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The New Normal: How COVID-19 Became the Catalyst for Change

When COVID-19 disrupted life sciences, solutions were needed in real-time. As the pandemic grew, so did the need to innovate. Workers met the challenges. They completed tasks, fulfilled inspections, and remained vigilant in fulfilling regulatory requirements. This paper by Jürgen Hönig at PharmaLex GmbH, Germany, presents findings from a roundtable hosted by PharmaLex. It examines how life science professionals leveraged disruptive technologies during the pandemic.


The New Normal: How COVID-19 Became the Catalyst for Change

The global pandemic caused by coronavirus disease 2019 (COVID-19) forced the life sciences industry to rethink processes and procedures to continue operations. Lockdowns, travel restrictions, and the race for a vaccine all impacted operations for pharmaceutical companies and regulators, while a heavier reliance on technology to conduct business was needed to keep patient safety at the forefront.

PharmaLex hosted a round-table of experts to discuss how disruptive technologies in life sciences (DTLS) helped during the pandemic, and how they can be used in the future. The Disruptive Technologies in Life Sciences consortium was formed in early 2018 by a group of industry leaders with the aim of discussing advanced technologies in the life science industry. The consortium consists of representatives from pharma and biotech companies, Health Authorities (HAs) and leading technology providers. The talks of this year’s roundtable focused on six topics: decentralised clinical trials, modern data management, cybersecurity, rolling submissions, virtual inspections, and COVID-19 regulatory impact. The results of this year’s roundtable are to focus on the following question: What technology and business investments will be accelerated? This paper looks at how the aforementioned topics have been influenced by COVID and what trends we are likely to see further in the future.

Decentralised Clinical Trials

Decentralised trials (DCTs), a novel approach to clinical trials in which the trial is conducted partially or fully at the location of the patient rather than at a clinical site, have been of interest to and piloted by pharmaceutical companies for the past few years for several reasons. By making trial participation less burdensome to patients, DCTs present an opportunity to recruit patients faster and increase diversity in the patient population, and because of the increased convenience of trial participants, discontinuation rates are expected to be reduced. Prior to the COVID pandemic, health authorities (HAs) showed interest in this approach but, with few exceptions, were moving slowly towards its acceptance, and many of the supporting technologies that enable DCTs were under discussion concerning their regulatory status.

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