Portability, compatibility, scalability, and reliability are all crucial aspects of point-of-care (POC) devices in the biodefense setting. On top of these requirements, clinical-level data must be generated and digested to feed back into decision support networks. The Knowledge Foundation’s 23rd Annual Biodetection Technologies: Point-of-Care for Biodefense will bring together the user community (government and academic labs) and industry (diagnostics tool providers) to address three main components in POC for biodefense: Optimizing performance of field technologies, FDA approval of diagnostic tools, and data analysis to enable decision making.
This event follows Knowledge Foundation’s Biodetection Technologies: Pathogen and Biothreat Detection, being held from June 22-23, 2015. Together, these two events will provide three full days of programming around biodetection technologies in both the lab and in the field.
TUESDAY, JUNE 23
12:15 pm Conference Registration
1:40 Chairperson’s Remarks
Amy L. Altman, Ph.D., Vice President, Biodefense and Protein Diagnostics, Luminex Corporation
1:45 The Future of Biological Incident Characterization – A High Level View
| Gerald Epstein, Ph.D., Deputy Assistant Secretary for Chemical, Biological, Radiological, and Nuclear Policy at U.S. Department of Homeland Security In the event of a bioterrorist attack, officials will require information as quickly as possible about the organism that was involved, the environment that was affected, and the population that was exposed. Gathering and making sense of this information places great stress on environmental biodetection and clinical diagnostic capabilities. This talk will explore issues involved in providing the necessary information, including the role of biodetection and diagnostics. | |
2:30 Biodetection Systems—Solving for the Complex Challenges of Effective Surveillance, Timely Detection, and Accurate Attribution in a Fiscally-Constrained Environment
| Matthew J. Shaw, Vice President, CBRNE Defense, Battelle Amid an era of evolving natural and man-made biological threats, the need for highly accurate and fast biodetection systems and effective point of care is critical. Matt Shaw will discuss the future of biodetection technologies in a fiscally-constrained environment, how they have evolved and how they must adapt to meet needs of the changing threat, how they are essential for effective point-of-care, and the potential impacts of regulatory hurdles on their fielding. | |
3:15 Diagnostics for the Public Health Emergency Medical Countermeasures Enterprise: The BARDA CBRN Diagnostics Portfolio
Paul Eder, Ph.D., Senior Advisor, Tunnel Consulting Services (Contractor), BARDA
BARDA’s mission, within HHS’ Office of the Assistant Secretary for Preparedness and Response, is to develop and procure medical countermeasures that would mitigate the adverse health effects of CBRN incidents, antimicrobial resistance, pandemic influenza, or other emerging infectious disease outbreaks. BARDA’s diagnostics portfolio supports the development of rapid diagnostics to detect resistance, infection or onset of illness caused by these threats for the purpose of patient management and clinical decision-making.
3:45 Refreshment Break in the Exhibit Hall with Poster Viewing
4:15 EbolaCheck - The First True POC qRT-PCR Device for 3rd World Humanitarian Crisis Responses
Sterghios Moschos, Ph.D., Reader (Associate Professor), Biomedical Sciences, University of Westminster
EbolaCheck is a whole biofluid qRT-PCR POC system for simple, economical and <40 min molecular diagnosis of Ebola in the field. The battery-powered platform delivers sensitivity and specificity equal to clinical diagnostics with no specialist training requirements, suitable for humanitarian crisis responses. The work is funded by DfID / Wellcome Trust / Save the Children UK and ELRHA and represents the UK response for rapid point-of-need diagnostics.
4:45 Use of Advance Optical Imaging for Field Diagnostics of Biothreat Agents
Vinod Jyothikumar, Ph.D., Director, Office of Laboratory Safety, George Washington University
The use of optical imaging for medical diagnostics at the point-of-care (POC) has great potential, but is limited by cost and the need for highly trained personnel. To this end, the cost, complexity, and size of optical microscopy devices can be reduced. These techniques can perform particularly well at specific tasks such as cytometry, Field diagnostic, and infectious disease management.
