The development of bioanalytical devices that are portable, compatible, scalable and reliable is critical to effective biodefense at the point-of -care. In addition, clinical data must be generated and incorporated into the key operational decision-maker networks. Cambridge Healthtech’s 26th International Biodetection Technologies: Point-of-Care for Biodefense will bring together the global industry, academic and government biodefense community to discuss advancements in approaches for optimizing performance of field technologies, translational challenges, regulatory approval of diagnostic tools, and data analysis to enable effective decision-making.

Final Agenda

Thursday, June 28, 2018

12:30 pm Registration

Aberration Detection

1:25 Chairperson’s Opening Remarks

David L. Hirschberg, PhD, Lecturer and Scientist, Department of Interdisciplinary Arts and Sciences and the Institute of Global Engagement, University of Washington, Tacoma

1:30 Instrumentless Molecular Diagnostics - Screening at the Source

Kris Scaboo, PhD, Co-Founder, Gate Scientific

2:00 BioWatch at Age 15: Maturing or Arrested Development?

Tom Slezak, PhD, Program Leader Informatics, Lawrence Livermore National Laboratory

Even within the Biodefense domain, many people are not very familiar with the BioWatch program: a nation-wide collection of aerosol collectors run 7x24x365 and tested daily for evidence of a wide-area bio-aerosol attack. As the nation’s bio-disaster early-warning insurance policy, it involves collaboration between DHS, the CDC, and state and local public health agencies. LLNL has been involved in developing, maintaining, and enhancing multiple aspects of both BioWatch (launched in early 2003) and its predecessor system, BASIS (2000-2003). The talk will provide insider historical context and discuss some of the technical, social, and political challenges BioWatch faces today.

2:20 Coastal Viral Communities and the Human and Ecosystem Implications

Shawn Polson, PhD, Director, Bioinformatics Core Facility, Center for Bioinformatics and Computational Biology; Director, Bioinformatics Network of Deleware, Deleware INBRE; Associate Professor, Department of Computer & Information Sciences and Department of Biological Sciences, University of Delaware

Research exploring ocean and human interactions is advancing our understanding of anthropogenic influences and disease-causing organisms in coastal ecosystems, which are potential threats to the long-term sustainability of the system. With approximately 40% of the world’s population estimated to be residing within 100 km of the coast, identifying the impact humans have on these natural habitats as well as the role that the coasts play in human wellbeing is of great importance.

2:40 Early Notification through Electronic Disease Surveillance

Wayne Loschen, Software Engineer, Johns Hopkins University Applied Physics Laboratory

This presentation will discuss the capabilities of ESSENCE, how it has evolved to be the civilian (CDC) and military (DoD) national syndromic surveillance system, and future directions to include advanced visualization, analytics, and predictive capabilities.

3:00 Technological and Scientific Gaps in Biosurveillance and BioDetection

David Hodge, PhD, Program Manager, Chemical Biological Defense Division, U.S. Department of Homeland Security

3:30 Refreshment Break in Exhibit Hall with Poster Viewing

Tools and Technology at the Point-of-Care

4:15 PANEL DISCUSSION: Impact of Diagnostic POC Technology

Moderator: Joany Jackman, PhD, Senior Scientist, Johns Hopkins University Applied Physics Laboratory

Panelists: Kris Scaboo, PhD, Co-Founder, Gate Scientific

Kent Lewandrowski, PhD, Director of Clinical Laboratories, Pathology, Massachusetts General Hospital

William Clarke, PhD, Director, Clinical Toxicology, The Johns Hopkins Hospital

Point-of-care (POC) technology is a game changing development in the field of medicine. It is potentially disruptive technology in that it has the potential to change the way that care is delivered to patients and in the way that clinicians and patients interact. In this panel we will discuss the impact of POCT, how should it be determined, what benefits are yet to be realized and what other impacts need to be evaluated. Please join the panel of experts to discuss the application of POCT and the metrics used to determine its value.

5:15 End of Day and Dinner Short Course Registration

6:00 Dinner Short Courses*

*Separate registration required

Friday, June 29, 2018

8:00 am Morning Coffee

Optimizing Performance of Traditional Point-of-Care Detection

8:25 Chairperson’s Remarks

Joany Jackman, PhD, Senior Scientist, Johns Hopkins University Applied Physics Laboratory

8:30 KEYNOTE PRESENTATION: The Application of Point-of-Care Laboratory Testing for Pathogen Detection and Patient Management

Kent Lewandrowski, PhD, Director of Clinical Laboratories, Pathology, Massachusetts General Hospital

9:00 Integrated Droplet Based Microfluidic Platform for Rapid Antimicrobial Susceptibility Testing and Bacterial Growth Analysis

Tania Konry, PhD, Assistant Professor, Department of Pharmaceutical Sciences, Northeastern University

The rapid emergence of antibiotic resistance presents an alarming challenge for management; it is now increasingly likely that many patients will be treated with inactive therapy, leading to adverse outcomes. Here, a novel technology called ScanDrop that incorporates a bead-based assay and microfluidics device will address the shortcomings of current diagnostic technologies. As conceived, ScanDrop provides ultrafast (< 20 min), highly sensitive, direct-from-patient sample diagnostics for UTI pathogens without the need for culture pre-amplification, and provides AST results within 15 min of specimen acquisition.

