How AstraZeneca's Clinical Trials Procurement Team Adapted To The Pandemic's Demands
By John Dickson, chief procurement officer, AstraZeneca
Among other challenges, the COVID-19 pandemic has tested AstraZeneca’s Global Operations organization to ensure clinical trials continue, ensuring that patients receive clinical drug supply, enabling the investigation of medicinal efficacy, supporting the strict timelines associated with trials, and protecting patient safety.
As a function, procurement plays a key role across this supply chain, with a strong emphasis on assuring supply of product on time, to the highest levels of quality and with solid service by third-party suppliers to respond to any shifts in demand throughout the trials. Beyond the need to ensure robust commercial terms, these elements are prerequisites to smooth and efficient operation of the trials.
Disruption at any stage of a trial can impact it in many ways and it often comes with increased cost to the program. It also can have adverse impact on the well-being or psychology of patients involved in the trial and could influence readouts for that and, potentially, subsequent trials. Patient identification and recruitment, as well as retention throughout the trial, requires stability and clarity of the many elements existing within a study.
The advent of the pandemic added a layer of complexity beyond the normal pressures associated with managing clinical trials that are ultimately medical research reliant upon patient participation. COVID-19 restrictions resulted in patients being unable to travel to clinics that often were closed or had capacity diverted away from core therapy areas to treating COVID-19 patients. The inability to travel became a critical threat to monitoring and evaluating patients, which mainly happens via an in-person clinical trial visit. As a result, the challenge for AstraZeneca was clear: We needed to change the way we conducted clinical trials and, as a consequence, there was an urgent requirement for procurement to identify third parties capable of collaborating in the design and build of a new approach that would prove effective and timely in gathering the appropriate data while protecting the patients involved in the trial.
Identifying And Adapting To Potential Disruptions
With time of the essence, our procurement team was swift to act, identifying an extensive range of potential disruptions across all aspects of the clinical trial supply chain and establishing detailed mitigation plans to ensure our commitments to patients were met in accordance with AstraZeneca’s traditionally high standards. Collaborating as part of a strong cross-functional team tasked with supporting clinical trial continuity, procurement was able to identify, source, and secure key products and services in half the time of normal sourcing activities, an achievement intensified by the significant increase in demand for many core products and services necessary both within and outside the pharmaceutical industry. This pace was achieved through the instigation of a fast-tracked supplier assessment process designed to ascertain the risk profile of the vendor quickly while ensuring compliance to standards, coupled with upfront payments to ensure suppliers were set up and financially capable of responding to demands. This process supported smaller and medium-sized companies in particular. Maintaining a continuous watchful eye on the shifting dynamics in the supply marketplace was essential, as was retaining a proactive stance toward a changing data landscape. With scientists and health authorities alike grappling with the enormity of the pandemic impact, it was evident that procurement needed to be nimble and agile, while utilizing scale to influence third-party providers and engage constantly with internal stakeholders.
Striving to achieve minimal disruption to clinical studies and research projects, we managed to maintain 171 project-related studies during the pandemic. This included implementing “at home” patient solutions to protect the most vulnerable, such as home nursing services, electronic consent, and remote data collection. We also provided home drug deliveries to a few thousand patients across 35 countries.
Using our extensive supplier relationships and expertise, we rapidly secured a large number of products and services (testing kits, protective personal equipment, freight and logistics services, home nursing, electronic consent and remote data collection technology), yet we found ourselves in a situation where global demand for these products and services was unprecedented. To assure supply and thus continuation of trial activity, we identified new small and incredibly responsive suppliers that could cope with ambiguity and were energized by the pursuit of the challenge or common goal of maintaining this critical activity in exceptional circumstances. The overall success of this approach meant that not only did we deliver more than 99% of our clinical supply during 2020, but as a direct consequence of this proactive action, none of our trial timelines were negatively impacted.
Working with new providers also meant adapting our contracting and payment approaches in many cases. Setting up full master service agreements and detailed contracts would have been too time consuming, so we quickly shifted to establishing shorter contracts. In addition, to secure the products and services, we made the decision to take on the financial risk and pay for supplies up front.
Breaking Down Organizational Boundaries
Internally, our procurement team quickly broke down the organizational boundaries and established a cross-functional project team with a lead per workstream, which removed category boundaries and siloed thinking. Bureaucracy was discouraged while maintaining compliance with the SOP environment and many across the function felt a level of empowerment that became refreshing and underpinned the ability to act at pace. New relationships were built across the business, providing procurement an opportunity to engage regularly with internal stakeholders to align on key milestones and thus ensuring key projects continued to be delivered. The new paradigm provided the function a platform upon which they could assimilate the needs of the business and coordinate solutions through a highly motivated external ecosystem of suppliers to deliver in service of the trials and, ultimately, the patients concerned, all in record time.
Where new sources of supply were introduced, our processes for third-party risk assessment, due diligence, and onboarding needed to change, too. Historically slow and with devolved responsibility to colleagues within business units, we quickly established an internal fast-track approach and a dedicated team to provide quick, insightful yet compliant decisions to enable speedy approvals.
Our Lessons Learned That We’re Taking With Us Into The Future
Learnings from our experience throughout the pandemic continue to be very positive and procurement is working to maintain some of the more positive aspects of our response to the pandemic. Primarily, these are the need for flexibility and adaptability in an increasingly uncertain world, a feeling of collective power in harnessing a group of people (internally and externally) to address a common problem with high stakes, and ensuring speed of decision-making while respecting the need for due diligence to manage risk to organizations but, above all, protect the patient.
Some of the processes implemented during the pandemic have actually accelerated our development. Initiatives such as the at home patient solutions have allowed us to develop new relationships with our patients and remote data collection has matured in both practice and technique, an approach that we can continue to explore as we move beyond the pandemic.
Strong engagement internally with stakeholders across the enterprise has always been valued but really came to the fore in this environment, with Global Operations being recognized as a crucial player in the response to the pandemic.
For procurement, while immensely challenging, the response to the pandemic proved us resilient, flexible, diligent, creative, and, importantly, a function not driven by a single dimension of cost management. We operated as true business partners in bringing solutions that maintain the focus on science in support of a patient community that needs speed and decisive action under normal circumstance but even more so during times of severe uncertainty.
About The Author:
John Dickson joined AstraZeneca in 2018 as the chief procurement officer, where he is accountable for the external spend and supplier base across the end-to-end value chain. He has over 30 years of experience in senior procurement roles across a range of industries, including public sector transport, oil & gas, aerospace, fast moving consumer goods and pharmaceuticals, holding senior positions at Network Rail, BP, Rolls Royce, Heinz, Diageo, and GSK. He has an Honours Degree in Business Studies from Nottingham Trent University.