createll b tcollaboratecommunicate

Chemical & Biological Chemical & Biological DefenseDefense

Small Business Small Business Innovation ResearchInnovation Research

DEFENSE THREAT REDUCTION AGENCY JOINT SCIENCE AND TECHNOLOGY OFFICE CHEMICAL AND BIOLOGICAL DEFENSE

Mr Larry PollackCBD SBIR Program Manager NIH SBIR / 1 JUNE 2012

LOUISVILLE, KY

Mr. Larry Pollack

DEFENSE THREAT REDUCTION AGENCY MISSION

“To safeguard the US and its Allies from Weapons of Mass “To safeguard the US and its Allies from Weapons of Mass Destruction (Chemical, Biological, Radiological, and Nuclear) and Destruction (Chemical, Biological, Radiological, and Nuclear) and ( g g )( g g )HighHigh--Yield Explosives by providing capabilities to reduce, eliminate Yield Explosives by providing capabilities to reduce, eliminate and counter the threat, and mitigate its consequences”and counter the threat, and mitigate its consequences”

Chemical Biological Radiological NuclearHigh-Yield Explosives

JOINT SERVICE CHEMICAL AND BIOLOGICAL DEFENSE PROGRAM

1994 Public Law 103-160, Section 1703,Established the Joint Service Chemical andBiological Defense Program

JOINT SERVICE CHEMICAL AND BIOLOGICAL DEFENSE PROGRAMBIOLOGICAL DEFENSE PROGRAM

Mission: Provide state-of-the-art defenseMission: Provide state of the art defense capabilities to permit U.S. military forces to operate and successfully complete missions in p y pchemical and biological warfare environments

STRATEGIC THRUSTS AND ENABLERS

Disease Surveillance, Threat Detection Disease Surveillance, Threat Detection Threat Activity Sensing and ReportingThreat Activity Sensing and Reportingand Point of Need Diagnosticsand Point of Need Diagnostics Threat Activity Sensing and ReportingThreat Activity Sensing and Reporting

Broad-Spectrum DetectionFieldable Dx Sequencing Broad-Spectrum DetectionFieldable Dx Sequencing

Point DetectionAgent CharacterizationPoint DetectionAgent Characterization

Molecular Recognition Host ResponseExposure Prediction Functional Consequences

Molecular Recognition Host ResponseExposure Prediction Functional Consequences

Mathematical RecognitionTransport & Dispersion Risk-Based Hazard PlotsAgent Fate

Mathematical RecognitionTransport & Dispersion Risk-Based Hazard PlotsAgent Fate

Adaptive Medical Countermeasures Adaptive Medical Countermeasures and Technologiesand Technologies

Rapid Response and Restoration Rapid Response and Restoration Science and TechnologyScience and Technology

Functional ConsequencesFunctional Consequences Agent FateAgent Fate

VaccinesImmune ModulatorsBio-Prophylaxes Bi Th ti

VaccinesImmune ModulatorsBio-Prophylaxes Bi Th ti

Individual ProtectionNanostructured MaterialsSmart Materials Simulation and Analysis

Individual ProtectionNanostructured MaterialsSmart Materials Simulation and AnalysisBio-Therapeutics

Regulatory Sciences Mfg Technologies

Bio-TherapeuticsRegulatory Sciences Mfg Technologies

Simulation and AnalysisDecision SupportDecontamination

Simulation and AnalysisDecision SupportDecontamination

Novel Threat ResearchNovel Threat ResearchApplied Math Tools

Multifunctional MaterialsFlexible Design & Manufacturing

Systems Biology

DETECTION

Develop a real-time capability to detect, identify, quantify and track the presence of all CB agent threatsquantify and track the presence of all CB agent threats

• Description of Efforts- Lightweight, integrated point

d t t

Advanced Sequencing Capability

detectors- Biological sample preparation- Whole pathogen genome

i t d iMEMS Scale Chemical

Point Detectionsequencing system design- Data fusion, multi-technology

system design

• Issues and Challenges- Expansion of the number of detectable materials

T h i d l ith f di i i ti i t f l- Techniques and algorithms for discriminating signatures from a complex background

- High sensitivity imaging of contaminants on surfaces- Near-real time sequencing of entire pathogens

PROTECTION / HAZARD MITIGATION ISSUES AND CHALLENGES

• Individual ProtectionReduced thermal burden with CB protection- Reduced thermal burden with CB protection

- Second Skin: responsive materials (sense, respond, decon)

•Air Purification•Air Purification- Develop materials against wider range of threats, e.g. TICs- Mixed-bed technology: novel materials with & without carbon

