SOLICITATION NOTICE
A -- CRO Support for NCATS Drug Product Development, Manufacture, and Stability Studies
- Notice Date
- 7/21/2016
- Notice Type
- Presolicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 3155, MSC 9593, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- N01TR-17-2003
- Point of Contact
- Jeffrey Schmidt, Phone: (301) 402-1488, Lisa V. Bielen, Phone: (301) 451-7167
- E-Mail Address
-
schmidtjr@mail.nih.gov, lisa.bielen@nih.gov
(schmidtjr@mail.nih.gov, lisa.bielen@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is not a Request for Proposals (RFP). This is a Pre-solicitation Announcement only. RFP No. N01TR-17-2003, titled "CRO Support for NCATS Drug Product Development, Manufacture, and Stability Studies," will be issued via fedbizopps on or about August 7, 2016. The Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Science (NCATS) conducts translational research in the area of 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). For certain drug development programs, DPI will support its candidate's development up to human Phase IIB studies if and when determined by DPI management team as necessary to achieve DPI's mission. 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 technical areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program. Approximately one-half of ongoing and recently completed TRND and BrIDGs projects involved compounds to be administered by routes that require sterile dosage forms (e.g. intravenous, subcutaneous, intramuscular, inhalation of atomized solutions, and ophthalmic drop applications). The remaining projects involved the development of solid oral dosage forms, primarily capsules. In addition to these sterile and solid dosage forms, and because a number of TRND projects explore treatment of certain genetic conditions that initially present in young children, future projects may involve the development of orally administered solutions or suspensions. The objective of this contract is to support the DPI drug development programs by providing services related to the development, manufacture, and conduct of stability studies for non-sterile and sterile pharmaceutical dosage forms. To accomplish this objective and ensure adequate CRO and CMO support is provided to DPI, and out of a recognition that it is unlikely that a sufficient number of contractors will have capabilities for both sterile and non-sterile dosage forms, this solicitation is divided into three technical areas. Technical Area 1: Administrative Reporting Requirements sets forth the required services for the overall administration of the contract. Technical Area 2: Non-Sterile Dosage Forms sets forth the anticipated activities related to the development, manufacture, and stability studies for non-sterile drug products. Technical Area 3: Sterile Dosage Forms sets forth the anticipated activities related to the development, manufacture, and stability studies for sterile drug products. To qualify for award, organizations must have capabilities in Technical Area 1 and at least one other technical area. If an organization has capabilities in Technical Area 2 and Technical Area 3 and wishes to be considered for award under those technical Areas, the organization must respond fully to all three technical areas. The Government anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts under this solicitation. The ultimate goal of DPI and this planned project is to bring new drugs to market. To this end, the Government will seek 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 will enable DPI contributors to retain control of their intellectual property, 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. 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 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. Contracting Office Address: NINDS R&D Contracts Management Branch NCATS Section 6001 Executive Boulevard Suite 3287, MSC 9531 Bethesda, Maryland 20892-9531* *Use Rockville, MD 20852 for Fed-Ex/USPS/Courier/Hand-Delivery
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N01TR-17-2003/listing.html)
- Record
- SN04191827-W 20160723/160721235953-d3fcc49a49d705ef8947ecef4b31f9ee (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |