WHITEPAPER

Why Integrate Cellular

Orchestration with
Logistics Providers?

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Why Integrate Cellular Orchestration with Logistics Providers?

By Chris Came

VP Global Alliances & Client Services

Chris Came has over 15 years of experience working within Information

Technology and Customer Services and has expertise in managing and
deploying Enterprise Applications on a global scale.

Chris supports both clients and partners in utilising and joining our
integrated network of service providers, ensuring they are able to fully
leverage all the efficiencies associated with seamless, real-time data
transfer. This spans the process from the exploration of the challenge and
the business case for the integration, through to mapping the details of the
data transfer and end user experience.

Within his role, Chris is responsible for the implementation and

management of the TrakCel Customer Service and Support model, working
tirelessly with his team to deliver customer support and training. As part of
this role Chris and his team are a vital part of product development, feeding
back common problems and solutions and frequently asked questions to
the product development teams.

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Why Integrate Cellular Orchestration with Logistics Providers?

Why Integrate Cellular Orchestration with Logistics providers?

Cellular orchestration solutions (COS) exist to streamline the Advanced Therapy Medicinal
Product (ATMP) supply chain whilst reporting and safeguarding both the chain of identity and
the chain of custody – vital components of the ATMP patient journey.

One of the things that COS systems excel at is managing large data volumes into reportable
patient journeys, automatically extracting elements that require action and notifying users what
is required and by when. This helps not only quality and safety audits but ensures stakeholders
are able to easily, efficiently and cost effectively progress patient journeys for different therapies
with different processes.

The ATMP sector is growing, with more therapies in clinical trial phase and approaching
commercialization (in Q4 2021, The American Society of Cell and Gene Therapy stated 3,483
therapies in development, with 32 in Phase III, a 10% increase from the previous quarter alone1).
There is no doubt that healthcare staff and supply chain partners will be handling more patient
journeys, following vastly different paths. By automating as much of this process as possible and
creating an interface that guides key personnel through the steps, the opportunity for error is
significantly lessened.

Logistics partners are key players in the supply chain, as the time-scales, conditions and records
of transfer are critical in ATMP shipments. Whilst it is advantageous to retain the ability to
manually input shipping data (to cover a partner system failure, or an ad hoc courier needed to
cover a shipment that cannot be managed by the normal, integrated courier); integration has
numerous advantages over manual input.

Data passing between integrated systems flows more quickly, with no drain on human resource
and no chance of errors from manually re-keying data from one system to another. Beyond
this, integration has a major impact on automating work-flows, ensuring all stakeholders are
informed and reactive to what can be a rapidly changing situation. This article looks to explore
some of the key advantages that result from a COS that is fully integrated with logistics partners.

1 Pharma Intelligence Quarterly Report Q4 2021

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Why Integrate Cellular Orchestration with Logistics Providers?

Avoiding Errors

Therapy diversification as the science behind ATMP progresses is seeing therapies coming
to trial and approval that have hugely different supply chain demands. From practical
considerations such as whether material is shipped frozen or fresh through to the partners that
are involved and additional steps or cycles that need to take place within specified time frames.
This variety needs to be facilitated to maximize the treatment options for patients but becomes
increasingly complex for the stakeholders managing them.

In busy environments where many samples are being processed, following different procedures
it is easy for mistakes to be made or deadlines to be missed. However, integrating the COS
with logistics partners automates logistics from the booking stage, ensuring that information
transferred (e.g., collection and delivery times, contacts, the type of shipment and the
conditions) is complete, consistent, and accurate.

Work-flows that are set in the COS for each therapy or sample type specify the data fields to be
sent to the partner system, prompting users to enter vital information into mandatory fields. COS
work-flows also reduce repetition, as if certain information is consistent within a process (e.g.
shipping container on temperature) it is sent without the operator entering it for each booking.

A COS should have the capability to generate compliant product and shipping labels, again,
reducing the chance of data input errors.

