The traditional supply chain is becoming increasingly outmoded as the pharmaceuticals industry shifts its focus to more sensitive biosimilar and biologic approaches. Catalent Pharma Solutions explains how demand-led supply is helping to expedite efficient drug development.
The changing nature of R&D pipelines is having many knock-on effects for the pharmaceutical and biopharmaceutical industries. Asset development costs are up by a third since 2010, and a rise in the total number of FDA-approved new molecular entities over the last two years has been supported, in part, by the growth of biological-based drugs and orphan drugs. It is estimated that this will be fuelled by a 30% loss of exclusivity in the biosimilars market by 2019. This shift to more specialised and niche indications has been mirrored by the change of clinical studies, which have become smaller and more targeted.
Today's clinical sponsors face a number of challenges and clinical supply is key, especially with the rising value of investigational drugs. Pressures exist to begin trials with minimal stock, and with injectable drugs outnumbering orally delivered drugs in development, having a safe and secure cold chain is critical.
The traditional clinical supply models can often be a poor fit for the industry's growing biosimilar and biologics focus. Models that produce a large number of finished patient kits in advance of the start of the trial often involve long lead times, and there is a lack of flexibility, which can be problematic if any packaging changes are necessary once the study starts. With the speed to clinic being critical to establish a competitive advantage, any delay can have serious consequences.
An evolution of supply chain models towards more patient-centric, demand-led supply (DLS) is an approach that fits well with many clinical trials, and is well-suited to those with cold chain challenges. DLS uncouples secondary packaging from primary packaging, as in the traditional supply model to make for a more efficient, responsive and flexible approach. Using DLS, temperature-sensitive products are physically closer to where they need to be when the final packaging stage is implemented, so the approach can significantly shorten lead times and minimises the time they spend in transit. This enables faster site activation, while reducing waste and stock-out risk, lowering overall cost through efficiency.
Under the demand-led approach, the drug first undergoes primary packaging at a central location and is then sent to regional and local secondary packaging facilities much closer to the clinical sites involved in the study. Secondary packaging (kit assembly) and final, patient-specific labelling, all take place within the regional packaging hubs once an order is received, and finished kits that receive single-panel, country-specific labelling can be shipped directly to the clinical site from the packaging hub to arrive in a matter of days
The model removes the need for a multilingual booklet label, which greatly reduces the lead time required for the secondary packaging process, and additional countries can be easily added. Furthermore, the latest possible expiry date can be applied to all patient kit items at the point of assembly into the finished patient kits. This facilitates the efficient use of stock, and eliminates the need for clinical sites to update expiry dates. This is especially important with biologics, where the expiry date is generally shorter compared than it is for drugs.
Having local secondary facilities also increases efficiency in the importation of materials and compliance with specific regional legal documentation and requirements, to avoid any delays that may see products held up in transit. Again, for products needing cold-chain transportation, it is especially important to reduce time spent in transit and the risk of temperature excursions.
To react to the continued increase in complexity of clinical trials and the drive towards a patient-centric design, sponsors are looking to the supply chain to offer flexible and integrated solutions.
A demand-led model, especially for cold-chain critical products, is one way of enabling a more proactive management approach and increasing efficiency in supply chains, while looking to drive down the overall
cost and waste, especially where drugs are high value and limited in supply.