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ABERDEEN PROVING

GROUND

ADVANCED PLANNING

BRIEFING TO INDUSTRY

Joint Project Management Office for

Medical Countermeasure Systems

Presented by: COL David P. Hammer 2 FEB 2017

The forecast data is for planning purposes, does not represent a pre-

solicitation synopsis, does not constitute an invitation for bid or request for

proposal, and is not a commitment by the government to purchase the desired

products and services

PROGRAM OVERVIEW

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITIES

Joint Vaccine Acquisition Program

• Marburg Vaccine

• Western, Eastern, and Venezuelan Equine Encephalitis Virus Vaccine

Biological Defense Therapeutics

• Antiviral Therapeutic Prototype

• Anti-Alphavirus Therapeutic Prototype

• Antibacterial Therapeutic Prototype

Chemical Defense Pharmaceuticals

• Improved Nerve Agent Treatment System (INATS) Improved Oxime Treatment Increment

• Expansion of Autoinjector Manufacturing Base – Dual Drug Delivery Device (D4)

Diagnostics

• Next Generation Diagnostics System Increment 2 Platform Component Development

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

ABERDEEN PROVING

GROUND

ADVANCED PLANNING

BRIEFING TO INDUSTRY

Joint Project Manager for Medical Countermeasure Systems

Joint Vaccine Acquisition Program (JVAP)

The forecast data is for planning purposes, does not represent a pre-

solicitation synopsis, does not constitute an invitation for bid or request for

proposal, and is not a commitment by the government to purchase the desired

products and services

PROGRAM OVERVIEWMedical Countermeasures Systems (MCS) mission area

is the development, production and fielding of medical solutions to counter Chemical, Biological, Radiological and Nuclear threats.

Within MCS, the Joint Vaccine Acquisition Program (JVAP) has the mission to develop, produce and field FDA–licensed biological defense vaccines.

Current JVAP portfolio includes vaccines for protection against Filoviruses, Equine Encephalitis viruses (western, eastern and Venezuelan) Botulinum Toxins (serotypes A and B), Ricin toxin and pneumonic Plague.

Future focus areas include vaccines for protection against Francisella tularensis, Coxiella burnetii (Q-Fever), and Burkholderia

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITYTITLE: • Marburg Vaccine to Protect Against Aerosolized Marburg Virus

GOAL:• Development of multiple Marburg Vaccine Prototypes Against Aerosolized Marburg

Virus through a Phase 1 clinical trial

PROGRAM OFFICE CONTACT: Chris [email protected]

CONTRACT OFFICE CONTACT:Alexandra Trunzo,Contract [email protected]

JVAP intends to meet this requirement through a competitive award through the OTA Consortium.

– RPP release anticipated in Feb 2017– Award anticipated April 2017– Period of performance expected to be through Phase 1 clinical trials– Scope will include all manufacturing efforts, non-clinical studies and regulatory

efforts required to support execution of a phase 1 clinical trial

JVAP intends to competitively award a follow on contract for all activities leading to FDA licensure starting in early 2020

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITYTITLE: • Western, Eastern, and Venezuelan Equine Encephalitis Virus Vaccine to Protect Against

Aerosolized exposure to above alphaviruses

GOAL:• Development of an multiple-target single-vector Vaccine Prototype Against Aerosolized

Equine Encephalitic viruses including Venezuelan Equine Encephalitis Virus through a Phase 1 clinical trial

PROGRAM OFFICE CONTACT: • Andrew Glenn

[email protected]

CONTRACT OFFICE CONTACT:• Alexandra Trunzo,

Contract [email protected]

JVAP intends to meet this requirement through a competitive award through the OTA Consortium.

