There are incredibly innovative trends taking place in clinical supply right now. Clinical trials are being “brought to life” from synopsis to final protocol to FPI in a few weeks. Direct-to-patient shipments and remote patient monitoring are becoming essential practices for dealing with difficult situations.
There continues to be inherent risk and uncertainty in the clinical trial supply chain. Protocols change fast and sponsors add new regions almost instantaneously. It is critical to react smoothly to enrollment challenges and site startup delays. Add in a new global pandemic this year. Many Converge clients struggle with managing risk in their clinical supply chain while maintaining agility to mitigate these uncertainties.
We recently teamed with 4G Clinical to bring together industry experts for a discussion on what building and sustaining agility means for today’s clinical supply chain, especially given the current pandemic situation.
Agility means building the capability to move quickly and “change on a dime” in a dynamic clinical supply environment, Chad Presher, clinical supply chain director at Apellis Pharmaceuticals, told the group. It provides the ability to move into new geographies when needed. He pointed out how infrastructure is an essential element in a counter-intuitive way. Agility often means slowing down today to be fast and nimble in the future.
It also requires differentiating between types of supply risk – most notably predictable risks and unforeseen risks. “Agility evolves over time,” said Mike Nest, senior consultant at Converge Consulting and former global head of clinical supply chain at Blueprint Medicines. “In early phases, your levers (funding, resources, tools) for agility are limited.” It’s important to secure organizational alignment on which risks are critical to manage, how to manage them, and the budget for this effort. Nest typically asks, “Do my contingency plans have contingency plans?”
The COVID-19 pandemic forces clinical trial sponsors to be agile in unforeseen ways. In some cases, this is making things busier than usual. Some Converge clients are introducing new COVID-related studies on top of keeping ongoing trials moving forward.
Regulations around the world are changing in response, in some cases providing greater leniency for keeping ongoing trials running. The pandemic forced Gossamer Bio to adopt new policies and practices quickly. This includes direct-to-patient shipments, more contingency and mitigation planning, plus remote monitoring to increase accountability for CRAs who can’t visit clinical sites. “Virtual and remote trials are here to stay,” according to Summer Doty, clinical supply chain director at Gossamer Bio.
For Presher’s team at Apellis, the short-term focus is on “maintaining the right inventory at the right place” to ensure continued supply. For example, pushing inventory to forward stocking locations so they can react reliably.
Our experts described several approaches to build in agility for the long term, including:
- Increase supply velocity. Presher shared that Apellis is “focused on velocity.” By getting up and running as fast as possible, they reach major decision points even quicker.
- Reduce batch sizes to improve reaction times. Nest pointed out how for many companies the short-term focus is on having enough of the right inventory in large batches, while in the longer-term they move to bringing batch sizes down to become more efficient.
- Cross-functional coordination between teams and systems. All four experts agreed that cross-functional coordination is a requirement for building and sustaining clinical supply agility. This includes Quality, Regulatory and Clinical Operations.
- Virtual trials. Neta Bendelac, senior director of strategy at 4G Clinical, believes virtual trials will bring significant long-term changes to the clinical trial process overall. “The whole concept of planning clinical trials [at sites] can be completely ignored with direct site-to-patient shipments.” She predicts the depot’s role will change as it absorbs dispensing pharmacy duties, especially while sites maintain patient responsibility and accountability.
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