Multi-Modality Analytical Strategies Aim to Overcome Bottlenecks in Next-Gen Cell and Gene Therapy Development
核心洞察
Cell and gene therapies are redefining medicine across oncology, rare diseases, hematology and regenerative medicine, but sponsors face growing challenges in demonstrating safety, identity, purity, potency and long-term efficacy.
An upcoming Xtalks (搜索) webinar will explore how integrating flow cytometry, genomics and bioanalytical testing can accelerate CGT development and overcome translational bottlenecks.
Experts from Cerba Research (搜索) will discuss assay standardization, data integration and global deployment to support consistency and scalability across complex clinical trials.
Cell and gene therapies (CGTs) are redefining the future of medicine, offering transformative treatment options across oncology, rare diseases, hematology and regenerative medicine. However, as these complex "living drugs" advance through clinical development, sponsors face increasing challenges in demonstrating safety, identity, purity, potency and long-term efficacy while meeting evolving regulatory expectations.
An upcoming webinar hosted by Xtalks (搜索), titled "Bypassing the Bottlenecks: Multi-Modality Considerations for Next-Gen Cell and Gene Therapy," will explore how a multi-modality analytical strategy can help accelerate CGT development and overcome critical translational bottlenecks. The live session is scheduled for Wednesday, September 30, 2026, at 11am EDT (5pm CEST / EU-Central).
A Multi-Modality Approach to Characterization
The featured speakers will provide an overview of today's cell and gene therapy landscape, including key distinctions between cell therapies, such as CAR-T (搜索) and hematopoietic stem cell therapies, and gene therapies, including AAV (搜索)-based and RNA therapeutics. The session will highlight how specialized technologies—flow cytometry, genomics and bioanalytical (BioA) testing—work together to provide a comprehensive understanding of therapeutic products.
Participants will learn how these complementary approaches can be used to assess cellular phenotype and function, characterize genetic modifications, evaluate therapeutic activity and generate the integrated datasets needed to support clinical and regulatory success. According to the organizers, an integrated, multi-omic approach can bridge the gap between molecular design and cellular function, enabling more informed decision-making, reducing development risk and supporting the successful advancement of next-generation CGTs from discovery through commercialization.
Operational Challenges in Global Trials
In addition to the scientific considerations, the session will address the operational and scientific challenges of implementing complex characterization strategies across global clinical trials. Experts will share practical considerations for assay standardization, data integration and global deployment to help ensure consistency, scalability and study success across regions.
Featured Speakers
The webinar will feature experts from Cerba Research (搜索): Kirsty Maclean, Global Head of Research & Development, and Karthikeyan Devaraju, Senior Scientist, Cell & Gene Therapy. Attendees will learn how integrated analytical strategies can support cell and gene therapy development across different modalities, with the featured speakers discussing how flow cytometry, genomics and bioanalysis can be used together to characterize cellular phenotype, genetic modifications and therapeutic activity.