Issue:October 2016

EXECUTIVE INTERVIEW – Catalent: Increasing Efficiency & Flexibility for the Clinical Supply Chain

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 demand-led supply?

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 unused.

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 approach.

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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