5:15 End of Day
WEDNESDAY, JUNE 24
8:00 am Morning Coffee
8:25 Chairperson’s Remarks
David R. Hodge, Ph.D., Program Manager, Chemical Biological Defense Division, U.S. Department of Homeland Security (DHS)
8:30 Development and Validation of Rapid Detection and Diagnostics Assays: The Simplified Approach to Production of Successful Assays
David R. Hodge, Ph.D., Program Manager, Chemical Biological Defense Division, U.S. Department of Homeland Security (DHS)
The creation and validation of rapid point-of-care detection and diagnostic assays are often thought of as separate parts of a project. Instead they must be combined together in order to be successful in the final commercialization and end user acceptance of the assays. Here we describe a comprehensive yet inexpensive program inside DHS known as Public Health Actionable Assays, which involves a series of simple techniques and steps required to properly validate assays, and gain acceptance of such tools by the government and private end users.
9:00 ScanDrop – Portable Lab-on-a-Chip Diagnostic Platform for Ultra Fast Pathogen Detection and Susceptibility Testing
Tania Konry, Ph.D., Assistant Professor, Department of Pharmaceutical Sciences, Northeastern University
The ability to shrink the window of empiric therapy by rapidly identifying and determining antimicrobial susceptibility for pathogens will improve patient outcomes by ensuring early, active therapy. Therefore, our novel portable Lab on a Chip technology, ScanDrop, provides ultrafast and highly sensitive detection without the need for culture pre-amplification as well as phenotypic susceptibility results within 3 hours of specimen acquisition. Importantly, the ScanDrop microfluidics-based technology can be deployed with simple, inexpensive, portable instrumentation and disposables, which make the technology ideally suited to permit significantly accelerated institution of appropriate, tailored antibiotic therapy, thereby significantly improving patient outcomes and fostering antimicrobial stewardship goals. Lastly, the portability and low cost of consumables should allow for wide utility across the healthcare continuum.
9:30 Moving Biological Sensors Forward: Challenges and Opportunities
Charles Young, Ph.D., Principal Professional Staff, Chief Scientist, Applied Biology Group, Asymmetric Operations Sector, The Johns Hopkins University Applied Physics Laboratory
This presentation will touch on specific drawbacks of existing sensor technologies as well compare the current move toward point-of care-instrumentation in hospitals and how it overlaps with Department of Defense’s needs. Unfulfilled DOD needs will also be addressed in the context of existing and new point-of-care technologies.
10:00 Coffee Break in the Exhibit Hall
10:45 PANEL: Portability, Compatibility, Reliability, and Scalability of Diagnostic and Detection Devices
- Getting regulatory approval – What must be considered?
- Enabling response – Should testing originate clinically or environmentally?
- Understanding the business case
Moderator: David R. Hodge, Ph.D., Program Manager, Chemical Biological Defense Division, U.S. Department of Homeland Security (DHS)
Panelists: Tania Konry, Ph.D., Assistant Professor, Department of Pharmaceutical Sciences, Northeastern University
Charles Young, Ph.D., Principal Professional Staff, Chief Scientist, Applied Biology Group, Asymmetric Operations Sector, The Johns Hopkins University Applied Physics Laboratory
11:45 Current Requirements in the World of Point-of-Care Applications: A Short Overview
Roberto Spricigo, Ph.D., OEM Manager, QIAGEN Lake Constance
Healthecare professionals are looking for faster patient evaluation and efficient diagnosis. Rapid point-of-care tests are therefore becoming increasingly important as they provide precise quantitative results. The presentation will cover the requirements for POC devices for lateral flow and isothermal amplification applications.
