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2013 Archived Content

Companion Diagnostics Advancing Technologies and Getting Reimbursed 

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WEDNESDAY, AUGUST 21

11:00 am Registration


11:00 PLENARY KEYNOTE DISCUSSION

Perspectives on Evaluating Novel Diagnostics for Reimbursement

Moderator: Andrew C. Fish, Executive Director, AdvaMedDx

  • Levels of evidence needed to support novel diagnostics
  • Health economics
  • Analytical issues
  • CMS policy
  • Rate schedule

Panelists:

Aaron D. Bossler, M.D., Ph.D., Clinical Associate Professor, Director Molecular Pathology Laboratory and Molecular Genetic Pathology Fellowship Program, University of Iowa Hospitals and Clinics and Co-Chair, AMP Economic Affairs Committee

Dwight Denham, MBA, Director, Clinical Research, Beckman Coulter, Inc.

Elaine K. Jeter, M.D., J1 MolDx Medical Director, Palmetto GBA

Lee H. Newcomer, M.D., Senior Vice President, Oncology, United Healthcare


12:30 pm Enjoy Lunch on Your Own


MOVING TOWARDS MULTIPLEX COMPANION DIAGNOSTICS 

1:50 Chairperson’s Opening Remarks

2:00 The Challenges of Clinical Assay Development and Implementation in the Era of Targeted Cancer Treatments

Mickey WilliamsP. Mickey Williams, Ph.D., Director, Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research

This talk will discuss some of the challenges that lie ahead in developing effective and efficient multi-analyte clinical assays to accompany the growing number of targeted cancer therapies with a focus on next-generation sequencing technologies.

2:30 Strategic and Computational Considerations in the Development of Multiplexed Companion Diagnostics

Amir Handzel, Ph.D., Associate Director, Translational and Clinical Sciences, OSI Pharma (Astellas)

The diverse challenges in developing validated complex diagnostic biomarkers have been highlighted by several failures in the last decade. The universe of molecular entities for biomarkers is rich and their extremely large numbers present difficult problems of selection and validation in a statistically robust way. In addressing them, an array of technical, operational and organizational approaches must be employed. I will discuss these strategic and technical elements while pointing to pitfalls and how to avoid them.

Luminex3:00 The Future of Companion Diagnostics

Jeremy Bridge Cook Jeremy Bridge-Cook, Ph.D., Senior Vice President, Research & Development, Luminex

The speaker will focus on recent CDx market developments, drivers, constraints and other key considerations for future growth.

 

 

Rheonix3:30 Microfluidics: Deriving Big Benefits from Small Structures

Richard A. Montagna, Ph.D., Senior Vice President, Scientific Affairs, Rheonix, Inc.

A microfluidic platform has been developed that permits the performance of sophisticated molecular diagnostic testing in a fully automated and unattended manner.  Once a raw clinical specimen is introduced, the system, consisting of a robotic workstation and a disposable microfluidic cartridge and reagent packs, automatically performs all sample preparation, analysis and readout under the control of software.  A variety of diverse assays will be described with applications in personalized medicine and companion diagnostics.  In all cases, highly complex assays can easily be performed by individuals of varying skill level.

4:00 Refreshment Break in the Exhibit Hall with Poster Viewing


BRINGING A NOVEL COMPANION DIAGNOSTIC TO THE GLOBAL MARKETPLACE 

4:30 Expert Panel Discussion: Bringing A Novel Companion Diagnostic to the Global Marketplace- What are the Issues to Think About?

Moderator: Jonathan Roy, Senior Director, Head,Commercial Diagnostics, GlaxoSmithKline

  • Timeline for reimbursement: What happens during waiting time for reimbursement
  • Who pays for testing?
  • LDTs in Global markets vs. FDA approved tests
  • Aligning goals and timelines
  • How do you see the environment evolving?
  • Maintaining quality across markets

Panelists:

Richard Ding, CEO, bioTheranostics

Kenneth J. Bloom, M.D., CMO, Clarient, Inc.

Keith Miller, CSO, UCL Cancer Institute, School of Life and Medical Sciences, University College London

Joseph V. Ferrara, President, Boston Healthcare

6:00 Dinner Short Course Registration

6:30-8:30 pm Dinner Short Courses*

New Dealmaking Strategies in Companion Diagnostics

*Separate registration required



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2014 Brochure

2014 Brochure 

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