Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland...

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Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency Biological Countermeasures NDIA Homeland Security Symposium Dr Steven Buchsbaum Program Manager, HSARPA [email protected]

Transcript of Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland...

Page 1: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

Dr Steven Buchsbaum, NDIA Homeland Security Symposium

27 May 2004

U.S. Department of Homeland Security

Homeland Security Advanced Research Projects Agency

Biological Countermeasures NDIA Homeland Security Symposium

Dr Steven BuchsbaumProgram Manager, [email protected]

Page 2: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 2

Biological Countermeasures Thrust Areas System Architecture Studies

End-to-End Studies Provide Quantitative Basis for Countermeasures Strategy

Define Future Directions and Requirements for Systems

Detection Systems RA03-01, BAND & RABIS Future Directions

Assays Development BAA04-03, Bioinformatics and Assays Development

Page 3: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 3

BW Architecture Studies Architecture Study of Urban Outdoor Threat Scenarios

Exam both Reference Scenarios and Capabilities Based Threats

Preliminary Study of Indoor Threat Scenarios Inclusive of Homeland Security Specific Challenges

Evaluate Threats to Food and Agriculture

Evaluate CBRN Threats to Water

Page 4: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 4

Bio-Aerosol Defense Architecture Study Objective

Develop biosensing and medical response architecture for large scale bioaerosol attacks

Approach Characterize performance of environmental

sensing networks Evaluate benefit of traditional and non-traditional

medical surveillance options Use epidemiological models to determine

response requirements Assess cost and benefit of different architecture

options Recommend near-, mid-, and far-term solutions

AnthraxAttack

NationalPharmaceutical

Stockpile

BioSensors

Page 5: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 5

Detection Systems for Biological Countermeasures RA03-01

Bioagent Autonomous Networked Detectors (BAND) Upgrade and Expand BioWatch Reduce Costs While Expanding Coverage Support other Bioaerosol Surveillance Missions Enable “Detect to Treat” Response to Attacks

Rapid Automated Biological Identification System (RABIS) Real-time Monitor for Buildings and Selected

Outdoor Locations and Events Enable “Detect to Protect” Response to Attacks

Page 6: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 6

Bioagent Autonomous Network Detector (BAND) Technical Topic Area 1 (TTA1) Bioagent Autonomous Network Detector (BAND)

Detect-to-Treat Biological Surveillance Sensor System Build on Current BioWatch Architecture

Current Biowatch System Exploits Distributed Collector Systems with Centralized Evaluation of Samples

Current Approach Limits Timeliness of Response Current Approach Limits Spatial-Temporal Coverage Granularity Current Approach Driven by Large Logistical and Labor Costs

BAND Will Permit Extending Breadth of Coverage in Threat Space and Increasing Spatial-Temporal Coverage

Must Significantly Reduce Total System Operating Costs

BW Architecture Studies Will Update Strategy and Requirements

Page 7: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 7

TTA-1 Goals – Performance Targets Continuous, Fully Autonomous Operation with 3 Hour Sample

Intervals and 1 Hour Latency (2920 Samples per Year) Broad Agent Coverage > 20 Agents

Spore, Vegetative Cell, Toxin, DNA Virus, RNA Virus

High Sensitivity – Limit of Detection (LOD) of 100 Organisms Assumes 3 Hour, 100 Liter/Minute, 90% Efficient Collection

• Performers Free to Scale to Alternative Approaches

LOD of 10 nanograms for Toxins

Single Agent False Positive Rate of 10-7 with a goal of 10-8

BAND TTA-1

Page 8: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 8

TTA-1 Goals – Cost & System Requirements

Cost of Ownership BAND Unit Acquisition Cost of $25K per Unit or Less

• Assume Quantities of 1,000s

BAND Operating Costs per Unit of $10K per Year or Less• Inclusive of all Costs: Consumables, Maintenance, Spare Parts, etc.

