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Post-Approval Requirements: Takeaways from Meeting on the Mesa 2021

November 8, 2021

Aaron Berger was at the Cell & Gene Meeting on the Mesa

Aaron Berger, Executive Director, US Late Stage Operations

The Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mesa is a premier event to meet with innovators and hear what is prominent in the cell and gene therapy development space. I was thrilled to be in Carlsbad, CA with our team for this event in early October to discuss the important dynamics involved in bringing these transformative therapies to patients.

One of the clear takeaways from this event was the need for rigorous generation of fit-for-purpose evidence to support not only the marketing authorization journey but also the post approval landscape where the demand for evidence from regulators and payors is growing.

Many biopharmaceutical companies attending this conference are currently in the pre-clinical or first-in-human stage. However, by 2026, there are expected to be over 500 cell and gene therapies reaching phase II / III.

As more cell and gene therapies progress through the development continuum, organizations will focus on post-approval requirements. In many of the rare diseases targeted by cell and gene therapies, the natural history data landscape is fragmented. Greater collaboration and consolidation of data is needed to gain valuable insights into disease progression and treatment patterns. Modernized approaches to assembling data from disparate secondary data sources including existing registries and mapping those data elements into common models are needed to generate meaningful insights derived from larger patient populations. These methodologies are essential components of an evidence generation program that will satisfy rigorous post-approval requirements from regulators and in meeting the growing demands from HTA and other payor bodies to justify the value of these treatments.

UBC combines our deep knowledge of drug development, regulatory requirements, safety expertise, and healthcare data technology to deliver strong, real world evidence of our client’s therapies. With our end-to-end data architecture solution, UBC MOSAIC, we provide full data ingestion, aggregation, and warehousing for our biopharmaceutical partners.

UBC understands the challenges that our biopharmaceutical partners are facing when considering their clinical development, post-approval, and commercial evidence generation strategies. To learn more about how we can help you throughout the development of your cell and gene therapy, click here.