UNCLASSIFIED

Joint Program Executive Office for Chemical and Biological Defense

UNCLASSIFIED

Distribution Statement A: Approved for public release; distribution is unlimited.

June 2016

Medical, Biomedical & Biodefense Support to the Warfighter Symposium

Dave Williams CPHIMS, PMP, RN

Senior Medical Portfolio/Acquisition Manager

david.williams8.civ@mail.mil

UNCLASSIFIED

WARFIGHTER NEEDS

2

FDA Licensure Process

Science & Technology (S&T) Development

S & T Requirements JRO Requirements Documents

Requirements Identified

Acquisition Documents

- Initial Capabilities Document (ICD)

- Capabilities Development Document (CDD)

- Capabilities Production Document (CPD)

- Key Performance Parameter = FDA Licensure

ICD CDD CPD

CBRN Threat

Warfighter

Advanced Development

JPEO-CBMS

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CHEMICAL AND BIOLOGICAL DEFENSE PROGRAM

3

Information Systems

Areas of Responsibility

Vaccines

Decontamination

Biosurveillance

Individual/Collective Protection

Chemical & Biological Agent Detection

Weapons of Mass Destruction Elimination

Weapons of Mass Destruction Civil Support

Installation/Force Protection

Diagnostics

Treatments

Under Secretary of Army for AL&T Force Structure, Resources & Assessment, The Joint Staff (J8)

Assistant Secretary of Defense for NCB

Under Secretary of Defense for AT&L

Acquisition

Authority

Oversight &

Governance

of CBDP

Deputy Assistant Secretary of Defense NCB/CBD

Requirements

Technology

Capability Solutions

3

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JPEO-CBD ORGANIZATION STRUCTURE

4

Medical Countermeasure Systems

COL Russell Coleman

NBC Contamination Avoidance

COL Jeffrey Woods

Information Systems Mr. Scott White

Information Systems Mr. Scott White

Medical Countermeasure Systems

COL Russell Coleman

Protection Mr. Scott Paris

Guardian Col Daniel Garber

JPEO Mr. Doug Bryce

Army

Marine Corps

Navy

Air Force

Chief of Staff Mr. Alan Burket

Our Joint Project Managers

DJPEO COL Alfred Abramson III

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JPEO-CBD: CURRENT MAJOR INITIATIVES

5

• Biosurveillance

• Joint US Forces Korea Portal and Integrated Threat Recognition

• Biosurveillance Portal

• Global Crisis Response

• Diagnostics/Critical Reagents Program

• Therapeutics/Vaccines

• Force Protection Systems

• Deployable CWMD Destruction Capability

• Emerging Threats

• NTA capabilities to WMD Civil Support Teams/active components

• Installation & Force Protection (Installation as a System)

• Radiological/Nuclear

• Joint Personal Dosimeter Program

• Radiological Detection System

• Long term planning and Analysis (30yr Plan)

• Advanced Technology Demonstrations

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No Single Agency has Visibility into the Entire Development Portfolio

6

Readiness & Stockpiling

Commercialization & Procurement

NIH

DTRA-JSTO

CDC

Joint Program Executive Office - CBD

Civ

ilian

Pro

gram

s

• Full-Scale Production

• Safety Follow-Up

• In Vitro & Animal Models

• Animal Testing

• Lab-Scale Production

• Human & Animal Efficacy,

Dose, & Safety Testing

• Formulation

• Production of Clin. Supplies

OPEO

• Warm base production • Regulatory Submission

• Manufacturing Scale-Up

BARDA

DARPA

Mili

tary

Pro

gram

s

Individual Services

FDA

CBDP

Filing & Launch Preparation

Clinical/ Non-clinical

Development

Preclinical Development

Basic Research

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INTEGRATED NATIONAL BIODEFENSE MCM PORTFOLIO

7

Common

• Anthrax VAC & Tx • Smallpox VAC & Tx • Ebola/Marburg VAC & Tx • Tularemia Tx • Botulism Tx • Radiation Tx • Nerve agent VAC & Tx

HHS-Unique

• Smallpox VAC for special populations

• Burkholderia sp. Tx • Junin Tx • Plague Tx

DoD Focus is on Protecting Forces Prior to Exposure. HHS Focus is on Response to Threats to General Civilian Population After Exposure.

