The growing volume of clinical studies and the increasing ‘need for speed’ is symptomatic of a highly competitive biopharmaceutical marketplace. When coupled with the emergence of biologics,predicted to grow at a CAGR of 9.7 percent between 2016 and 2021¹, it becomes apparent that over the last decade drug development has evolved and will continue to do so.

However, if we accept that clinical trials have evolved, isn’t it time we stopped trying to hammer square pegs into round holes in terms of our design strategy? The time has arrived for sponsors to embrace an adaptive supply chain approach. 

Pre-empt the risk-make it personal

Smaller, yet more global, clinical studies are expanding with the rise of personalized medicine. In these specialized trials, all risks to the clinical supply chain must be managed precisely-including the patient impact. When your population for specialized treatments is small to start, it’s critical to “think personal” and develop new mechanisms that cultivate a co-existence between cost-effective operations and the patients in the trial.

For example, consider the personal impact a patient could experience if a trial is delayed. Sponsors can more effectively pre-empt that risk delay by isolating the “root” causes of why delays commonly occur, and apply an adaptive strategy to meet those causes. In my experience, the most frequent cause of delays in a trial stems from failing to adequately manage supply of IMP. If a trial sees many patients “drop out” due to poor access, this just further snowballs, as it’s estimated that 80 percent of all trials encounter delays of at least one month when there are significant recruitment and retention issues¹. 

Surely, there are many factors beyond this example that can impact patient satisfaction and delays alike. But with so many risk factors present, sponsors simply cannot afford to leave simple “root” causes, like timely supply, on the table as a concern. By putting an adaptive strategy in place, this can be avoided.  

Tackling new challenges with new tools

Drugs gathering dust in inventory, ‘just in case’ the demand arises isn’t good for patients or budgets, as expensive product can quickly surpass expiry date criteria and become waste. This creates potential delay in patient access, as well as increasing spending. 

Instead, what’s needed is a more flexible approach that is redesigned around patients. An approach that empowers sponsors to respond rapidly to unpredictable demand by creating a personalized kit for each patient, just in time. These personalized kits are created based upon patients’ specific dosing needs, resulting in better understanding of the prescription instructions and compliance with them.  When combined with the rapid pace in which a just in time approach to clinical supply can make, pack, label and ship orders-in days opposed to weeks or months, patients are not only receiving a more personalized service but a much faster one too. As a result, patient retention can be significantly improved. 

Whereas the counter argument points to the additional upfront costs needed to implement an effective just in time manufacturing strategy, the return on investment resulting from reduced waste, shortened timelines (up to 50 percent for initial supplies and by up to 60 percent for supplies requiring revision), and the saved cost of managing high volumes of returns (destruction and accountability), is undeniable. 

With almost 50 percent of clinical sites failing to recruit patients in line with estimates², significant quantities of seeding stock, produced as part of a standard batch manufacturing approach, is likely to remain unused and require destruction and replacement. Given the high cost of biologics, the opportunity for sponsors to mitigate the risk of waste or over-production and obtain more robust cost control is significant. Furthermore, the just in time model provides a mechanism for sponsors to continuously address inconsistencies between supply and demand to ensure finished patient kits are produced and shipped only when needed. 

Adopting a more ethical approach to designing clinical trials will not hinder commercial success. This patient centric approach will instead enhance it, as evidenced by a report published by The Economist Intelligence Unit, which identified that ‘patient centric trials took almost half the time to recruit participants, recruited double the number of patients, and the drug was 19 percent more likely to be launched³ as a result. 

A flexible, just in time manufacturing strategy is one of the core ways sponsors can foster a co-existence between patient centricity and cost-effective clinical supply chain management and should be a key consideration for all sponsors undertaking drug development in today’s clinical trials’ landscape. 

Natalie Balanovsky, Just in Time Manufacturing Solutions Manager, Almac Clinical Services

References 

1. Lionbridge LIFE SCIENCES; Bairu et al 2014; Metadata Solutions 2013
2. Source: Tufts CSDD, n=15,965 sites participating in 153 global phase II and III clinical trials
3. https://acrpnet.org/2018/11/13/achieving-patient-centricity-in-clinical-trials-uncovering-the-mystery/