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Archived Content

Molecular Diagnostics 

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Thursday, February 23



8:30 am Chairperson’s Remarks

Thomas F. Soriano, President and CEO, DOCRO, Inc.

8:35 Talk Title to be Announced

Elizabeth Mansfield, Ph.D., Director, Personalized Medicine, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health (CDRH)

9:05 IDE Requirements for Companion Diagnostic Studies: Case Studies to Identify Best Practice

Sam Rua, Vice President, Regulatory Affairs and Quality Systems, HTG Molecular Diagnostics, Inc.

9:35 Companion Diagnostics: Challenging Dx and Rx Business Models

Joseph V. Ferrara, President, Global Consulting, Boston Healthcare Associates, Inc.

While companion diagnostics and targeted therapeutics offer the potential to change well-established practices for physicians and patients, the concept presents a direct challenge to the business models of two health care stakeholders essential to the realization of personalized medicine— pharmaceutical and diagnostics companies.  At the core of the challenge is a central question— how will a personalized medicine paradigm change these companies’ innovation and commercialization approaches?  This question can be aimed at nearly every aspect of innovators’ current strategies— how clinical trials are conducted, the depth and breadth of the clinical evidence developed, and, perhaps most importantly, how value is created and captured.  The presentation will review strategic considerations, case studies, and success factors for value capture in Dx/Rx.

Sponsored byAbbott Molecular10:05 Best Practices in Companion Diagnostics CollaborationsPamela Swatkowski, Director, Regulatory Affairs, Abbott MolecularThis talk will address partnering from discovery to commercialization, managing expectations and achieving a true partnership, and present learning from a 2011 U.S. IVD launch.
Sponsored byPMI_ResearchDevelopment 10:20 Verification of Systems Biology Research in the Age of Collaborative-CompetitionMarja Talikka, Ph.D., Philip Morris International
10:35 Coffee Break

11:00 Business Models and Value Capture in the Co-Development of Drugs and Diagnostics

Peter Collins, Ph.D., Vice President & Head, Diagnostics, GlaxoSmithKline Biologicals

The talk will consider the critical issues that must be addressed by both parties when embarking upon co-dvelopment programmes including a recognition from the outset of the many areas where they are inevitably misaligned. Key challenges in Regulatory strategy are both complex, still evolving and span different geographies; Commercial challenges also abound on a per geography basis. There will also be discussion of the issue of value capture and risk sharing approaches which are impacted by the quite different way in which payers the world over value and reimburse Pharmaceutical products versus they way they reimburse Lab testing services. The critical point being how do Healthcare systems manage the issue of valuing and reimbursing a co-developed Rx Dx combination when one is viewed as Product and the other a service. How can this conundrum be addressed?

11:30 Capturing the Value of Diagnostic Innovation

William Welch, Senior Vice President, Diagnostics, Sequenom, Inc.

The development of clinical diagnostics often takes 5 years or more to identify the appropriate markers, validate clinical utility and technically validate and commercialize in a CAP/CLIA clinical laboratory operation.  Often the technologies used to bring new clinical markers to market are novel and are not captured by the existing coding process.  Additionally, establishing new treatment paradigms with providers and payers can be challenging.  This discussion addresses the process for commercializing novel molecular diagnostics during the a time of change in regulatory, coding and reimbursement policies.

12:00 pm PANEL DISCUSSION WITH MORNING SPEAKERS: Clarifying Myths and Misconceptions of Companion Diagnostics (or: “I thought you said...”)

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:50 PANEL DISCUSSION: Transforming Translational Tools: The Commercialization of Novel Diagnostics from Life Science Technologies

Moderator: Kristin Ciriello Pothier, Partner, Health Advances, LLC


Nancy Krunic, Ph.D., Vice President, Molecular Diagnostics, Luminex 

Austin Tanney, Ph.D., Scientific Liaison Manager, Almac 

Pamela Swatkowski, Director, Regulatory Affairs, Abbott Molecular 


The evolution of true translational and transformative technologies such as molecular diagnostics, next generation sequencing, digital pathology, and mass spectrometry into the clinical markets from their original life science markets is occurring rapidly, but not without major commercialization challenges for life science companies as they develop their strategies for a very different clinical market. This session will share the experiences of the panelists and the moderator on robust commercialization strategies of these technologies in the clinical market, share the experiences of the panelists on the most poignant successes and failures, detail how to build global market analysis around the true potential and overall strategy and tactics, and explore opportunities for the future both from a company perspective and an investor perspective.

3:20 Close of Conference

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