•Hazard Mitigation- Apply new microbiology tools to decontaminate CWAsD l i t f f l ti f ti i d li ti- Develop point-of-use formulations for optimized application

- Develop an improved decon for sensitive equipment, large mobile structures and fixed structuresD l t l ti t h l i f id d f A th d- Develop a new catalytic technologies for wide-area decon of Anthrax and other bio-threat materials

7

JSTO-CBD TRANSLATIONAL MEDICAL DIVISION VISION / STRATEGY

SymptomaticPre-Event Post-Event Post-Exposure,Pre-Symptomatic

DIVISION VISION / STRATEGYEVENT

Wide Spectrum Rx Threat and Host Strategies:Immunomodulators, Vaccines, Anti-virals, Anti-bacterials, Chem Therapeutics

Pretreatments TherapeuticsDx-Directed TreatmentsRapid CountermeasuresRapid Countermeasures

Antibiotic R i

RegulatorySciences

Resistance Markers

Pre‐symptomatic Biomarkers

HostBiomarkers

Diagnostic and Disease

Flexible Adaptive

Manufacturing

Biomarkers

Pathogen ID

and Disease Targets

VACCINES & HOST RESPONSE CAPABILITY AREA

• Thrust Areas• Viral Vaccines MW

220 KD

VEEV

EEEV

WEE

V

(267 a.a.)

• Bacterial & Toxin Vaccines• Vaccine Platforms & Research Tools

• S&T Needs

220 KD

97 KD66 KD45 KD

30 KD

E1+E2

• S&T Needs• Novel, adaptable, vaccine platforms,

including multivalent and/or broad spectrum• Strategies to develop effective vaccine

(262 a.a.)

candidates against bacterial threat agents• Universal adjuvants • Mechanisms to predict/understand the

human immune responsehuman immune response • Biomarkers, correlates of protection• Animal models • Alternative delivery technologies and thermal

stabilization methodologies

POST-EXPOSURE PROPHYLAXES & THERAPEUTICS CAPABILITY AREA

• Thrust Areas• Viral• Bacterial• Toxins

• S&T Needs• S&T Needs• Novel, broad-spectrum small molecule based

antimicrobials targeting host- or pathogen-pathwaysp y

• Emphasis on anti-virals• Small molecule inhibitors of, and host-directed

therapeutics effective against toxins• Immune modulators• Immune-modulators• re-purposing FDA approved drugs• Animal models

CHEMICAL MEDICAL COUNTERMEASURES

• Thrust Areas• Pretreatments S193

• Therapeutics

• S&T Needs• catalytic bioscavengers

R214

• catalytic bioscavengers• enzyme modulators• synthetic nerve agent binders• Compounds that reactivate OP-inhibited AChE

H115

p• Innovative therapeutic strategies and drug

candidates to ameliorate the acute and long-lasting functional damage resulting from nerve agent intoxicationagent intoxication

• Therapeutic strategies that minimize injuries to dermal and ocular tissues resulting from CWAs

• re-purposing FDA-approved drugsp p g pp g

A CLOSER LOOK: BIOSURVEILLANCE AND DIAGNOSTICSDIAGNOSTICS

Devices & Assays

Point of Care, Lab-Based

FDA-Cleared AND

Environmental AssaysAssays

Biomarker Pathogen Biomarker Discovery and

Verification

gCharacterization

(Sequencing, Phenotyping)

Host-Pathogen Interactions

Disease “Real-Time” EnvironmentalDisease Surveillance

Real Time Surveillance

Environmental Monitoring

CBD SBIR PROGRAM OVERVIEW

• One acquisition element of the Science & Technology component of the Joint Chemical and Biological Defense Programthe Joint Chemical and Biological Defense Program

• $15M FY12 CBD SBIR program

• NEW – FY12 CBD to participate in the DoD FY12.2 SBIR solicitation

• Approximately 7-10 new topics annually; FY12 = 8 topics

• Topics released on 24 Apr 2012Topics released on 24 Apr 2012• Formal solicitation began 24 May 2012• Phase I proposals due No Later Than 6am Eastern Time, 27 Jun 2012

• Phase II proposals requested by invitation only

• No CBD STTR program• No CBD STTR program

CBD SBIR – FY12.2 SOLICITATION TOPICS

Capability AreaTopicCBD12-101 Formulation Development to Enhance

Bioavailability and Pharmacokinetic P fil f P t i b d D

p yMedical

TherapeuticsProfile of Protein-based Drugs

CBD12-102 Advanced Purification Technology for Medicalthe Manufacture of Vaccines, Biologic Drugs, and Enzymes

