SPECIAL NOTICE
A -- Preclinical Drug Development Services for the NIH Center for Translational Therapeutics (NCTT), National Center for Advancing Translational Sciences (NCATS)
- Notice Date
- 5/2/2012
- Notice Type
- Special Notice
- 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
- NHLBI-CSB-RFC-TR-2013-19-KB
- Archive Date
- 6/18/2012
- Point of Contact
- Kelli T Broda, Phone: 301-435-0332, Lynn M Furtaw, Phone: 301-435-0357
- E-Mail Address
-
brodak@mail.nih.gov, lynn.furtaw@nih.gov
(brodak@mail.nih.gov, lynn.furtaw@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- REQUEST FOR COMMMENTS ON THE PROPOSED USE OF A DETERMINATION OF EXCEPTIONAL CIRCUMSTANCES (DEC) for the Preclinical Drug Development Services for the NIH Center for Translational Therapeutics (NCTT), National Center for Advancing Translational Sciences (NCATS) SUMMARY: The National Center for Advancing Translational Sciences (NCATS) is seeking public comment on a proposed use of a Determination of Exceptional Circumstances (DEC), as provided for under the Bayh-Dole Act, for its Preclinical Drug Development Services Program. BACKGROUND: To carry out the NIH mission of promoting “Science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability,” the NCATS organizationally located within NIH conducts translational research in the area of human therapeutics development. The NCATS Division of Pre-clinical Innovation (DPI) aims to help bridge the gap in investment in early development phases for new drugs to help patient populations with unmet medical needs. Currently, NCATS DPI has two programs, 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. NCATS may create additional programs needing pre-clinical drug developments services in the future. Through the BrIDGs program (formerly the NIH RAID Program), NIH makes available, on a competitive basis, certain critical resources needed for the development of new therapeutic agents. It is intended to advance promising therapies into the clinic by providing in-kind services to overcome late stage preclinical therapy development obstacles. The TRND program’s goal is to encourage and speed the development of new drugs for rare and neglected tropical diseases. This program is specifically intended to stimulate drug discovery and development research collaborations between NIH and academic scientists, non-profit organizations, and pharmaceutical and biotechnology companies working on rare and neglected illnesses. The TRND program provides an opportunity to partner with and gain access to rare and neglected tropical disease drug development capabilities, expertise, and clinical/regulatory resources in a collaborative environment with the goal of moving promising therapeutics into human clinical trials. TRND uses an application and evaluation process to select collaborators. Selected TRND collaborators/contributors will provide their proprietary drugs, drug manufacturing process and development platforms and disease expertise throughout the project. NCATS through its internal resource, contracts and subcontracts will provide screening, lead optimization, preclinical development and product development of a contributor’s proprietary Materials, as needed. NCATS’ experience has shown that many owners of candidate Material and/or Technology, particularly in the commercial sector, will refuse to submit their Material and/or Technology for screening, lead optimization, preclinical development and product development where there is a risk that Government contractors will obtain rights to Subject Inventions relating to the Material and/or Technology. Material and/or Technology owners have argued forcefully that the risk of losing rights in patents that would effectively block the commercialization of their own proprietary Material and/or Technology, in which they have invested considerable resources to develop and upon which their very viability as a business is dependent, is not acceptable. The projects undertaken by the TRND and BrIDGs Programs will most likely generate new inventions. The Bayh-Dole Act establishes the rights and obligations of grantees and contractors to Subject Inventions-inventions that are conceived or first actually reduced to practice in the performance of work under a funding agreement by the Federal Government. One of the goals of the Bayh-Dole Act is to incentivize the commercialization of Government-supported Subject Inventions. Under the Bayh-Dole Act, Government contractors generally retain the right to elect title to inventions made by its researchers as a result of their work performed under a Government-supported agreement. A Determination of Exceptional Circumstances (DEC) to the Bayh-Dole Act directs ownership of inventions made by the funding recipient to the Government or other party. Thus, without a Determination of Exceptional Circumstances, the NCATS contracted medicinal chemists, screening facilities, contract research organizations and other services would retain the right to elect title/ownership of inventions to all new proprietary therapeutics intellectual property that they develop under an agreement with NCATS. In order to ensure those pharmaceutical companies, biotech companies, small businesses, academic institutions, and others will collaborate with NCATS in order to help in identifying, testing, developing, and commercializing new therapeutics, diagnostics, prognostics and prophylactic measures against human diseases, NCATS has determined that exceptional circumstances exist, as described above, and that the Contractor’s and subcontractor’s rights (at all tiers) in subject inventions should be limited accordingly. Because the TRND and BrIDGs Programs will be helping move a Provider’s proprietary intellectual property, including Materials and Methods through the drug development pipeline, this DEC will better ensure Provider’s ability to promote the commercialization and therefore public availability of these inventions without unduly encumbering future research and discovery by the contractor. Discussions with potential TRND and BrIDGs Contributors and Contractors suggest that allowing the Contractors to retain ownership to any newly developed proprietary therapeutics intellectual property would actually impede the further development and commercialization of new drugs. In order to develop good lead therapeutics, the TRND and BrIDGs Program must attract promising, high quality drug development projects including starting therapeutics. Potential Contributors have consistently informed NCATS that they would participate in TRND and BrIDGs only if they could be assured full ownership of patent rights to all analogs generated from their starting therapeutics as well as any novel processes to scale up the therapeutics. PROPOSED IP STRATEGY: For the Preclinical Drug Development Services Program, the NCATS is considering a Determination of Exceptional Circumstances (DEC), as provided for under the Bayh-Dole Act. The DEC would cover two classes of Subject Inventions: Class 1: Subject Inventions that require the use of, improve, or incorporate any Material and Subject Inventions that are methods of manufacturing or synthesis of a Material. If the Contributor declines offer of assignment, then NCATS may dispose of the invention rights as NCATS determines would be in the best interests of the program and public health (e.g., allow Contractor to retain invention rights). Class 2: Subject Inventions that do not fall into Class 1 above. Rights to all other Subject Inventions will be retained by the Contractor pursuant to the Bayh-Dole Act. RESPONSES: The NCATS invites comments on this strategy and use of a DEC for the Preclinical Drug Development Services Program. Alternative strategies that will support the development and encourage the contribution of novel therapeutics to the program will be considered before a final determination is made regarding the use of a DEC. Please submit your comments to the attention of Kelli Broda, Contract Specialist, at the address below by 4:00 PM Local Time on May 17, 2012. Office of Acquisitions, DERA, NHLBI 6701 Rockledge Drive, RKLG II, Room 6100 Bethesda, MD 20817 Electronic submittal will also be accepted at the following email address: brodak@mail.nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-RFC-TR-2013-19-KB/listing.html)
- Place of Performance
- Address: N/A, United States
- Record
- SN02737063-W 20120504/120502235403-4c78cc3b9fd7d503ff94b9ff39c16812 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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