TUESDAY, AUGUST 19
12:30-1:30 pm Registration
FILLING THE TECHNOLOGY GAPS IN
BIODEFENSE AND POINT-OF-CARE DIAGNOSTICS
(Shared Session with Systems Integration in Biodefense Conference)
1:30 Chairperson’s Remarks
Steven Buchsbaum, Ph.D., Senior Program Officer, Global Health Technologies, Bill & Melinda Gates Foundation
1:40 Featured Presentation
Technical Hurdles Facing Homeland Security Bio-Countermeasures Development
Keith B. Ward, Ph.D., Chief, Chem-Bio R&D Branch, Science and Technology Directorate, Department of Homeland Security
DHS customers comprise a diverse group having wide ranging requirements. Low cost and low probability of false alarms are particularly challenging for detection platforms and will require innovative solutions. Understanding how best to address novel engineered and emerging threats effectively also will require overcoming numerous technical hurdles.
2:15 NIAID Biodefense Diagnostic Program: Filling the Technology Research Gaps
Maria Y. Giovanni, Ph.D., Assistant Director for Microbial Genomics & Advanced Technology, Division of Microbiology and Infectious Diseases, NIAID/NIH/DHHS
Presentation will describe NIAID/NIH comprehensive diagnostic program that spans a broad spectrum of projects from emerging technologies to further advanced product development of established techologies and platforms for Biodefense. Cooperative grant programs will be highlighted that describe successful partnering with the scientific community, industry, government agencies and others.
2:50 Leveraging Cell Phone Technology to Make Point-of-Care Diagnostics Accessible in the Developing World
Boris Nikolic, M.D., Senior Program Officer, Bill & Melinda Gates Foundation
In order to establish the broadest access for the developing world, we are exploring the use of mobile technology for health care applications. One of our current areas of focus is the use of the cell phone technology as related to health information systems and health care diagnostics. Specifically, we are exploring the integration of mobile point-of-care devices that could leverage the cell phone for computation, control, data download and upload. In addition to strictly diagnostic devices, we are also exploring an integration of a wide range of devices and systems from the most cost-effective integration of biometrics into the cell phone (for the identification of the patients and health care providers, identification of counterfeit drugs), to data security, transfer and management in the context of diagnostic test provision. Our goal is to help create and bring effective and appropriate medical tests to areas in need in the developing world.
3:20 Refreshment Break, Exhibit and Poster Viewing
4:00 Expert Panel: REGULATORY GUIDANCE AND REIMBURSEMENT ISSUES
Moderator: Kathleen Claessens, MS, RN, Reimbursement Affairs, Roche Diagnostics
- New guidance for waived testing under CLIA
- Reimbursement for point of care vs centralized testing
Panelists:
Steven I. Gutman, M.D., Director, Office of in Vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration
Paul Radensky, M.D., J.D., Partner, McDermott Will & Emery LLP
Thomas A. Gustafson, Ph.D., Senior Policy Advisor, Arnold & Porter, LLP
5:00 Close of Day