7 Factors to Consider when Optimizing Clinical Supply Strategies

7 Factors to Consider when Optimizing Clinical Supply Strategies






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  • This is a very nice presentation of Clinical Supply Chain Management! Well done. I would love to have heard the talk.
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  • Thank you Shiela. Welcome!, Good Morning! And Good afternoon and evening to those in Europe and Asia.Thank you for joining us today.Today we are going to talk about factors that affect how we manage supplies for clinical studies.I am excited about this topic because teams can make decisions to not only make studies more efficient but also save 100s of thousands of dollars in some cases.Throughout the presentation, please ask questions.Also, if you have success stories or specific challenges you have encountered over the years, we want to know.Let’s open with a story that we are all familiar with in one form or another.
  • It was a dark and stormy night…
  • and we are managing a large global study.
  • The study has multiple treatment arms and is complicated.
  • We havea host of different kit types that must be sent to each site.
  • Also, the drug is expensive. And on top of that
  • it is temperature controlled which adds to the complexity and expense of the study.
  • Finally, the enrollment is expected to be extremely unbalanced in different regions across the globe.
  • In this story,We have expensive drugOn a global studyWith multiple treatment armsWe have to accommodate multiple treatment arms with a host of different kit typesOur enrollment is expected to be heavily unbalancedAnd, to top it off, the drug is temperature controlledDoes this sound familiar?So, we start to raise the questions…
  • Each study is uniquely different but we can use 7 common factors to help us evaluate supply strategies.
  • Supply Cost
  • Clinical supply costs are usually highly visible.The supply cost is typically used for the basis of the supply optimizationbut it is not enough to use the supply cost alone.Other factors should be evaluated in relative comparison to the supply cost.
  • Especially shipping costs
  • Controlled substance and temperature controlled drugs can rapidly drive up shipping costs depending on the supply scheme that is used.When evaluating optimal schemes, your software or teams should take into account the shipping costs relative to the base supply cost and availability.
  • Supply availability…
  • …can influence how tightly supplies should be managed.If an abundant supply is available, it may be more cost effective to supply more to the sites if shipping costs are high.However, if the next manufacturing run is cost or time prohibitive (which is typically the case), it may be wise to manage tighter supply schemes.
  • Is the trial global?
  • If it is, you want to look at the placement of each regional depot.
  • It is often necessary to evaluate key factors for each region independently in order to reach an optimal scheme.Factors that can impact the region include:Cost, Time, EnrollmentEach region can be different.
  • When evaluating the time factor…
  • …the lead time to dose or administer drug can make a difference in the scheme selected.Often times, longer lead times may provide opportunity to run tighter control schemes which can save money on shipping costs and minimize drug waste.Again, it will take longer to ship and there are more complications with controlled substance and temperature controlled supplies.And, keep in my mind, particular packaging companies may only ship Monday through Thursday which may influence your desired stock levels.
  • Shelf life can have a big impact
  • When we look at expiration dates
  • We want to understand our expected enrollment because we don’t want expiring drug sitting a low performing sites.When reviewing the overall strategy, the expected site enrollment and drug expiration dates should impact the initial shipments to the site.If you have a robust inventory that is quickly expiring however, it may be more economical to ship more drug to the sites in the early phase of the study and then change schemes when a new lot is produced.
  • Specifically with site enrollment…
  • Site estimates and expected volumes can play a key role in the strategy.Ultimately, we want high performing sites to have the tools and supplies in place to meet their volumes. Additionally, the systems and schemes should help manage peak visits.Even at low volume sites, you may have a lot of doses in a single week – we call that peak visit.It may be that a just-in-time shipping scheme needs to be in place for these lower volume sites.
  • When looking to create clinical supply strategies, it can be helpful to look at these 7 factors:Start with the obvious - Supply CostDon’t underestimate - Shipping CostUnderstand Supply AvailabilityEvaluate factors for each Regional DepotBuild in extra Time (to ship and to dose)Shelf Life – Know your expiration datesExperience pays – especially when estimating site enrollment
  • Let’s look at a quick example…