Medical Therapeutics

CBD12-103 Design Automation Software for DNA-Based Architectures

Medical Diagnostics; Detection; Therapeutics

CBD12-104 Detection of Liquid Contaminantson Surfaces Using Hyperspectral Imaging

Detection-Chemicalon Surfaces Using Hyperspectral Imaging

http://www.dodsbir.net/solicitation/sbir122/cdb122.doc

CBD SBIR – FY12.2 SOLICITATION TOPICS

Capability AreaTopicCBD12-105 Oxygen Storage Technology for

Closed-Circuit Self-Contained

p y

Protection

Breathing Apparatus\

CBD12-106 Carbon Dioxide and Water Removal ProtectionCBD12 106 Carbon Dioxide and Water Removal Technology for Closed-Circuit Self-ContainedBreathing Apparatus

Protection

CBD12-107 Continuous Ionization System for Electrostatic Collection of Bioaerosols Protection/

Hazard Mitigationin Building Protection Applications

Hazard Mitigation

http://www.dodsbir.net/solicitation/sbir122/cdb122.doc

CBD SBIR – FY12.2 SOLICITATION TOPICS

Capability AreaTopicCBD12-108 Rapid Sample Transport in Austere

Environments

p yDetection;

Medical Diagnostics

http://www.dodsbir.net/solicitation/sbir122/cdb122.doc

Phase I proposals due No Later Than p p6am Eastern Time

27 June 2012

TECHNICAL QUESTIONS ABOUT TOPICS

Direct Contact with Topic AuthorsDirect Contact with Topic Authors– During Pre-Release, the names of the topic authors, phone numbers

and e-mail addresses are listed with the topic Q ti b li it d t ifi i f ti l t d t ti l– Questions are be limited to specific information related to a particular topic’s requirements

– Offerors may not ask for advice or guidance on solution approach, nor b i ddi i l i l h i hsubmit additional material to the topic author

SBIR/STTR Interactive Topic Information SystemSBIR/STTR Interactive Topic Information System (SITIS) www.dodsbir.net/sitis

– After Solicitation Opens, offerors may submit written questions p y qthrough SITIS; no direct contact is allowed

– Questioner and respondent remain anonymous and all questions and answers are posted electronically for general viewingp y g g

CBD SBIR PROCESS

Phase IPhase I

Phase IIPhase II

Feasibility StudyPhase III

Feasibility Study$100K, 6 months(+ $50K option upon

Prototype Development$1M, 2 years

Phase II selection)

Phase I + Phase II = $1.15M Total SBIR Commercialization

$ , y

All projects are funded via contractCommercialization

no SBIR Funds

CBD SBIR EVALUATION PROCESS

• Conducted by Government personnel; subject matter experts

• Three tier evaluation Technical Evaluators Team Chief/Topic Author

S i & T h l M t th J i t S i & Science & Technology Managers at the Joint Science & Technology Office for Chemical and Biological Defense (JSTO-CBD)( )

• Approximately 1 in 10 Phase I proposals selected for contract award

• Approximately 2 proposals per topic selected for Phase I contract award

CBD SBIR EVALUATION CRITERIA

PH I PH II• Soundness, technical merit, and

innovation of the proposed approach 50 40p p pp• Qualifications of the proposed/key

investigators, supporting staff, and 30 30g , pp g ,consultants

• Potential for commercial (Gov. or

30 30

Potential for commercial (Gov. or private sector) application and benefits expected to accrue from this

20 30

commercialization

DOD SBIR KEY TECHNOLOGY AREAS

•Air Platforms

KEY TECHNOLOGY AREAS

•Information Systems Technology•Air Platforms

•Battlespace Environments

•Information Systems Technology

•Space Platforms TechnologyBattlespace Environments

•Chemical & Biological Defense

p gy

•Biomedical

•Weapons •Sensors, Electronics & Electronic Warfare

•Human SystemsWarfare

•Nuclear Technology•Materials & Processes

gy

•Ground and Sea Vehicles T h lTechnology

BIOTECHNOLOGY & DOD SBIR/STTR

Biotechnology encompasses a large and diverse array ofBiotechnology encompasses a large and diverse array of topic areas & technical disciplines –

Detectors/SensorsMedical Pre-treatments, Therapeutics, and DiagnosticsBiological Decontamination & ProtectionBioinformatics & Data Analysis Systems / BiosurveillenceSoldier Support, Health & Performance Proteomics, Molecular Biology, Drug DevelopmentAnd many more…….

