The life sciences industry is unlocking new frontiers to deal with ever-increasing complexities and needs to speed therapeutic discovery, development, and delivery. The convergence of science, technology, and human engagement supporting a scalable, end-to-end clinical R&D platform will be a key driver in the future of life sciences and healthcare innovation.
Innovating Study Execution, Scalability, and Access
Over the past two years, the need to rethink traditional approaches to life sciences R&D has never been more apparent. We have seen incredible progress across the industry with regard to biologic platforms such as mRNA, cell and gene therapies, and CAR-T therapies.
“We need similar platforms at scale for technology, data, and AI that can replicate the speed, agility and innovation that we all witnessed in the manufacturing and delivery of the COVID-19 vaccines,” said Sastry Chilukuri, co-CEO of Medidata.
A life sciences cloud platform is the best way to bring together real-time AI and customer engagement to the point of use and close the loop across research and discovery, development, manufacturing, and commercialization.
“We will increasingly see augmented workflows, AI and embedded analytics being deployed to drive and deliver actionable insights for shortened timelines, business value creation, and timely outcomes for patients,” said Rama Kondru, co-CEO of Medidata.
Patient Engagement and Experience Take Center Stage
With the increasing experience and sophistication of advanced trial technologies to customize the clinical research process that fit a host of sponsor needs, the issue has appropriately shifted to: How do we keep patients top of mind, more informed, and more engaged? Three elements emerge:
- Physical: The trial participant’s ability to travel to/access sites and, if taken outside of a trial environment, their ability to self-administer therapies or use medical-grade sensors and other patient-facing technologies
- Financial: Trial participation can place a financial burden on patients either directly or indirectly, in the form of lost working hours, travel, child care, and/or healthcare reimbursement
- Mental/emotional: Clinical trials can represent the only option for patients with rare diseases or unmet medical needs. And ensuring that trial staff are culturally competent and can address the individual’s cultural, language, and personal issues is pivotal.
Technology, especially remote technologies, plays a growing role in improving the patient experience and broadening access to trials. Decentralized clinical trials (DCTs) can capture participant data from anywhere, at any time. Aggregating and transforming that data, monitoring the data to identify quality issues to mitigate risk and ensure patient safety, and running powerful analytics to draw new insights leads to better outcomes for patients, researchers, sites, sponsors, and contract research organizations (CROs). The COVID-19 pandemic didn’t launch decentralized clinical research, but it certainly created the necessity of wide adoption.
For example, Medidata deployed a DCT approach with Moderna and used real-time AI to identify sites to predict where the pandemic was headed. More than 30,000 participants provided real-time sensor and outcome data that we had to collect in a compliant and robust manner. Kondru added, “We put in place all kinds of new and optimized capabilities that allowed Moderna to be able to make changes to the study as they were going in real-time, as well as achieve unprecedented development speed.”
The Future State
Looking into 2022 and beyond, the life sciences industry will continue to expand usage of advanced technologies that promote connectedness, scalability, and patient-centricity in R&D to make the trial experience less burdensome and maintain patient retention throughout a study. This approach – this wide, encompassing view of bench-to-bedside development – will continue to improve collaboration among industry stakeholders and regulators, helping address new disease states and patient populations while ensuring data quality and patient safety.
We’re in a world driven by connected experiences. While our priorities continue to center on patients, we must ensure the information and evidence we generate are performed in a trusted, compliant manner. A comprehensive DCT program, for example, is allowing for truly digital oversight, where physical and virtual interaction with sites can be optimized while maintaining patient safety and data quality.
Chilukuri added, “The future also rests on identifying and developing talent across the industry and its sectors; investments in technology must be matched by investments in people. Accelerating the development pipeline of important medicines, vaccines, and diagnostics will only be possible if we – as an industry and as a society – support initiatives to increase resources for training and education.”