– RPP release anticipated in Feb 2017– Award anticipated April 2017– Period of performance expected to be through Phase 1 clinical trials– Scope will include all manufacturing efforts, non-clinical studies and regulatory efforts

required to support execution of a phase 1 clinical trial

JVAP intends to competitively award a follow on contract for activities leading to FDA licensure starting in early 2020

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

ABERDEEN PROVING

GROUND

ADVANCED PLANNING

BRIEFING TO INDUSTRY

Joint Project Manager for Medical Countermeasure Systems

Biological Defense Therapeutics (BDTX)

The forecast data is for planning purposes, does not represent a pre-

solicitation synopsis, does not constitute an invitation for bid or request for

proposal, and is not a commitment by the government to purchase the desired

products and services

PROGRAM OVERVIEW

JPM-MCS-BDTX has provided a broad Statement of Objectives (SOO) for a consortium Other Transactional Authority (OTA) solicitation and the MCS Broad Agency Announcement (BAA), for therapeutics against Biological Warfare Agents (BWAs)

Viral Threats: Filoviridae (Zaire ebolavirus, Sudan ebolavirus, Marburg marburgvirus, Tai Forest, and Bundibugyo); Alphaviridae (Eastern Equine Encephalitis, Western Equine Encephalitis, Venezuelan Equine Encephalitis); Bunyaviridae (Hantaan)

Bacterial Threats: Bacillus anthracis (Anthrax), Brucellaspp. (Brucellosis), Burkholderia mallei (Glanders), Burkholderia pseudomallei (Meliodosis), Francissilatularensis (Tularemia); Yersinia pestis (Plague)

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITYTITLE: Antiviral Therapeutic Request for Prototype Project

CONTRACT TYPE: CPIF/CPFF

(to be awarded via OTA W15QKN-16-9-1002)

ESTIMATED VALUE: <$240M

CONTRACTING CONTACT:

ACC-NJJim [email protected]

Solicitation #: MCDC-RPP-17-01

ESTIMATED SOLICITATION RELEASE DATE: 2QFY17

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITYTITLE: Anti-Alphavirus Therapeutic Request for Prototype

Project

CONTRACT TYPE: CPIF/CPFF

(to be awarded via OTA W15QKN-16-9-1002)

ESTIMATED VALUE: <$240M

CONTRACTING CONTACT:

ACC-NJJim [email protected]

Solicitation #: MCDC-RPP-17-01

ESTIMATED SOLICITATION RELEASE DATE: 2QFY17

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITYTITLE: Antibacterial Therapeutic Request for Prototype Project

CONTRACT TYPE: CPIF/CPFF

(to be awarded via OTA W15QKN-16-9-1002)

ESTIMATED VALUE: <$100M

CONTRACTING CONTACT:

ACC-NJ

Jim Cummiskey

973.724.7278

[email protected]

SOLICITATION #: MCDC-RPP-17-01

ESTIMATED SOLICITATION RELEASE DATE: 2QFY17

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

UNCLASSIFIED

UNCLASSIFIED

Dr. Erin Reichert2 February 2017

Aberdeen proving ground

advanced planning briefing to

industry

CBM Mission

Medical S&T Division is responsible for ensuring robust

pipelines of vaccine and therapeutic candidates that can be

transitioned and matured into products by our advanced

development partners. This directly supports the overall

enterprise goal of developing and delivering novel medical

technologies to address current and emerging biological

threats in order to protect the lives and maintain the battle

readiness of our warfighters.

Bio-Pretreatments Branch

Discovery and development of vaccines

for: alphaviruses, filoviruses, Bacillus

anthracis (anthrax), Burkholderia mallei

(glanders), Burkholderia pseudomallei

(meliodosis), Francisella tularensis

(tularemia), Coxiella burnetii (Q Fever),

and botulinum, ricin and SEB toxin

Bio-Therapeutics Branch

Discovery and development of

therapeutics for alphaviruses,

filoviruses, botulinum toxin, and broad-

spectrum antibiotics targeting multi-drug

resistant bacterial threat pathogens

J9 CBM Focus Areas

Supporting S&T

Investments in animal model development, novel manufacturing technologies that

exploit readily adaptable expression platforms and leverage flexible

biomanufacturing technologies, understanding host-pathogen/toxin interaction for

identification of targets and/or biomarkers, adjuvants and stabilization

technologies, drug delivery methods, and compound library compilation and

characterization

Biological Prophylaxis &

Pretreatment

Core Capability Concept

Provide the warfighter protection against biowarfare agents through the administration of prophylactic pre- and post-exposure vaccines and mAbsagainst known bacterial, viral and toxin threats

