FDA Technology Transfer. Dr. Vicki Seyfert Margolis Senior Advisor for Science and Innovation Office of the Chief Scientist December 6, 2010

Transcription

1 FDA Technology Transfer Dr. Vicki Seyfert Margolis Senior Advisor for Science and Innovation Office of the Chief Scientist December 6,

2 Technology Development and Transfer Continuum R&D Activity: FDA Research Expertise Information Technology Unique material Develop tech through Collaborations with outside organization Expertise Information Technology Unique material Publish research, grant license for full development FDA Invention Reported Optimize Resources Make Technologies Available to Public T2 Mechanisms Used: MTA CDA Acronyms MTA Material Transfer Agreement CDA Confidential Disclosure Agreement RCA Research Collaboration Agreement CRADA Cooperative Research and Development Agreement CDA RCA CRADA License Agreements Peer reviewed reviewed Publications Published Patent Applications/Patents Improved Public Health 2

3 FDA Technology Transfer (T2) Program Major Areas of Responsibility Management of government intellectual property (IP), including inventions and confidential information. T2 evaluates inventions reported by FDA research staff, seeking patent protection as needed Strives to develop inventions through facilitating collaborations or licensing to outside entities Provide expertise and guidance in use of T2 agreements, such as CRADAs, to enhance FDA regulatory science. Negotiate the T2 legal agreements to minimize risks to the Agency while still making it possible for the research program to access resources Ensure that the terms of the agreements comport with relevant statutory, regulatory, and PHS policy requirements 3

4 FDA Technologies FDA holds ~500 invention properties, which come out of FDA scientists research efforts. Of these ~12%, including research tools, met criteria that recommended against seeking patent protection, so no patent applications were filed. Over 15% of the invention properties are licensed for development. Of the 18 PHS Employee Invention Reports filed in FY 10, FDA filed patent applications for 9 of these. Of FDA licensed technologies, about half are research tools for which patent protection is not sought. FDA receives royalties from licensed inventions. Under an interagency agreement, NIH Office of Technology Transfer handles the patenting and licensing of FDA s inventions. This is done in consultation with the Agency. In FY10, over $350,000 were received for FDA technologies. A portion of royalties goes toward re imbursement of patent expenses. FDA spent over $700,000 on patent prosecution and maintenance in FY10. Remaining royalties are distributed to the inventors, Centers, and Agency, according to legal and policy requirements for royalty distribution. 4

5 FDA Technologies Transferred through Licensing Cancer Treatment: IL13-PE38QQR is a tumor-targeting toxin developed under a collaboration between FDA, NCI, and the University of Michigan. NeoPharm, Inc., exclusively licensed IL13-PE38QQR from FDA and NCI, and continues to develop the agent as a treatment for glioblastoma multiforme, a deadly form of brain cancer. Rapid Bacterial Detection for Food Safety: Rapid, flow-cytometric detector of bacteria in food or other complex matrices, such as human sputum, was developed under a collaboration between FDA and Litmus, LLC. The technology is used to detect bacterial contamination in food, where it has been shown to count from 1 to 100,000 cells of a target species in 2-5 minutes in a small sample of rinsed or pulverized food. Litmus has a license to the technology and is commercializing the technology for use in multiple settings to ensure food safety, accurate diagnoses of infectious diseases, and recognition of bioterror agents. HIV Diagnostic: FDA invented and developed a diagnostic test for the detection of HIV-1 and HIV-2 infection. An important feature of the diagnostic is its ability to distinguish between antibodies generated by HIV infection and antibodies generated by HIV vaccines. This FDA technology is included in a Patent Collaboration Agreement between NIH and the Institut Pasteur, under which the organizations pooled patented and patent pending technologies with relevance to HIV-1 diagnostics. The patent pooling presents a complete package of technology rights, promoting the commercial sector s ability to develop improved HIV diagnostics. Polysaccharide-conjugated meningitis vaccine: Scientists at CBER developed new conjugate vaccines against Neisseria meningitidis and methods for synthesizing and manufacturing the polysaccharide-protein conjugate vaccines at high yields. PATH licensed the FDA technology to develop an affordable vaccine for those countries in the meningitis belt in sub-saharan Africa. Through the licensing partnership between FDA and PATH, and the collaborative research performed by FDA, PATH, and the Serum Institute of India, the FDA conjugation technology was used to successfully develop the vaccine. The vaccine received prequalification from the WHO in June

