By Deborah Borfitz 

April 21, 2020 | Study sponsors are facing an unprecedented level of clinical supply disruptions caused by the COVID-19 pandemic. For insights on the current struggles of clinical supply study managers, innovations being deployed and ways to build a more resilient supply chain for future trials, Clinical Research News spoke with Barry Moore at randomization and trial supply management provider 4G Clinical. 

Moore is 4g’s newly appointed vice president of delivery, and the previous head of clinical supply solutions at GlaxoSmithKline (GSK). While at GSK, he also served as chairman of the Clinical Supply Blockchain Working Group, developer of a blockchain-powered iPhone app for pharmaceutical clinical supply chains. 

Editor’s note: Moore’s responses were edited for brevity and clarity. 

Clinical Research News: Was your hiring by 4G Clinical amidst a pandemic intentional or coincidental? How does the timing impact the focus of your job for the next six months? 

Barry Moore: I have known the leadership of 4G for a long time, and we had been exploring opportunities to work together since early last year. The commitment was made well before COVID-19 became a pandemic. Joining 4G Clinical during the pandemic, my focus has been on how we can help our clients in the midst of uncertainty, including the potential shift to new trial models like DtP [4G’s Direct-to-Patient platform], on accelerating timelines and trial continuity. 

What are the chief clinical supply struggles being experienced by trial sponsors as a result of COVID-19 and are they being experienced differently by those pursuing trials for COVID-19-related treatments and diagnostics vs. all other types of trials? 

Clinical supply professionals are experiencing challenges with supply chain disruptions, ranging from production (contract manufacturing organization), to shipping coordination (couriers, depots, logistical service providers, country restrictions), patient access (patients not able to get to clinical sites) and unpredictable demand (enrollment challenges/patient drop-out). These challenges are being experienced irrespective of trial type. 

For those pursuing trials for COVID-19-related treatments and diagnostics, there is an increased element of urgency. Sponsors are most likely employing a risk-based approach to standing up these studies, to ensure both speed and patient safety as well as quickly coordinate with all supply chain and trial partners. They’re also relying on the flexibility of their partners… as new data emerges on the virus itself, [and as] trial data or any revised regulations [materialize]. It is critical to get in front of any issues that may arise, and a tight collaboration is the only path forward. 

What technologies are enabling non-COVID-related trials to continue during the pandemic, and what technologies are facilitating the enormous number of COVID-related trials that have begun or are about to? 

Non-COVID related studies are facing challenges with trial continuity. Sites are slowing or halting enrollment. Patients are fearful of going into the clinic for treatments because they may be exposed to COVID-19, especially those who are immune-compromised, such as oncology patients. Some of the technologies that are enabling trials to continue have been around for a while, with limited adoption. Think of telehealth. Insurance companies were unlikely to cover [e-consults] before COVID-19, but that has shifted and now many patients can have virtual visits with their physicians. 

One thing we’re seeing at 4G is the movement toward a decentralized clinical trial model. While not a new concept, DtP hasn’t started gaining support until now. It can help enrollment for new trials, as well as ensure patients can remain in a clinical trial with easier access to medications by shipping drugs directly to their home. 

In response to the need, 4G Clinical rapidly built a DtP functionality within Prancer RTSM [randomization and trial supply management]—a feature that gives sponsors more options to keep their trial running. Our quality team is working with regulatory agencies to understand the guidance on this relatively new technique [the Food and Drug Administration recently issued guidance that encourages study sponsors to use the direct-to-patient model in a controlled manner]. 

At 4G, we have many technologies to help get COVID-related studies up and started quickly—for example, we leverage natural language processing to make the build process fast and efficient for our RTSM, enabling trial sponsors to stand up their study in two weeks from spec to go-live. Since these studies need to evolve [in response to what is learned about the virus, direction from regulatory agencies and supply chain challenges that arise], we [might expect] an increase in [protocol] changes post go-live. Since our system is 100% configurable and flexible, 4G is able to implement these changes quickly, so there won’t be any more disruption to the study beyond what comes from the crisis itself. 

Another technology to watch is supply forecasting. Modern and dynamic forecasting tools can significantly reduce waste and ensures the right medication gets to the right patient at the right time, no matter where the patient is (site vs. home). 

What technologies have you seen newly deployed specifically because of COVID-19 and how, if at all, have those technologies improved the situation? 

Two capabilities are [critical] to the situation we now all face—to stand up a study quickly and handle some of the supply chain constraints I talked about earlier. 

