March 19 – 20 | Cambridge, MA
Join BioData Solutions at the Boston Society Gene & Cell Therapy Conference
As cell and gene therapy (CGT) programs continue to evolve – including AAV gene therapies, CRISPR-based approaches, CAR-T, and allogeneic cell therapies – teams face increasingly complex challenges in immunogenicity assessment. Key questions often include how to evaluate immunogenicity risk, select appropriate bioanalytical assays and endpoints, and navigate regulatory requirements such as IVDR and CLIA.
At the upcoming Boston Society Gene & Cell Therapy Conference, BioData Solutions will contribute to these discussions through expert insights and on-site engagement.
Featured Presentation
Immunogenicity in Cell and Gene Therapy: Risk Assessment, Assays, and IVDR Implications
Joleen White, PhD
Friday, March 20 | 9:35 AM PT
This session will provide a practical, integrated framework for immunogenicity in CGT development, covering:
- Risk assessment strategies tailored to diverse modalities
- Selection of fit-for-purpose assays for ADA and cellular immune response
- Key considerations for IVDR and CLIA compliance
- Alignment of immunogenicity strategy with clinical and regulatory expectations
Meet the Team
Also attending is Stephanie Pasas Farmer, PhD, who is part of the conference organizing committee. Together, the BioData team brings deep expertise in IND-enabling bioanalytical strategy, immunogenicity assessment, and regulatory alignment for CGT programs.
Connect With Us
If you are attending the conference:
- Join the session on immunogenicity in cell and gene therapy
- Connect with BioData experts onsite
- Discuss your CGT bioanalytical and immunogenicity strategy