Transcript Joint Program Executive Office for Chemical and Biological Defense JOINT PROJECT MANAGER CHEMICAL BIOLOGICAL MEDICAL SYSTEMS (JPM-CBMS) April 26, 2005 Advanced Planning Brief to Industry COL.

Joint Program Executive Office for Chemical and Biological Defense
JOINT PROJECT MANAGER
CHEMICAL BIOLOGICAL MEDICAL
SYSTEMS (JPM-CBMS)
April 26, 2005
Advanced Planning Brief to Industry
COL STEPHEN BERTÉ
JPM-CBMS
Joint Program Executive Office
for Chemical and Biological Defense
[email protected]
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Joint Program Executive Office for Chemical and Biological Defense
Outline
• Program Overview
• Warfighter Needs
• Technical Challenges
• Acquisition Strategy/ Funding/ Schedule
• Upcoming Business Opportunities
• Contacts
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Joint Program Executive Office for Chemical and Biological Defense
Overview
• Develop, Procure, Field, and Sustain Premier Medical
Protection and Treatment Capabilities Against
Chemical and Biological Warfare Agents
• Ultimate Outcomes are FDA Licensed Drugs, Medical
Devices and Vaccines
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Joint Program Executive Office for Chemical and Biological Defense
Warfighter Needs
• Provide the Capability to Protect Service Members
from the Effects of Chemical, Biological,
Radiological, and Nuclear (CBRN) Agents Before the
Appearance of Symptoms
– Medical Identification & Treatment Systems (MITS)
• Bioscavenger: Prevent Incapacitation and Death from Exposure
to Nerve Agents
– Joint Vaccine Acquisition Program (JVAP) Uses the Prime
Systems Contract Integrator Approach with DynPort Vaccine
Company (DVC) to Meet DoD Biological Defense Vaccine
Requirements
• DVC Obtains and Maintains FDA Licenses
• Special Studies Allows DVC to Evaluate and Integrate Emerging
Technologies into Vaccine Systems
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Joint Program Executive Office for Chemical and Biological Defense
Warfighter Needs (cont’d)
• Provide the Capability To Treat Service Members for
the Effects of CBRN Agents After the Appearance of
Symptoms.
– Advanced Anti-convulsant System (AAS) will Replace
Convulsant Antidote Nerve Agent (CANA) System
• Intramuscular Auto-injection of Drug (midazolam) for Enhanced
Control of Seizures
• Effective Against Broader Spectrum of Nerve Agents and NonTraditional Agents (NTAs)
– Improved Nerve Agent Treatment System (INATS) Active
Ingredient will Replace and Provide better Protection than
Current Oxime, 2-PAM
• System Approach Will Also Develop Broader Indications for
Pretreatment Pyridostigmine Bromide
• INATS will Use Current Delivery System
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Joint Program Executive Office for Chemical and Biological Defense
Warfighter Needs (cont’d)
• Provide a Reusable, Portable, Modifiable Biological
Agent Identification and Diagnostic System Capable
of Simultaneous Reliable Identification of Multiple
Biological Warfare Agents and Other Biological
Agents of Operational Significance
– Joint Biological Agent Identification and Treatment System
(JBAIDS) Will Provide Portable Diagnostic Capability to
Warfighter. Evolutionary Approach:
• JBAIDS Block I System Capable of Identifying 10 BWAs
• JBAIDS Block II System Will Add Capability to Identify 5 Toxin
Types
• JBAIDS Block III System: Reduce to Hand Held Device
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Joint Program Executive Office for Chemical and Biological Defense
Technical Challenges
• Proving Product Efficacy
– FDA ‘Animal Rule’ Allows Use of Data From Animal Instead of
Human Trials to Prove Product Efficacy
– Full Spectrum of Human Safety Studies Still Conducted
– ‘Animal Rule’ Approach Not Necessarily Cheaper or Faster
• Requires Facilities Capable of Animal Testing for
Biological and Chemical Warfare Agent
Countermeasures
• Manufacturing
– Complexity of Biological Manufacturing Process
– FDA Process is Averse to Technology Insertion
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Joint Program Executive Office for Chemical and Biological Defense
Technical Challenges (cont’d)
• AAS
– Ability of the CANA Drug-containing Chamber to Hold
Midazolam Instead of Diazepam
– Stability of the Midazolam in the Drug-containing Chambers
of the CANA
• INATS
– Active Ingredient is New Active Pharmaceutical Ingredient
(API) in U.S.
