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Opportunities for Sharing Data

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Sage Bionetworks Commons Congress 2012

Sage Bionetworks

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Partner:: Sage Bionetworks
Location:: Hyatt Regency
San Francisco, CA
Event Date:: 04.20.12
Speaker:: Vicki L. Seyfert-Margolis
Tags:: data; bioscience; biotechnology

Summary: New opportunities for sharing data, including an update on the role of the FDA to build large public disease biology-based clinical and genomic datasets. Approaches will be presented to extend beyond the 2011 pilot project of accessing the “clinical trial comparator arms” of industry clinical trials (CTCAP) and will examine new joint opportunities in regulatory sciences."

Bio

Vicki L. Seyfert-Margolis

Vicki Seyfert-Margolis, Ph.D., serves as the Senior Science Advisor to the FDA's Chief Scientist in the mission of upgrading science, with a focus on bioinformatics and advancing regulatory science. She has most recently been Chief Scientific Officer at Immune Tolerance Network, a non-profit consortium of researchers seeking new treatments for diseases of the immune system; and an Adjunct Associate Professor with the Department of Medicine at the University of California - San Francisco.

Prior to that, Seyfert-Margolis was a program director in innovative scientific research at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. Dr. Seyfert-Margolis research interests are: Immunology, biomarker development, advancing scientific computing environment/high density data, health information technology, validation and standards development.

Chapters

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33 min 23 sec

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01.: Introduction

01 min 10 sec

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02.: Health Care is the Front and Center Issue in Washington

04 min 33 sec

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03.: The Scope of the FDA and Dealing with Data

02 min 45 sec

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04.: The Biotech Ecosystem

04 min 51 sec

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05.: The FDA's Approach to Collecting and Interpreting Data

07 min 06 sec

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06.: Fostering Health and Science Data Communities

07 min 26 sec

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07.: Audience Q&A

05 min 33 sec

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: Watch Full Program

33 min 23 sec

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Challenge for FDA Regulators in a Global Market

02 min 04 sec

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Vicki Seyfert-Margolis of the FDA points to the increasing amount of imported products that the agency must regulate and the challenge of handling so much data.
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33 min 23 sec

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Encyclopædia Britannica Article

bioengineering: Application of engineering principles and equipment to biology and medicine. It includes the development and fabrication of life-support systems for underwater and space exploration, devices for medical treatment (see dialysis, prosthesis), and instruments for monitoring biological processes. Development has been particularly rapid in the area of artificial organs, which culminated in the implantation of an artificial heart into a human being in 1982. Bioengineers also develop equipment that enables humans to maintain body functions in hostile environments, such as the space suits worn by astronauts during extravehicular maneuvers.; bioengineering on britannica.com