..This Month's Clinical Focus:
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DIA 2019 Annual
JUN 23-27 SAN DIEGO CA
CALL Ronny Schnel 310-619-6691
FDA Program you're NOT watching: FDA Technology Transfer Program
Collaborations are Key to Advancing Regulatory Science into the Private Sector
FDA scientists, together with collaborators in academia, industry and government, develop technologies that support
the evaluation, development, manufacture, and use of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of the products FDA regulates. The goal of the Technology Transfer Program is to ensure the full use of the
results of FDA’s investment in research and development.
The program achieves this by engaging in collaborations to develop innovations and by transferring, through collaborations
or by licenses, FDA technologies to organizations able to translate FDA’s innovations into new products that protect and advance public health.
FDA’s Technology Transfer Program performs a variety of technology transfer activities to support the development of FDA research:
Establish collaborative research
agreements with outside parties that facilitate collaborations between FDA researchers and industry, academics, and nonprofits
• Evaluate employee invention reports
and select the most effective mechanism for bringing the technology to the public
• Manage the patenting of new discoveries
from FDA laboratories
• License new technologies, biological materials, and animal models that FDA scientists invent
• Manage the establishment of transactional agreements
- like Material Transfer Agreements--that transfer materials to academic and non-profit organizations for research use.
FDA Technology Portfolio
FDA's Technology Transfer Program team helps move these technologies to the private sector by patenting and licensing these developments so that new products in areas like vaccines, food pathogen detection systems, counterfeit drug detection, and manufacturing
can be created and made available on the market.
In the last few years alone, FDA researchers have produced and reported about 20 patentable inventions annually. And
FDA holds over 600 invention properties that represent over 100 unique technologies of which about 15% are licensed for development.
In working to meet the missions of FDA product centers and offices, FDA scientists have discovered and developed a broad
range of technologies. To view FDA technologies that are available for licensing
FDA Licensing Opportunities web page or the Available Technologies Search Tool at the Federal Laboratory Consortium.
SOURCE: Used by Permission of FDA (Online Public Domain)
Tools for Science & Research in Medical Devices (yes, you read that right)
Open Source Software Tools are FREE to Researchers
A core function of the FDA's CDRH (Center for Devices and Radiological Health) is to advance regulatory science, the science of developing new tools, standards and approaches to
assess the safety, efficacy, quality, and performance of medical devices and radiation-emitting products. Science at CDRH includes laboratory and field research in the areas of physical, life, and engineering sciences as well as epidemiological research in
postmarket device safety.
Research is conducted in FDA laboratories and through collaborations with academia, healthcare providers, other government agencies and industry. CDRH relies upon this work to support its efforts ensuring public safety in areas as varied as medical imaging,
medical device software, breast implants, and drug eluting stents.
An important segment of the CDRH provides Public Domain Data, Modeling, and Software -
open source software tools free of charge for researchers. Data, modeling, and software developed by government employees are considered public domain. Therefore, these tools are free, open, and available to all. To accomplish this goal, CDRH and the
Office of Science and Engineering Laboratories (OSEL) advocate that developers publish and maintain these tools in web-accessible repositories.
The following computational research projects contain tools available through external software repositories,
available on the website:
• HIFU Simulator
• SENN Nerve Stimulation
• Virtual Family
To promote the visibility and transparency of computational research, developers are also encouraged to release early and often in accordance with open source software development philosophy. This approach creates a tight feedback loop between software developers
and testers/users, expediting the development of higher quality software.
SOURCE: Used by Permission of FDA (Online Public Domain)
Image credits: Tech brain by Geralt; Researcher Laptop by rawpixel; both via PixaBay.com Free Lic CC0
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Ph II mRAS Colorectal Cancer
Ph II Pancreatic Cancer
Ph I/II Colorectal Cancer
Ph II Metastatic Breast Cancer (x2)
Ph II NSCLC (x2)
Retrospective Studies in Lung Cancer (x2)
CRITERIUM, Inc. CRO
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Call Ronny Schnel 310-619-6691
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Clinical Trials for over 25 years!
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