DoD-Unique • Brucellosis VAC • WEVEE/MEE VAC & Tx • Plague VAC • Botulism VAC • SEB VAC & Tx • Tularemia VAC • Ricin VAC & Tx • (other, unfunded)

VAC = Vaccine Tx = Therapeutic

UNITY OF EFFORT AND PURPOSE Requirements – Unique and Common

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The Complexity of Medical Acquisition Integration of DODi 5000.02 Defense Acquisition Management

Framework and 21 CFR FDA Regulatory Process

8

Integration of DODi 5000.02 Defense Acquisition Management

Framework and 21 CFR FDA Regulatory Process

MRL 1 - 4 MRL 5 - 6 MRL 7 - 8 MRL 9 MRL 10 TRL 1 - 4 TRL 5 - 6 TRL 7 TRL 8 TRL 9

FDA Review

Investigational New Drug

Warm Base Manufacturing

Pre-Clinical/Clinical Development Clinical Development Regulatory Submission Post Licensure Research/ Discovery FD

A

BLA/NDA

Biologic License Application Licensure/ Approval

Phase 4 Post Marketing Surveillance

Phase 2 Human Trials (safety/dose/schedule)

•Indication(s) for Use •Route(s) of Administration •Manufacturing Process (initial)

Validation & Demo Lots Consistency Lots

Pivotal Animal Efficacy Studies

Proof of Concept Animal Studies

Phase 3 Human Trials (expanded safety)

Dose Range, Schedule & Safety in Animals

Phase 1 Human Trials (safety)

Animal Efficacy Trials

Clinical Assay Development

Lab Scale Production

Process Development & Pilot Lot Production

Manufacturing Scale Up

Initial Assay Development

Emergency Use Authorization (EUA) May Be Considered

IND Submission - Product Commitment

New Drug Application

DOD 5000.02 Documentation

•ICD •TDS •AoA

DOD 5000.02 Documentation

•CDD •LCMP •APB

DOD 5000.02 Documentation

•CPD •LCMP •APB

Milestone A

Full Rate Production

Initial Operational Capability

Low Rate Initial Production

Milestone B

FOC

Stockpile

IOC

Milestone C LRIP (Vaccines)

Materiel Solution Analysis

Technology Development Engineering & Manufacturing Development Production & Deployment Operations &

Support DO

D

MDD

Full Operational Capability

Sustain

• The product sponsor is the only direct interface with the FDA

• DoD has no special relationship with the FDA • TRLs, MRLs agreed among DoD and HHS;

UK/CAN/AS

• Development timelines are in line with industry standard

FDA DOD LEGEND:

MRL = Manufacturing Readiness Levels

TRL = Technology Readiness Levels

Capabilities Development Document Lifecycle Management Plan Acquisition Program Baseline

Initial Capabilities Document Technology Development Strategy Analysis of Alternatives

Department of Defense (DoD) Food & Drug Administration (FDA) Department of Health & Human Services (HHS)

Milestone C FRP (Drugs)

Pre-EMD

Reference: DODi 5000.02 & FDA 21 CFR

Medical Acquisition Programs must be

Compliant with DoD 5000, FAR, and 21 CFR FDA Regulatory Process

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JPEO-CBD FY16 FUNDING PROFILE BY APPROPRIATIONS ($K)

9

Defense-Wide Chemical and

Biological Defense, RDT&E, [VALUE]

Defense-Wide Chemical and

Biological Defense, RDT&E, BA5, [VALUE]

Defense-Wide Chemical And

Biological Defense RDT&E, BA7, [VALUE]

Defense-Wide Chemical and

Biological Defense Procurement,

[VALUE]

Nuclear Matters RDT&E, [VALUE]

Army Operations and Maintenance,

[VALUE]

Army Procurement, [VALUE]

Army RDT&E, $14,926

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• Contracting with JPEO-CBD

http://www.jpeocbd.osd.mil/Packs/Default.aspx?pg=330

• DTRA BAA Portal

https://www.dtrasubmission.net/portal/

DTRA-JSTO/JPEO-CBD

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Questions?

Dave Williams CPHIMS, PMP, RN

Senior Medical

Portfolio/Acquisition Manager

www.jpeocbd.osd.mil

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