DESIGNING A

ROBUST SUPPLY

CHAIN FOR ATMPs

P H A C I L I T A T E P R E S E N T S

LARS KROSCH

V I C E P R E S I D E N T S A L E S

T I M E : M A T T E R S

L U F T H A N S A C A R G O

Understanding the layers of complexity and working towards full

transparency are essential to achieving a robust and agile supply

chain for ATMPs

One of the main barriers to commercial viability for ATMPs is the supply chain,

which contributes significantly to the overall cost of goods (COGs) and is limited by

infrastructure, temperature requirements and, of course, the time frame for

transportation vs. cell viability.

An often overlooked but major challenge of the supply chain in addition to these

factors is the ‘when’. When is the optimum time to start designing your supply chain

and how will it look in relation to your clinical supply chain? One of the most

important elements of the ‘when’ is understanding how the formulation of a product

impacts the supply chain and its cost and flexibility. Left unconsidered, this can

render an advanced therapy product essentially useless, as the costs are too high

and the market cannot afford to pay for it.

In this interview, Lars Krosch, VP Sales at time:matters gives his perspective on the following:

How thorough supply chain planning can speed up the vein-to-vein process without increasing the riskThe importance of an agile supply chainThe value of full supply chain transparency and tracking is in the physical accessibility of the shipmentWhen to involve handling agents and airlines in your supply chain design

The supply chain for an ATMP or cell and gene therapy product is inherently complex.

How can manufacturers ensure timely logistics of starting materials and finished

products while maintaining product quality and integrity?

Thoroughly planned logistics can contribute a great deal to speeding up the overall vein-to-

vein process and make it more reliable. Fortunately, faster transport can go hand in hand

with reduced risk in regard to the quality of the product. Slower transportation is usually

associated with detours, consolidation and long waiting times in potentially hazardous

environments (e.g., on tarmacs).

In contrast, shorter lead times will not only counteract quality loss of cell material but also

ensure that uncontrollable irregularities are less likely to occur. Therefore, we encourage

manufacturers to design their own tailored logistics supply chain rather than adjusting to a

supposedly inflexible transport infrastructure that is already in place.

What is the importance of an agile supply chain?

An agile supply chain is flexible in order to adjust to fast-changing circumstances.

Challenges could include fast ramp-up of a successful ATMP or new approvals for the

therapy in countries far removed from the manufacturing site.

For the transport setup, certain attributes such as guaranteed capacity, access to airlines,

high density of the transport network used and availability, at night, on weekends and over

holidays, are of utmost importance for flexibly buffering the impact of unforeseen events. The

delivery time and product quality expected by the patient must be adhered to even under

difficult circumstances.

Is it possible to achieve full transparency throughout transit, given the number of

third parties involved, and what is the significance of this?

Today, technology enables almost complete remote tracking of shipments while in transit –

be it with sophisticated geo-locating systems or sensors that automatically transmit while

travelling with the product. However, this can only be the first step. Supply chain managers

will reasonably demand to also be able to intervene in the transport if temperatures leave the

permitted range or products are not travelling according to the planned itinerary, for

example.

The true performance potential of a logistics provider is thus to be measured by their level of

physical access to the shipment throughout the entire transport chain – and this has always

been particularly challenging when using air transportation.

The airport (cargo centers and tarmac) present two of the highest risk points for time-

and temperature-sensitive products. What are the difficulties here and how can these

risks be mitigated?

Do not x-ray, do not tilt, load upright – incorrect handling of cell material and ATMPs can do

just as much damage to the product as extensive exposure to ambient temperatures on the

tarmac. In the conventional model, courier companies give up physical access to the

shipment upon handover to the airport staff.

Therefore, supply chain managers must consult with their logistics providers and attempt to

affect the procedures behind the airport gates. Ideally, handling agents and airlines will also

be at the table when you sketch your ideal cell and gene therapy logistics supply chain.

about the author

time:matters GmbH is located in Neu-Isenburg, Germany and is a daughter company of Lufthansa

Cargo. As the experts for high performance and special speed logistics, time:matters offers

worldwide customized and last-minute logistics solutions for particularly urgent and highly sensitive

products to different industries, such as the life and health industry. Life sciences customers like cell

and gene therapy companies and stem cell registries trust in the offered tailor-made services.

Lars Krosch joined time:matters GmbH in 2009 as Head of Operations, Products & IT with

responsibility for the strategic implementation of new airline products and operational efficiency of a

worldwide partner network with > 20 airlines and 500 partners wordwide, the development of a new IT

strategy and infrastructure as well as the implemtation of a new business and tender process. Before

joining time:matters, Lars Krosch was Director of Process and Information Management at Lufthansa

Cargo.. Lars studied Business Administration and Computer Science at the University of Bamberg,

Germany.

Lars will steer the Phacilitate roundtable “Sketch your ideal cell & gene therapy logistics supply chain:

high performance vein-to-vein process with maximum control” on January, 23rd, 1:00pm – 2:00pm in

Miami.

Lars Krosch VP Sales time:matters

One must start considering the supply chain

challenges from the very start of development with

the very first TPP. The product, the process

development and the clinical evidence generation

must be achieved in parallel with the development of

a market viable supply chain development

As many more companies enter late stage clinical trials and

approach commercialization, the most significant challenge is

scaling their supply chains post-manufacturing. Ensuring that

advanced therapies are shipped carefully, stored correctly, handled

properly, and administered flawlessly will require significant

innovations in instrumentation, processes, and tracking. If

advanced therapies are to become ubiquitous, the underlying supply

chain must be as revolutionary as the treatments themselves.

Supply chain planning is integral to the development

of a cohesive manufacturing process and so should

be part of defining a commercially viable

manufacturing strategy. The biggest challenge we

face is delivering the final product to patients, given

challenging shelf lives, and without burdensome

requirements placed on the patient in terms of timing

and location, as well as in a form that is user-friendly

for the clinician and requires no specialised training

to administer.

M D P H D , C H I E F O P E R A T I N G O F F I C E R , T X C E L L S A

Miguel Forte

Sven Kili

Sam Kent V P G L O B A L S A L E S , M E D C I S I O N

V P A N D H E A D O F C E L L A N D G E N E T H E R A P Y D E V E L O P M E N T , G S K

More from the industry...

you can hear more from Lars at the

Phacilitate Leaders Forum January 22-

25 at Hyatt Regency Miami

don't forget!

W W W . C E L L A N D G E N E T H E R A P Y W O R L D . C O M

/ R E S O U R C E S

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