Sponsors need a team that is ready to move fast with the technology to support them. They need to render their studies across all the clinical platforms [e.g., interactive response technology, RTSM, electronic data capture, enterprise resource planning (ERP), electronic clinical outcome assessment] in timelines much more aggressively than in the past. And they need teams with the skills to test and validate these systems, to build out system interfaces as needed and to have trust in the quality control and validation processes to ensure the platforms are robust. Component and modular builds with the standards to support them is key. The virus will not wait for the industry to catch up and so speed of deployment has been absolutely critical for the COVID-19 studies we have seen. 

We also know that in these times where much of society is in lock down, patients may find it difficult to get to a clinical site for their medication. The site may have closed, or making the visit presents increased risk [because] they already have a compromised immune system. Having the technology to configure the supply chain by study, country, site, or patient and coordinate different routes of supply to get the medication to the patient’s home is very powerful. It is too early to say what impact this capability will have on patient access and patient compliance, but all indications suggest that if done right it will become a staple technique for running all clinical trials in the future when the dosage form permits. 

Based broadly on your previous experiences before starting with 4G Clinical, what technologies were the most popular and unpopular with clinical supply managers and why? Have these sentiments in any way changed (or possibly been amplified) due to working conditions in the current pandemic? 

The role of clinical supply study managers is pretty complex. They wear a number of different hats—including project manager, pharmacist, regulatory specialist, manufacturing scheduler, logistics coordinator and supply chain planner. But always they are balancing drug supply and demand across their study. 

Every study that they manage can be thought of as a set of specialized product supply chains that require access to an incredible amount of data. And I should note … the rising operational complexities [associated with] adaptive, platform, basket, and umbrella study designs mean having the systems capabilities on hand to run the supply chain [is doubly] important. Clinical supply chain managers really dislike having to shoe-horn their study into legacy systems that can’t really accommodate the advances in thinking around study design. Managing drug pooling on a spreadsheet is not a fun activity! 

Another huge problem for clinical supply chain managers is lack of visibility or out-of-date information. So, having system-to-system interfaces to get real-time information on a complex, fast-moving study supply chain is critical—for example, knowledge of which sites are enrolling [and which are not] for forecasting, inventory positions of drugs with a very close eye on expiry dates, and lead times [on] shipping through customs into a country. 

Supply chain managers dislike having to run inventory reports from myriad systems from different vendors to get the complete picture. Having a single overarching view of inventory positions in a single place is what matters most and allows them to ensure that the right drug is available when their patients present. The same skills and requirements are especially relevant for COVID-19 pandemic treatments. 

When the pandemic ends, what sorts of permanent changes do you foresee trial-sponsoring and trial-supporting companies making to build a more resilient supply chain for future research studies? 

Although there have been many successful trials of direct-to-patient technology, it really never hit the mainstream because many study designers had difficulty justifying the expense or handling the differing regulatory issues country to country. But I think the current pandemic and its impact on supply chains will give many of us in the industry, including regulatory agencies, the experience and confidence to move forward. I [expect] we will see direct-to-patient and direct-from-patient [data] become a standard part of many clinical trials in the future. This a great thing for everyone involved in a clinical trial, but most especially patients. 

Personally, I hope [the direct-to-patient model] improves trial access to minorities and patients in low-incomes sectors of society. Removing the time and travel burdens [of trial participation], as DtP does, should help achieve that goal. 

Do you or will you advocate for a blockchain-powered clinical supply framework? Is this happening at any level today and, if so, where? 

I am aware of several initiatives for a blockchain-powered clinical supply chain, and I worked on a few such cross-industry projects while in my previous role [at GSK]. There is much promise in an open, decentralized messaging network for the clinical supply industry. I think having a combination of standards will increase accessibility and make enabling interfaces between parties a trivial thing in the future. The industry is working on GS1 standards right now to [facilitate] the sharing of data across the supply chain—from master item definition to shipping orders and inventory positions. 

A brokerage service, built on blockchain, would dramatically increase the effectiveness of our supply chain decisions by enabling message sharing … [and] end-to-end supply chain visibility. Imagine if every one of those decisions had a supported data standard, and that every transmitted message had a single destination and … a single sender. We could remove point-to-point messages and replace them with a robust distributed ledger running on blockchain. 

Setting up a supply chain across multiple organizations would be a matter of picking and choosing the interfaces [suited] to the needs of a study; standards and interfaces would do the rest and it wouldn’t matter what internal ERP or pharmacy system or what external clinical systems were in use. This could [radically] simplify the role of supply managers and allow us to apply more advanced capabilities such as machine learning and artificial intelligence to the clinical supply chain. But that’s another conversation for another day.