2013 Archived Content
Innovation for the Future of Personalized Healthcare
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In today's rapidly evolving diagnostics landscape, innovation is essential. While point-of-care testing has the potential to streamline healthcare and improve clinical outcomes, technology developers, regulators, and clinicians must be creative to translate this potential into a reality. The second annual Point-of-Care Diagnostics symposium will provide a comprehensive overview of the point-of-care testing landscape, from novel technologies to reimbursement and regulatory approval. Physicians will offer their perspective on point-of-care adoption in the clinical setting as well as in the global health environment, and the actual economic impact of point-of-care tests will be debated. This symposium will highlight breakthroughs, solutions, and next steps for making rapid testing for rapid intervention the future of personalized healthcare.
Monday, February 11
7:30 am Registration and Morning Coffee
8:25 Chairperson’s Opening Remarks
8:30 How Pharma, Point-of-Care, & Molecular Diagnostics Will Work Together Comfortably
Keith F. Batchelder, M.D., CEO, Genomic Healthcare Strategies
Peter S. Miller, COO, Genomic Healthcare Strategies
For decades, pharma business models have been reasonably static.The industry has done well; the blockbuster model has paid off; and hard times have been dealt with through consolidation, new research models/outsourcing research, and layoffs.This session will discuss the new problems and opportunities facing pharma caused by molecular medicine and the increased information required by doctors, payors, labs, patients, and institutions.
- The impact of molecular diagnostics on pharma business models
- Information needs of other participants
- Where companion diagnostics will fit in
- Effects on business models of point-of-care instruments
- How it will all fit together
10:00 Coffee Break with Exhibit and Poster Viewing
10:30 KEYNOTE PRESENTATION: P4 Medicine:A Platform for Diagnostic Assessment in the New World of Medicine
Clay Marsh, M.D., Executive Director, Center for Personalized Health Care; Vice Dean and Senior Associate Vice President, Research, College of Medicine; Professor, Internal Medicine, Pulmonary, Allergy, Critical Care and Sleep Medicine; Director, Center for Critical Care and Respiratory Medicine, Ohio State University Medical Center
This talk will help attendees understand the rational for transitioning medicine delivery from therapeutics to diagnostic focus, the definition of Wellness and how diagnostic capabilities might impact this field, and what is meant by precision medicine.
11:00 PANEL DISCUSSION: POC Products for Diverse Settings
Moderator: Peter S. Miller, COO, Genomic Healthcare Strategies
Panelists: David Steinmiller, COO, OPKO Diagnostics
Richard Gill, Ph.D., Director & CEO, TruTouch Technologies, Inc.
Shuqi Chen, Ph.D., CEO, IQuum, Inc.
12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:25 Chairperson’s Remarks
1:30 Clinical and Economic Impact of Point-of-Care Testing
Gyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Department of Laboratory Medicine, Lahey Clinic Medical Center
POCT tends to be more expensive and more complex to manage in the hospital setting than tests on automated central laboratory platforms. POCT, on the other hand, can offer shorter turnaround times and convenience, and might impact outcomes. Proposed new programs should be evaluated for clinical benefit, quality of the results, potential pre- and post-analytical errors, and added costs such as implementation and training, maintenance, quality control, information technology, and the physician, nurse, and medical technologist time. The talk reviews the economy of POCT in the context of recent technological advancements and the changing healthcare environment, and highlights examples of clinical applications.
2:00 Technology Developer Perspective on POC in the Clinic
John McDonough, CEO & President, T2 Biosystems
This talk will focus on the challenges of developing diagnostic technologies for use in the point-of-care setting. The talk will highlight the key requirements for driving market adoption including the types of diagnostic tests that are needed at the point-of-care, how tests must compare to central lab tests and ease of use requirements including the need for CLIA Waiver. The discussion will include a review the reasons why diagnostic testing in the point-of-care is poised for rapid growth and the technological and environmental challenges that could continue to limit adoption.
2:30 Sophisticated Point-of-Care Diagnostic Devices based on 2D Paper Networks
Barry R. Lutz, Ph.D., Research Assistant Professor, Bioengineering, University of Washington
Two-dimensional paper networks (2DPNs) can perform complex chemical processes, but a far lower cost than conventional microfluidic or macrofluidic systems. We lead two ongoing “demonstration projects”. NIH supports development of a device to perform more sensitive and multiplexed immunoassays based on chemical signal amplification. DARPA supports development of isothermal nucleic acid amplification in a fully-disposable paper-based format.
3:00 Refreshment Break with Exhibit and Poster Viewing
3:30 Implementation of Molecular Point-of-Care HIV-1 Diagnostics in Resource-Limited Settings
Marco L. Schito, Ph.D. (contractor), Henry M. Jackson Foundation, Vaccine Clinical Research Branch, DAIDS, NIAID, NIH
Despite the need to strengthen existing laboratory infrastructure, there are clear diagnostic needs where conventional laboratory support is insufficient. Even with the advantages of near-patient testing, developers and implementers must also consider the environment where the assay is deployed, the technical skill of the operator, and balance the gains by assessing costs beyond the instrument and cartridges.
4:00 PANEL DISCUSSION: How Will POC Save Money?
Moderator: Keith F. Batchelder, M.D., CEO, Genomic Healthcare Strategies
Panelists: Gyorgy Abel, M.D., Ph.D., Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Department of Laboratory Medicine, Lahey Clinic Medical Center
John McDonough, CEO & President, T2 Biosystems
5:00 Breakout Discussions
6:00 Close of Day
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