12:00 pm HIV RNA Detection and Quantification by Nucleic Acid Testing-PNA Enzyme Linked Assay (NAT-PELA) for Viral Load Assays
Daniel Appella, Ph.D., Senior Investigator, LBC, NIDDK, NIH
This presentation will demonstrate how to engineer peptide nucleic acids (PNAs) to detect HIV RNA at levels competitive with standard PCR assays. Since PNA is resistant to degradation by enzymes, diagnostic devices using PNA probes are very stable. With the proper PNA probes, standard ELISA platforms can be used to directly detect HIV RNA and may be used to quantify viral load in plasma at clinically useful levels.
12:15 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:40 Chairperson’s Remarks
Brian Young, Ph.D., Technology Initiatives Leader, Applied Genomics, Battelle
1:45 Moving HTS from Research Lab to Diagnostic Core
Yuriy Fofanov, Ph.D., Professor, Department of Pharmacology & Toxicology; Director of Genomics and Bioinformatics Lab at The Sealy Center for Structural Biology & Molecular Biophysics (SCSMB), University of Texas Medical Branch (Galveston)
The price of High Throughput Sequencing (HTS) has dropped dramatically, while the speed of the instruments has also improved. As such, three major challenges remain to be resolved before this technology will be able to move from being nearly exclusively a research tool to routine diagnostic use. This talk will focus on strengths and weaknesses of available approaches to resolve these challenges.
2:15 Opportunities and Challenges for Diagnostic Applications of NGS
Richard Winegar, Ph.D., Chief Scientist, Biosurveillance and Diagnostics, Global Health Security, MRIGlobal
NGS has potential to provide the ultimate characterization of infectious agents. This could be especially useful in diagnosis of sepsis and fevers of unknown origin. However, significant challenges must be addressed before NGS-based diagnostics become widely adopted. These include sample and library preparation, automation, trusted reference libraries, bioinformatics, and regulatory pathways. This presentation will focus on MRIGlobal’s research projects to accelerate the use of NGS as a powerful diagnostic tool.
2:45 Strengths and Weakness of NGS in Biosurveillance
Brian Young, Ph.D., Technology Initiatives Leader, Applied Genomics, Battelle
Here I describe how NGS extends the range of species and strain identification possible within single assays and why NGS provides broader support for attribution. NGS also provides ancillary information such as virulence and resistance not possible from other genetic tests. However, metagenomic data presents significant data analysis challenges; where improper use of analytical tools can result in false positives or over-interpretations. The proper roles of NGS in both detection and identification are discussed.
3:15 Dessert Break in the Exhibit Hall with Poster Viewing
4:00 Tools to Enhance Situational Awareness in Infectious Disease Surveillance
Alina Deshpande, Ph.D., Scientist, Defense Systems and Analysis Division, Los Alamos National Laboratory
Los Alamos National Laboratory has developed a suite of publicly available web-based tools that provide actionable information and knowledge for enhanced situational awareness during an unfolding event--the Surveillance Window Application (SWAP), the Biosurveillance Resource Directory (BRD), and the Biosurveillance Analytics Resource Directory (BARD). This presentation will review each tool and its application to various disease surveillance situations.
4:30 The BioWatch Program: Mission and Future
Michael Walter, Ph.D., Detection Branch Chief, BioWatch Program Manager, Office of Health Affairs, U.S. Department of Homeland Security (DHS)
Dr. Walter will provide an overview of the various BioWatch mission components, opportunities for integration and collaboration within the larger biodetection community, and the importance of engagement with regional coalitions. As the Program is looking at ways to improve bio-aerosol threat monitoring capability and capacity while increasing overall cost effectiveness, the future of the program’s technology and analysis of specific capability areas for advancement will be discussed, the overall goal being to reduce the time required to accurately detect the presence of biological threats.
5:00 Close of Conference
For more details on the conference, please contact:
Samantha Lewis
Conference Director
Knowledge Foundation, a division of CHI
Phone: (+1) 781-972-5461
Email: slewis@healthtech.com
For partnering & sponsorship information, contact:
Sherry Johnson
Manager, Business Development
Knowledge Foundation, a division of CHI
Phone: (+1) 781-972-1359
Email: sjohnson@healthtech.com