Aligning Technology and Oversight

Throughout 2024, we have witnessed a multitude of advancements in the clinical research industry—many of them in technology. In a space that is so closely regulated, it is remarkable that sponsors and their service-provider partners are continuing to find new and innovative ways to bring therapies to patients faster. In this September issue of Applied Clinical Trials, we dive into the evolving regulatory landscape governing the life sciences and what some of these companies are doing to remain compliant.

Our quartet of feature articles begins with a look at the biologics setting, specifically how strategic, regulatory-focused chemistry, manufacturing, and controls (CMC) approaches can help advance their development. For biological products in particular, such as cell and gene therapies, a strong emphasis on risk assessment, departmental collaboration, and communication with regulatory authorities are all key in remaining compliant throughout all stages of development. Following is a piece on navigating diverse clinical trial patient payment and data requirements. With differing global standards and crossover into other elements such as data privacy and finance, it is crucial to remain compliant.

Our next feature brings us into the world of artificial intelligence (AI) and digital twins. The use of digital twins in clinical trials has been a gray area for regulators in past years. However, both the FDA and European Medicines Agency have expressed a willingness to explore the area further. Now that the two agencies have created "action plans" of sorts in the formal incorporation of AI, now is the time to begin moving forward with models such as digital twins. Rounding out this month’s features is an overview of the FDA’s recent actions in advocating for clinical trial diversity—in the form of various guidance documents. While the promise and benefits from new technology is exciting, it means very little if clinical trials are failing to adequately represent diverse populations. New guidances from the FDA have put strict oversight on sponsors that will hopefully create more movement in continuing to diversify trials.

As evidenced by our coverage, the regulatory landscape is constantly evolving. For the latest insights and news in this space, stay tuned to our website. As always, thank you for reading.

Mike Hennessy Jr is president and CEO of MJH Life Sciences®