Post-Pandemic Planning: Using Direct-To-Patient Deliveries For Supply Chain Management

A conversation with Tero Laulajainen, vice president – head of global clinical science and operations, UCB

It’s not every day (at least, not anymore) that we talk or even think about the effects of the COVID-19 pandemic. But many of the sacrifices, concessions, and adaptations made during that unprecedented time have had a lasting effect, not the least of which is the way clinical research professionals think about clinical trial design and how to deliver and treat participants with investigational therapies.

What gathered momentum as a way to navigate shelter-in-place, quarantine, and isolation orders, as well as folks’ preference to limit time spent in public places, direct-to-patient deliveries continue to be used even in the long tail of the coronavirus pandemic.

Here, UCB Vice President – Head of Global Clinical Science and Operations Tero Laulajainen gets us up to speed on DTP and how UCB is leveraging it today.

How can we implement post-pandemic experiences and lessons in clinical trial supply?

Laulajainen: The COVID-19 pandemic compelled the pharmaceutical industry to adapt and find solutions that would ensure uninterrupted access to treatment. One such solution was direct-to-patient (DTP) deliveries, which mitigated the impact of restricted access to healthcare facilities.

DTP refers to a model where an investigational medicinal product (IMP or more commonly, study drug) of a clinical trial is brought directly to the patient’s home. DTP can include medication delivery and tracking and the use of digital technology (such as devices and mobile apps) to monitor patients' compliance remotely. There could be even healthcare professional visits to a patient’s home for procedures like administering injections or drawing blood. This approach can be used for both remote clinical trials and hybrid clinical trials where some elements are conducted at a traditional clinical trial site.

These DTP deliveries necessitated enhanced digitalization of documents within the supply chain. Prescriptions, patient information, and shipping records were all digitized, helping to prevent disruptions and expedite lead times. We are currently running clinical trials with remote components due to the ongoing digital transformation — but if these trials had been conducted without this digital support, patients could have missed out on taking their study drugs for weeks at a time. This would have had serious consequences for each trial’s robustness and therefore the validity of its results.

In addition, delivering a supply of medication directly to patients has the potential to improve trial outcomes by enhancing medication adherence. Direct delivery ensures that patients have the necessary medication on hand, reducing the need to travel and the likelihood of missed doses due to difficulties in accessing the trial site, allowing patients to get the best treatment regardless of the situation at hand.

Pharma should aim to provide uninterrupted supply to patients, including access to new medical products, while improving efficiency in the supply chain. At UCB, this effort has the dual outcome of providing enhanced care as well as fulfilling our environmental goals and commitment to reducing greenhouse gas (GHG) emissions in our supply chain.

What are the impacts of direct-to-patient trials on patient recruitment and enrollment?

Laulajainen: In the two completely virtual studies we have run, we have seen positive results from an operational perspective. The trials were run centrally by just one investigator site and covered patients in 37 U.S. states. This direct-to-patient approach has impacted patient participation by:

• Increasing enrollment. By removing the need for regular clinic visits, more patients might be willing to participate, especially those from remote areas.
• Reaching more diverse demographics. DTP can lead to a more diverse patient population as it can include those who might have been excluded due to geographical constraints or mobility issues.
• Reducing dropout rates: Patients might be less likely to drop out if a trial is less burdensome in terms of travel and time commitment.

What are some of the challenges of or complications with direct-to-patient shipping?

Laulajainen: Direct-to-patient deliveries have necessitated enhanced digitalization within the supply chain. While this has advantages, such as improving medication adherence, there are challenges, too.

One of the challenges is finding efficient ways to offer study medications with different types of administration. Currently, drugs that are administered intravenously cannot be delivered direct-to-patient. As technology continues to evolve, we are leveraging emerging tools, advanced data analytics, artificial intelligence, tokenization, and machine learning to enhance our supply chain capabilities and hopefully address these challenges.

About The Expert:

Tero Laulajainen joined UCB in 2017 as Vice President - Head of Global Clinical Science and Operations. He leads the operational design, execution, and reporting of global clinical trials across all therapeutic areas and phases. His background is in life sciences, having studied biochemistry at the University of Helsinki. After graduating, he began his career as a scientist working in research for a pharmaceutical company. Following this, he moved into clinical operations where he discovered his passion for ensuring robust global clinical trial design, driving digital transformation in the clinical operations ecosystem and continual process improvement.