Regulatory agencies will present their view on the emerging field of precision medicine and what they are seeing as the needed criteria to ensure a fair and efficient approval process.
Science Advisor Office of Regulatory Science and Innovation, Food and Drug Administration, Silver Spring, USA
|Regulatory Considerations of the Use of Next Generation Sequencing and Biomarkers to Support the Implementation of Precision Medicine |
The discussion will focus on FDA efforts to advance regulatory science to support the review and evaluation of Next Generation Technologies, and the use of biomarkers in clinical drug development. The discussion will also address FDA efforts to collaborate with other federal agencies, academic institutions, and other stakeholders to address scientific and regulatory challenges related to precision medicine.
Innovation Lead, Precision Medicine, Innovate UK, Swindon, UK
The role of Innovate UK in the development of Precision Medicine
Innovate UK is the UK’s innovation agency. We have a strong business focus and a track record of driving growth by working with companies to de-risk, enable and support innovation – putting them in a stronger position to attract investment and facilitating access to investors, collaborators, customers and export markets. We have an interest in the area precision medicine as part of the Health & Life Science sector portfolio. We perform a range of activities to help companies working in the precision medicine area, including a range of funding opportunities. We also work with a wide range of stakeholders that can help companies develop their value proposition and technology and help companies to work with these organisations. This presentation will review the work of the Precision Medicine team and how it helps companies develop precision medicine technologies in the UK.
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