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.
In this webinar, the featured speakers will explore how a multi-modality analytical strategy can help accelerate CGT development and overcome critical translational bottlenecks. Attendees will gain an overview of today’s cell and gene therapy landscape, including key distinctions between cell therapies, such as CAR-T and hematopoietic stem cell therapies, and gene therapies, including AAV-based and RNA therapeutics. The session will highlight how specialized technologies, including 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.
In addition, 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.
Register for this webinar to discover how 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.
Speakers
Kirsty MacLean, Global Head of Research & Development, Cerba Research
As Head of R&D at Cerba Research, Kirsty leads the scientific vision behind the company’s next generation biomarker and diagnostic solutions. She drives innovation across Cerba Research’s global laboratories, integrating advanced immunohistochemistry, multiplex technologies, spatial biology and AI-enhanced pathology to deliver high-quality, decision-enabling data for biopharma partners.
With more than 20 years of experience spanning oncology, translational science and clinical biomarker development, Kirsty plays a pivotal role in shaping Cerba Research’s scientific strategy and strengthening the organization’s position as a trusted partner for precision medicine and complex clinical trials. Kirsty has authored 40+ peer-reviewed publications and several book chapters. She earned her PhD in Hematology from University College London, a BS (Hons) in Biochemistry from Glasgow Caledonian University and extensive clinical experience from St. Jude Children’s Research Hospital in Memphis TN.
Message Presenter
Karthikeyan Devaraju, Senior Scientist, Cell & Gene Therapy, Cerba Research
Karthikeyan is responsible for molecular assays, from development to implementation, in cell and gene therapy clinical trials. He brings over 20 years of research experience across healthcare, academia, biotechnology and clinical research, working in multiple geographies and in a variety of scientific and technical roles. His expertise spans neurodegeneration, neural regeneration, stem cells and organoids, genome editing, cellular reprogramming and both cell and gene therapy using viral and non-viral vectors. He has extensive hands-on experience with advanced molecular, protein, cellular and imaging techniques and has contributed to end-to-end development from bench research through to regulated clinical applications. Karthikeyan joined the R&D team at Cerba Research in Rijswijk, The Netherlands, in 2022. Prior to this, he held positions within a CDMO, research university hospitals and the biotech industry. He holds a PhD in Stem Cells and Neurology from Lund University in Lund, Sweden.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Biotech and pharmaceutical professionals developing cell and gene therapies, including CAR-T, TCR-T, gene editing, AAV, RNA and regenerative medicine products
- Scientific, translational and biomarker leaders supporting advanced therapy development
- Clinical Development and Operations teams involved in CGT trials
- Anyone looking to accelerate cell and gene therapy programs through specialized testing and translational science
What You Will Learn
Attendees will gain insight into:
- The current cell and gene therapy trial landscape, including distinctions between cell therapies such as CAR-T and hematopoietic stem cell therapies and gene therapies such as AAV-based and RNA therapeutics
- How flow cytometry, genomics and bioanalysis (BioA) work together to characterize living drugs
- Practical approaches to addressing translational bottlenecks and implementing characterization strategies globally
Xtalks Partner
Cerba Research
Cerba Research, a strategic provider of diagnostic solutions, supports drug development by leveraging patient data and scientific insight to optimize R&D and commercialization globally. Providing early phase research, clinical development through central laboratory and diagnostic testing, assay and biomarker development and validation — through our global network of specialty laboratories. We partner with government agencies, non-government organizations, as well as pharma and biotech organizations to change the shape of clinical development and advance healthcare. Cerba Research is part of Cerba HealthCare, a leading player in medical diagnosis.
Cerba Research accelerates cell and gene therapy (CGT) development by integrating advanced flow cytometry, genomics, histopathology and bioanalytical (BioA) services. We provide comprehensive characterization of therapeutic products from discovery through global clinical trials using a multi-omic approach to ensure the safety, identity, purity, and potency of next-generation therapies. By bridging the gap between molecular design and cellular function, we provide the complete dataset required for regulatory success.
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