2016 Agenda & Participants

Workshop Agenda

8:30-8:45         Welcome, Objectives and Introductions – Gary Marchant, Sandra Day O’Connor College of Law, ASU

8:45-9:45         FDA Update – Alberto Gutierrez, Director of the Office of In Vitro Diagnostics, FDA (by Skype)

9:45-10:00       Coffee Break

10:00-11:00     CMS Update – Louis Jacques, ADVI

11:00-12:30     Reimbursement Trends

Covering Cancer Panels:  Paying For Clinical Utility While Facilitating Evidence Development – Donna Messner, Center for Medical Technology Policy

Markets and Regulation Are Blocking Access to Precision Diagnostics and Drugs – Kirk Hartley, LSP Group LLC

Roundtable Discussion

12:30-1:15       Lunch

1:15-3:00         Specialized Topics

Digital Health: The Impact on Genomics – Bruce Quinn, FaegreBD Consulting

Molecular Diagnostics and Micro-Sampling: Disruptive Technology or Flash-In-The Pan?  – Amalia Issa, University of The Sciences

Patient as Payor: The New Frontier in Access to Innovation – Laura Housman, Molecular Health

Liability: Carrot or Stick for Clinical Use of Molecular Diagnostics? –Gary Marchant, ASU

Roundtable Discussion

3:00-3:15         Coffee Break

3:15-5:00         Congressional Initiatives
Ralph Hall, University of Minnesota School of Law



Workshop Participants

Tania Bubela, University of Alberta

Stephanie Buchholtz, T-Gen

Lauren Burkhart, ASU

Doug Campos-Outcalt,  Mercy Care Plan

Calvin Chan, Vermillion Inc.

David Feigal, NDA Partners LLC

Ellen Feigal, NDA Partners LLC

Kevin Fickenscher, The MITRE Corporation

Robert Friedman, Craig Venter Institute

Alberto Gutierrez, FDA (by Skype)

Steven Gutman, Myraqa, Inc.

Ralph Hall, University of Minnesota

Kirk Hartley, LSP Group LLC

Robert Hill, Myriad Genetics

Marcia Horn, ICAN

Laura Housman, Molecular Health

Sally Howard, Human Longevity, Inc.

Amalia Issa, University of the Sciences

Louis Jacques, ADVI

David Jansen, Vermillion Inc.

Roger Klein, Cleveland Clinic

Noralene Lindor, Mayo

Lauren Madjidi, ASU

Mary Anderlik Majurnder, Baylor College of Medicine

Gary Marchant, ASU

Gary Martucci, Foundation Medicine Inc.

Steve Mastrian, Ashion Analytics

Donna Messner, Center for Medical Technology Policy

Bob Milligan, Milligan Lawless P.C.

Scott Morris, Paradigm Diagnostics

Bruce Quinn, FaegreBD Consulting

Pilar Osario, University of Wisconsin

Mollie Roth, PGx Consulting

Kathryn Scheckel, ASU

Grant Senner, University of Arizona

Yvonne Stevens, ASU

Robert Wassman, Lineagen Inc.

Carl Yamashiro, ASU


Brian Hart, ASU

Jon Loe, University of Arizona

Erin McGee, ASU

Erin Redmon, University of Arizona


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