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Why Integrate Cellular Orchestration with Logistics Providers?

Simplify Scheduling

As supply chain steps become more numerous or complex and resources in the industry are put
under more pressure from increased demand, there are more factors to consider in the timings
of the steps and shipments.

A COS will consider the whole therapy journey and determine a critical path for the supply chain
steps and key milestones. As this is done automatically based on the parameters specific to
each therapy or partner, managing multiple partners with differing needs becomes far simpler.
For example, different manufacturers may have differing times when they are able to accept
deliveries, certain routes may require international considerations such as customs clearance
etc.

The COS system will be configured to manage this variation, different opening times for the
various partners and recipients, travel times, customs requirements, shipper availability and
all the other details that are easily missed or can take significant training, organization and
coordination and time to achieve manually.

Not only will a logistics integrated COS set these critical time-lines, but it will pro-actively
monitor them, triggering alerts in real-time if a deadline is approaching but the preceding steps
are not yet complete. For example, if a sample collection or a label print was not complete
ahead of a pending collection, the COS could use the receipt of way-bill from the logistics
system to trigger a notification in line with the collection date.

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Why Integrate Cellular Orchestration with Logistics Providers?

Enhanced tracking

A COS is set up to record transfer events in the supply chain as part of the chain of custody
with labelling solutions to assist with safeguarding the chain of identity; as a result, all the
information regarding these transactions must be input to the COS either manually or via
automated information flow from other systems. Whilst it may be feasible to track the main
‘transfer points’ using manual data entry, there are circumstances where ‘live’ information about
a shipment is extremely useful. In these instances, getting live information in a non-integrated
situation involves third-party tracking systems or calls to supply partners to try to track a
shipment down.

In an integrated COS model, the COS will either receive real-time ‘push’ notification from the
logistics partner system or will be set to interrogate their system every few minutes to check
for updates. This is like having a continually open comms line or ringing a courier every five
minutes to see what has changed, something that would not be possible (or desirable) in a
manual system. This means changes in custody are visible within moments of taking place
and accompanying ‘paperwork’ can be electronically attached to the therapy record and
timestamped without paper-chains or the need to pull documents from other systems like
email.

As with all other steps, real-time data flow also means that notifications of status changes can
be sent to those who need them, so key decision makers can see when a shipment has been
collected, cleared through customs, delivered etc. and if there is any need for further action.

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Why Integrate Cellular Orchestration with Logistics Providers?

Contingency Planning

Many world events impact pharmaceutical supply chain and logistics, as has been clear from
the extensive disruption that COVID-19 caused. In a recent podcast by World Courier, who
support ATMP companies in over 2000 clinical sites across the globe; the challenges cited
included staff shortages, infrastructure and capacity and cost of airfreight as having been
affected. World Courier shared the impact on air freight with costs having increased 35%
compared with pre-COVID costs and the prediction that capacity will remain restricted for a
further 18-24 months2.

Many factors have the power to cause similar disruption, everything from long-term issues such
as conflict or fuel costs through to transitory issues such as severe weather, systems failures,
national holidays, accidents, or simply increased demand can have an impact.

The nature of ATMP shipments and the critical status of many patients mean that it is desirable
to have adequate contingency built into processes to prevent a therapy journey stalling or
failing. This will often mean working with several partners of the same type to try to maximize
flexibility in the event that there is an interruption to normal service or simply a lack of
availability.

Setting multiple couriers up in the COS can help to streamline and prevent errors as specific
work-flows for each courier are used to build the critical pathways e.g., only couriers able to
handle the specified sample type, will be shown when users are selecting providers. Integrating
with multiple partners can facilitate treatment speed and efficiency as team members see all
available services and select the best fit.

Even back office administration is made simpler as bookings on a partner can be consolidated
into a single account with each provider or automatically split to different accounts based on
therapy or originator if required.

