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  1. Science & Research (Biologics)

Collaborations and Partnerships

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People working together in a lab and studying data

Biomedical research in the 21st century depends on cooperation and collaboration. To best serve the public in CBER’s regulatory mission, CBER and FDA research incorporate a wide variety of collaborations. CBER collaborations range from direct interactions with labs throughout the world to large-scale partnerships with other public health organizations. Examples of some of these follow.

CBER Partnerships with the World Health Organization (WHO)

CBER scientists and its laboratories play an integral role in public health responses coordinated by WHO. CBER is one of four WHO Essential Regulatory Laboratories (ERLs), which are major components of WHO's worldwide Global Influenza Surveillance and Response System. Collectively, this international network collaborates to protect people everywhere from influenza by conducting flu virus surveillance and coordinating the many activities needed to produce seasonal and pandemic flu vaccines. Further, CBER is one of eight WHO Collaborating Centers for Biological Standards. These laboratories contribute to preparing and storing reference materials that allow comparisons of biological products between manufacturers or between countries, as well as evaluation of product consistency.

CBER and FDA Technology Transfer Program

CBER supports collaborations between CBER researchers and other scientists by applying formal technology transfer tools when appropriate. These processes ensure that the public has access to scientific resources and technological innovations created by FDA scientists. Mechanisms leveraged include filing employee invention reports to manage patenting of new discoveries from FDA laboratories, as well as licensing of novel technologies and biological materials invented by FDA investigators. Other common collaborative arrangements include Research Collaboration Agreements (RCAs), Material Transfer Agreements (MTAs), and Cooperative Research and Development Agreement (CRADAs) to allow shared research funding.

Centers for Excellence in Regulatory Science and Innovation

FDA’s five Centers of Excellence in Regulatory Science and Innovation (CERSIs) are collaborations between FDA and academic institutions, designed advance science related to product development through cooperative research between academic and FDA scientists. Collaborative interactions include not only research projects, but also training, education, and information exchange via fellowships, workshops, courses, and seminars.

Public Private Partnerships

CBER and FDA engage with a number of public-private partnerships (PPPs), which are consortia involving multiple stakeholder organizations, such as government partners, academia, non-profit organizations, and/or industry. These efforts foster scientific discussions to advance the science underpinning product development, encourage the development of new therapies, and stimulate innovation.

Broad Agency Announcement Contracts

For areas where FDA has limited expertise or capacities, FDA launched the Broad Agency Announcement (BAA) program. This awards funds to spur regulatory science innovation by the scientific community at large, leveraging its knowledge and infrastructure. Awards are provide using a contract mechanism, providing FDA flexibility in taking advantage of the breadth of innovative scientific and technical solutions available throughout the U.S.

CBER Advanced Technologies Program

Recognizing the fast pace of change in manufacturing platforms being explored for biologic products, CBER’s Advanced Technologies Team (CATT) has been created to promote conversations between CBER and prospective developers of advanced manufacturing and testing technologies prior to filing a regulatory submission. As part of this program, CBER supports manufacturing-related research projects when knowledge gaps for emerging manufacturing technologies are identified. Project proposals may be solicited through the FDA Broad Agency Announcement (BAA) program or the NIH Grants and Funding portal (grants.nih.gov) and supported using either grants or contracts.

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