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Medical Diagnostic S&T Investments to Strengthen Medical Biodefense Capabilities


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2018 Annual Meeting of the Council of Sponsoring Institutions
Dr. Richard Schoske

Published in: Government & Nonprofit
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Medical Diagnostic S&T Investments to Strengthen Medical Biodefense Capabilities

  1. 1. UNCLASSIFIED UNCLASSIFIED Dr. Richard Schoske February 2018 Medical Diagnostic S&T Investments to Strengthen Medical Biodefense Capabilities Distribution Statement A: Approved for public release; distribution is unlimited.
  2. 2. UNCLASSIFIED UNCLASSIFIED DTRA Mission “To safeguard the US and its Allies from Weapons of Mass Destruction (Chemical, Biological, Radiological, and Nuclear) and High-Yield Explosives by providing capabilities to reduce, eliminate and counter the threat, and mitigate its consequences” Chemical Biological Radiological Nuclear High-Yield Explosives
  3. 3. UNCLASSIFIED UNCLASSIFIED DTRA strategic vision MISSION “To invest in transformational ideas, innovative people, and actionable technology development for Chemical Biological Defense solutions” VISION “Create…Collaborate…Communicate”
  4. 4. UNCLASSIFIED UNCLASSIFIED Medical Diagnostics Goal
  5. 5. UNCLASSIFIED UNCLASSIFIED Medical Diagnostics S&T Strategy
  6. 6. UNCLASSIFIED UNCLASSIFIED Antimicrobial Resistance 6 The Problem: Bacterial and viral infections have similar symptomology often making them clinically indistinguishable Leading to overuse of antibiotics and anti-microbial resistance
  7. 7. UNCLASSIFIED UNCLASSIFIED A National, Global, and Military Problem 7 • CDC – Top 5 Health Threats • #1 Antibiotic resistance, untreatable infections • 2 million patients/year contract infectious disease (10% of all hospitalized patients) • Hospital-acquired infections = 4th leading cause of death in US (100,000/year). • National Action Plan for Combatting Antibiotic Resistant Bacteria • Advance Development and Use of Rapid and Innovative Diagnostic Tests for Identification and Characterization of Resistant Bacteria. • War Wounds • >80% clinical isolates from wounded are resistant to >3 types of antimicrobials (esp. Acinetobacter baumannii) • Infectious Diarrhea • 55-75% personnel affected (Operations Iraqi Freedom, Enduring Freedom) • 25% incapacitated, 10% hospitalized • World Health Organization • “Antimicrobial resistance … threatens the success and continuation of clinical medicine as we know it. • “Effective surveillance is the cornerstone of …international efforts to control antimicrobial resistance.”
  8. 8. UNCLASSIFIED UNCLASSIFIED 8 Two Complementary Approaches 1) Rapid Differentiation of Viral vs Bacterial Infections using host- based biomarkers 2) Real-time, Single-Cell Antimicrobial Susceptibility Testing
  9. 9. UNCLASSIFIED UNCLASSIFIED First Approach 9 Host-Based Response Biomarkers • Measures the level of three protein biomarkers in combination to distinguish between bacterial and viral infections • Preliminary results show sensitivity and specificity outperforms many laboratory measurements, clinical parameters, and well-established biomarkers TRAIL p<1 0-66 p<0 .33 IP-10 p<1 0-10 p<1 0-40 CRP p<1 0-65 p<1 0-44
  10. 10. UNCLASSIFIED UNCLASSIFIED Host-Based Response Biomarkers 10 Advantages Requires only a small blood sample Answer within 15 minutes Provides “front-line” medical treatment information to support immediate or screening decisions (antibiotics vs antiviral) Prevents antibiotic misuse
  11. 11. UNCLASSIFIED UNCLASSIFIED Second Approach 11 • Real-time, Single-Cell Antimicrobial Susceptibility Testing • Measures growth activity of a single bacteria in the presence of different antibiotics at varying concentrations • Combines single cell rapid microfluidic channel with electrochemical detection for identification of resistant bacterial and determination of Minimal Inhibitory Concentration (MIC) Agent-based Susceptibility Markers
