Pre-Conference Symposia | Day 1 | Day 2

PLENARY KEYNOTE SESSION

GAINING REGULATORY APPROVAL FOR MOLECULAR DIAGNOSTIC TESTS

Ensuring the Safety and Validity of Molecular Diagnostic Tests

Alberto Gutierrez, Ph.D., Deputy Director, OIVD, Office of in Vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration

 

 

 

 

Bringing Point-of-Care HIV Diagnostics to Market: FDA Perspectives

Elliot Cowan, Ph.D., Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, FDA/CBER/OBRR

 

 

 

 

Featuring Sessions on

• CONNECTIVITY, DISEASE MANAGEMENT AND e-HEALTH
• BARRIERS TO NEXT GENERATION POINT-OF-CARE DIAGNOSTICS AND ROLE OF STANDARDS
• NEAR PATIENT DIAGNOSTICS
• VALUE OF PUBLIC-PRIVATE PARTNERSHIPS: Highlighting Open Platforms
• CASE STUDIES IN DISEASE MANAGEMENT
• NEXT GENERATION PRODUCTS

Pre-conference Symposia

(SC1) CIRCULATING TUMOR CELLS AS SURROGATE ENDPOINTS IN CLINICAL TRIALS

(SC2) REALITY CHECK ON COMPANION DIAGNOSTICS 

Scientific Advisory Board

Steven Buchsbaum, Ph.D., Senior Program Officer, Global Health Technologies, Bill & Melinda Gates Foundation

Shuqi Chen, Ph.D., Chief Executive Officer, IQuum, Inc.

Harry Glorikian, Managing Partner, Scientia Advisors

Brenda J. Korte, Ph.D., Program Director, Discovery Science & Technology, National Institute of Biomedical Imaging and BioEngineering, NIH

Thomas Li, Ph.D., Senior Director, Technology Management, Chief Technology Office, Roche Diagnostics, Pleasanton

Matthew Lorence, Ph.D., M.B.A., Vice President, Marketing and Sales, Tessarae, LLC

Linda McAllister, M.D., Ph.D., Vice President, Diagnostics, Arbor Vita Corporation

Valerie Ng, Ph.D., M.D., President-Elect, ACMC Medical Staff; Chairman, Pathology; Director, Clinical Laboratory, Alameda County Medical Center/Highland General Hospital

Hakan Sakul, Ph.D., Senior Director and Global Head, Diagnostics, Molecular Medicine Group, Pfizer Global R&D

Sunday, August 9

4:00-5:00pm Early Registration

Monday, August 10

7:30-8:30am Registration and Morning Coffee

CONNECTIVITY, DISEASE MANAGEMENT and e-HEALTH

8:30 Chairperson's Remarks

Thomas Li, Ph.D., Senior Director, Technology Management, Chief Technology Office, Roche Diagnostics, Pleasanton

8:40 Keynote Presentation
Enabling the New Point of Care: Care Beyond the Hospital

Mark N. Blatt, M.D., MBA, Director, Healthcare Industry Solutions, Digital Health Group, Intel Corporation

Hear about new clinical and business trends that are empowering clinicians in the developed world to provide care to citizens directly in their homes. These concepts are being applied in the developing world to better enable rural healthcare workers to care for citizens in remote village settings.

9:10 e-Health and Point-of-Care Technology - Opportunities for the World

Craig Lehmann, Ph.D., CC (NRCC), FACB, Interim Executive Dean, Health Sciences Center, Dean, School of Health Technology & Management, Professor, Clinical Laboratory Sciences, Health Sciences Center, Stony Brook University

In World Population Prospects (2004), the United Nations projected that in 2005, globally, the number of individuals 60 and older was 672 million and is expected to reach 1.9 billion by 2050. Of the 58 million deaths in developed and developing countries, approximately 35 million will be a direct result of heart disease, stroke, cancer, chronic respiratory diseases and diabetes. These chronic diseases are the number one killers of adults in the world and, in the next ten years, are expected to increase by 17 percent (WHO 2005). This presentation will discuss the use of e-health and POC technology in community health environments in the United States and Kenya.

