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by July 16th and SAVE up to $200!
12:45-1:45 pm Registration
1:45 Chairperson’s Comments
John C. Carrano, Ph.D., Vice President, Research and
Development, Luminex Corporation
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1:50 Global Health Diagnostics
Steven Buchsbaum, Ph.D., Senior Program Officer, Global Health
Technologies, Bill & Melinda Gates Foundation
This talk will provide a brief introduction to the Global
Health program at the Bill and Melinda Gates Foundation and
describe the foundation’s priorities for the development of
diagnostics. In particular, the talk will focus on opportunities
for the development of Point of Care diagnostics appropriate for
developing country settings and where there are common
technological challenges in biodefense and therefore the potential
to leverage biodefense investments.
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2:20 FIND: Bridging the Gaps in the Development and
Rollout of Innovative Diagnostics for Poverty Related
Diseases
Giorgio Roscigno, M.D., Chief Executive Officer, FIND
Diagnostics
New technologies have revolutionized the simplicity, speed, and
accuracy of diagnostic tools for identifying diseases in the
developed world. However, the developing world, especially the
public health sector, has yet to benefit from this technological
revolution. A critical factor affecting the development of
technologies for diseases of the poor is the absence of a bridge
that can effectively link academic research and the diagnostic
industry to the specific needs of developing countries. FIND
provides this bridge by leveraging the strengths of its diverse
range of partners to develop technological platforms for diagnosis
of poverty-related diseases for the public, as well as the
non-profit private health sector in the developing world.
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2:50 In Vitro Diagnostic (IVD) POC Devices: How
They Differ from Other Devices and How the FDA Regulates
Them
Sally A. Hojvat, MSc, Ph.D., Director, Division of
Microbiology Devices, Food and Drug Administration
This presentation will cover the FDA’s role in assuring
the safety and efficacy of a POC device from product
development phase to post market product surveillance. The new
CLIA waiver review process, required for all POC products,
will also be discussed.
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| 3:20 Poster Session with Refreshments and Exhibit
Viewing |
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3:50 A Unified Technological Approach to Point-of-Care
Diagnostics and Biological Sensing
John C. Carrano, Ph.D., Vice President, Research and Development,
Luminex Corporation
During the past several years, we have witnessed an explosive
growth in the development of rather sophisticated biological
detection
technologies. This has been driven, in part, by a least two major
needs. The first is the desire to greatly reduce healthcare costs
by developing simple to use, yet accurate, point-of-care
diagnostic instruments, which would allow a clinician to rapidly
diagnose, and prescribe treatment for a wide variety of diseases.
The second driver is the unfortunate and growing threat of
bio-terrorism. Convolved with these two driving forces is the
significant pressure on companies to keep research and development
costs under control, and focused on high margin products. Although
the government has stepped in with vast sums for funding research
into technologies related to bio-defense; and, despite the growing
interest of some major philanthropic organizations in sponsoring
research to mitigate the ravages of disease, the reality is that
these technologies will only become available as products if
companies see a beneficial long-term return-on-investment. Hence
the motivation to pursue a unified technological approach to
point-of-care diagnostics and biological sensing. In this talk we
will present novel technological approaches using bead-based
multiplexing of biological assays to address the compelling, yet
at times seemingly contradictory requirements for the development
of advanced products for both biological agent sensing and
point-of-care diagnostics. In so doing, we describe a pragmatic
path toward the productization of technologies critical to
humanitarian and bio-security needs, while allowing for a major
commercial market driver.
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4:20 Biothreat Detection and Diagnosis: The Joint
Biological Agent Identification and Diagnostic System (JBAIDS)—Current
Status and Future Vision
James W. Karaszkiewicz, Ph.D., Senior Scientist, Goldbelt
Raven LLC and Chief Scientist, JBAIDS Program Office,
JPM-Medical Identification and Treatment Systems
The Joint Biological Agent Identification and Diagnostic System
(JBAIDS) is the U.S. Department of Defense program of record for
the detection and
diagnosis of biothreat agents. JBAIDS provides a standardized,
validated and FDA-cleared, multi-service solution that is
ruggedized, deployable, and provides demonstrated capability for
pathogen identification in both environmental and clinical sample
types. This presentation will describe the current JBAIDS
technology
and discuss a vision for the future.
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4:50 Semi-homogeneous Fluidic Force Discrimination Assays for Attomolar
Diagnostics
Lloyd J. Whitman, Ph.D., Head, Surface Nanoscience and Sensor Technology Section, Naval Research Laboratory |
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5:05 Expert Panel: Bullet Proof Approval Process |
- How are multiplex assays going to be approved?
- CMS and Reimbursement- will
they pay for additional tests?
- How will Doctors interpret results and use them to change
the course of treatment?
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Additional Panelist:
Andrew I. Brooks, Ph.D., Associate Professor, Environmental
Medicine and Genetics, and Director, Bionomics Research and
Technology Center (BRTC), Environmental and Occupational Health
Science Institute, University of Medicine and Dentistry of New
Jersey; Associate Director, Technology Development, Rutgers
University Cell and DNA Repository (RUCDR), Rutgers University
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5:30 Close of Day One
View Day 2
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