System Requirements Preserve Samples for 5 Days

• Confirmation and Forensics

Robust Wireless, Autonomous Remote Operation Maintenance Interval Exceeding 1 Month Operation in Full Range of Outdoor Environments Modest Packaging and Logistical Requirements

• (Ex: 2 cubic feet Volume)

BAND TTA-1

Page 9: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 9

Key Technical Challenges Very High Sensitivity in Cluttered Background

100 Organisms in a Backgound of > 18,000 liters of air

Extending Breadth of Threat Coverage (>20) Either Multiplexed Testing or Large Number of Tests Alternative Approach – Universal Analysis

Achieving Very Low False Alarm Rate Single BAND System Pfa in the Range of 1 per 10 to 100 Years

Proliferation of BAND Systems Requires Low Single System Pfa

Achieving Low Cost of Ownership Single Sample Cost Goal of ~ $3.50 per Test (Multiplexed) Single Sample, Single Agent Cost Goal of ~ $0.17 per Test

(Non-Multiplexed)

BAND TTA-1

Page 10: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 10

Requirements – Additional Thoughts Sensitivity of 100 Organisms in 18,000 liters of air

Drives Technology Limited Exploration of Full Range of Alternative CONOPS

Same Sensitivity Required of Viruses Individual Viral Threat Particles too Small Multiple Organisms per ACPLA

• Order 10^5 in DoD Speak

Toxin Detection Drives Complexity and Cost Possibly Detectable from Residual DNA

Cost Targets Extremely Aggressive at this Performance

BAND TTA-1

Page 11: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 11

Notional Program Schedule

Phase ITTA-1TTA-1 Phase IIPDR

Phase IIILab Prototype EvaluationField Prototype CDR

FY06FY05FY04 FY08FY07

Scientific Development – PDR Risk Reduction

Engineering for CDR

Field Prototype Production & Testing

Key Decision Points

Proposal includes:• Preliminary Conceptual Design • Preliminary Estimates of

Performance Relative to Goals• Key Issues for Phase I Execution

• Test & Validation plan• Requested GFE

Phase I Completion:• Detailed PDR for both Lab & Field

Prototype• Validated Performance Predictions for

Lab and Field Prototype• Work Plan for Phase II

Phase II Completion:• CDR for Field Protoype• Work Plan for Phase III• Detailed Cost Estimates for

Manufacture• Plan for Commercialization

Performers are encouraged to accelerated schedules if possible!

BAND TTA-1

Page 12: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 12

Programmatic Strategy

Northrop Grumman • Baseline automated PCR / Immunoassay• Spiral development of advanced isothermal assays

MFSI• Next generation reusable microfluidic platform• Modular components - decreased size, increased

longevity, increased functionality

Nanolytics• Miniaturized assay volume by evaporative

concentration• Nanofluidics via electrowetting microactuation

IQuum• New tape encapsulated PCR• New assay concepts (padlock

probes for high multiplexing)

SAIC• Highly multiplexed

amplification• CGE & microarray

readout

USG• Genomic BarCodes, Fast, No

amplification• Single reagent set for all pathogens

Diversify Risk in Two

Dimensions

Diversify Risk in Two

Dimensions

Diversify Engineering Challenge Autonomous Multiplexed Micro-

fluidic PCR

Diversify Engineering Challenge Autonomous Multiplexed Micro-

fluidic PCR

Diversify Scientific Challenge Broadband Approaches for

Sequence Diversity

Diversify Scientific Challenge Broadband Approaches for

Sequence Diversity

BAND TTA-1

Page 13: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 13

© 2004 U.S. Genomics, Inc.

BAND Using Genomic Barcoding

Environmental Sample Taken

DNA Prepared & Tagged

Barcode Generated

Barcode Compared Against dBase

-5 0123456789 HPVC 18

HPVC 11

-4 -2 0 2 4012345

E. coli

B. anthracis strainX

B. anthracis strainY

S. aureusSample barcode

USGenomics Broadband Approach for Detection

BAND TTA-1

Page 14: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 14

MFSI Technical Approach

Air Collector

EluteNucleic Acids

Sonicate

PCR

Agitate

Add/mix 3 ml6 M GuSCN

Pillarchip

Prepare 10-ulaliquots

SampleAerosol

Archive 1 ml

EtOH

Air

Tris-Buffer

Waste

Add/mix

Collector

Sample Processing

NA Analysis

5 ml

4 ml

10-100 ul

Pillar chip with antibodies

Toxin Analysis 3 ml

1 ml

Reconstituted reagents

Add/mix

Command and control

(after 3 hours of collection)

