Joint Program Executive Office for Chemical and Biological Defense
May 6, 2009
John Gorrell
Deputy Director, Current Acquisition
703.681.0808
090506_CBDAIF_DODI 500002_MDD_Gorrell
UNCLASSIFIED
1

Joint Program Executive Office for Chemical and Biological Defense
• DoDI 5000.2 (December 2008)
• New Policy Directed by Congress
• New or Revised Regulatory Policy
• Statutory & Regulatory Information & Milestone Requirements
• The Defense Acquisition Management System - Milestones,
Phases and Key Activities
090506_CBDAIF_DODI 500002_MDD_Gorrell
UNCLASSIFIED
2

Joint Program Executive Office for Chemical and Biological Defense
User Needs
Technology Opportunities & Resources
ICD
Materiel
Solution
Analysis
A
Technology
Development
B
Engineering and
Manufacturing Development
CDD
Materiel
Development
Decision
AoA PDR or
Pre-Systems Acquisition
PDR
Post PDR
Assessment
CDR
Post CDR
Assessment
C
CPD
Systems Acquisition
IOC
Production &
Deployment
FRP
Decision
Review
FOC
Operations &
Support
Sustainment
Old (2003)
Concept Refinement (CR)
Technology Development (TD)
Systems Development &
Demonstration (SDD)
New (2008)
Materiel Solution Analysis
Technology Development (TD)
Engineering & Manufacturing
Development (EMD)
Change from 2003
More robust AoA
Competitive prototyping
More robust system engineering
090506_CBDAIF_DODI 500002_MDD_Gorrell
UNCLASSIFIED
3

Joint Program Executive Office for Chemical and Biological Defense
User Needs
Technology Opportunities & Resources
Materiel
Solution
A
Technology
Development
B
Engineering and
Manufacturing Development
C IOC
Production &
Deployment
FOC
Operations &
Support
Materiel
Development
Decision
AoA PDR
CDD
PDR
Post PDR
Assessment
CDR or
Post CDR
Assessment
CPD
FRP
Decision
Review
Sustainment
Pre-Systems Acquisition
Old (2003)
N/A
New (2008)
Concept Decision (CD) Materiel Development Decision
(MDD)
Post-PDR Assessment
Design Readiness
Review DRR
090506_CBDAIF_DODI 500002_MDD_Gorrell
Post-CDR Assessment
Systems Acquisition
UNCLASSIFIED
Change from 2003
MDD required prior to entering the process at any point
MDA’s assessment of PM’s PDR
Report (if PDR after MS B)
MDA’s assessment of PM’s CDR
Report
4

Joint Program Executive Office for Chemical and Biological Defense
From two processes…
•
Incremental Development:
End-state is known; requirements met over time in several increments
•
Spiral Development: End-state is not known; requirements for increments dependent upon technology maturation and user feedback.
To one process…
No spirals!
•
Capability delivered in increments, recognizing up front need for future capability improvements
•
Each increment:
depends on mature technology
is a militarily useful and supportable operational capability
Successive Technology
Development Phases may be needed to mature technology for multiple increments
090506_CBDAIF_DODI 500002_MDD_Gorrell
UNCLASSIFIED
5

Joint Program Executive Office for Chemical and Biological Defense
“ The TDS and associated funding shall provide for two or more competing teams producing prototypes of the system and/or key system elements prior to, or through, Milestone B.
Prototype systems or appropriate component-level prototyping shall be employed to reduce technical risk, validate designs and cost estimates, evaluate manufacturing processes, and refine requirements. . . .”
A
ICD
Materiel
Solution
Analysis
Technology
Development
Materiel
Development
Decision
AoA
Pre-Systems Acquisition
PDR or
B
Engineering and
Manufacturing Development
CDD
PDR
Post PDR
Assessment
CDR
Post CDR
Assessment
Systems Acquisition
C
CPD
IOC
Production &
Deployment
FRP
Decision
Review
090506_CBDAIF_DODI 500002_MDD_Gorrell
UNCLASSIFIED
FOC
Operations &
Support
Sustainment
6

