Smarter Tools, Safer Therapies: Supporting the FDA’s Roadmap with in silico Immunogenicity Assessment

by Elena Iemma | May 19, 2025 | Blog

FDA Roadmap to Reducing Animal Testing:A Step Toward Smarter Tools for in silico Immunogenicity Risk Assessment The FDA’s new Roadmap to Reducing Animal Testing in Preclinical Safety Studies lays out a phased plan to move away from animal models and toward...

EpiVax and CUBRC Awarded FDA Contract Worth $2M for Development of Control Peptides for Immunogenicity Risk Assessment Assays Supporting Regulatory Filings of Generic Peptide Drugs

by Elena Iemma | Oct 24, 2024 | News

PROVIDENCE, R.I., Oct. 24, 2024 /PRNewswire/ — EpiVax, Inc. and CUBRC, Inc. announce today that they have been awarded a two-year, $2 million contract (#75F40124C00094) from the Office of Generic Drugs (OGD) of the Food and Drug...

Immunogenicity Risk Assessment: In Silico, In Vitro, and What’s Next

by Elena Iemma | Aug 18, 2024 | Blog

Immunogenicity Risk Assessment: In Silico, In Vitro, and What’s Next Don’t Miss This one! Put this one on your calendar: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk … The gang will all be...

ISV 2022 Computational Vaccinology Pre-Conference Workshop September 17th, 2022 ***Updated with Pictures******

by Elena Iemma | Jul 22, 2022 | Events

A big thank you to everyone that came out to the pre-conference Computational Vaccinology workshop at ISV! Agenda and pictures from the day below. ISV 2022 Computational Vaccinology Conference Workshop Saturday September 17, 9-4 pm ET Delta Hotels Québec 690 Boul René...

AAPS BPABC Community Presentation: In silico Immunogenicity Prediction for Protein and Peptide Therapeutics

by Elena Iemma | Mar 11, 2021 | Events, Webinars

Aimee Mattei, Senior Project Manager on our Bioinformatics team, will be presenting to the AAPS BPABC(biopharmaceutical product attributes and biological consequences) Community on March 18th at 12pm ET. You’ll need to join the group to register, membership is...