CHEMICAL BIOLOGICAL MEDICAL SYSTEMS (CBMS)

Transcription

1 CHEMICAL BIOLOGICAL MEDICAL SYSTEMS (CBMS) Presented To 2003 DoD APBI Presented By COL David Danley Project Manager April 03 1

2 CBMS Mission The Chemical Biological Medical Systems Project Management Office (CBMS-PMO) is responsible for the overall development and productions of Food and Drug Administration (FDA) licensed biological and chemical medical products to protect the war fighter in a chemical/biological warfare (CB/BW) environment. 2

3 CBMS Wiring Diagram BG Reeves PEO-CBD COL Danley CBMS Project Manager DR Clawson CBMS Deputy Project Manager DR Balady Regulatory Affairs Manager LTC Clayson JVAP Product Manager Jennifer Starks Business Management Operations Support Manager John Anderson Product Management Support Team Manager LTC Mudrow MITS Product Manager Linda Sheffer Finance Team Manager Licensed Vaccines (AVA, DryVax) Advanced Development Vaccines (Prime Contractor) Bio/Chem Defense Drugs and Therapeutics DR Emanuel CRP Detection Reagents LTC Neimeyer JBAIDS Diagnostics Vaccines and Biologics Drugs and Devices 3

4 CBMS Integrated Products PREVENTION DETECTION DIAGNOSIS TREATMENT CHEMICAL DEFENSE YEARS MONTHS DAYS HOURS MINUTES HOURS DAYS SERPACWA BIOSCAVENGER PB SKIN DECON ATROPINE 2 PAM MANAA BIOLOGICAL DEFENSE VACCINES IMMUNE GLOBULINS DRUGS JBAIDS 4

5 CB Medical Product System: More Than a Pill or a Shot Product Active Ingredients Other Ingredients Delivery Format & Packaging Labeling & Insert Testing Manufacturing Production Capacity Industrial Base Maintenance Logistics and Training Storage & Transportation Other Medical Supplies Disposal Recipient Education Provider Training Information Management Information Management (IAW DoD and FDA Requirements) 5

6 CBMS Product Development 6

7 BD Vaccine Development & Licensure Good Laboratory Practices PRODUCT SAFETY PRODUCT EFFICACY Animal Rule Center for Biologics Evaluation & Research PRODUCT SAFETY PHASE 1 PHASE 2 PHASE 3 SURROGATE EFFICACY BIOLOGICS LICENSE APPLICATION FDA LICENSURE Good Clinical Practices Investigational New Drug (IND) MANUFACTURING VALIDATION Quality System Regulations (QSR) 7

8 Drug Development & Approval PRODUCT SAFETY PRODUCT EFFICACY Center for Drug Evaluation & Research Good Laboratory Practices PRODUCT SAFETY PHASE 1 PHASE 2 PHASE 3 SURROGATE EFFICACY NEW DRUG APPLICATION FDA APPROVAL Good Clinical Practices Investigational New Drug (IND) MANUFACTURING VALIDATION Quality System Regulations (QSR) 8

9 Medical Device Development & Approval Good Laboratory Practices PRODUCT SAFETY PRODUCT EFFICACY Center for Devices and Radiological Health PRODUCT SAFETY PRODUCT EFFICACY 510K Clearance or PHASE 1 PHASE 2 PHASE 3 Good Clinical Practices Investigational New Device (IDE) Pre Market Approval (PMA) Approval MANUFACTURING VALIDATION Quality System Regulations (QSR) 9

10 Animal Efficacy Rule May be used for product licensure/approval when: 1. Drugs & biologicals that reduce or prevent serious or life threatening conditions caused by exposure to lethal or permanently disabling toxic chemical, biological, radiological, or nuclear substances 2. Expected to provide meaningful therapeutic benefit over existing therapies 3. Human efficacy trials not feasible or ethical 4. Use of animal efficacy data scientifically appropriate CBMS experiences: Critical alternative for CBD medical product licensure/approval Not necessarily faster, not necessarily cheaper 10