Joint Program Executive Office for Chemical and Biological Defense
John Gorrell
Deputy Director, Current Acquisition
703.681.0808
090506_CBDAIF_DODI 500002_MDD_Gorrell
UNCLASSIFIED
7

Joint Program Executive Office for Chemical and Biological Defense
Technology Opportunities & Resources
User Needs
Strategic
Guidance
Joint
Concepts
Capabilities - Based
Assessment
ICD MDD
Materiel
Solution
Analysis
A B
Technology
Development CDD
Engineering & Manuf
Development
C
CPD
Operations & Support
Production &
Deployment O&S
OSD/JCS COCOM
FCB
Incremental Development
Acquisition Process
MDD is Formal Entry into Defense Acquisition Management System
MDD Required Regardless of DAMS Entry Point
“Following the Materiel Development Decision (MDD), the MDA may authorize entry into the acquisition management system at any point consistent with phase-specific entrance criteria and statutory requirements.”
090506_CBDAIF_DODI 500002_MDD_Gorrell
UNCLASSIFIED
8

Joint Program Executive Office for Chemical and Biological Defense
• Transitions from Tech Base to Acquisition Program
• Funding
– 6.2/6.3 transitions to 6.3/6.4
• Requirements Maturation
– From MDD to Material Solution Analysis through Technology
Development Phase
• Contracting
– Dual Prototyping
– Limits to Recompete in Later Phases
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UNCLASSIFIED
9

Joint Program Executive Office for Chemical and Biological Defense
• DUAL PROTOTYPE – Technology Development Phase
– Early Technology Commitment in the Technology Development
Phase
– Early Industry Resource Commitments to Compete in Technology
Development Phase
– Industry Must Understand Requirements Early to Get in Front of the Government Process
– Shifts more Risk to Industry
090506_CBDAIF_DODI 500002_MDD_Gorrell
UNCLASSIFIED
10

Joint Program Executive Office for Chemical and Biological Defense
090506_CBDAIF_DODI 500002_MDD_Gorrell
UNCLASSIFIED
11

Joint Program Executive Office for Chemical and Biological Defense
• JRO – Presents the ICD
– Preliminary concept of operations
– Description of needed capability
– Operational risk(s)
– Basis for determining the a “non-material” approach will not sufficiently mitigate the capability gap
• PAIO – Proposes Study Guidance for the AoA
• MDA – Approve the AoA Study guidance
– Determines the acquisition phase of entry
– Identifies the Milestone Reviews
– Designates the Lead DoD Component or Principal Staff Assistant
– Documents the decision(s) by ADM
090506_CBDAIF_DODI 500002_MDD_Gorrell
The AoA is not performed by the PM
UNCLASSIFIED
12

Joint Program Executive Office for Chemical and Biological Defense
• Lead DoD Component
– Proposes an AoA Study Plan
– AoA assesses the preliminary material solutions
– Identifies key technologies
– Prepares and estimate of Life Cycle Costs
– Study Plan coordinated with the MDA; approved by the PAIO prior to start of the AoA
– Final AoA to be provided 60 days in advance of the Milestone
Review
– PAIO (in this case) evaluates the AoA and provides assessment to the Lead Component/Principal Staff and to the MDA
• Illuminates capability advantages/disadvantages
• Considers joint operational plans
• Examination of sufficient feasible alternatives
• Discuss key assumptions, variability and sensitivity to changes in calculated costs, technology risk maturity (TRL), training
Material Solution Analysis Phase Ends When the AoA is Completed
090506_CBDAIF_DODI 500002_MDD_Gorrell
UNCLASSIFIED
13

Joint Program Executive Office for Chemical and Biological Defense
• JPM develops for presentation at MS A
– Strategy for executing MS A to MS B to include Dual (or more)
Prototyping
– Technology Development Strategy (draft approved as part of MS review)
– Systems Engineering Plan (Compare/contrast FDA fulfilled requirements to programmatic)
– Test and Evaluation Strategy
• Lifecycle concept
• Tech Development Test Plan
• T & E Resourcing Strategy
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UNCLASSIFIED
14