JSTO Deliverables

Near-Term• rVSV-ZEBOV, also MARV and SUDV

• WEVEE DNA vaccine

• B. anthracis capsule conjugate

• Botulinum toxin mAbs

Mid-Term• Burkholderia OMV and CRM

conujugate

• Live-attenuated Francisella

• Ricin subunit vaccine

Far-Term• T Cell-based Q-fever vaccine

• Informatics-informed next

generation vaccines

• On-demand prophylaxis

Capability

Provide advanced prophylactic MCMs to protect the warfighter against loss of morbidity and

mortality due to live biological and biotoxin threats

16

Viruses

• Hemorrhagic Fever Viruses – Ebola & Marburg

• Encephalitic Alphaviruses – EEEV, VEEV,

WEEV

Toxins• Ricin

• BoNt

• SEB

Bacteria

• Bacillus anthracis

• Francisella tularensis

• Burkholderia mallei /pseudomallei

• Coxiella burnetii

• Yersinia pestis

Focus Agents Current Approaches

Vaccines – Current Approach

• Animal model development

• Basic research into host-pathogen/toxin interaction

• Stabilization technologies

Enabling Technologies

• Protein Subunit

• Bacterial vector platforms

• Live Attenuated

• Virus Like Particles

• DNA vaccine

• Viral vectored vaccine

• Protein Subunit

• mAbs

Core Capability Concept

Provide the warfighter protection against biowarfare agents through the post-exposure administration of therapeutics against known bacterial, viral and toxin threats of interest and emerging infectious threats

Capacity

Discovery and development of therapeutic countermeasures to protect the warfighter against

biological and biotoxin threats

Far-Term• Utilization of predictive models

• Drugs employing nontraditional

antibacterial modalities

Biological Therapeutics

JSTO Deliverables

Mid-Term• SMI/improved pan filo and pan alpha

virus therapies

• Small-molecule therapeutics against

novel bacterial targets

Near-Term• Panfilovirus mAb cocktail

• Alphavirus mAb cocktail

• Repurposed antibiotics for BW threats

• Botulinum Toxin SMI

18

Viruses• Filoviruses (Ebola, Marburg) and

hemorrhagic fever viruses

• Encephalitic Alphaviruses VEEV, EEEV,

WEEV

Toxins

• Botulinum Toxin

Bacteria

• Burkholderia spp.

• Bacillus anthracis

• Francisella tularensis

• Yersina pestis

Focus Agents

• Novel therapeutic approaches

• Host-directed & agent-based

• Antibiotic potentiation

• Circumvent/address resistance

• FDA-approved drug repurposing

• Novel therapeutic approaches

• Host-directed & agent-based

• Novel mAb treatments

• Repurposing of FDA-approved drugs

Approach

• Small molecule therapeutics

• Repurposing of FDA-approved drugs

Therapeutics – Current Approach

• Animal and other predictive models • Novel manufacturing technologies • Protein stabilization technologies

• Controlled drug delivery technologies • Novel formulation and dosing methods• PB-PK-PD toolbox • Regulatory Science

• Basic research into host-pathogen/toxin interactions for identification of new targets and/or biomarkers

Enabling Technologies

ABERDEEN PROVING

GROUND

ADVANCED PLANNING

BRIEFING TO INDUSTRY

Joint Project Manager for Medical Countermeasure Systems

Chemical Defense Pharmaceuticals (CDP)

The forecast data is for planning purposes, does not represent a pre-

solicitation synopsis, does not constitute an invitation for bid or request for

proposal, and is not a commitment by the government to purchase the desired

products and services

PROGRAM OVERVIEW

Improved Nerve Agent Treatment System (INATS)

– Family of Systems to provide FDA-approved improved oxime to be used in conjunction with Atropine in a combined autoinjector delivery system

• Improved Oxime Treatment Increment

– To replace 2-PAM with a medical countermeasure that will provide treatment to a broad spectrum of traditional nerve agents and emerging threats

• Expanded Indication for Pyridostigmine Bromide (PB) Increment

– Complementary to Improved Oxime Treatment Increment

– FDA approval for use beyond Soman; for additional traditional nerve agents and emerging threats

• Increased Survival Increment

– Complementary adjunct to Improved Oxime Treatment Increment

– A centrally‐acting (CA) therapeutic to increase survival

Expansion of Autoinjector Manufacturing Base – Dual Drug Delivery Device (D4) project

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITY

TITLE: Improved Nerve Agent Treatment System (INATS),

Improved Oxime Treatment Increment

CONTRACT TYPE: This opportunity will be submitted to the MCS

OTA Consortium

ESTIMATED VALUE: $40M-$60M

CONTRACTING CONTACT: ACC-New Jersey/Picatinny E.

