National Institutes of Health, National Cancer Institute, Frederick National Laboratory for Cancer Research Opportunities-Special Announcements:

This Special Notice is not a formal Invitation for Bid (IFB), Request for Proposal (RFP), Request for Quotation (RFQ) nor any type of solicitation for offers. In accordance with FAR 15.201(d), this special notice is intended FOR INFORMATIONAL PURPOSES ONLY in order to: 1) publicize the requirements of the Frederick National Laboratory for Cancer Research (FNLCR); and 2) increase participation by qualified HUBZone small business, small, small disadvantaged, women-owned small business, veteran-owned small business and service-disabled veteran-owned small business concerns, as applicable.

The FNLCR is a Government-Owned Contractor-Operated (GOCO) Federally Funded Research and Development Center (FFRDC) located at Fort Detrick, Maryland. The FNLCR partners with university, government, and corporate scientists to speed the translation of laboratory research into new diagnostic tests and treatments for cancer and AIDS. FNLCR is a multi-program laboratory currently operated by Leidos Biomedical Research Inc. for the National Cancer Institute (NCI) under Prime Contract No. HHSN261200800001E, which provides Operations and Technical Support (OTS) for the Frederick National Lab.

The Government assumes no liability for reimbursement for any effort or associated costs to respond, nor for any information provided as a result of this notice as no information is being requested. Please be advised that any submissions provided despite the aforementioned notice that no information is requested become Government property and will not be returned, nor will there be any ensuing discussions or debriefings of any responses.

Responses submitted to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. It is the responsibility of the interested parties to monitor this site and any sites referenced herein for additional information pertaining to business opportunities with the FNLCR, if any.

The solicitation referenced below is issued by Leidos Biomedical Research, Inc. (Leidos Biomed), a wholly owned subsidiary of Leidos Corporation under its prime contract with the National Cancer Institute (NCI) at Frederick.

Leidos Biomed is the Operations and Technical Support Contractor for the operation of the Frederick National Laboratory for Cancer Research (FNLCR) under contract from the National Cancer Institute (NCI). Leidos Biomed is responsible for managing the scientific and administrative aspects of the FNLCR's research endeavors.

Title: Natural Product - Nanotechnology

Project Background and Objectives:
Natural products and their derivatives are active pharmaceutical ingredients (API) in a significant number of Food and Drug Administration (FDA) approved therapeutic oncology products. The development of new therapeutics based on promising natural products often encounters technical roadblocks at late preclinical and early clinical stages, excessive serious toxicities resulting in narrow therapeutic index (low selectivity for diseased tissue), and/or insufficient solubility for preparing formulations of sufficient strength to achieve pharmacologically active tissue levels.

The development of promising therapeutics based on natural products has also been stymied by poor oral bioavailability, poor solubility in biological fluids, and inappropriate pharmacokinetics leading to less than satisfactory efficacy. Nanotechnology-based formulation approaches offer potential for significant (not just incremental) improvements in these properties. The National Cancer Institute (NCI) has identified several promising natural products, which entered development as the active pharmaceutical ingredients of investigational drug products that encountered roadblocks during development - roadblocks that solutions from the field of nanotechnology may be able to address.

The National Cancer Institute (NCI) has established the NCI Alliance for Nanotechnology in Cancer (http://nano.cancer.gov) to harness the power of nanotechnology to reduce the burden of cancer. Several recent developments in the design and fabrication of new nano-constructs and nano-devices show that improved approaches to prevention, diagnosis, and therapy can be realized using nanotechnology. The development of new therapies based on localized nanoparticle delivery is of particular interest to oncology due to the potential for solving developmental roadblocks described above.

NCI's Division of Cancer Treatment & Diagnosis (DCTD) and the NCI Office of Cancer Nanotechnology Research (OCNR) seek to stimulate the strategic conception, creation, initial proof of concept, and small-scale production of prototype nanotechnology preparations of these natural product APIs (API-nanoformulations).

Note that this program is not focused on generating or creating novel nanotechnology products per se, but rather on using existing nanotechnology approaches to reach a Technical Goal by utilizing one specified active pharmaceutical ingredient identified in the Statement of Objectives and thereby overcome a particular developmental roadblock for one of the natural products.

Each nanotechnology formulation of a natural product (API-nanoformulation) proposed should be able to achieve superior therapeutic and/or pharmaceutical performance over the corresponding legacy natural product formulation.

Proposal Submission Deadline: 2:00 PM (EST) on Thursday, October 1, 2015

Contact Details: For a copy of the Solicitation and Draft Leidos Agreement please contact: Kim Iman at [email protected] or 301-228-4033

For information concerning other opportunities with the FNLCR, please refer to: http://ncioa.cancer.gov/oa-internet/sbo/welcome.jsp

Bid Protests Not Available