2017 Agenda & Participants



8:30-8:45         Welcome and Introductions

8:45-10:00       FDA Developments
Speaker: Alberto Gutierrez, Director, FDA Office of In Vitro Diagnostics

10:00-10:15     Coffee Break

10:15-11:15     CMS Developments
Speaker: Louis Jacques, ADVI

11:15-12:00     Implementation of the Clinical Laboratory Provisions of the Protecting Access to Medicare Act of 2014 (PAMA)
Speaker: Roger Klein, Roger D. Klein, MD JD Consulting

12:00-1:00       Lunch

1:00-1:45         Evolving Regulatory Approach to Software and IVDs
Speaker: David Feigal, NDA Partners

1:45-2:30         Cancer Diagnostics Reimbursement and Experimental Exclusions
Speaker: Kirk Hartley, LSP Group

2:30-3:15         Pathogen Testing/Whole Genome Sequencing
Speaker: Jeremy Ellis, Fry Laboratories

3:15-3:30         Coffee Break

3:30-4:45         Congressional Developments
Speaker:  Ralph Hall, University of Minnesota

4:45-5:00         Workshop Conclusions and Closing





Mara Aspinall International School of Biomedical Diagnostics, ASU
Aaron Bare Thunderbird School of Global Management, ASU
Leila Barraza Univeristy of Arizona
Paul Billings Biological Dynamics, Inc
Stephanie Buchholtz Tgen
Lauren Burkhart ASU
Doug Campos-Outcalt Mercy Care Plan
Calvin Chan Lineagen
Carolyn Compton Arizona State University
Jeremy Ellis Fry Laboratories
David Feigal NDA Partners
Ellen Feigal NDA Partners
Robert Friedman  Venter Institute
Alberto Gutierrez Director, FDA Office of Vitro Diagnostics
Steve Gutman Myraqa, Inc.
Ralph Hall University of Minnesota
Elizabeth Hall-Lipsy College of Pharmacy, University of Arizona
Kirk Hartley LSP Group
Marcia Horn ICAN
Louis Jacques ADVI
David Jansen Lineagen
Judy Joseph Fry Laboratories
Roger D. Klein Yale University
Noralane Lindor Mayo Clinic
Gary Marchant ASU
Gary M. Martucci Foundation Medicine, Inc
Danelle Miller Roche Diagnostics
Scott Morris Paradigm Diagnostics
Pilar Ossorio University of Wisconsin
Erin Redmon University of Arizona
George Runger ASU
Grant Senner University of Arizona
Yvonne Stevens ASU
E. Robert Wassman LIfe Designs Ventures
Rina Wolf XIFIN Connected Health
Carl Yamashiro ASU


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