Blancuzzi, [email protected]; (973) 724-2200

SOLICITATION #: TBD

ESTIMATED SOLICITATION RELEASE DATE: 1QFY18 –

2QFY18

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITY

TITLE: Expansion of Autoinjector Manufacturing Base – Dual Drug

Delivery Device (D4) project

CONTRACT TYPE: This opportunity has been submitted to the

MCS OTA Consortium, and is currently undergoing the RPP

process

ESTIMATED VALUE: $10-30M

CONTRACTING CONTACT: NCBDC Consortium Management

Firm, ATI, Attn: Ms. Mica Dolan, 315 Sigma Drive, Summerville,

SC 29486, E-mail [email protected]

SOLICITATION #: RPP 16-02, Subobjective Area (TRE-16-03)

ESTIMATED AWARD DATE: 2QFY17

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

UNCLASSIFIED

UNCLASSIFIED

Dr. Alison Director-Myska2 February 2017

Aberdeen proving ground

advanced planning briefing to

industry

UNCLASSIFIED

UNCLASSIFIED

J9CBS Advanced & Emerging Threat

Chemical Medical

Countermeasures (MCMs)

Deliver novel medical concepts and

technologies (i.e. pretreatments &

therapeutics) to address current

and emerging chemical threats to

protect the lives of our warfighters.

CB Research Center of

Excellence

Provide capabilities and

competency to the DoD labs

through the DTRA Fellowship

program, explore collaborative

opportunities, and recruit and

mentor young talent through

scholarly programs (e.g. STEM

and NRC Post doc).

Mission: Develop and transition novel concepts and technologies to address current and emerging threats to protect the lives of our warfighters

Provide rapid validated chemical

and biological agent property and

reactivity data and determine

toxicological mechanisms to

inform risk assessment.

Threat Agent Science (TAS)

DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.

Nerve Agent Prophylaxis &

Pretreatments

Core Capability Concept

Provide protection through the administration of broad spectrum MCMs to the Warfighter against the adverse effects of organophosphorus (OP)–based Chemical Warfare Agents (CWA) either prior to or post-exposure, but before presentation of symptoms

JSTO Objectives

Near-Term• Alternative manufacturing process

• Technologies for expressing prophylactic enzymes in vivo

• FDA-approved drugs

• Animal models to support FDA approval

Mid-Term• Technologies for expressing prophylactic enzymes in vivo

• FDA-approved drugs

• Animal models to support FDA approval

Prophylaxis

Capability

Provide advanced MCMs to prolong Force strength and capability against the effects of a broad spectrum of

organophosphorus (OP)–based Chemical Warfare Agents (CWA)

26

DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.

Core Capability Concept

Provide increased CNS penetration of MCM regimen to improve the therapeutic effectiveness against organophosphorus (OP)–based Chemical Warfare Agents (CWA)• Adjuncts to existing regimen• Substitutions for parts of existing regimen• Alternatives to existing regimen

Capability

Provide centrally-acting Medical Countermeasures (MCMs) therapeutics for increased survival, reduced

morbidity and decreased neurological damage when used as part of an MCM regimen against

organophosphorus (OP)–based Chemical Warfare Agents (CWA)

Nerve Agent Therapeutics

27

JSTO Objectives

Near-Term• Protection of the central nervous system against

organophosphorus (OP) chemical warfare agents

(CWAs).

• Broad spectrum cholinesterase reactivators

• FDA-approved drugs against a range of priority chemical

threats

• Animal models to enable FDA approval

Mid-Term• FDA-approved drugs against a range of priority chemical

threats

• Animal models to enable FDA approval

DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.

Capability

Provide effective medical countermeasure (MCM) against Emerging Chemical Threats

Emerging Threats

28

Core Capability Concept

Develop and utilize representative animal models to evaluate and exploit FDA-approved drugs against DoD emerging chemical threats needs to provide MCM advice and options to the warfighter.