9:30 Implications of Infectious Virus in Exhaled Breath and Next Steps in Defining the Role of Airborne Transmission in Influenza

Donald K. Milton, MD, PhD, Professor, Environmental & Occupational Health Medicine, Maryland Institute for Applied Environmental Health, Department of Epidemiology & Biostatistics, School of Public Health, University of Maryland

Lack of human data on influenza virus aerosol shedding fuels debate over the importance of airborne transmission. We provide overwhelming evidence that humans generate infectious aerosols and quantitative data to improve mathematical models of transmission and public health interventions. We show that sneezing is rare and not important for - and that coughing is not required for - influenza virus aerosolization. Our findings, that upper and lower airway infection are independent and that fine-particle exhaled aerosols reflect infection in the lung, opened a pathway for a deeper understanding of the human biology of influenza infection and transmission.

10:00 Networking Coffee Break

Tools and Technology at the Point-of-Care

10:30 Universal Point-of-Care Diagnostics for All Bacterial Pathogens

Harshini Mukundan, PhD, Team Leader, Chemistry Division, Los Alamos National Laboratory

Our innate immune system is able to detect all pathogens and discriminate bacterial and viral pathogens to mount a timely response. Mimicking this recognition in the laboratory can provide rapid, universal and agnostic strategies for point-of-care detection for all pathogens. Our team had utilized this core inspiration to develop and validate a diagnostic tool kit for Gram-positive, negative and indeterminate pathogens. The concept, development of the approach and validation in blinded clinical samples in resource poor nations will be shown.

11:00 Radiation Biodosimetry: A Mass Screening Tool for Radiological/Nuclear Events

Mary Sproull, Biologist, National Institutes of Health, National Cancer Institute

There has been great advancement within the field of radiation biodosimetry in the last decade in response to the need for development of new medical countermeasures for radiological and nuclear events. Our work has centered on development of new dose prediction models for unknown received radiation dose using a proteomic approach. Our current work expands on these previously characterized models to test their application for mass screening utility using a variety of murine strains. Our findings indicate that these dose prediction models have potential utility for mass population screening.

11:30 Digital Assay Solutions and Global Spatiotemporal Surveillance System

David Winterheimer, Director, Sales & Marketing, Cellmic

We have introduced a universal point-of-care platform for high-performance immunoassay analysis with trans-visual sensitivity and secure cloud services for global spatiotemporal surveillance to address the rapidly evolving needs of the national security, the public health, and the emergency services. Our universal platform includes software packages and mobile optical readers that can analyze any immunoassay with exceptional sensitivity and accuracy beyond the ability of human vision and other commercially-available instruments, therefore, enabling rapid, point-of-care diagnostics of various biological and chemical threats and diseases markers using inexpensive and disposable tests in the field.

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

Next Generation Resources for Biodetection at the Point-of-Care

1:40 Chairperson’s Remarks

Harshini Mukundan, PhD, Team Leader, Chemistry Division, Los Alamos National Laboratory

1:45 Facilitating the Path to Commercialization via Resources Provided by Centers for Point-of-Care Technology

Joany Jackman, PhD, Senior Scientist, Johns Hopkins University Applied Physics Laboratory

Starting in 2007, the National Institute of Biomedical Imaging and Bioengineering (NIBIB), established a network of centers to enhance the progression of promising technologies to the commercial market. The Johns Hopkins Center for Point of Care Tests for Sexually Transmitted Diseases is one of those centers. It provides resources to industry and organizations at no charge to speed the progression of promising technologies to commercialization. These resources include technology comparisons, access to physicians and other end users, de-identified clinical samples, implementation guidance, critical path funding and other resources to help companies reach the market faster.

2:15 Bringing Precision Medicine to the Point-of-Care

Phillip LaJoie, Vice President of Operations, 2bPrecise, LLC

Barriers exist in the clinical workflow; the gap between genomic information and its timely, meaningful application at the point of care. Today, the science of genomics occurs in labs (blood, tissue testing), research facilities (omics, sequencing), pharmaceutical companies (biomarkers for specific drug efficacy) and clinical trial programs. But, it’s not accessible in actionable, meaningful clinical terms; nor is it structured and harmonized with the clinical context of the patient. And it is not available in the current workflow of the clinician. For the first time, we’re seeing some alignment on the importance of precision medicine. These stakeholders are coming together to help realize the promise of genomic knowledge. When delivered at the point-of-care, precision medicine will have the greatest impact.

2:45 Networking Refreshment Break

Advances in Fieldable Technologies and Assays

3:00 Rethinking Our Approach to Fieldable Infectious Disease Diagnostics

Charles Young, PhD, Chief Scientist, Applied Biology Group, Johns Hopkins University Applied Physics Lab

Current approaches to fieldable infectious disease diagnostics are based simply on reducing the size and logistical burden of standard methods currently used in hospital laboratories. Many of the challenges faced in fielding systems to austere environments have not been addressed and some of the issues may simply prove too difficult to overcome. Perhaps it is time to reassess our current efforts and work to introduce new, novel approaches that may be more amenable for disease diagnosis under field-forward, austere conditions.

3:30 Immune Profiling to Identify Exposure to Infectious Agents

Richard DiPaolo, PhD, Associate Professor, Molecular Microbiology & Immunology, Saint Louis University School of Medicine

Our lab is developing a diagnostic assay to diagnose previous exposure to a vaccine (smallpox vaccine) or infectious agent (monkeypox). The assay was developed by performing large scale sequencing of immune receptors (T cell receptors) in vaccinated and infected individuals, identifying vaccine and infectious associated receptors, and developing the diagnostic assay based on the absence or presence of these receptor sequences in a small sample of blood.

4:00 Bacteria-Specific Tracers as Imaging Biomarkers to Diagnose and Monitor Infections

Alvaro Ordoñez, MD, Post-Doctoral Fellow, Johns Hopkins University

The talk summarizes our efforts to develop rapid, noninvasive, whole-body imaging technologies that can localize bacterial infections with specificity and provide a quantitative readout of disease burden in response to treatment.

4:30 Close of Conference