6 FDA CRADAs CRADAs are used by FDA to bring together expertise of FDA scientists with expertise of scientists from outside entities (Collaborators) CRADA activities should enhance FDA s research ability to reach FDA regulatory science research goals CRADA research is proposed by the FDA PI and Collaborator PI 6

7 FDA CRADAs Under the CRADA, materials, personnel, and equipment may be exchanges between the parties for CRADA research use only. Any other requirements that are needed for exchanges to happen must be met. For example, Collaborator s researchers might work on site at FDA for CRADA research after completing Guest Researcher Agreement and any other personnel or security requirements. FDA is authorized to receive CRADA funding, if it is needed for the CRADA research activities. However, this is not a mechanism for federal funding to go out. There are currently ~35 active CRADAs across the FDA. Three of these were signed FY10. 7

8 FDA CRADAs FY00 FY10 By Center By Collaborator Type

9 Collaborative Research Outcomes from CRADA Partnerships Selected Examples Previous CRADA between CDER and CONFORMIA provided FDA with an understanding of industry s critical challenges in the implementation of the ICH Quality Vision (ICH Q8, Q9, Q10) across the product and process lifecycle. Previous CRADA between CDRH and CELLULAR COMMUNICATION & INTERNET ASSOCIATION (CTIA) led to conclusion that no association was found between exposure to radiofrequency (RF) radiation from cell phones and adverse health effects. Ongoing CRADA between ORA and KAPLAN EDUNEERING led to creation of ORA U. ORA U provides FDA-customized, web-based learning activities and regulatory training courses to over 30,000 federal, state, and local investigators. Ongoing CRADA between CDRH and FRAUNHOFER USA, Inc. CESE develops software forensic tools so that software system architecture can be more accurately visualized and evaluated. 9

10 What is intellectual property? Intellectual property (IP) refers to creations or expressions of the human mind. Examples of these creations or expressions are inventions, discoveries, information, artistic works, literary works, software, designs, and symbols. IP is intangible; contrast to properties like your home or car IP has commercial value, just like tangible property IP is an asset. IP may receive the legal protection that any other type of property may receive to protect it from unauthorized use. There are four ways to protect different types of IP: patents, trademarks, copyright, and trade secret

11 Why does FDA care about intellectual property? For FDA to do its part in making sure technology is transferred and developed, FDA has to maintain control of its IP so that the IP can be accessible and protected as appropriate. Why do we need to protect the IP? So that FDA we can make sure the technology is used to the fullest potential. FDA has to achieve this within the framework of its legal authorizations and requirements.

12 What is Technology Transfer? Technology transfer is the practice of transferring scientific findings, know how, inventions, or research materials from one organization to another for further development and commercialization. Through technology transfer new products such as medicines, educational tools, electronic devices, safety equipment and health services can be developed and become available to the public.

13 Why Practice Technology Transfer at FDA? The Federal Technology Transfer Act makes it the responsibility of each technical employee and the Agency's managers to develop opportunities to transfer technology. In the late 1980s, concerns about U.S. industrial strength and global competitiveness led to a series of legislative changes that facilitated public private partnerships involving industry, universities, and government labor. These partnerships can facilitate technology transfer from the federal laboratories to the market in support of both FDA s mission and technology based economic growth. These partnerships increase the possibility that FDA inventions become fully developed products used to improve public health.

14 Conclusions: The FDA is involved with the invention of multiple technologies and has a significant portfolio of inventions. Collaborations through CRADA s, grants or contracts with FDA present potential new business opportunities particularly with respect to development of new technologies that benefit product development, review or analyses of data. As a regulatory agency, the FDA must put safeguards in place to protect against potential conflicts of interest that may arise as a pre-competitive or early stage project matures. The FDA is building the infrastructure to support more such partnerships and agreements. QUESTIONS and COMMENTS: Vicki.Seyfert-Margolis@fda.hhs.gov or Alice.Welch@fda.hhs.gov 14