• Flow-through process- archiving, sample preparation and

detection• Dried-down reagents and stable wet chemistries• Two-mode wireless connectivity

• Sonication lysis and pillar chip nucleic acid purification

• Flow-through PCR and immunoassay detectors• Embedded pumps and valves

Protective case that maintainsconstant internal temperature.

Aerosol collector inlet

Hardware and bulk reagents

Reusable Cartridge

Peristalticpumps

Archivedsamples

Sets ofantibodychips

PCRreactors

Dried-downreagents

Hydrated reagentsholding chambers

NA chipsSonicationchambers

Dockingstation forcartridge

BAND TTA-1

Page 15: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 15

Northrop GrummanBroadband Approaches for DetectionCommon integrated weatherproof chassis containing:

• Sample aerosol collection on a dry surface

• Dry surface serves as sample archive

• Common HVAC, communications and control systems

Initial deployment of mature automated identifiers• PCR

• Immunoassay

Future insertion of advanced identifiers• Fast isothermal reactions• Microfluidics to reduce consumable costs• MEMs based transduction• Advanced amplification and

orthogonal approaches reduce FAR

BAND TTA-1

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27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 16

2

2

22

22

11 1

13

3 33

34

4

4

55

666

6

1 2 3 4 5 6 • •

Amplify many sites in the genome in

one reaction

De-multiplex by length, using electrophoresis

De-multiplex by sequence, using DNA microarray

Each genome yields a unique pattern

22

2

3

336

6

66 1

1

1 44

44

6 6633 4

4441

1 1

22 2

Label them with fluorescent dye

• SAIC/GHC/Ibis BAND System Exploits Many Genome Identification Sites with Two Different Technologies

A

B

6

C D

GCGC

Broadband Approach for DetectionBAND TTA-1

Page 17: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 17

Rapid Automated Biological Identification

System (RABIS) TTA-2 Rapid Automated Biological Identification System (RABIS)

Detect-to-Protect Biological Surveillance Sensor System Enable New Paradigms in Biodefense

• Building Protection Architecture• Selected Outdoor Event Coverage

Detect-to-Protect Requires Very Fast Response Time (< 2 Minutes) Very Low False Alarm Rates Broad and Sensitive Threat Coverage

TTA-2 Will Require Significant Innovation Extraordinarily Challenging Technical Goals

RABIS TTA-2

Page 18: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 18

TTA-2 Goals – Performance & Cost Targets Continuous, Fully Autonomous Operation with 2 Minute or

Shorter Sample Intervals Including Latency ~250K Samples per Year

Broad Agent Coverage > 20 Agents Spore, Vegetative Cell, Toxin, DNA Virus, RNA Virus

Limit of Detection (LOD) of 100 Organisms per Liter of Air LOD of 0.05 nanograms per Liter of Air for Toxins

System False Alarm Rate of No More than Once per Month Goal to Reduce System False Alarm Rate < 1 Year

RABIS Unit Acquisition Cost of $50K per Unit or Less Assume Quantities of 100s

RABIS Operating Costs per Unit of $20K per Year or Less Inclusive of all Costs: Consumables, Maintenance, Spare Parts, etc.

