Article: A Changing Landscape - New Ways of Working for Clinical Supply Chains
The sheer scale and pace of change brought
about by the impacts of COVID-19 are extraordinary, both for biopharma
companies and their supply chain partners. The ability to respond with speed
and adopt new business practices could be a key driver of success for trial
sponsors. In this article, we’ll explore three current industry challenges and propose
ways to overcome them.
Clearing the sample testing backlog and the imperative of sequencing
One of the biggest pain points for investigators when it comes to logistics is sequencing. Samples that arrive or are tested out of sequence can invalidate results. The manual workaround to correct this a huge undertaking, especially as samples will be arriving from various locations. Even on a good day this can be difficult. But when you add a crisis situation to the mix, it becomes even harder.
“I look back to the ash cloud. It took nine months to sort out the sample results, and you’re only talking about a two or three-week period in Europe. The task ahead is huge” -Stewart Black, Partnership Logistics Service Director, World Courier.
Now the backlog of samples is unparalleled. Managing this effectively will be a marathon mission requiring a shift in approach. Central labs will need sustained support from their logistics partners to maintain the systems and processes. Those seeing mass samples returned from multiple locations will have to select a delivery partner who can deal with sequencing to ensure that databases are ready for results and reporting, to ensure trials stay on track.
How lean is too lean?
Something that has become apparent this year are the potential limitations of lean or just-in-time production. Whether it’s closure of land borders or cancelled flights, the ability to freely move products across countries has been greatly diminished. That means having to urgently find new ways to get treatments to patients.
“We will see lean manufacture fall by the wayside – there will be no more ‘toilet roll shortages’ in pharma. A return to late-90s abundance. It has proved that for the next few years the world isn’t going to be as instant and available. There will be more stock on shelves that covers 80% of risk” - World Courier Research Participant.
Lean will still have a place in the post-COVID-19 supply chain. But how can we adapt lean to work now? Manufacturers will have to be flexible – for the short term at least. We are seeing many backtracking on late-stage customization and pooling supplies, and reverting to the old way of doing things – stocking more product than needed. This will at least help to manage uncertainty in the coming months.
As we discussed in our recent white paper, creating a contingency plan where treatments are held in-country or in the local region will help to sure up any gaps in the supply chain. With backup stocks nearby it will be easier to continue with bulk trial supply.
There has been some speculation that this storage approach could be maintained into the medium term. World Courier has a depot in Montevideo, Uruguay that can provide efficient, cost-effective storage and fast distribution across the entire South American region, as it’s located in a Free Trade Zone. If the ‘new normal’ is to include more regional lockdowns and travel difficulties, a shift to greater localized storage and distribution is sure to be a good thing.
Creating value through decentralized trials
Logistics accounts for a large portion of trial costs and there is the perception direct-to-patient models increase this overall. But even before the pandemic, direct-to-patient models were increasing, and this has only accelerated since the logistical impact of the virus became apparent. As well as providing more convenience to patients, we see that the direct-to-patient model can deliver cost savings and drive long-term value.
For example, recruiting enough eligible patients requires substantial time and money investments, with $2.28 billion spent annually1. The cost of failing to recruit on time is also severe, with the potential to delay the start of trials or even cancel them altogether. By offering patients the option to be treated at home, many of the objections and worries they usually have can be dispelled. In a competitive landscape, such benefits will stand out and give studies an advantage.
“The work that we’ve done so far shows that, in site-by-site comparisons, 63% of patients are more likely to take part in a clinical trial if home care is offered. Patients are also more likely to stay on the study. Our retention rates run in excess of 95%. Patients have no reason to drop off the study, because we bring the study to them, rather than bringing the patient to the study2” - Stuart Redding, Chief Operating Officer, MRN.
This more patient-centric approach will reduce the costs associated with recruitment, offering patients added convenience, reduced travel spend and fewer site visits. It will also allow more patients with certain health and mobility issues to participate in trials. The burden on the wider healthcare system can be lowered too, by minimizing the number of visits and volume of storage needed. For more detailed insight into the benefits of direct-to-patient treatment, download our free e-book, “Direct-to-Patient Services for Clinical Trials and Commercial Distribution: Patient-Centric Partnerships for the 21st Century”.
Conclusion: Adapt to thrive
The cost of being left behind during this seismic change and disruption will be considerable. On the other hand, those who can adapt and offer new services and operational models may find themselves uncovering new competitive advantages.
“Patient services will become a competitive driver and are no longer optional for pharmaceutical companies. Pharmaceutical companies should no longer be asking whether they should offer services. Instead, they should ask which ones to offer, and how best to offer them3” - Accenture Life Science Report.
At World Courier, we have a global network of experts who can share learnings and put their expertise to work on your behalf. Whether it’s choosing the right model and appropriate care partners for direct-to-patient services, or providing the right storage solution in the right place, our teams can help you thrive in this changing landscape.
Learn more about our services on our website or visit our COVID-19 content hub for more expert analysis and insight.
“Examination of Clinical Trial Costs and Barriers for Drug Development”, U.S. Department of Health and Human Services, July 25, 2014
“The Patient Is IN: Pharma’s Growing Opportunity in Patient Services”, Accenture Life Science