JSTO Objectives

Near-Term• Assess FDA-approved drugs against a specific class of

Emerging Chemical Threat

• Develop Human equivalent dosing of MCM against

compounds of interest

Mid-Term• Assess FDA-approved drugs against a range of priority

chemical threats

• Establish human equivalent dosing of MCM against likely

threats and recommended path forward

HOW IT WORKS:

Identification of threat agent Screen currently available

drugs as MCM

Determine efficacy of MCM

against threat agent

Transition

Information

packet

CONOPS

UNCLASSIFIED

UNCLASSIFIED

Personnel / Patient

Decontamination

29

Core Capability Concept

Develop effective therapeutic strategies to minimize cutaneous tissues injuries from exposure to chemical warfare agents (CWAs) and decrease adverse dermal effects resulting from injuries to lingering CWA reservoirs.

Capability

Provide effective therapeutic strategies to minimize or ameliorate cutaneous tissue injuries resulting from

exposure to chemical warfare agents (CWAs)

Challenges• Shelf life stability (years not

months)

• Multi-Agent efficacy

• Neutralizes agent, non-toxic to

patient

Effort• Understanding cutaneous absorption

and reservoir effect

• Developing novel dermal therapeutic

and/or decontamination compounds

and methods of application

Issue• Current formulations are only

approved by the FDA for small

area applications on intact skin

• Life-cycle costs

• Desire for ocular and wound

DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.

ADMET CoE

• Utilizes pharmaceutical industry-standard Test

and Evaluation (T&E) and Modeling and

Simulation (M&S) protocols,

• Supports the pre-Milestone A determination of

MCM technical maturity for the Chemical

Biological Defense Program (CBDP), and

• Provides life-cycle benefits in cost, schedule

and performance to the MCM portfolio by

reducing risk.

The Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) Center of Excellence

(CoE) partnership with DoD laboratories enhances the successful development of novel medical

countermeasures (MCMs)

30

EXCRETION

DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.

Opportunities

• Current:• Fundamental Research to Counter Weapons of Mass

Destruction

• Solicitation Number: HDTRA1-14-24-FRCWMD-BAA

• Estimated value: Up to $1M/yr

• Contracting contact: TBD

• Future:• Chemical/Biological Technologies Program Build

DTRA BAA

• MCS OTA Consortium

• Combating Weapons of Mass Destruction (CWMD) Research and Technology Development ID/IQ

31

ABERDEEN PROVING

GROUND

ADVANCED PLANNING

BRIEFING TO INDUSTRY

Joint Project Manager for Medical Countermeasure Systems

Diagnostics (DX)

The forecast data is for planning purposes, does not represent a pre-

solicitation synopsis, does not constitute an invitation for bid or request for

proposal, and is not a commitment by the government to purchase the desired

products and services

PROGRAM OVERVIEW

Next Generation Diagnostics System Increment 2 (NGDS Inc 2) will provide a set of affordable and supportable materiel solutions to address CBRN diagnostics

NGDS Inc 2 is part of a Family of Systems approach

– Seeking complementary diagnostic capability with NGDS Inc 1 PCR analyzer (FilmArray)

– Near term mature solutions for CBRN diagnostics that would add value to treatment decisions

– Considering platform development effort that could address a broad range of CBRN threats and diagnostic approaches, to include host response biomarkers

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

OPPORTUNITYTITLE: Next Generation Diagnostics System Increment 2

Platform Component Development

CONTRACT TYPE: FFP/CPFF*

ESTIMATED VALUE: $40M-$60M

CONTRACTING CONTACT: ACC-Natick Jessica [email protected]

SOLICITATION #: TBD

ESTIMATED SOLICITATION RELEASE DATE: Draft release

2QFY19

* The above opportunity will be considered for inclusion under

the upcoming MCS OTA Consortium effort

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

HOW TO JOIN MEDICAL CBRN

DEFENSE CONSORTIUM (MCDC) • Visit: www.medcbrn.org

• Complete and sign Membership Application

• Review and sign Articles of Collaboration

• Provide DD2345 Certificate Number

• Military Critical Technical Data Agreement

• To obtain access to unclassified technical data

• If operating under Foreign Ownership, Control or

Influence (FOCI)

• DSS-approved mitigation plan OR signed

Export Compliance Acknowledgement Form

Send to [email protected]

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

UNCLASSIFIED

UNCLASSIFIED

Chemical and Biological

Technologies Department (J9CB)

Defense Threat Reduction Agency & USSTRATCOMCenter for Combating WMD & Standing Joint Force

Headquarters-Elimination

Advanced Planning Briefing to Industry

UNCLASSIFIED

UNCLASSIFIED

Medical Diagnostics

37

Near-term:

• Host-based biomarker discovery in blood and other clinical relevant matrices.

