docJoint Program Executive Office for Chemical and Biological Defense
download 
Report Transcription
Joint Program Executive Office for Chemical and Biological Defense
UNCLASSIFIED Joint Program Executive Office for Chemical and Biological Defense Medical, Biomedical & Biodefense Support to the Warfighter Symposium Dave Williams CPHIMS, PMP, RN Senior Medical Portfolio/Acquisition Manager david.williams8.civ@mail.mil Distribution Statement A: Approved for public release; distribution is unlimited. UNCLASSIFIED June 2016 WARFIGHTER NEEDS ICD CDD CPD Requirements Identified Acquisition Documents - Initial Capabilities Document (ICD) - Capabilities Development Document (CDD) - Capabilities Production Document (CPD) - Key Performance Parameter = FDA Licensure Science & Technology (S&T) Development Advanced Development CBRN Threat FDA Licensure Process Warfighter Requirements 20160603 Bio Med Def JPEO v2 JRO Requirements UNCLASSIFIED Documents S&T JPEOCBMS 2 CHEMICAL AND BIOLOGICAL DEFENSE PROGRAM 3 Under Secretary of Defense for AT&L Under Secretary of Army for AL&T Assistant Secretary of Defense for NCB Force Structure, Resources & Assessment, The Joint Staff (J8) Deputy Assistant Secretary of Defense NCB/CBD Acquisition Authority Oversight & Governance of CBDP Requirements Technology Capability Solutions Areas of Responsibility Treatments Vaccines Decontamination Diagnostics Information Systems Biosurveillance Individual/Collective Protection Installation/Force Protection Weapons of Mass Destruction Civil Support Chemical & Biological Agent Detection Weapons of Mass Destruction Elimination 20160603 Bio Med Def JPEO v2 UNCLASSIFIED 3 JPEO-CBD ORGANIZATION STRUCTURE Army Marine Corps Navy JPEO Mr. Doug Bryce DJPEO COL Alfred Abramson III Air Force Chief of Staff Mr. Alan Burket Our Joint Project Managers Medical Countermeasure NBC Contamination Systems Avoidance COL Russell Coleman COL Jeffrey Woods 20160603 Bio Med Def JPEO v2 Information Systems Mr. Scott White Protection Mr. Scott Paris UNCLASSIFIED Medical Countermeasure Information Systems Mr.Systems Scott White COL Russell Coleman Guardian Col Daniel Garber 4 JPEO-CBD: CURRENT MAJOR INITIATIVES • 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 20160603 Bio Med Def JPEO v2 UNCLASSIFIED 5 No Single Agency has Visibility into the Entire Development Portfolio FDA Preclinical Development Basic Research Military Programs Civilian Programs • In Vitro & Animal Models • Animal Testing • Lab-Scale Production Clinical/ Non-clinical Development • Human & Animal Efficacy, Dose, & Safety Testing • Formulation • Production of Clin. Supplies Filing & Launch Preparation • Regulatory Submission • Manufacturing Scale-Up NIH Commercialization & Procurement • Full-Scale Production • Safety Follow-Up Readiness & Stockpiling • Warm base production BARDA OPEO CDC DARPA CBDP DTRA-JSTO 20160603 Bio Med Def JPEO v2 Joint Program Executive Office - CBD Individual Services UNCLASSIFIED 6 INTEGRATED NATIONAL BIODEFENSE MCM PORTFOLIO UNITY OF EFFORT AND PURPOSE Requirements – Unique and Common DoD-Unique • Brucellosis VAC • WEVEE/MEE VAC & Tx • Plague VAC • Botulism VAC • SEB VAC & Tx • Tularemia VAC • Ricin VAC & Tx • (other, unfunded) 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. VAC = Vaccine Tx = Therapeutic 20160603 Bio Med Def JPEO v2 UNCLASSIFIED 7 The Complexity of Medical Acquisition DOD Materiel Solution Analysis FDA MRL 1 - 4 TRL 1 - 4 Research/ Discovery Integration of DODi 5000.02 Defense Acquisition Management Framework and 21 CFR FDA Regulatory Process MRL 5 - 6 TRL 5 - 6 MRL 7 - 8 TRL 7 MRL 9 TRL 8 Integration of DODi 5000.02 Defense Acquisition Management Engineering & Manufacturing Technology Development & Deployment Framework and 21 CFR FDA RegulatoryProduction Process Development Pre-Clinical/Clinical Development Clinical Development MRL 10 TRL 9 Operations & Support Regulatory Submission Post Licensure Lab Scale Production Initial Assay Development MDD Proof of Concept Animal Studies DOD 5000.02 Documentation •ICD •TDS •AoA •Indication(s) for Use •Route(s) of Administration •Manufacturing Process (initial) Pre-EMD Phase 1 Human Trials (safety) Milestone B • 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 DOD Manufacturing Scale Up Animal Efficacy Trials • Development timelines are in line with industry standard LEGEND: Investigational New Drug Process Development & Pilot Lot Production Clinical Assay Development Dose Range, Schedule & Safety in Animals Initial Capabilities Document Technology Development Strategy Analysis of Alternatives Medical Acquisition Programs must be Compliant with DoD 5000, FAR, and 21 CFR FDA Regulatory Process IND Submission - Product Commitment Milestone A FDA MRL = Manufacturing Readiness Levels TRL = Technology Readiness Levels Reference: DODi 5000.02 & FDA 21 CFR 20160603 Bio Med Def JPEO v2 DOD 5000.02 Documentation •CDD •LCMP •APB Validation & Demo Consistency Lots Milestone C LRIP (Vaccines) Lots Low Rate Initial Production Phase 2 Human Trials Phase 3 Human Trials (safety/dose/schedule) (expanded safety) Pivotal Animal Efficacy Studies Capabilities Development Document Lifecycle Management Plan Acquisition Program Baseline Biologic License Application Department of Defense (DoD) Food & Drug Administration (FDA) Department of Health & Human Services (HHS) New Drug Application DOD 5000.02 Documentation BLA/ NDA FDA Review Phase 4 Post Marketing Surveillance Warm Base Manufacturing •CPD •LCMP •APB Milestone C FRP (Drugs) Licensure/ Full Rate Production Approval Stockpile IOC Sustain FOC Initial Operational CapabilityFull Operational Capability Emergency Use Authorization (EUA) May Be Considered UNCLASSIFIED 8 JPEO-CBD FY16 FUNDING PROFILE BY APPROPRIATIONS ($K) Army Procurement, [VALUE] Army RDT&E, $14,926 Defense-Wide Chemical and Biological Defense, RDT&E, [VALUE] Army Operations and Maintenance, [VALUE] Nuclear Matters RDT&E, [VALUE] Defense-Wide Chemical and Biological Defense Procurement, [VALUE] Defense-Wide Chemical and Biological Defense, RDT&E, BA5, [VALUE] Defense-Wide Chemical And Biological Defense RDT&E, BA7, [VALUE] 20160603 Bio Med Def JPEO v2 UNCLASSIFIED 9 DTRA-JSTO/JPEO-CBD • Contracting with JPEO-CBD http://www.jpeocbd.osd.mil/Packs/Default.aspx ?pg=330 • DTRA BAA Portal https://www.dtrasubmission.net/portal/ 20160603 Bio Med Def JPEO v2 UNCLASSIFIED 10 Questions? Dave Williams CPHIMS, PMP, RN Senior Medical Portfolio/Acquisition Manager www.jpeocbd.osd.mil 20160603 Bio Med Def JPEO v2 UNCLASSIFIED 11