As well as offering consistency and information when everything is going to plan, integration
into courier(s) systems can make the supply chain more robust when things do not progress as
intended. As well as placing bookings on a partner system, an integrated COS can also cancel
them and will work with the specific courier SLAs (Service Level Agreement) and notice periods
when doing this.

If a collection is cancelled or delayed, the COS will re-calculate subsequent milestone dates
based on the new dates selected by the user, preventing a late notice ‘knock on’ impact to
partners or patients later in the therapy journey. This not only reduces cost and inconvenience
but helps all parties ensure available resource is utilized.

A well scoped COS will not impede flexibility if a shipment needs to be transferred from one
courier to another or even if a new courier must be used to cover an emergency as in this
instance, the shipment can be manually input to ensure that the therapy journey progresses,
and key information is still captured.

2 Podcast: Capacity disruption, personalized medicines, and pharma investments in 2022, World Courier.

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Why Integrate Cellular Orchestration with Logistics Providers?

Record Storage

Logistics of course move goods physically and this means that the paper trail can also be
geographically disparate. In the worst case this could mean transporting paper records or, more
likely, retrieving electronic records from a system such as email or a supplier portal, manually
matching and attaching to the therapy records to complete the audit trail.

This can be avoided with an integrated system, as every step of the process is recorded
electronically within the COS. The whole audit trail and supporting documents such as way-bills,
labels and delivery documents can be automatically captured and attached to the record in
real-time to support data sharing, audit or troubleshooting as required.

If a shipper captures information such as the ambient or internal conditions of the parcel
throughout transit, then this can also be recorded or can trigger alerts in the event of an
issue. This could be critical information as a biopharma survey in 2019 reported almost half of
respondents (44.6%) reporting multiple temperature excursions per year, costing the industry as
a whole an estimated $34bn in 20143.

3 2019 Biopharma Cold-Chain Logistics Survey, Pelican BioThermal.

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Why Integrate Cellular Orchestration with Logistics Providers?

Things to Look for when Integrating

As customer data is being transferred in these integrations it is essential to look at the security
of both the integration, and to consider what information is being transferred and who will have
access to it in the partner system. The privacy burden will rest with you as the data controller but
it is important to explore what key partners can do to assist.

It is also worth speaking to your integrations team about the stability of the integration work
and the methodology of connection. You do not have to get involved in the detailed technical
aspects, but it is prudent to ask questions such as the impact of the third-party system you are
connecting to being updated or upgraded would have on the integration.

It is also key to work with your integrations team to understand and map the work-flows and
data fields that are involved in the integration and associated work-flows, that way, if something
changes such as a partner’s SLA (Service Level Agreement) terms then your work-flows can be
quickly updated to match.

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Why Integrate Cellular Orchestration with Logistics Providers?

Greater Flexibility and Resilience

Opting for courier integration within your COS does not have to significantly restrict your
choice of partners, in fact, it can offer greater flexibility and ease of management. Mature COS
platforms will have a number of logistics partners that have an established integration and
these can be applied in tandem to give you the highest level of flexibility, geographical coverage
and mix of specialist services.

These developers will also have tried and tested methodology for connecting to third party
applications securely, and will be well versed in the types of data that needs to flow between
the systems. Equally, your integration team are in a strong position to advise exactly what
information logistics partners can offer or receive, given the close working partnership between
them.

The experience of working with multiple third party systems means that even if your preferred
logistics partner is not already integrated, a bespoke integration can be explored on
deployment or when reviewing requirements at key points of change or scale-up.

COS systems that use a multi-tenant hosting environment are particularly good at leveraging
this experience, making them cost effective when integrating partners. These systems have
sufficient commonality behind base modules that you are often able to benefit from integration
work, reporting formats or interface screens that have already been completed for other clients,
reducing your cost and development times.