11 Impact of Animal Rule on Medical Product Development P R O G R A M M A N A G E M E N T O F F I C E System - C H E M I C A L B I O L O G I C A L M E D I C A L S Operations Y S T E & M S Concept & Technology Development Development & Production & Deployment 4-8+ years Demonstration Support 4-8+ years 2-4+ years TBD Milestone A Define Technology Develop Animal Models of Pathogenesis And Protection Prime System Contractor as Manufacturer Pre IND Meeting Component Advanced Development IPR Initial Pilot Lots Pre-Clinical Testing cgmp IND Application Pilot Lot Phase 1 IND Amendment Trials Milestone B Phase 2a Trials Process Development Conformance Lot Production Develop Animal Surrogate Markers Evaluate Human Surrogate Markers IND Amendment Pivotal Animal Efficacy Study Milestone C Phase 2b Trials Biologics License Application FDA Review FDA Licensure Studies to Correlate Animal Response to Human Response Production Post Marketing Surveillance Phase IV 11

12 JVAP Mission The Joint Vaccine Acquisition Program (JVAP) is the DoD activity responsible for the development and production of FDA-licensed vaccines and antisera to protect the war fighter in a biological warfare environment. 12

13 Dynport Vaccine Company (DVC) BD Vaccine Prime Contractor Company Contract uses commercial biotech to meet DoD requirements - Award in 1997, started in 1998, duration 10 years - Type: Vaccine development Cost Plus Vaccine production Firm Fixed Price - Able to pass indemnification to subcontractors with Government approval - BD Vaccine Manufacturer responsible for obtaining and maintaining FDA licenses. Business representative to other agencies and organizations Contract Options develop and produce vaccines/antisera against 18 BWA Special Studies allows contractor to evaluate and integrate emerging technologies into vaccine systems 13

14 Current BD Medical Product Development Efforts Next Generation Anthrax Vaccine Smallpox Vaccine and Vaccinia Immune Globulin (VIG) Recombinant Botulinum Vaccine Plague Vaccine Tularemia Vaccine Venezuelan Equine Encephalitis Vaccine 14

15 Future Business Opportunities DVC subcontracts for most vaccine work elements Production scale-up Fill and finish Assay development Toxicology Clinical trials Sample testing FY04 Vaccine Effort Next Generation Anthrax Vaccine Plague Vaccine Botulinum Vaccine Venezuelan Equine Encephalitis Vaccine Contact Ms. Donna Dawson

16 MITS Mission The Medical Identification and Treatment Systems (MITS) centrally manages the development and acquisition of products used for the prophylaxis, treatment, and diagnosis of chemical and biological warfare agent exposure in U.S. Service members. 16

17 Current CD Medical Product Development Efforts Recently FDA Approved ATNAA (Antidote Treatment Nerve Agent Autoinjector): Dual-chambered autoinjection SNAPP (Soman Nerve Agent Pretreatment Pyridostigmine): Pre-exposure PB tablets SERPACWA (Skin Exposure Reduction Paste Against Chemical Warfare Agents): Protective paste against derma/exposure RSDL: Reactive Skin Decontamination Cream In Development BioScavenger Next Generation Oxime Improved Anticonvulsant 17

18 Future Business Opportunities FY04 Prime contractor for Improved Anticonvulsant FY05 Prime contractor for Next Generation Oxime 18

19 Joint Biological Agent Identification and Diagnostic System (JBAIDS) COTS PCR platform and diagnostic system complete package Identify BW agents, infectious disease agents & biological toxins Test clinical specimens and environmental samples of medical importance Government furnished agent targets and protocols Funded to take, key assays through FDA clearance Block upgrades: Increase diagnostic capabilities Reduce size and logistics tail Tie into electronic medical reporting systems 19

20 Future Business Opportunities No funding in FY04 for Block II & III Tech watch Expanded detection/diagnostics - Lab on a chip Bioinformatics Automated sample processing Reduced logistics tail 20

21 Critical Reagents Program (CRP) Provides quality antigen-antibody and PCR reagents to support different BWA detector platforms FY04 business opportunity Ab production contract 21

22 CBMS Collaborative Efforts Goals Optimize schedule and performance Share costs Reduce risks Promote interoperability Partners Department of Health and Human Services (NIAID, CDC) Agreements: smallpox vaccine and VIG, anthrax vaccine, botulinum antisera, and tularemia vaccine (pending) Canadian DND and UK MoD Agreements: smallpox vaccine and VIG, and plague vaccine (pending) Strategies Allow funded program to develop a product Develop and test competing products and down select the best product 22

23 Conclusion Medical products against WMD are required by the DoD, our nation, and our Allies CBMS ready to respond with flexibility and proven management team 23