Partnering with NHLBI and Office of Technology Transfer and Development Client Institutes
As agencies of the Federal government, NHLBI and the Office of Technology Transfer and Development (OTTAD)’s client Institutes do not directly commercialize their discoveries. Because of that, OTTAD works proactively to facilitate partnerships with outside organizations, with the ultimate goal of benefitting public health in a variety of basic, translational, and clinical areas.
OTTAD’s Client Institutes
OTTAD assists the following NIH institutes in their technology transfer efforts:
The National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The NIAAA supports and conducts research on the impact of alcohol use on human health and well-being. This is done across a wide range of scientific areas, including genetics, neuroscience, epidemiology, prevention, and treatment. Researchers in NIAAA‘s Division of Intramural Clinical and Basic Research (DICBR) seek to unravel the biological basis of alcohol use disorder and related problems and develop new strategies for treatment and prevention.
OTTAD Point of Contact: Peg Koelble M.S.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The basic and clinical scientists of the NIAMS conduct research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases and then disseminate their research discoveries in these diseases to the R&D community.
The National Institute of Biomedical Imaging and Bioengineering (NIBIB)
The NIBIB develops and accelerates the development of new biomedical imaging and bioengineering techniques and devices to improve the detection, treatment, and prevention of disease.
OTTAD Point of Contact: Michael Davis, Ph.D., J.D.
The National Institute on Deafness and Other Communication Disorders (NIDCD)
The NIDCD conducts and supports research on disorders of hearing and other communication processes, including diseases affecting hearing, balance, smell, taste, voice, speech, and language.
OTTAD Point of Contact: Brian Bailey, Ph.D.
The National Institute of Environmental Health Sciences (NIEHS)
The NIEHS supports a wide range of research and health initiatives that address how environmental exposures contribute to human illnesses. These initiatives lead to the development of prevention strategies, health and safety guidelines, and potential treatments for asthma, cardiovascular disease, cancer, and other environmental-related diseases.
OTTAD Point of Contact: Peg Koelble M.S.
The National Institute of Nursing Research (NINR)
The NINR promotes and improves the health of individuals, families, communities, and populations by supporting and conducting clinical and basic research on health and illness across the lifespan.
OTTAD Point of Contact: Vincent Kolesnitchenko, Ph.D.
OTTAD works closely with these Institutes to provide a full range of technology transfer services, including expertise in the negotiation of a variety of technology transfer-related agreements, the promotion of technology, and the general management of intellectual property development and protection.
Mechanisms for PARTNERING with NHLBI and OTTAD’s Client Institutes
A variety of mechanisms exist that allow the NHLBI and OTTAD’s client Institutes to collaborate with external partners for research and development purposes. The most appropriate mechanism will be determined by the type of partner that the NHLBI or OTTAD’s client Institutes will be working with, as well as the specific research project to be done.
OTTAD assists the following NIH institutes in their technology transfer efforts by closely working with and providing them with a full range of services, including expertise in the negotiation of a variety of technology transfer-related agreements, the promotion of technology, as well as the general management of intellectual property development and protection.
For external partners interested in exchanging research materials with an NIH scientist, a Material Transfer Agreement (MTA) may be used to memorialize the transfer. If confidential or proprietary information is to be exchanged, a Confidential Disclosure Agreement (CDA) may be used to limit the public release of confidential information and mitigate the inappropriate use of such information. For research collaborations, a Research Collaboration Agreement (RCA) provides the advantages of a CDA and an MTA, such that collaborators may freely exchange proprietary materials, data, and information.
Collaborations with external partners in the private sector can be far more complex. A for-profit corporation may desire to obtain rights that will allow them to exclusively or nonexclusively license inventions made during the course of the research. A Cooperative Research and Development Agreement (CRADA) allows NIH to offer the collaborator a first option to license inventions made in NIH laboratories during the performance of, and within the scope of, the CRADA’s research plan. Additionally, CRADAs allow the collaborator to provide funds to NIH that directly support the CRADA’s research. In contrast, the RCA provides faster entry into a collaborative research project with an NIH investigator, but does not offer a first option to license inventions made during the project, and does not permit the intake of outside funding for use in covering expenses directly related to the collaboration. Several variations of CRADAs allow both the transfer of proprietary materials in the absence of substantial involvement of the external partner (Materials-CRADA), and co-development within clinical trials (Clinical Trial-CRADA).
NHLBI and OTTAD’s client Institutes also collaborate with external partners to perform clinical trials for the development of new methods of treatment. A Clinical Trial Agreement (CTA) is designed to address the unique demands that come with performing clinical research on patients. A CTA defines who will perform the trials, who is responsible for providing the drug or other materials needed, as well as detailed terms assigning responsibility for complying with Federal regulations on protecting human subjects.
All agreements discussed above must be reviewed by OTTAD prior to signature, and must be signed by a designated Authorizing Official of the NHLBI or OTTAD’s client Institutes.
Deciding which type of agreement to use can be a challenge. Therefore, for those who are interested in partnering with the NHLBI or any of OTTAD’s client Institutes to engage in research of mutual benefit, OTTAD highly recommends having a discussion with one of its Technology Development Specialists to determine which agreement is best suited for the type of partnership desired.