2015 Agenda

Molecular Diagnostics: The Shift to Complexity

April 17, 2015; 8:30 am-5:00pm


Workshop Agenda


8:30-8:45         Workshop Welcome, Objectives and Introductions

Gary Marchant, Sandra Day O’Connor College of Law, ASU


8:45-9:15         The Shift to Multiplexity

George Poste, Center for Complex Adaptive Systems, ASU


9:15- 9:45        Case Study: HealthTell

Neal Woodbury, Biodesign Institute, ASU


9:45-10:10       Roundtable Discussion (Chaired by Rachel Lindor)


10:10-10:15     ASU’s new School of Biomedical Diagnostics

Mara Aspinall, ASU


10:15-10:30     Coffee Break


10:30-11:00     FDA Initiatives

Alberto Gutierrez, Director of the Office of In Vitro Diagnostics, FDA


11:00-11:30     Roundtable Discussion (Chaired by Rachel Lindor)


11:30-12:00     CMS Initiatives

Tamara Syrek Jensen, Director, Coverage and Analysis Group, CMS


12:00-12:30     Roundtable Discussion (Chaired by Rachel Lindor)


12:30-1:15       Lunch


1:15-1:45         Molecular Diagnostics Regulation: Where Do We Go From Here?

David Feigal, NDA Partners (former Director of FDA CDRH)


1:45-2:15         Congressional Initiatives

Ralph Hall, University of Minnesota School of Law


2:15-2:45         Roundtable Discussion (Chaired by Gary Marchant)


2:45-3:00         Coffee Break


3:00-5:00         Continue Roundtable Discussion on Solutions (Chaired by Gary Marchant)



 Presented by:

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