; and toxicologists working closely together to perform medicinal chemistry lead optimization.

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 November 21, 2018. Proposals will be due 45 calendar days following release of the RFP.

The Government anticipates making multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract awards -with the eventual contracts being administered and funded via Task Orders (TOs). 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 proposals that are 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 fourth quarter of FY2019.

ABOUT DPI AND NCATS

The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) 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 Investigational New Drug (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 research and development (R&D) operational strategy is to combine the capabilities of DPI in-house staff and DPI partners, who may be the drug riginators. Each drug program operates in a multi-disciplinary, multi-partnership matrix team environment, and a DPI program officer 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

NCATS Section
NIDA Office of Acquisition, NIH
6001 Executive Blvd
Suite 3287, MSC 9534
Bethesda, MD 20892-9534 *

* Use Rockville, MD 20852 for FedEx/USPS/Courier/Hand Delivery