Joint Program Executive Office for Chemical and Biological Defense
“Entrance into this phase depends on the completion of the AoA, a proposed materiel solution, and full funding for planned Technology Development Phase activity.
At Milestone A, the MDA shall review the proposed materiel solution and the draft
Technology Development Strategy (TDS).
The Technology Development Phase begins when the MDA has approved a materiel solution and the TDS, and has documented the decision in an ADM. Technology development for an MDAP shall not proceed without Milestone A approval.
For business area capabilities, commercially available solutions shall be preferred.
A favorable Milestone A decision DOES NOT mean that a new acquisition program has been initiated.”
A
ICD
Materiel
Solution
Analysis
Technology
Development
Materiel
Development
Decision
AoA
Pre-Systems Acquisition
PDR or
B
Engineering and
Manufacturing Development
CDD
PDR
Post PDR
Assessment
CDR
Post CDR
Assessment
Systems Acquisition
090506_CBDAIF_DODI 500002_MDD_Gorrell
UNCLASSIFIED
C
CPD
IOC
Production &
Deployment
FRP
Decision
Review
FOC
Operations &
Support
Sustainment
15

Joint Program Executive Office for Chemical and Biological Defense
Materiel Solution
Analysis
Research /
Discovery
Technology Development
Pre-Clinical / Clinical Development
Engineering and Manufacturing
Development
Clinical Development
Production & Deployment
Regulatory Submission
DoD FDA
Operations &
Support
Post Licensure
Lab scale production
Initial assay development
Proof of concept animal studies
DoD 5000
Documentation
• ICD
• TDS
• SEP
• AoA
•
Milestone A
Process development & pilot lot production
Clinical assay development
IND Submission - Product Commitment
( Investigational New Drug) • Indication(s) for use
Manufacturing scale up
• Route(s) of administration
• Manufacturing process (initial)
Dose range, schedule & safety in animals
Phase 1 Human
Trials (safety)
Animal Efficacy Trials
PDR after initial successful human trials
(Phase I Safety)
PDR
DoD 5000
Documentation
• CDD
• SAMP
• APB
• etc.
Milestone B
CDR
Validation &
Demo Lots
Consistency
Lots
Phase 2 Human Trials
(safety/dose/schedule)
Milestone C LRIP
(Low Rate Initial Production )
Phase 3 Human trials
(expanded safety)
•
CDR after Validation &
Demo lots produced successfully
090506_CBDAIF_DODI 500002_MDD_Gorrell
Pivotal animal efficacy studies
BLA / NDA Submission
Biologic License Agreement /
New Drug Application
FDA
Review
Full Rate Production IPR
DoD 5000
Documentation
• CPD
• SAMP
• APB
• etc.
(Initial Program Review)
Warm Base
Manufacturing
IOC
Licensure
Post marketing surveillance
Stockpile
(Initial Operating Capability)
FOC
Sustain
Emergency Use Authorization may be considered
UNCLASSIFIED
16

Joint Program Executive Office for Chemical and Biological Defense
Focus of major changes
User Needs &
Technology Opportunities
Defense Acquisition Management
Framework- 2003
Concept
Refinement
A
Technology
Development
B
Program
Initiation
System Development
& Demonstration
Concept
Decision
Design
Readiness
Review
C
IOC
Production &
Deployment
FRP
Decision
Review
FOC
Operations &
Support
User Needs
Technology Opportunities & Resources
Materiel
Solution
Analysis
Materiel
Development
Decision
A
Technology
Development
B
Program
Initiation
Engineering and
Manufacturing Development
C
PDR PDR
Post PDR
Assessment
Post-CDR
Assessment
090506_CBDAIF_DODI 500002_MDD_Gorrell or UNCLASSIFIED
Defense Acquisition Management
System - 2008
IOC
Production &
Deployment
FRP
Decision
Review
FOC
Operations &
Support
17