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Walter E. Washington Convention Center

Jun 14, 2015 2:30 PM - Jun 18, 2015 6:45 PM

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

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Safety in Special Situations: Vaccines, Stem Cells and Beyond

Session Chair(s)

Joy A. Cavagnaro, PhD

President

Access BIO, United States

This symposium will provide insights on the key safety considerations influenced by product specific attributes of vaccines, stem cells and novel combination therapies.

Learning Objective : Discuss protocol design issues including cohort size, timing between cohorts, unique safety parameters, monitoring and independent oversight and long term follow for early and late stage clinical development; Identify challenges based on signal detection methodologies in special situations.

Speaker(s)

Vaccines

Julia Barrett, MD, MPH

Greenleaf Health, Inc., United States

Executive Vice President, Drug and Biological Products

Stem Cells

Curtis L. Scribner, MD, MBA

CLSCRIBS Consulting , United States

Consultant

Clinical and Regulatory Considerations for Cell Therapy Development

G. Alexander Fleming, MD

Kinexum, United States

President and Chief Operating Officer

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Registration override should work.