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FBO DAILY ISSUE OF JULY 11, 2012 FBO #3882
SOLICITATION NOTICE

A -- Preclinical Drug Development Services for the Division of Preclinical Innovation (DPI), National Center for Advancing Translational Sciences (NCATS)

Notice Date

7/9/2012
 

Notice Type

Presolicitation
 

NAICS

541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
 

ZIP Code

20892-7902
 

Solicitation Number

HHS-NIH-NHLBI-CSB-TR-2013-19-KB
 

Archive Date

6/10/2013
 

Point of Contact

Kelli T Broda, Phone: 301-435-0332
 

E-Mail Address

brodak@mail.nih.gov
(brodak@mail.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

The National Heart, Lung, and Blood Institute (NHLBI), on behalf of the Division of Preclinical Innovation (DPI), National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH) has a requirement for preclinical drug development services. It is anticipated that multiple awards will be made under Indefinite Delivery, Indefinite Quantity (IDIQ) task order type contracts for a period of six years. The estimated start date is June 2013. The solicitation will be issued under full and open competition; however, the Government anticipates making 50% of awards to small businesses. The applicable NAICS Code is 541712 and the size standard is 500 employees. BACKGROUND DPI aims to help bridge the gap of time and resources in early development phases for new drugs to treat human diseases. DPI programs that will utilize these services include, but are not limited to, the Therapeutics for Rare and Neglected Diseases (TRND) program and the Bridging Interventional Development Gaps (BrIDGs) program, to assist academic scientists, non-profit organizations, and pharmaceutical and biotechnology companies working on developing novel therapies for unmet medical needs. The DPI business model is to operate as a collaborative partner for small molecule and biologics drug development, generating data that allows drug candidates to move 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). For certain drug development programs, DPI will support its candidate development up to human phase IIB studies if determined by DPI management team as necessary to achieve the mission. DPI drug development programs originate from academia, industry, non-profit foundations, or internally from DPI and other NIH institutes. The DPI R&D operational strategy is to combine the capabilities of in-house staff and partners, who may be the drug originators, to identify technical areas best suited for outsourcing, and utilize contract research organizations (CROs) to conduct some or all parts of a given drug development program. Each drug development program operates in a multi-disciplinary, multi-partnership matrix team environment. DPI programs use the "IND-driven, question-based" drug development approach. A DPI Project Manager is responsible for the overall planning, executing, and reporting of the program. PROJECT REQUIREMENTS The services to be performed under these contracts will only include preclinical drug discovery and development activities. It will not include clinical studies involving human subjects. The required services fall into the following four task areas: (1) Medicinal Chemistry for Lead Optimization, (2) In Vitro Pharmacological profiling and ADME and Toxicology (ADMET) Testing, (3) In vivo DMPK, Toxicology, and Disease Animal Model Development, and (4) Chemistry, Manufacturing, and Control (CMC). DPI intends to make multiple awards for each task area. Offerors may propose services in any one or more task areas. POINT OF CONTACT INFORMATION Kelli Broda, Contract Specialist, Phone (301) 435-0332, Fax (301) 480-3432, E-mail brodak@mail.nih.gov. DISCLAIMER AND IMPORTANT NOTES This is NOT a Request for Proposals (RFP). The RFP will be made available electronically on or about 15 calendar days after the date of this notice. No paper copies will be available. Proposals will be due on or about October 1, 2012. Offerors are responsible for downloading their own copy of the RFP and for routinely checking the internet site for any possible solicitation amendments that may be issued by the Government. This advertisement does not commit the Government to award a contract.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-TR-2013-19-KB/listing.html)
 

Place of Performance

Address: 6701 Rockledge Drive, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN02797116-W 20120711/120709234914-c9e88acb872315a706b66d6ce63b138c (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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