Full COC, COI and

audit reporting

Integrated to the Maximize logistics Aligned scheduling

OCELLOS COS hub options and critical path

Logistics User alerts and

partners notifications

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Why Integrate Cellular Orchestration with Logistics Providers?

References
1. Pharma Intelligence Quarterly Report Q4 2021
https://asgct.org/global/documents/asgct-pharma-intelligence-quarterly-report-q4-2021.aspx

2. Podcast: Capacity disruption, personalized medicines, and pharma investments in 2022, World Courier.
https://www.worldcourier.com/insights/podcast-capacity-disruption-personalized-medicines-and-
pharma-investments-in-2022

3. 2019 Biopharma Cold-Chain Logistics Survey, Pelican BioThermal.

https://cdn2.hubspot.net/hubfs/4107558/general%20content/PEL1046_SurveyReport_v4a.
pdf?__hssc=67202574.2.1584020853798&__hstc=67202574.a664b3452be748d6e54de5a7705
10e4d.1584020853797.1584020853797.1584020853797.1&__hsfp=3217936461&hsCtaTracking=-
de7c68e6-ff7f-4694-acba-4eae269a42f2%7Cfb6e72e0-d31e-46ff-9676-c3e43d310cc1

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Why Integrate Cellular Orchestration with Logistics Providers?

About TrakCel

TrakCel is a market leading developer of integrated cell orchestration solutions. TrakCel

has specifically designed these solutions to manage the international autologous and
allogeneic cell, gene and immunotherapy value and supply chains. Its platform has evolved
in collaboration with, and is increasingly adopted by, leading companies in the cell, gene and
immunotherapy industries.

TrakCel’s solutions enable real-time control for all organizations working across the entire
therapeutic value chain. This control includes patient eligibility (commercial) and enrolment,
sample collection, manufacturing and treatment delivery. The TrakCel platform accelerates
global scale-up and scale-out of cell and gene therapy products, increasing efficiency and
decreasing complexity, while safe-guarding Chain of Custody and Chain of Identity with a full
electronic audit trail for administration compliance and traceability.

TrakCel was founded in 2012. It’s head-quartered in Cardiff, UK with a US office in California.

As a pioneer in the cellular orchestration industry, TrakCel has leveraged years of experience
and innovation to design and deliver OCELLOS, the first modular, Salesforce-powered COS
solution for the cell and gene therapy industry.

At TrakCel we understand how uniquely complex each client implementation is, therefore
OCELLOS by TrakCel offers each client a unique therapy process through connecting base
modules and configurable forms, eliminating the need to create a custom solution and
deployment for each client.

TrakCel Founders (left to right): Dr Matthew Lakelin - VP Scientific Affairs & Innovation, Ravi
Nalliah - Chief Product & Strategy Officer and Dr Fiona Withey, Chief Executive Officer.

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Why Integrate Cellular Orchestration with Logistics Providers?

About the OCELLOS Platform

The OCELLOS platform powers both OCELLOS and OCELLOS Lite, cellular orchestration solutions
for both clinical and commercial therapies. The system modules are connected with leading
third-party software and service provider (couriers, manufacturing systems, etc.) through our
industry-leading “Integration Hub” built on the leading middleware solution from MuleSoft.

From patient enrollment, scheduling, manufacture, right through to final product delivery and
administration, OCELLOS gives complete visibility of the patient’s journey.

Available on the Salesforce AppExchange, the world’s leading online marketplace, implementing
a cellular orchestration platform for your advanced therapy has never been easier.

Enrollment

Reporting Scheduling

Infusion Collection

Transportation Logistics

Manufacturing

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 Innovating today.
Uniting patient with therapy.
Transforming tomorrow.

TrakCel Europe TrakCel US

11 Raleigh Walk, 360 Post Street,
Waterfront 2000, Suite 601,
Cardiff, San Francisco,
CF10 4LN, CA 94108
UK www.trakcel.com US
+44 (0) 2920 483 729 enquiry@trakcel.com +1 833 236 2052