• Diagnostic assays for emerging threat agents (refining and developing novel assay designs).

• Biomedical informatics tools and applications (genomic/clinical bioinformatics).

• Rapid multiplex low-cost actionable assays.

• Enabling technologies for wearable threat exposure warning.

• Orthogonal diagnostic platforms and CLIA-waivable point-of-care devices.

• Sample collection, stabilization, transport, and preparation technologies.

• Expand biological warfare agent diagnostics for NGDS increment 2.

Mid-term:

• Diagnostics for host-based biomarkers from blood and/or other clinical matrices.

• Rapid and innovative diagnostic assays for emerging threat agents and antimicrobial resistance microbes.

• Diagnostics using high-throughput sequencing technologies.

UNCLASSIFIED

UNCLASSIFIED

Basic Research BAA Solicitation:

HDTRA1-11-21-BRCWMD-BAA

38

• In effect March 2011-September 2021

• Typically multiple opening & closing periods, with at least one annual opportunity solicited

by an Amendment to the BAA posted to Grants.gov in early December

• However, with the transition of the DTRA Basic Research Program to the Office of the Chief

Scientist, a consolidation of solicitations is taking place to streamline processes and to

present a single opportunity to the university-centric research community

• This transition began with the December 1, 2016 publication of FY2018 Basic Research

Topics within the Fundamental Research BAA, HDTRA1-14-24-FRCWMD-BAA (see next

slide)

• The Basic Research BAA Solicitation is valid for use through September 2021 should the

Office of the Chief Scientist choose to use it, but the current intent is not to use this BAA for

future topics

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

UNCLASSIFIED

UNCLASSIFIED

Fundamental Research BAA Solicitation:

HDTRA1-14-24-FRCWMD-BAA

39

• In effect March 2015-September 2024; posted at Grants.gov

• General Thrust Areas continuously OPEN for submissions; TRL1 – early TRL4

• Basic and exploratory Applied Research (6.1 & 6.2)

• Required: ~250-word abstract sent to applicable Thrust Area e-mail address detailed in

BAA; based on interest, a white paper may/may not be invited

• Majority of awards will be grants; other award types are permissible

• Basic Research Topics G1-G19 are OPEN for white paper submissions

• Responses to these topics must address only basic research

• These topics do NOT require abstract pre-coordination

• White Paper Deadline: February 1, 2017, by 11:59pm EST

• Invitation-Only Full Proposal Deadline: On/About April 24, 2017

• The majority of awards for Topics G1-G19 will be grants

• All applications MUST be submitted to Grants.gov using the application packages posted

with the opportunity

• Questions? Email: [email protected]

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

UNCLASSIFIED

UNCLASSIFIED

Chem-Bio Technologies BAA Solicitation:

HDTRA1-17-S-0001

40

• Chemical Biological Technologies Department BAA, FY2017 Program Build

• Applied Research & Advanced Technology Development

• Seeks R&D projects with strong technical merit valuable to program requirements and goals

to improve military chemical and biological defense capabilities

• Phase II Proposal Receipt Deadline January 13, 2017 at 1400hrs EST (by invitation

only)

• Parallel DoD/Government ‘Service Call’ for Government Labs

• Questions? Email: [email protected]

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

UNCLASSIFIED

UNCLASSIFIED

Science and Technology New Initiatives BAA

Solicitation: HDTRA1-17-S-0002-BAA

41

• In effect November 2016-October 2021; posted at www.fbo.gov

• Efforts that advance technical state-of-the-art or increase knowledge and understanding of

overarching challenges for countering WMD; TRL2 – TRL6

• BAA will be conducted via a single phase: formal proposal submission

• Offerors may choose to pre-coordinate a white paper/quad chart as detailed in the BAA.

