by Elena Iemma | Jun 18, 2026 | Blog
Replacing Animal Models with Human-Relevant New Approach Methodologies (NAMs) for Immunogenicity in Clinic Global Regulatory Agency Perspective on NAMs as a Human-Relevant, Risk-Based Framework for Immunogenicity Recent FDA guidance and parallel global regulatory...
by Elena Iemma | Mar 18, 2026 | Blog
Immunogenicity Risk Assessment Outputs to Drive a Streamlined, Risk-Based Preclinical and Clinical Strategy Overview: A Strong Immunogenicity Risk Assessment Strategy Starts Early and Carries through Development Unexpected immunogenicity can derail even the most...
by Elena Iemma | Jan 12, 2026 | Blog, News
In 2025, EpiVax advanced the science of immunogenicity assessment through AI-driven ADA prediction, enhanced in silico tools, expanded in vitro assays and consulting offerings, and new regulatory frameworks supporting biologics and generic peptides. Advancing...
by Elena Iemma | Dec 23, 2025 | Blog
EpiVax Supports Life-Saving Programs Through Partnerships with GAIA Vaccine Foundation and Clínica Esperanza/Hope Clinic At EpiVax, we believe in the power of science to improve human health, but we also recognize that science alone cannot reach every community. That...
by Elena Iemma | Dec 1, 2025 | Blog
Doing Well and Giving Back in December On Being Human Humans share 96-98% of our DNA with non-human primates. And yet, for many years, we have caged our “NHP” brothers and sisters and used them to validate our scientific hypotheses. Finally,...
by Elena Iemma | Oct 22, 2025 | Blog
The Power of Tregs: From Sakaguchi’s Nobel Discovery to EpiVax Innovation If you know us, you know we love Tregs. Regulatory T cells (Tregs) are central to how we think about the immune system and nearly everything we do at EpiVax. So, we were thrilled to see this...