RABIS TTA-2

Page 19: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 19

Key Technical Challenges Combined Goals of Short Response Time with High Selectivity

Likely to Require Significant Innovation

Short Sample Interval Exacerbates Technical Challenges to Achieve Low System False Alarm Rates

Approximately 250K Threat-Multiplexed Tests per Year

Short Sample Interval Exacerbates Technical Challenges to Achieve Low Cost of Ownership

Multiplexed (or Broadband) Single Interval Test Cost of ~ $0.08

RABIS TTA-2

Page 20: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 20

Notional Program Schedule

FY06FY05FY04 FY08FY07

Feasibility Analysis

Scientific Development – PDR Risk Reduction

Engineering for CDR

Field Prototype Production & Testing

Key Decision Points

Phase I Completion:• Detailed PDR for both Lab & Field

Prototype• Validated Performance Predictions for

Lab and Field Prototype• Work Plan for Phase II

Phase II Completion:• CDR for Field Protoype• Work Plan for Phase III• Detailed Cost Estimates for

Manufacture• Plan for Commercialization

Bidders are encouraged to provide accelerated schedule if possible

TTA-2TTA-2 I-A Phase I-BFeasibility Decision

Phase IIPDR

Phase IIILab Prototype EvaluationField Prototype CDR

Phase I-A Completion:• Detailed evaluation of RABIS feasability• Updated Phase I-B work plan

Proposal includes:• Preliminary Conceptual Design • Preliminary Estimates of Performance

Relative to Goals• Work Plan for Both Phase I-A & Phase I-B

• Feasability Decision Criteria for Continuation from Phase I-A to Phase I-B

• Phase I-B as Executable Option • Key Issues for Phase I Execution

• Test & Validation plan• Requested GFE

RABIS TTA-2

Page 21: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 21

Possible Future HSARPA Directions

Key Characteristics Nearly instantaneous detection

Extremely low acquisition costs

Extremely low operation costs

Design Trade Characteristics LOD as a function of FAR

Key Characteristics Nearly instantaneous trigger detection

Moderately low acquisition costs

Extremely low operation costs

Moderately fast confirmation step

Extremely low false alarm rate for confirmation step

Design Trade Characteristics LOD as a function of trigger FAR and

number of confirmation tests (cost of operation).

Development of Family of Detection Technologies to Enable Detect-to-Protect

Trigger for Rapid Automated Detection

Trigger and Confirmation Detection System

Page 22: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 22

BIAD Program Technical Topic Areas TTA-1 Extension of Baseline Protein and

Nucleic Acid Assays

TTA-2 Assays for New, Emerging, or Engineered Threats

TTA-3 Bioinformatics Tools

TTA-4 Assays and Tools for Forensic Analysis

TTA-5 Methods to Characterize Extraction and Preparation Methods

BIAD BAA04-03

Page 23: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 23

BAA04-03 BIAD Program Goals

Enabling future enhancements to existing detection systems

Enabling new types of detection systems

Supplementing our current family of confirmatory assays

Supplementing our current family of forensic assays

Creating next generation assays which are robust against

novel and engineered threats

Creating new bioinformatics tools to enhance assay

development

Characterizing and increasing sample extraction efficiencies

BIAD BAA04-03

Page 24: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 24

Schedule for BAA04-03

FY08FY06FY05FY04 FY07

Par

t I DemonstrationConcept & Strategy Development Assay FormulationTTA-2 Test & Eval. of Assays

Concept Development Test & Eval. of AssaysTTA-4 Transition to Customer

Assay formulation Assay OptimizationTTA-1 Transition to BaselineTest & Eval. of Assays

Evaluate Bioinformatics Tools New Tools Advocacy & DevelopmentTTA-3 Implement Tools Final Report

Par

t II

Re-open BAA

Phase I Phase II Phase IIILegend

TTA 1 - 5

Method & Concept Development Method Test & OptimizationTTA-5 Performance Analysis Final Report

Bidders are encouraged to provide accelerated schedule if possible

BIAD BAA04-03

Page 25: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

27 May 2004Dr Steven Buchsbaum, NDIA Homeland Security Symposium 25

For HSARPA R&D funding opportunities, please monitor:

www.dhs.gov, www.hsarpasbir.com, www.hsarpabaa.com, and www.fedbizopps.gov

Page 26: Dr Steven Buchsbaum, NDIA Homeland Security Symposium 27 May 2004 U.S. Department of Homeland Security Homeland Security Advanced Research Projects Agency.

Dr Steven Buchsbaum, NDIA Homeland Security Symposium

27 May 2004