Introduction slides for the workshop on best practice for optimizing the clinical supply chain visibility held at the Clinical Trials Supply Forum 2018 conference in London.

1. 22.01.2018London, UKClinical Trial Supply Forum 2018
Optimizing
Management of
Clinical Trial
Supply Chains
Through Improved
Visibility and
Tracking Practice
by Antony Pham
@clinicalsupply
sply.dk

2. Hi! I am Antony
Pham
Pharmacist / MSc Pharm
CEO and Consultant at SPLY ApS
Building
linkedin.com/clinicaltrialsupply
@clinicalsupply
Email: ap@sply.dk

3. ”I am here to touch upon
trends and best practice
within clinical trial supply
chain optimization and
how to increase visibility”

4. Exploration of Future
/ ”Hyped” Technology

5. What is Blockchain
Technology?
Public distributed and shared ”ledger” containing
all transactions with well defined rules
Removes the need for a trusted 3rd party
(For some people) A blockchain is a new type of
database for sharing information – directly
accessble on the blockchain
Technology for storing and transmitting
information while recording all transactions
Transactions on a blockchain are encrypted –
impossible to forge data

6. What is the problem in clinical supply?
Sponsor running global trials with multiple sites involves a lot of international shipments with a lot of
touch points and communications - It can be difficult to monitor and account for all movements.
Sourcing of comparators on the open market. Need for track back and prevent counterfeit drugs.
What is the potential?
Managing the supply chain on a private blockchain-based platform may improve traceability ,
transperancy and efficiency – and secure the shipment and distribution records – would only succeed if
all supply chain links agrees to use the platform. Generally great potential but should only be applied to
task in which it is well suited.
Blockchain in a Clinical Supply Context

7. What is Internet of
Things (IoT)?
Sofistacted devices, sensors and chips embedded
in the things that surronds us each transmitting
data in real-time
Data let us know how these things work an work
together
IoT platforms brings data together and applies
analytics – helping us to adjust and make data
driven decisions

8. What is the problem in clinical supply?
Many sponsors are currently running trials with limited transperancy in e.g. the temperature monitoring
of cold chain IMPs – This often results in non-compliance.
What is the potential?
IoT and sensors provides continuos monitoring (position, temperature etc.) and visibility via a cloud
based platform
IoT-enabled devices may improve efficiency in the clinical supply chain
IoT in a clinical supply context

9. Do you have any plans to drive IT
innovation (NLP, block chain, cloud
computing, machine learning) into the
drug supply organization over the next 2
years?

10. Have you formed an internal commitee
or working group that meets about
innovation, and is drug supply
considered?

11. What are the major barriers for
implementing new IT innovations?

12. Clinical Supply Chain
Optimization

13. Complex landscape of various systems,
suppliers, regulations, manufactures
Sponsor has to rely on wholesalers,
manufacturer, depot, sites etc. In practice all
supply chain links until the last mile
Vulnerable to errors, fraud and
misinterpretation
Clinical Supply Chain Landscape

14. Common CTS
Planning Hurdles
Complex supply chain
Long and variable lead times
Capacity constraints at suppliers
Silo planning within operational functions
Low drug stability
Changes in enrollment
Expensive drug requiring cold chain management

15. Why Opt for Clinical Supply Chain
Optimization and Visibility?
Study: Market for clinical manufacturing, storage &
distribution and supply chain mangement to hit
US$3.3bn by 2025*
To prevent falisified medicinal products enters the
chain and to ensure product integrity and quality
Increased visibibility in all supply chain links will help
track, manage and direct supply operations centrally
Continue to meet current and new regulatory
requirements
*According to report from Grand View Research, July 2017

16. What Are We
Trying To Achive?
Reduce timelines and cost at the same time
without disruption of drug to patient
Ensure that there is a enough drug at site but not
too much to keep the waste low and avoid
shortage on other sites
Implementation of cost efficent solutions that
will help you plan ahead and take data driven
decision – and reduce stress ☺

17. The Building Blocks
COSTQUALITY FLEXIBILITYSPEED

18. Inefficient Supply
Chain Management
and low visibility
will result in:
Inventory build-up and excessive overages
Suppliers are not able to support you with cutting
excess inventory and they will eventually loose
crediability…
No true version of the demand plan or consensus
with the forecast – multiple planning numbers
and general low agreement in the team

19. Basic Steps for
Optimizing
Clinical Supply
Chain

20. Start With The
Basic!
Clinical supply manager are members of many
teams – Ensure a strong communication and
teamwork
Clinical trials are dynamic and all IMPs are unique
– Understand the drug product, processes and the
needs for each trial
Changes will occur – Manage risks and involve
strategies and back-up plans to reduce timelines
and risks.

21. Study Changes are
Bound to Occur
Planning
Understand how study changes may affect
supplies (test what-if situations and mitigate)
Use a simple solution that offers end-to end
visibility and into the supply chain
Technology
Go for systems with operational efficiencies (fast
deploy and easy integration to other systems)
and ability to support changes

22. Use Metrics to
Drive Decisions
Examples
Enrollment accuracy (forecast accuracy)
Number of expedited shipments
Effectiveness of IRT delivery (From URS to Go-live,
issues during UAT etc.)
Conformance in timelines (deviation handling,
CMO avtivities etc.)

23. Benifits of an
Optimized supply
chain
Becoming data driven will help increase visibility
of inventory, consumption and distribution
trends
With data generated: contracts and workorders
with suppliers can be negotiated better
Manufacturing and sourcing of materials would
be tracked down quickly and systematically.

24. Group 1
What actions are needed to
initiate the process of clinical
supply chain optimization?
Group 2
What are some of the
competive and operational
advantages of having full
transperancy in the supply
chain?
Group 3
Do you have any plans to drive
IT innovation (NLP, block chain,
cloud computing, machine
learning etc. ) into the drug
supply organization over the
next 2 years?
Where to start?
Brainstorm Exercise!

25. Key
Takeaways