CPSA Digest 2001

Proceedings -Thursday, October 11, 2001

ThOB3

Mechanisms, Resources and Opportunities for Collaboration in the Development of Therapeutics

Background
The Technology Transfer Branch (TTB), a part of the National Cancer Institute, makes it easy for industry and academia to interact and partner with National Institutes of Health laboratories and scientists. TTB provides a complete array of services to support the National Cancer Institute's technology development activities. To ensure that these activities comply with Federal statutes, regulations and the policies of the National Institutes of Health, a large part of TTB's responsibilities includes the day-to-day negotiations of transactional agreements between the NCI and outside parties. These parties may be universities, pharmaceutical companies and biotechnology companies.

The agreements arranged between NCI and other parties provide for: 1. The exchange of research materials under a Simple Letter of Agreement (SLA) 2. Collaborative research conducted under cooperative research and development agreements (CRADAs) 3. Preclinical and clinical studies of the safety and efficacy of new pharmaceuticals under clinical trial agreements (CTAs) 4. Exchange of confidential information under confidential disclosure agreements (CDAs)

TTB also reviews employee invention reports, generates patentability reports and makes recommendations to the NIH's Office of Technology Transfer (OTT) concerning filing of domestic and foreign patent applications. The NCI TTB staff participates in meetings, discussions and conferences, as appropriate, to stay apprised of and monitor the scientists' needs. In addition, the NCI TTB staff negotiates and secures execution of license agreements for information technology products under authority of the National Cancer Act. The TTB conducts trademark registration and licensing for the Public Health Service.

TTB Mission Statement:

1. Serves as the Institute focal point for the implementation of pertinent legislation, rules and regulations, and the administration of activities relating to collaborative agreements, inventions, patents, royalties and associated matters;
2. Provides advice, guidance, and assistance to Institute staff on such things as the development and management of intellectual property; registration and management of patents; terms and negotiation of licensing and collaborative agreements; management and administration of royalties; transfer of research materials; interpretation of laws, policies, rules and regulations especially those related to the implementation of the Federal Technology Transfer Act of 1986 and other related matters;
3. Proposes and implements innovative business and commercial development strategies and partnerships for Institute technology;
4. Proposes and assists in the development of Institute policy and prepares and disseminates operating procedures and guidelines for Institute staff on matters related to the areas of responsibility assigned to the Branch;
5. Reviews and analyzes planned collaborative agreements to ensure that they are in accord with applicable NCI, NIH, and DHHS policy and procedures;
6. Prepares or coordinates the preparation of regular and special reports on matters falling within the purview of the Branch; and
7. Serves as liaison with individuals, committees, and organizations within and outside the Federal Government who are interested or involved in matters relating to the Branch's assigned areas of responsibility;
8. Serves as the technology transfer service center for a number of NIH ICDs.

Many examples of collaborations and CRADAs were presented. As an example, consider hydrophobic, endothelium-mimic, polymer films containing nitric oxide (NO) releasing (10-72h) Diazeniumdiolate functions. Hexanediamine analogs are dispersed in poly(vinylchloride) or polyurethane matrices. A piperazine analog is covalently attached to the PVC backbone. An ion-paired diazeniumdiolated heparin species is transformed into an organic soluble complex blended into PVC. The main advantage of this polymer coating is that nitric oxide prevents platelet adhesion/activation and coagulation and promotes vasodilatation; unwanted systemic anticoagulant effects are avoided. A potential area of application is to prevent thrombus formation at polymer surfaces of biomedical devices that contact blood. Currently, this project has demonstrated resistance to thrombus formation in vivo in dogs, ex vivo in rabbits, and in numerous in vitro systems. Applications are being sought for a variety of products such as vascular graft, shunts, extracorporeal tubing and implants.

Links and Resources

NCI-Technology Transfer Branch

NCI-Developmental therapeutics program resources


K.A. Mowery and L. Keefer et al., Biomaterials 21: 9-21 (2000).

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