Joint Vaccine Acquisition Program

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Joint Vaccine Acquisition Program
JVAP Status Review (A Program in Change) To Armed
Forces Epidemiology Board 21 May 2002 COL
David L. Danley Project Manager Joint Vaccine
Acquisition Program [phone] David.Danley_at_de
t.amedd.army.mil
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Charter for the Joint Program Office

• 1994
• Milestone Decision Authority for all Biological
  Defense (BD) Programs
• Manage BD Detection Programs
• Manage BD Medical Programs
• Monitor Transition Emerging BD Technology
• 2002
• PEO
• Provides Program Management for the Development,
  Acquisition, Distribution and Deployment of
  Highly Specialized and Dynamic JOINT C/B Defense
  Detection and Medical Diagnostic Systems, Drugs
  and Vaccines
• JPEO Decision Pending

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New Relationships
USD (ATL)
?
ASA (ALT)
?
JPEO-CBD
Falls Church, VA
JPM CHEM/BIO DEFENSE MED SYSTEMS
Fort Detrick, MD
Medical Identification And Treatment
Systems (MITS)
Joint Vaccine Acquisition Program
Med Chem Defense
Critical Reagent Program (CRP)
Diagnostics JBAIDS
JVAP
Anthrax Vaccine Adsorbed (AVA)
Drugs Therapeutics
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JVAP Mission

• Develop and Produce FDA Licensed Medical Products
  to Protect the Warfighter in a Biological Warfare
  Environment

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JVAP Background
Apr 95 May 95 Dec 96 Nov 97
Sec Army establishes BD Vaccine
Requirements Defense Acquisition Executive
directs use of Prime Contract approach JVAP
Program Management Office Established Prime
Contract Awarded to DynPort Vaccine Company
DVC
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Managing the Complex Process of Vaccine System
Integration
Antigen
Manufacturing
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Challenges

• Development of safe, effective, licensed
  vaccines.
• Addressing emerging/changing requirements
• Cooperative development with potential domestic
  and international partners
• Limited industrial base largely comprised of
  small businesses

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Integration of the Vaccine Development Process,
the FDA Regulatory Process and the DoD
Acquisition Process
Concept Technology Development 4-8 years
System Development Demonstration 2-4 years
Production Deployment 4-8 years
Operations Support TBD
Milestone A
Prime System Contractor as Manufacturer
Pre IND Meeting
Define Technology
Component Advanced Development IPR
Initial Pilot Lots
Pre-Clinical Testing
Formulation Loop
IND Application
cGMP Pilot Lot
IND Amendment
Phase 1 Trials
Milestone B
Formulation Loop
Phase 2a Trials
Surrogate Testing
Milestone C
Conformance Lot Production
Phase 2b Trials
IND Amendment
Biologics License Application
FDA Review
Production
FDA Licensure
Post Marketing Surveillance
Full Rate Production IPR
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Acquisition of Biological Defense Medical Products
RAD 4/Research Laboratories
JVAP/Prime Systems Contractor
Technology Transition
BA3

BA4
Procurement
BA5
Review
C
A
Full Scale Production IPR
Component Advanced Development IPR
B
System Development Demonstration
Production Deployment
Acquisition Phase
Sustainment Disposal
Concept Technology Development
PROGRAM PEO Medical OIPT OVERSIGHT
Integrated Teams
Vaccine IPT (Product Specific)
Tech Base PDT
Consolidated PDT
DVC PDT
Technical Readiness Levels
Replenishment Production Post-Marketing Surveilla
nce Disposal
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JVAP Products

• Products in Advanced Development
• Smallpox vaccine and Vaccinia Immune Globulin
• Tularemia vaccine
• Multivalent Recombinant Botulinum vaccine (A,B)

• Products in Transition
• Plague vaccine
• Next Generation Anthrax vaccine
• Venezuelan Equine Encephalitis vaccine
• Products in Tech Base
• Staphylococcal Enterotoxin (SE) vaccine
• Brucellosis vaccine
• Marburg vaccine
• Ebola vaccine
• Ricin vaccine

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BD Vaccine Development Schedule
VACCINES
FY00
FY01
FY02
FY03
FY04
FY05
FY06
FY07
FY08
FY09
FY10
FY11
FY12
FY13
FY14
Smallpox
Tularemia
Next Gen Anthrax
rBotulinum Bi-valent (AB)

VEE
Plague



LEGEND
Component Advanced Development
System Development and Demonstration
Production and Deployment
Event Complete Event Ongoing

Operations and Support
In Process Review
Submission of BLA
Baseline Stockpile Quantities Obtained
As of 16 May 02
IPRs at completion of Phase1 trials,
initiation of consistency lot testing and FDA
licensure/Full Rate Production
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IND Contingency Stockpile

• Investigational New Drugs (INDs) include
• - Venezuelan Equine Encephalitis
• - Tularemia Vaccine
• - Smallpox Vaccine
• - Eastern Equine Encephalitis
• - Western Equine Encephalitis
• - Botulism Antitoxins
  
• - Pentavalent Botulinum Toxoid
• Primarily used for at-risk laboratory personnel
  through the Special Immunization Program (SIP)
• Completed evaluation of stockpile for suitability
  as IND vaccines. New testing initiated
• Completing emergency IND protocols for Tier 1
  vaccines Smallpox vaccine (DryVax) and VIG,
  Pentavalent Botulinum Toxoid, and Anthrax Vaccine
  (post-exposure). Also for Bot Antitoxins and
  Cidofovir
• ISSUE Tier 2 vaccines are they required as
  INDs

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International Collaboration

• Goals
• Ensure availability of licensed BD medical
  products for US and allied forces
• Reduce program costs
• Ensure interoperability
• Achievements
• Completed CANUKUS CBR MOU Project Arrangement
  (PA) with Canada to co-develop smallpox vaccine
  and VIG
• Request to negotiate new PA for plague vaccine

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Summary

• Vaccine Development Lengthy, complex and highly
  regulated
• Prime System Contract in place
• Critical step between technology base and
  production
• Flexible to meet changing requirements
• Established "Manufacturer" for FDA licensure
  issues

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Joint Biological Agent Identification and
Diagnostic System

• (JBAIDS)

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Joint Biological Agent Identification and
Diagnostic System (JBAIDS)

• JBAIDS is a portable biological agent
  identification and diagnostic device capable of
  simultaneously identifying multiple biological
  agents of operational concern and other pathogens
  of clinical significance

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JBAIDS Acquisition Strategy

• JBAIDS Block 1 will be NDI or modified NDI
• A two step selection process will be used to
  determine which contractor will develop and
  manufacture the system platform, agent specific
  kits and the protocols/operating procedures for
  using the sytem
• The contractor will begin efforts for FDA
  approval of the platform, kits and protocols
• Pending FDA approval, the Block 1 device will be
  used for medical surveillance, but not as a
  diagnostic device for patient treatment
• Anticipated procurement of gt400 devices in FY03/04

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(DRAFT) Performance Parameters
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Schedule Milestones
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(DRAFT) BD Pathogen Assays

• Block 1
• Anthrax
• Brucella
• Ebola-Marburg
• Venezuelan Equine Encephalitis
• Glanders
• Plague
• Q-fever
• Smallpox
• Tularemia
• Typhus
• Block 2
• Botulinum toxins A and B
• Ricin
• Staphylococcal Enterotoxins A and B

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Issues

• BD program cannot fund development and FDA
  approval of assays for ID
• Availability of ID funding for JBAIDS assay
  development and FDA approval?