Risk Management Plan Page 10
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10Appendix B – Example Risk Register
Risk Register for "Generic Vaccine"
Gantt
WBS
Risk
Overall Impact
Mitigation
Contingency
CSP Impact
Timing / Option
Additional
FDA does not agree with the
$400,000 for NHP
characterization results (non-clinical
Update program design with FDA
Model Study
and clinical studies planned, example
input, modify SOW, obtain BARDA
if FDA requires NHP instead of used
Occasional +
Early and frequent meetings with the
CO, PO, and Management Approval of
Addition of ~9
30 1.3.2.4
animal model)
Moderate = 3C
FDA prior to study execution.
new SOW, and provide budget request
months
Q3, FY11 - BASE
1. Slow the pace of the studies to
accommodate the production
Lab unable to produce an adequate
Subcontract negotiations with CMO to
availability
amount of product to conduct all
produce product for use in non-clinical
2. Use available lab product until CRO
studies that are currently scheduled
studies.
cGMP product is available
1. Use available lab product and
schedule studies based on available
product.
2. Transition financial resources from
subcontract to expansion of lab for
production.
Subcontract negotiations with CMO to
3. Transition financial resources to
produce non-GMP product for use in
expedite the execution of the cGMP
Contract negotiations failure
non-clinical studies.
subcontract.
1. Second manufacturing attempt
2. Discontinue contract and use lab
product
Complete technical package and
3. Discontinue contract and expedite
Manufacturing failure
assistance available from lab.
the cGMP manufacturing contract.
Contract negotiations failure with
Early RFP for evaluation of multiple
cGMP facility
CMO facilities
Alternate facility RFP
Completion of detailed manufacturing
Manufacturing process development,
Tech Transfer failure (lack of detailed
technical transfer package and SME
testing, optimization and validation
information)
provisions during pilot lot preparations
requirement
Study Task 2 (subtask studies task
lines 37 and 38) could yield negative
Preliminary studies conducted with
Alternate study design and potential
results, not meet success criteria
positive results
product redesign
Study Task 1 (subtask studies task
lines 45 and 46) could yield negative
Preliminary studies conducted with
Alternate study design and potential
results, not meet success criteria
positive results
product redesign
Study Task 3 (subtask studies task
lines 52, 53, 54, and 55) could yield
negative results, not meet success
Preliminary studies conducted with
Alternate study design and potential
criteria
positive results
product redesign
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