7 Factors to Consider when Optimizing Clinical Supply Strategies 7 Factors to Consider when Optimizing Clinical Supply Strategies Presentation Transcript

  • 7 Factors to consider when optimizing Clinical Supply StrategiesDATATRAK Confidential
  • DATATRAK Confidential
  • Large Global StudyDATATRAK Confidential
  • cancer.gov Multiple treatment armsDATATRAK Confidential
  • A host of different kit typesDATATRAK Confidential
  • Expensive DrugDATATRAK Confidential
  • Temperature ControlledDATATRAK Confidential
  • Expecting Unbalanced EnrollmentDATATRAK Confidential
  • DATATRAK Confidential
  • How do we effectively manage supply? DATATRAK Confidential
  • How do we effectively manage supply?How do we effectively manage costs? DATATRAK Confidential
  • How do we effectively manage supply?How do we effectively manage costs?How do we ensure drug availability? DATATRAK Confidential
  • How do we effectively manage supply?How do we effectively manage costs?How do we ensure drug availability?How do we… DATATRAK Confidential
  • 7 Factors to consider when optimizing Clinical Supply StrategiesDATATRAK Confidential
  • 1 Start with the obviousDATATRAK Confidential
  • Supply CostDATATRAK Confidential
  • Highly Visible Basis for Optimization (usually) Evaluate with other factorsDATATRAK Confidential Supply Cost
  • 2 Don’t underestimateDATATRAK Confidential
  • Shipping Cost DATATRAK Confidential
  • Controlled substance Temperature controlled Evaluate shipping cost vs. base supplyDATATRAK Confidential Shipping Cost
  • 3 What supply is available?DATATRAK Confidential
  • SupplyAvailability DATATRAK Confidential
  • Abundant supply? Next lot run: Time prohibitive? Cost prohibitive?DATATRAK Confidential Supply Availability
  • 4 Is the trial global?DATATRAK Confidential
  • RegionalDepots DATATRAK Confidential
  • Evaluate each region independently Cost Time EnrollmentDATATRAK Confidential Regional Depots
  • 5 Build in extra timeDATATRAK Confidential
  • TimeDATATRAK Confidential
  • Lead time to dose Tighter scheme? Controlled substance Temperature controlledDATATRAK Confidential Time
  • 6 Shelf life, big impact.DATATRAK Confidential
  • ExpirationDates DATATRAK Confidential
  • Expected site enrollment Robust inventory? May be necessary to change schemes mid- studyDATATRAK Confidential Expiration Dates
  • 7 Experience PaysDATATRAK Confidential
  • SiteEnrollment DATATRAK Confidential
  • Evaluate expected site volumes Consider “peak visit” Ensure drug availability JIT possible?DATATRAK Confidential Site Enrollment
  • DATATRAK Confidential
  • ExampleDATATRAK Confidential
  • RandomizationFirst factor = three treatment regimensSecond factor = two MRI levels 6 kit types DATATRAK Confidential
  • Visit Dosing InformationFirst two visits need 4 months supplyMonth 7 - Placebo patients switch tostudy drug DATATRAK Confidential
  • Other Limitations$$$ Expensive to produceLimited quantityTemperature controlled $ expensive to ship limits on site storage DATATRAK Confidential
  • Start with $$$ 6 kit types 4 months of Drug supply ShippingDATATRAK Confidential
  • Solution Base supply + “sweep”DATATRAK Confidential
  • Initial Supply4 months of each kit type for one subjectResupplyPerform “3-month sweep”Measure inventory for next four monthsSend enough drug for active subjects DATATRAK Confidential
  • ResultMinimizes wasteReduces number of shipments Can save significant $$$ DATATRAK Confidential
  • Question and Answer Other questions? molly.gluck@datatrak.netDATATRAK Confidential