Tuesday, August 19

8:00 am Morning Coffee

INTEGRATED SYSTEMS- FROM SAMPLE TO OUTPUT

8:30 Chairperson’s Remarks
Kevin P. O’Connell, Ph.D., Visionary Solutions Architect, In-Q-Tel, Inc. 

8:40 Microluidic Biothreat Detection and Forensic Identification Systems
Joanne Horn, Senior Staff Scientist, Microchip Biotechnologies, Inc.
Microchip Biotechnologies Inc. (MBI) is developing a universal sample preparation system based on proprietary Micro On-chip Valve (MOV) technology that has been coupled with a variety of detection and separation systems.  The technology provides a flexible, robust and cost effective approach to target isolation with a clean transition to identification.  Bead based DNA and immunochemistry isolations have been integrated with a robust, versatile fluorescence detection system to provide sensitive, high dynamic range quantification of labeled beads, antibodies, PCR and qPCR products as well as micro channel and capillary separation outputs.

9:10 A High-Speed Biothreat Detection System Using Silicon Chip-Based PCR
Joel Grover, Ph.D., Chief Executive Officer, Thermal Gradient Inc
SAIC and Thermal Gradient are working to develop technologies for a high speed “detect-to-protect” aerosol biothreat detection system employing a flow-through silicon chip to perform multiplex PCR amplification of threat-specific genomic nucleic acid.  Candidate applications for the system include attack alert for high value office buildings and transportation facilities.  The system is designed as an integrated trigger/confirmer device using a front-end UV Laser-Induced Fluorescence (UV-LIF) detector as a trigger and multiplex PCR for threat detection and ID. Upon alert from the trigger, the confirmer performs high volume sampling of the air to collect an aerosol sample. Particulates are extracted from the sample and processed to yield amplifiable nucleic acid.  The PCR chip, a multilayer flow-through device, performs 30 or more PCR cycles in five minutes to amplify multiple genomic nucleic acid targets found only in biothreats. After these targets are amplified to detectable levels, detection is performed using a multi-color fluorescence readout approach. End-to-end processing time from trigger alert to threat confirmation is about ten minutes.

9:40 Coffee Break, Exhibit and Poster Viewing

10:10 Detection of Nucleic Acid and Toxin Targets on an Automated Portable System
Shuqi Chen, Ph.D., Chief Executive Officer, IQuum, Inc. 
The Liat™ system is an integrated system for rapid identification and diagnostic confirmation of biological agent exposure or infection. Based on IQuum’s Lab-in-a-tube technology, the Liat system is a man-portable, fully-automated device capable of accepting a raw sample and rapidly and simultaneous identifying multiple Biological Warfare agents (BWA) and other pathogens or toxins of operational concern using state-of-the-art laboratory chemistries such as real-time polymerase chain reaction. The system consists of the disposable Liat Tube with pre-packed regents, and a stand-alone Liat Analyzer, a highly integrated and miniaturized sample processor, which includes an embedded computer for automation control and readout display, as well as built-in network connectivity. The system can be operated in fixed medical laboratories and deployed medical units to fully support bio-defense and military medical diagnostic needs.

10:40 Near Real-Time Biological Threat Detection for Commercial Building Security Applications
Joe Hernandez, President and Chief Executive Officer, Innovative Biosensors, Inc.
An integrated biological aerosol collector and identification system is now available for rapid, sensitive detection and identification of biological threat agents.  This system integrates biological aerosol sample collection and concentration functions and a novel cellular based bioluminescent immunoassay method for cost effective, near real-time biological detection and identification.  Incorporated into a sophisticated building security system, the device provides area-wide biological monitoring information as part of an integrated CBRNE protection system.

11:00 Total Facility System Integration and Response for Biologics Threat Detection
Anthony D. Bashall, Executive Vice President, SecureTeq Corporation
What is described here is an approach to integrate the entire threat detection information and data within a single platform. A plethora of detectors and sensors provide a vast array but very little actionable intelligence. The threat detection platform outlined is able integrate and assimilate data from a multitude of CBRNE detectors at the same time fully integrating live video feeds. The system can also utilize apparently disparate such as wind direction, wind speed, time of day, global threat levels, occupancy levels, etc., to provide a more intelligent Standard Operating Procedure (SOP).

11:20 Expert Panel:
COLLABORATION AND BUSINESS CHALLENGES: Gap Analysis and Investment Perspective
Cole Van Nice, Partner, Chart Venture Partners
Penrose “Parney” Albright, Managing Director and Vice Chairman, Civitas Group LLC

12:10 pm Luncheon Presentation (Sponsorship Available) or Lunch on Your Own

FILLING THE TECHNOLOGY GAPS IN BIODEFENSE AND
POINT-OF-CARE DIAGNOSTICS

(Shared Session with Enabling Point-of-Care Diagnostics conference)

1:30 Chairperson’s Remarks:
Steven Buchsbaum, Ph.D., Senior Program Officer, Global Health Technologies, Bill & Melinda Gates Foundation

1:40 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 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:
REIMBURSEMENT AND REGULATORY ISSUES
Moderator: Kathleen Claessens, MS, RN, Reimbursement Affairs, Roche Diagnostics

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 Conference