BIOTECHNOLOGY & DOD & SBIR/STTR

Search for additional Chemical/Biological & Biotechnology topics outside of CBD SBIRBiotechnology topics outside of CBD SBIR

Army, Air Force, Navy y y DARPA SOCOM DHP DHS NIH EPA NSF NSF

Topics address one or more DoD Key Technology AreasTend to have narrow focus rather than broad

DHP SBIR PROGRAM OVERVIEW

• Office of the Assistant Secretary of Defense for Health Affairs, OASD(HA)OASD(HA)

• Defense Health Program, Research and Development Office htt //fh d il/ b t j ?t i 4 http://fhpr.osd.mil/about.jsp?topic=4

• $35M FY12 DHP SBIR program

• NEW – FY12: now shown as a specific ‘stand-alone’ SBIR component within DoDp prior DHP topics were included as part of the OSD SBIR solicitation

• 16 new topics released on 24 Apr 2012 (DoD FY12.2)6 e op cs e eased o p 0 ( o )• Formal solicitation began 24 May 2012• Phase I proposals due No Later Than 6am Eastern Time, 27 Jun 2012

• POC: Capt Sean Biggerstaff (703-681-8176)

HOW TO PARTICIPATE IN DoD SBIR/STTR

• Review the Topics in the current solicitation atwww dodsbir net/solicitation/www.dodsbir.net/solicitation/

• Register and submit proposals atd d bi t/ b i i /www.dodsbir.net/submission/

• General questions? Call the DoD SBIR/STTRGeneral questions? Call the DoD SBIR/STTR Help Desk at: 866-SBIRHLP (866-724-7457)

• Have questions about a solicitation topic? Contact the topic author listed with the topic during the pre-release period or ask via:during the pre release period or ask via: www.dodsbir.net/sitis/

• S b ib t th Li t t d d bi t/25• Subscribe to the Listserv at: www.dodsbir.net/

to receive program notices and updates

DOD SBIR/STTR COMPONENTS –WEBSITE HOMEPAGES

Component Agency SBIR WebsiteAir Force http://www.sbirsttrmall.compArmy http://www.armysbir.army.milNavy http://www.navysbir.comCBD http://www.cbdsbir.comCBD http://www.cbdsbir.comDARPA http://www.darpa.mil/Opportunities/SBIR_STTR/SBIR_STTR.aspx DHP http://fhpr.osd.mil/about.jsp?topic=4DLA http://www dla mil/dbDLA http://www.dla.mil/dbDMEA http://www.dmea.osd.mil/smallbiz.htmlDTRA http://www.dtra.mil/Business/OfficeSBP.aspx MDA http://www mdasbir com/MDA http://www.mdasbir.com/NGA http://www.nga.mil (Agency homepage)OSD http://www.defenselink.mil/osd/ (Agency homepage)SOCOM http://www socom mil/sordac/SBP/Pages/default aspxSOCOM http://www.socom.mil/sordac/SBP/Pages/default.aspx

SBIR DoD SBIRhttp://www sbir gov http://www dodsbir net

26

http://www.sbir.gov http://www.dodsbir.net

SBIR REAUTHORIZATION

• On December 31, 2011, the President signed into law the National Defense Authorization Act for Fiscal Yearthe National Defense Authorization Act for Fiscal Year 2012 (Defense Reauthorization Act), Pub. L. 112-81, 125-Stat. 1298, Section 5001, Division E of the Defense , ,Authorization Act containing the SBIR/STTR Reauthorization Act of 2011, amending the Small B i A d k l d hBusiness Act and makes several amendments to the SBIR Program.SBIR R th i d th 30 S t b 30 2017• SBIR Reauthorized thru 30 September 30, 2017

• Business as Usual (for now)• SBA Policy Directive drafted• SBA published on 15 May 2012, in the Federal Register,

its first proposed rule for size standards relating to SBIR/STTR

SBIR REAUTHORIZATION

Public Comment period thru 16 July 2012

Relates to Section 5107 of PL112-81

http://www regulations gov/#!documentDetahttp://www.regulations.gov/#!documentDetail;D=SBA-2012-0008-0001______________________________________________

www.regulations.gov

search for: RIN 3245–AG46

WWW.OREGONSBIR.COM

NATIONAL SBIR CONFERENCEP tl d ORPortland, OR

13-15 November 2012

29

Phase II Technology Transition Conference

For SBIR Phase II firms seekingFor SBIR Phase II firms seeking to facilitate technology transition

https://www.beyondphaseii.com/2012

30

CONTACT INFORMATION

Mr. Larry PollackChem-Bio Defense SBIR Program Manager

Acquisition & Program Management Support Office

Joint Science & Technology Office for Chemical and Biological Defenseg

larry.pollack@dtra.mil(703) 767-3307

DISCLAIMER

Information presented in this presentation is forpresentation is for

informational purposes only and is not binding upon DTRA

or the U.S. Governmentor the U.S. Government