Clinical trial supply is traditionally
rigid and inflexible, with high material overages and lengthy production lead
times. These factors combined can result in a lack of stock in the correct
location, which can jeopardize the execution of trials, put patients at risk, increase
pressure on clinical site workload, and increase costs of studies at a time
when the industry is looking to improve efficiency, minimize risks, and shorten
trial duration. Drug Development & Delivery recently interviewed
Wetteny Joseph, President of Clinical Supply Services at Catalent Pharma Solutions,
to discuss the changing nature of clinical trials and the supply of materials for
studies, and how Catalent is investing in new solutions, systems, and
facilities to assist the biopharmaceutical industry in bringing potentially
life-changing therapies to patients, faster and more efficiently.
Q: What is FastChainTM
A: Clinical studies
are becoming increasingly complex and creating a strategic imbalance between
sponsors’ evolving demands and the potential benefits of using a traditional
clinical supply model. Traditional models that work on either a supply-led or a
“just-in-time” additional labelling approach lack either the flexibility or
efficiency to match the needs of trials that are becoming more fluid in nature,
and where study sponsors are under increasing pressure to provide results
faster, and in a more efficient manner.
As such, it is vital the right drug is
in the right place, on time and on budget. Catalent has made significant
investments over a period of nearly 2 years to develop an alternative to the traditional
supply models available to the industry at large. FastChain demand-led supply
takes a dynamic approach to inventory management through the combination of
primary packaged bright stock and delayed secondary packaging processing, which
is conducted regionally instead of from a central location. This two-stage
process sees the primary packaging of the drug product being undertaken at a
central location, before being distributed to regional GMP secondary packaging
facilities, which are strategically located geographically around the world.
Secondary packaging (kit assembly) and the final, patient-specific labelling
only then takes place within these regional packaging facilities once there is
an actual patient or clinical site need.
Q: What are the
advantages of a demand-led model over a centralized supply-led one?
A: No single model is
a perfect fit for every study. Demand-led supply offers a number of strategic
benefits that make it possible for study sponsors to deploy a more flexible
supply chain that offers better alignment with individual trial requirements.
In the traditional supply-led model,
long lead times require that discrete primary packaging and secondary packaging
runs for each protocol are performed well in advance of the projected study
start. Where a study is planned for a number of countries, booklet labels
become necessary so that these pre-packaged patient kits can be distributed to any
clinical site regardless of country or language. These booklet labels are
costly to produce, have a significant lead time, and can be difficult to update
if new countries are added to the study. Each clinical site receives a bulk
shipment of uniquely numbered patient kits at the start of the study from the
centralized inventory that may not align with the site’s forecasted need versus
its actual need based on patient recruitment activity. A buffer stock of 200%
or more is commonly included in the supply forecast to help alleviate the
potential impact of uneven demand even though much of this excess stock may go
However, by using a demand-led supply
model, such as our FastChain approach, the clinical site where the kit is
needed is known, which makes applying country-specific labelling possible,
eliminating the need for booklet labels and their superfluous information. The
flexibility of having decentralized bright stock that is not committed until
there is an actual clinical site or patient need can reduce clinical waste to
less than 20%. Single language labels are also a significant benefit to the
patient by allowing them to easily and clearly see their trial instructions.
Q: What are the
differences between FastChain demandled supply and “just-in-time” labelling?
A: Just-in-time (JIT)
labelling is a model also based on a static stock-based approach that uses
discrete primary and secondary packaging runs by protocol to produce partially
finished, base-labelled patient kits. These kits are typically held in a
central location to await final, usually fixed text label updates prior to
release and distribution. The base-labelling on the partially finished kits
contains basic regulatory compliance information, such as storage conditions
and route of administration – booklet labels are used for multi-country studies.
Once an order for kits is received, the partially finished kits needed to
fulfil an individual order are pulled from inventory and have the final
preprinted label, with details such as protocol number, latest expiry date, and
investigator name. The kits are then inspected, released, and shipped to the
clinical site, although transit time may vary considerably depending upon where
the order is going. JIT labelling is a customization of the traditional model
that allows some flexibility at the point of dispatch. However, it can be a
disruptive process that can add cost.
FastChain demand-led supply produces
bright stock, which includes a batch-lot barcode (or other unique identifier)
and undergoes all necessary analysis and quality release immediately following
primary packaging. This information is fed into a centralized inventory
tracking system, which enables the movement of each item of bright stock to be
tracked throughout the supply chain. In some cases (depending upon established stability
data), release testing may be completed on the bulk primary packaged product and
remove the need to complete release testing of the finished patient kits later,
which could slow down the release process.
Under the FastChain demand-led
approach, bar code scanning during secondary packaging at regional
GMP-certified facilities verifies that all elements have been assembled
correctly in each kit, and the inventory system is automatically updated. Patient
kits are distributed to the clinical sites based on actual site and patient
need, finished kits receive a single-panel, country-specific label, and the
lead time to the clinical site is as short as a few days because they are
geographically closer to where they are needed. Again, the absence of a booklet
label greatly reduces the lead time required for the secondary packaging process,
and additional countries can be easily added with a country-specific label. The
decentralized secondary packaging and distribution is a patient-focused supply
model that enables new patients in all regions to be rapidly enrolled, which
promotes patient engagement.
Q: Are client demands
changing for clinical supplies?
A: As with every area of
the industry, clients are looking for shorter timelines, but they also want greater
efficiency, flexibility, and reduced costs. FastChain demand-led supply caters
to these needs and has drawn a lot of interest because of its flexibility and
speed. Furthermore, because no one clinical supply model can address all study
types, we are exploring ways in which our customers can benefit from a
combination of models to really take advantage of Catalent’s full suite of
services and global capabilities – allowing us to apply the most suitable
solution for the unique requirements of each study.
The inherent flexibility of demand-led
supply enables the model to be a potential fit for a variety of study types and
designs from highly targeted orphan disease studies to very large global trials.
Sponsors for whom it is strategically important to achieve shorter study
timelines, maximize the use of scarce or high-value stock, or reduce supply
chain variability risk may be well served to consider implementing a demand-led
Q: What geographical
changes are you seeing in the clinical trials market?
A: Asia has become a
thriving region for studies, especially within countries such as China and
South Korea. Already established in Singapore, Catalent opened its second
facility in the region in Shanghai in 2013 to better service this burgeoning
market. That facility was the first in China from a global clinical supply
provider standpoint to offer end-to-end clinical supply solutions from clinical
supply management, comparator/reference product sourcing and primary packaging
to clinical storage and distribution. In the 3 years it has been open, we have invested
further, expanding the facility to ensure it grows and accommodates the
increased market demand, most recently in its provision for a four-fold increase
in cold-chain storage capacity to reflect the trend toward more trials
involving biologics and temperature-sensitive drugs. Additionally, we have expanded
our Singapore facility to offer secondary packaging and additional clinical
storage capabilities, and in June, opened a new clinical packaging facility in
Kakegawa, Japan, to better service that local market.
Q: What other
investments is Catalent making to adapt to market demands?
A: Catalent’s global
clinical supply network has facilities in the US, UK, Germany, Singapore,
China, Japan, and a network of over 50 audited depots. We have made strategic
investments in our facilities around the globe, including those detailed, that reflect
the growing importance of the Asia-Pacific region. Other recent examples
include a 6,000-sq-ft separated and segregated potent handling suite that has been
added to our Kansas City facility, and we can now offer pre-filled syringe finishing
in Schorndorf, Germany, in addition to Philadelphia, while our Bathgate,
Scotland, facility can now handle products that require cryogenic storage
conditions just to name a few.
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