7 factors to consider when optimizing clinical supply strategies
TRANSCRIPT
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7 Factors to consider when optimizing
Clinical Supply Strategies
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Large Global Study
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Multiple treatment arms
cancer.gov
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A host of different kit types
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Expensive Drug
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Temperature Controlled
Expecting Unbalanced Enrollment
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How do we effectively manage supply?
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How do we effectively manage costs? How do we effectively manage supply?
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How do we ensure drug availability? How do we effectively manage costs? How do we effectively manage supply?
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How do we ensure drug availability? How do we effectively manage costs?
How do we…
How do we effectively manage supply?
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7 Factors to consider when optimizing
Clinical Supply Strategies
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Start with the obvious 1
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Supply Cost
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Supply Cost
Highly Visible Basis for Optimization (usually) Evaluate with other factors
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Don’t underestimate 2
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Shipping Cost
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Shipping Cost
Controlled substance Temperature controlled Evaluate shipping cost vs. base supply
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What supply is available? 3
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Supply
Availability
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Supply Availability
Abundant supply? Next lot run: Time prohibitive? Cost prohibitive?
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Is the trial global? 4
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Regional
Depots
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Regional Depots
Evaluate each region independently Cost Time Enrollment
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Build in extra time 5
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Time
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Time
Lead time to dose Tighter scheme? Controlled substance Temperature controlled
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Shelf life, big impact. 6
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Expiration
Dates
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Expiration Dates
Expected site enrollment Robust inventory? May be necessary to change schemes mid-study
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Experience Pays 7
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Site
Enrollment
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Site Enrollment
Evaluate expected site volumes Consider “peak visit” Ensure drug availability JIT possible?
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BRINGING IT ALL TOGETHER
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Example
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Randomization First factor = three treatment regimens Second factor = two MRI levels
6 kit types
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Visit Dosing Information First two visits need 4 months supply Month 7 - Placebo patients switch to study drug
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Other Limitations $$$ Expensive to produce Limited quantity Temperature controlled $ expensive to ship limits on site storage
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6 kit types Start with
4 months of supply
$$$ Drug
Shipping
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Solution Base supply + “sweep”
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Initial Supply 4 months of each kit type for one subject Resupply Perform “3-month sweep” Measure inventory for next four months Send enough drug for active subjects
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Result Minimizes waste Reduces number of shipments
Can save significant $$$