9:40 Industry Perspective on Connectivity

Becky Clarke, Executive Vice President, Telcor

When utilizing POC testing as part of disease management, one must consider efficient and effective ways to a. transmit the data b. integrate the data and c. communicate the data to clinicians. Relying on manual methods, rather than automating these activities, exposes everyone to delays, omissions and errors, all of which can affect timely and proper treatment.

 

10:10 Networking Coffee Break, Exhibit and Poster Viewing

Expert Panel:
BARRIERS TO NEXT GENERATION POINT-OF-CARE
DIAGNOSTICS AND ROLE OF STANDARDS

11:00 Moderator: Steven Buchsbaum, Ph.D., Senior Program Officer, Global Health Technologies, Bill & Melinda Gates Foundation

• What do we know about the key product specifications for a POC diagnostic platform for both developed and developing world markets
  Roger Peck, Research Scientist, PATH
• What are the key technical barriers to creating a high performance POC platform
  Mickey S. Urdea, Ph.D., Chief Executive Officer and Chairman, Tethys Bioscience, Inc.
• What are the key business and IP barriers to creating a high performance POC platform and how might we address them
  Andrew Leon, Associate General Counsel in Global Health, Bill & Melinda Gates Foundation
• Introduction to Gates foundation work on POC platforms
  Boris Nikolic, M.D., Senior Program Officer, Bill & Melinda Gates Foundation (invited)

12:00pm Sponsorship Presentation (Opportunity Available)

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

NEAR PATIENT DIAGNOSTICS

2:00 Chairpersonfs Remarks

Matthew Lorence, Ph.D., M.B.A., Vice President, Marketing and Sales, Tessarae, LLC

2:10 From the Laboratory Bench to a Point-of-Care Device – How the CUDA Platform will Enable Decentralized Molecular Diagnostic Testing

Richard Lee, Ph.D., Senior Manager, Development, Gen-Probe, Inc.

A next-generation, point-of-care Closed Unit-Dose Assay (CUDA) platform will be described. This platform uses actuator-driven fluidic movement to perform a complete sample-to-result molecular diagnostic assay in one hour. The platform harnesses Gen-Probefs magnetic bead–based target capture and isothermal real-time Transcription-Mediated Amplification (TMA) technologies. All reagents required to perform the assay are contained in stabilized form in a disposable pouch. The user introduces sample into the pouch through an easy-to-use entry port, places the pouch in the instrument, and initiates the assay in a single-touch operation. In this presentation, examples of real-time qualitative and quantitative assays for use on the CUDA platform will be given and the technical and non-technical challenges encountered during the development of the CUDA platform will be discussed. 

 2:40 Differentiation Makes the Difference: HX Diagnosticsf fluID and panfluID Rapid POC Tests

Wendy Benson, President and Chief Executive Officer, HX Diagnostics, Inc.

HX Diagnostics is focused on rapid diagnostics for infectious diseases. The fluID™ rapid influenza test developed is the only rapid, point-of-care platform to differentiate H1N1 and H3N2 subtypes, offering advantages for rapid diagnosis and treatment. The panfluID™ rapid H5 test offers the same easy-to-use format with application in a wide variety of settings. Our technology allows for continued product development and expansion of the current platform to develop a pipeline of highly sensitive and specific rapid POC tests for respiratory and other emerging diseases.

3:10 Networking Refreshment Break, Exhibit and Poster Viewing

Expert Panel:
VALUE OF PUBLIC-PRIVATE PARTNERSHIPS:
Highlighting Open Platforms

4:10 Moderators: Peter Moy, Ph.D., and Todd Merchak, Ph.D., Discovery Science & Technology, National Institute of Biomedical Imaging and BioEngineering, NIH

• Hardware Platforms for Point-of-Care testing
• Informatics Standards for Connectivity and Data Integration
• Clinical Applications in Disease Monitoring and Management

Panelists:

Craig Lehmann, Ph.D.

Steven Buchsbaum, Ph.D., Senior Program Officer, Global Health Technologies, Bill & Melinda Gates Foundation

James H. Nichols, Ph.D., DABCC, FACB, Professor of Pathology, Tufts University School of Medicine; Medical Director, Clinical Chemistry, Baystate Health

5:00 Networking Reception

6:00 Close of Day One

 

Pre-Conference Symposia | Day 1 | Day 2