• Ability to Make the Candidate Oximes IAW cGMP
• Formulation, Stability of the Formulation or Toxicology Problems
with Candidate Oximes
• Ability of Oxime-containing Chamber of ATNAA to Contain
Candidate Oximes
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Joint Program Executive Office for Chemical and Biological Defense
Technical Challenges (cont’d)
• Plasma-Derived Bioscavenger
– Aggressive 2 year Schedule
– Hand-off of pBioscavenger to DHHS
• Recombinant Bioscavenger
– Program Initiation in FY06
– Process Development and Small Scale (cGMP) Manufacturing
Required
– Full Development Program to FDA Approval
• JBAIDS
– FDA Approval of Device and Multiple Assays
– Miniaturization & Interoperability
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Joint Program Executive Office for Chemical and Biological Defense
Acquisition Strategy
• Addresses User Requirements Based on Capabilities
Needed and Chairman of the Joint Chiefs of Staff
Priorities
• Develops FDA Licensed Chemical and Biological
Defense (CBD) Medical Products
• Leverages Other Government Agencies, International
Partnerships, and Industry
• Manages Product Line Within Available Resources
– Funds Product Development Efforts to Minimize
Schedules
– Expands or Contracts Product Line Based on
Available Funding
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Joint Program Executive Office for Chemical and Biological Defense
JVAP: Meeting Warfighter Needs
FY04
FY05
FY06
FY07
FY08
FY09
FY10
FY11
Licensure
DoD Funded Programs
AVA In Production
VIG
18 Feb 05
MS C
rBOT (A/B)
MS B
MS C
Plague
2012
2010
MS A
VEE
MS B
MS C
2013
MS B
DHHS Programs
Smallpox
VIG
NGAV
BOT (CEF)
Tularemia
DoD Unfunded Programs
Ricin
SE
LEGEND:
Milestone
Transition
TBD
TBD
IND
Submission
NDA
Submission
Initiate Phase 1
Clinical Trial
Initiate Phase 2
Clinical Trial
Initiate Phase 3
Clinical Trial
BLA
Submission
Licensure
Transfer to DHHS
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Joint Program Executive Office for Chemical and Biological Defense
Program Schedule: MITS
FY04
FY05
FY06
FY07
FY08
FY09
FY10
FY11
FDA Approval
DoD Funded Programs
SERPACWA
ATNAA
SNAPP
In Production
In Production
In Production
AAS*
MS B
2011
INATS
pBIOSCAVENGER
MS B
MS A
MS C
MS A
rBIOSCAVENGER
2012
MS A
RADIOPROTECTANT
MS B
MS A
2012
MS B
DoD Unfunded Programs
ANTI-VESICANT
*Currently unfunded after MS B
LEGEND:
Milestone
Transition
IND
Submission
NDA
Submission
Initiate Phase 1
Clinical Trial
Initiate Phase 2
Clinical Trial
Initiate Phase 3
Clinical Trial
BLA
Submission
Licensure
Transfer to DHHS
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Joint Program Executive Office for Chemical and Biological Defense
Program Schedule: MITS
FY04
FY05
FY06
FY07
FY08
FY09
FY10
FY11
FY12
FY13
FY14
DoD Funded Programs
JBAIDS
BLOCK I
MS C
JBAIDS
BLOCK II
MS B
MS C
DoD Unfunded Programs
JBAIDS
BLOCK III
LEGEND:
MS B
Milestone
Developmental
Test
Operational
Test
Initial Operational
Capability
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MS C
FRP
Decision
Full
Operational
Capability
Transition
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Joint Program Executive Office for Chemical and Biological Defense
Upcoming Business Opportunities
Program
Description
Year
Estimated
Contract Value
MITS
JBAIDS (Block II)
FedBizOpps released
FY05
Fly Off
FY05
$65k/offeror
RFP to Fly Off “winners”
FY06
$15-20M
Pursuing P.O. with Meridian Medical
Technology (MMT) bulk drug purchase and
develop analytical assays. MS B is tentatively
scheduled for Sep 06
FY05
$15-25M
Recombinant Bioscavenger RFP for Prime Systems Contractor
FY06
$40-50M
INATS
FY06
$12M
Clinical Research Organization (CRO) and
multiple clinical site management for Plague
vaccine Phase 2 clinical trial
FY05
Venezuelan Equine
Lyophilization process development for VEE
Encephalitis (VEE) Vaccine vaccine
FY05
Cost is
evaluated
separately from
technical
Vaccinia Immune Globulin
(VIG)
FY06
AAS
RFP for Prime Systems Contractor
JVAP – subcontract through DVC
Plague Vaccine
Technology transfer and manufacture of VIG
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DVC’s Award
based on
Best Value
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Joint Program Executive Office for Chemical and Biological Defense
Points of Contact
• Project Manager Medical Identification & Treatment Systems
(MITS)
– LTC Keith Vesely
– (301) 619-8425
– [email protected]
• Project Manager Joint Vaccine Acquisition Program (JVAP)
– LTC Travis Bernritter
– (301) 619-7083
– [email protected]
• DVC
– Business Development Director:
• Barbara Solow, 301-607-5241
– Director of Contracts:
• Donna Dawson, 301-607-5009
– President:
• Terry Irgens, 301-607-5001
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