• Pre-coordination, while strongly encouraged, is not mandatory.

• Six R&D Technology Areas (TAs): Chemical/Biological; Counter WMD; Radiation/Nuclear;

Reach-back and Decision Support; Treaty Verification/Compliance; and Technology

Forecasting

• BAA continuously OPEN for submissions to the R&D TAs

• On a limited basis, Addendums to the BAA may be published that detail more specific

or urgent topics. Topics posted as Addendums are likely to have formal proposal

deadlines and will only be available for a limited time.

• Questions? Email: [email protected] forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to

purchase the desired products and services

UNCLASSIFIED

UNCLASSIFIED

CWMD RD IDIQ Contracts

1. Counter WMD Weapons and Targets

2. Modeling and Simulation

3. Systems Engineering

4. Systems Survivability

5. WMD Physical Countermeasures

6. WMD Medical Countermeasures

7. Technical Nuclear Forensics

8. Nuclear Detection

9. Standoff Detection

10. Treaty and Verification Technologies

11. Sensor Platforms

42The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

10-year-Multi-Award $4B Ceiling

Capability to conduct research and development resulting in the delivery of data, hardware,

software, equipment and documentation for the 11 functional areas listed below:

UNCLASSIFIED

UNCLASSIFIED

CBD SBIR and STTR

43

• The Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs are:

• Congressionally-mandated programs

• Established to fund R&D at small businesses

• Three-phased process

• Funded as a set-aside assessment of extramural R&D budget

• U.S. Small Business Administration (SBA) programmatic authority over Federal SBIR & STTR programs (Program Policy Directives)

• DoD has 12 SBIR/STTR Programs (3 Services & 9 ‘Components’)

• DTRA and Chem/Bio Defense (CBD) represent two separate programs; see: https://sbir.defensebusiness.org

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

UNCLASSIFIED

UNCLASSIFIED

DoD SBIR/STTR Solicitations

44

• Dates established by OSD Office of Small Business Programs; not all DoD Components

participate in each solicitation.

• CBD SBIR is participating in FY17.1 cycle and plans to participate in CBD STTR

FY17.C cycle

• A DoD Agency-wide announcement includes:

• DoD Instructions

• Service/Component-specific Instructions

• Topics

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

UNCLASSIFIED

UNCLASSIFIED

Proposal submission

45

• Fundamental Research (Solicitation HDTRA1-14-24-FRCWMD-BAA), to include Basic

Research Topics, submitted to:

http://www.grants.gov

• Chem-Bio Technologies BAA (Solicitation HDTRA1-17-S-0001) and the Science and

Technology New Initiatives BAA (Solicitation HDTRA1-17-S-0002-BAA) submitted to:

https://www.dtrasubmission.net

• ALL DoD SBIR & STTR proposals (small businesses only) submitted to:

https://sbir.defensebusiness.org

Proposals only accepted via electronic submission

READ THE ANNOUNCEMENT INSTRUCTIONS!

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

UNCLASSIFIED

UNCLASSIFIED

Some Helpful Resources

46

• Business Opportunities at DTRA: http://www.dtra.mil/Contracts/BusinessOpportunities.aspx

http://www.dtra.mil/Research/Basic-and-Applied-Science/Research-Funding-Opportunities

• Doing Business with DoD: http://www.defense.gov/landing/contract_resources.aspx

• Guide to DoD Contracting Opportunities:

http://www.acq.osd.mil/dpap/cpic/cp/docs/Doing_Business_with_DoD_%282Jun14%29.pdf

• Federal Business Opportunities: https://www.fbo.gov/

• Grants.Gov: http://www.grants.gov

• DoD Office of Small Business Programs – Doing Business with the DoD:

http://www.acq.osd.mil/osbp/sb/dod.shtml

• DoD SBIR/STTR Program Information for Small Business:

https://sbir.defensebusiness.org

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services

PROGRAM POINTS OF CONTACT

• COL David Hammer, JPM MCS

[email protected]

• Dr. Edward Clayson, Deputy JPM MCS

[email protected]

• Dr. Erin Reichert, DTRA J9CB

[email protected]

The forecast data is for planning purposes, does not represent a pre-solicitation synopsis, does not constitute an invitation for bid or request for proposal, and is not a commitment by the government to purchase the desired products and services