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Clinical Trial Supply Management: A virtual company’s lessons learned
Bruce H Morimoto, Ph.D. May 30, 2013
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Disclaimer
The views expressed in this presentation are mine and do not reflect those of my past, present or future employers…
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Senior Management View of CTS
Labeling Drug Depot
Clinical Sites
Drug Manufacturing
What’s so difficult? Devil is in the details…
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IMP Characteristics
Refrigerated storage product Stability OK for up to 1M at RT Not stable at > 40°C
Very expensive per unit cost Limited supply (only 10% overage) On-going stability—retest updates
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Clinical Trial Parameters
48 sites, 6 countries, 3 continents
Study duration: 12 month
Recruitment: 9-12 months
~300 subjects total
0.5 subjects per month per site
IMP in 3 month kits
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IMP-Driven Decisions
Cold chain supply
Refrigerated shipping
Shipments needed to be temperature monitored
Just-in-time shipping
Couldn’t keep inventory at sites
Randomization would trigger shipping
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Trial-Driven Decisions
Product manufactured in North America
Continents
North America
Europe
Asia-Pacific
All countries in Europe part of EU (!)
Single QP release for all of Europe
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(Idealized) Product Flow
Labeling & Packaging
(EU)
Drug Depot (US)
Clinical sites
Drug
Manufacturing (North America)
QP Release
Drug Depot (EU) Drug Depot (Asia-Pacific)
Clinical sites
Clinical sites
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Actual Product Flow
Drug Depot (US)
Labeling & Packaging
Active (EU)
Clinical sites
Bulk Drug (EU)
QP Release
Drug Depot (EU)
Drug Depot (Asia-Pacific)
Clinical sites
Clinical sites
Labeling & Packaging Placebo
(NA)
Drug Manufacturing (North America)
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Logistic Challenges
Customs Multiple QP release Volcanic eruptions
Find a customs broker—upfront! Got bill for $200K We were able to get most of it back, but…
Shipping-logistics expert (consultant)
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Case Challenge
Had 3 year stability on old formulation Changed IMP formulation IMP retest date driven by real-time stability Get stability data from manufacturer Update IMPD Submit to European country authorities with proposed
retest extension Receive approval Release newly labeled IMP into inventory
Shipped 3 month supply
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Lessons Learned
Have enough stability BEFORE you begin
Map out supply chain and plan for contingencies
Independent person to track and review inventory &
retest dates
Person needed to be unblinded to track placebo &
active kits
Required excellent coordination with regulatory
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Other Learning Discussions
Shipping:
Premium provider versus Standard Courier
Just-in-time shipping versus inventory at sites
Cost of drug and availability
Cost of each shipment
Temperature monitoring
Bulk shipments versus Individual shipments
Temperature monitors versus warmmarks
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Special Thank You to: Tracey Joell Liam Quinn
Lesley Parker Sue Anne Crocker
Mina Virtusio
Questions? Please email: [email protected]
Questions?