  12. 12. UNCLASSIFIED UNCLASSIFIED Agent-based Susceptibility Markers 12 Advantages Requires only a small blood sample Answer in less than 4 hours Provides detailed medical treatment information to support decisions on type and concentration of antibiotic to use Prevents antibiotic resistance
  13. 13. UNCLASSIFIED UNCLASSIFIED Multi-Echelon Diagnostics Program 13 This program seeks: •Early testing of Point-of-Care diagnostic platforms •Evaluation of multi-echelon diagnostic prototypes •Wireless upload capabilities in operational environments
  14. 14. UNCLASSIFIED UNCLASSIFIED Past and Present Platforms 14 Vertical Flow Immunoassay Fio Chem/Bio Diagnostics (DPP) 4-Plex LFI InBios ADMD 2-Plex LFI Fio Deki Reader v100 BioFire Film Array - SASFI Pouch - EZ-1 Pouch (Pre-EUA) InBios Multiplexed LFI Fio Deki Reader v200 Mesa Tech Multiplex Pathogen System Viral vs. Bacterial POC Ebola Box P a s t P r e s e n t
  15. 15. UNCLASSIFIED UNCLASSIFIED MEDx OCONUS Clinical Sites 15 Peru Sierra Leone Madagascar Thailand Australia
  16. 16. UNCLASSIFIED UNCLASSIFIED MEDx Opportunities 16 NRL is seeking partners thru a Broad Area Announcement: “Multiechelon Diagnostics (MEDx) Technology Development and Tiered Evaluation” Details of the BAA can be found at the following website: business/files/files/611706_Multiechelon_Diagnostics(MEDx)_Technology_Dev elopment_and_Tiered_....pdf Instructions on how and where to send the white paper can be found at the following website:
  17. 17. UNCLASSIFIED UNCLASSIFIED 17 Other ways to get involved
  18. 18. UNCLASSIFIED UNCLASSIFIED 18 ü Ability to reach innovators in Small Business and Non-Traditional Defense Contractors ü Remove barriers (FAR/DFARS) ü Accelerate development timelines ü Promote Public/Private cooperative relationships ü Often projects under can be awarded in 90 days Other Transaction Agreement (OTA) Why?
  19. 19. UNCLASSIFIED UNCLASSIFIED Must be for development of a prototype üCan be analysis, process improvement and/or hardware/software üFollow-on production is acceptable Must meet one of the following conditions: üNon-traditional Defense Contractor participating to a significant extent üOne-third cost-share requirement for Traditional Defense Contractors OTA Requirements 19
  20. 20. UNCLASSIFIED UNCLASSIFIED How to Get Started 20 ü Open to nonprofit and for-profit organizations and academia ü Non-traditional industry focus ü All requisite notices filed with government agencies pursuant to the National Cooperative Research and Production Act of 1993 ü $500 annual dues, waived for academic organizations for some OTAs ü If potential performer is not part of the identified consortium, direct them to website/consortium POC for membership application (takes a few weeks) Industry/Academia
  21. 21. UNCLASSIFIED UNCLASSIFIED Partner with DTRA… Join an OTA 21 You can find information on joining a consortium and solicitations at the following links: ü Medical CBRN Defense Consortium MCDC: ü Defense Innovation Unit Experimental DIUx: ü C5: Consortium for Command, Control and Communications in Cyberspace
  22. 22. UNCLASSIFIED UNCLASSIFIED WhereToFindBusinessOpportunities 22
  23. 23. UNCLASSIFIED UNCLASSIFIED Carefully review BAA and Amendment Plan ahead and allow time for peer reviews and corrections Revolutionary advancements over existing state of technology required Ability to achieve program milestones is critical Partnering is encouraged TipsForStrongProposals 23
  24. 24. UNCLASSIFIED UNCLASSIFIED BuildingaCompetitiveProposal 24 Concept Definition ü Why is the approach revolutionary? ü Challenges ü Potential solutions ü Risk mitigation Supporting Technical Analysis ü Previous experimental evidence ü Technical and quantitative rationale for ability to meet metrics Research Plan ü Specific, quantitative, intermediate milestones ü How will progress be assessed? Management Plan ü Plan for coordination and roles of all members ü Risk management approaches Clarity is Key
  25. 25. UNCLASSIFIED UNCLASSIFIED ? Questions? 25