In this episode, Adlai Goldberg asks Tamie Joeckel, ICON’s Cell and Gene Therapy Global Business Lead, if an increased volume of CGT clinical trials with an accelerated process leads to more life-saving approvals.
There are 2,600 cell and gene therapy clinical trials taking place this year. In the US alone, this could translate up to 20 new therapy approvals in 2022, which presents a clear opportunity to make more life-saving therapies available to a greater number of individuals.
In this podcast, Tamie Joeckel – ICON’s Cell and Gene Therapy Global Business Lead – tells us what makes an increase in the volume of trials and an acceleration of the clinical trial process significant. She explains how doing so will allow diseases such as Alzheimer’s, Parkinson’s and diabetes to receive more focus.
Within the trials, the role of a sound digital strategy is at the forefront. In cell and gene therapy trials, 80% of data comes in within the first two months, compared with an even spread over years during a traditional trial. The need for an organized and effective strategy is paramount to make critical decisions.
As the trials continue at speed, the knock-on effect also needs to be addressed. Supply chains models, manufacturing models and delivery models will need to evolve to ensure patients have access.
Despite the complexities involved, it’s a significant time in the life sciences sector. Even more so for Tamie. As a parent of a grown child with a rare disease, her mission is personal and emotive. With everything moving forward so encouragingly, she is optimistic and excited for the future.
Four things to take from the acceleration of cell and gene therapy clinical trials:
- An accelerated clinical trials process means more trials are progressed, leading to an increased number making it to commercial availability.
- There are challenges to overcome in regard to therapies reaching the patient – supply chain, manufacturing, delivery and, of course, cost.
- The digital strategy within clinical trials must be sound. Incoming data must be organized to be fully effective.
- COVID-19 led to trials becoming decentralized and for risk mitigation to be included in business continuity plans.
For your convenience, full text transcript of this podcast is also available. Read the transcript.
Duration 29m 13s
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EY Global Health Sciences and Wellness Industry Leader and Life Sciences Industry Leader