Technology Transfer and Public-Private Partnerships

Technology Transfer is the process of transferring skills, knowledge, technologies, and methods among governments and universities, as well as non-profit and industry organizations, to make sure that a wider range of users has access to scientific and technological innovations created by FDA scientists. These users can, in turn, develop and use the technology to create new products, processes, applications, materials or services. Legally required under the Bayh-Dole Act (Patent and Trademark Law Amendments Act, Public Law 96-517), the FDA Technology Transfer Program (FTTP) provides services to support the effective transfer of FDA research results and FDA-created technologies to the market in support of public health. These services include evaluating employee invention reports to select the most effective mechanism for bringing the technology to the public, managing the patenting of new discoveries from FDA laboratories, and licensing of novel technologies, biological materials and animal models invented by FDA investigators. The FTTP also selects the appropriate technology transfer agreement type for collaborative research projects between FDA and other parties after carefully considering the goals of the investigators and their collaborator(s), project funding, the specifics of the exchange of materials and data, and the management of publications and intellectual property. Types of agreements include the Cooperative Research and Development Agreement, Research Collaboration Agreement, or Material Transfer Agreement. FDA also engages in scientific Public-Private Partnerships (PPPs) and consortia with other government academic, scientific, patient, and industry organizations to encourage the development of new tools to facilitate innovation in medical product development. An example of a PPP with FDA involvement is The National Institute for Innovation in Manufacturing Pharmaceuticals.

 

 

CROSS-CUTTING TOPICS

Minority Health and Health Equity	Women’s Health	Maternal Health	Pediatric Health
Oncology	Rare Diseases	One Health Initiative

 

EXPLORE THE FOCUS AREAS OF REGULATORY SCIENCE

Advanced Manufacturing	Antimicrobial Resistance	Artificial Intelligence	Biomarkers
Complex Innovative Trial Design	Digital Health Technologies	Empowering Patients and Consumers to Make Better-Informed Decisions	Food Safety
Increasing Access to Complex Generic Drug Products	Individualized Therapeutics and Precision Medicine	Medical Countermeasures and Preparedness for Emerging Infectious Diseases	Microbiome Research
Model-Informed Product Development	Novel Foods and Food Ingredients	Novel Technologies to Improve Predictivity of Non-clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing	Patient and Consumer Preferences and Perspectives
Patient-Reported Outcomes and other Clinical Outcome Assessments	Product Safety Surveillance	Quality of Compounded Drugs	Regenerative Medicine
	Substance Use Disorders	Technologies to Reduce Pathogen Contamination	Use of Real-World Evidence to Support Biologic, Device, and Drug Development and Regulatory Decision-Making

 

Research Capabilities, Tools, and Resources

Research Management and Collaborations

Technology Transfer and Public-Private Partnerships

Physical Standards and Reference Materials

Intramural Grant Programs

Extramural Funding Mechanisms

Scientific Education, Training, and Communication

Fellowship and Training Opportunities

Professional Development and Continuing Education

Communication and External Meetings

Infrastructure

Facilities and Shared Resources

Safety and Compliance

 

ADDITIONAL ORGANIZATIONAL INFORMATION

Office of the Chief Scientist

Office of Regulatory Science and Innovation

Contact Us: FARS@fda.hhs.gov