<span>Cell and Gene Therapy Answers: What to know about companion diagnostics development</span>
June 4, 2024

Cell and Gene Therapy Answers: What to know about companion diagnostics development

A companion diagnostic (CDx) is an in vitro diagnostic providing essential information for the safe and effective use of a corresponding therapeutic product. By identifying patients most likely to benefit from or who are at risk of adverse events from a therapy, CDx can help guide decisions for targeted treatment strategies—which is why many regulatory bodies now recommend incorporating CDx within cell and gene therapy (CGT) programs. However, for many developers, questions remain about when CDx are truly needed, how to choose the right CDx partner and the kind of testing required for CDx assays. To gain clarity on CDx strategy and best practices, we spoke with Devin Craven, associate director of regulatory affairs for Labcorp, and Laura Huning, a scientist for Labcorp’s diagnostic development services.
<span>ECHA guidelines</span>
June 4, 2024

ECHA guidelines

ECHA sets deadlines to provide data after dossier and substance decisions are issued

Following a dossier or substance evaluation from the European Chemicals Agency (ECHA), standard deadlines to provide data (normally, new study data) will be provided in a draft decision letter.

May 16, 2024

Solving the puzzle of preeclampsia

Hear from the subject matter experts addressing the prevalence of preeclampsia in the U.S. From early patient education, at-home monitoring and clinical management to digital health intervention and testing for preeclampsia across all pregnancy trimesters—the panelists are shedding light on the work helping to improve pregnancy outcomes and advance health equity.
<span>Spilling the Tea on Biomarkers</span>
May 30, 2024

Spilling the Tea on Biomarkers

You might be asking yourself, “What is the hype about biomarkers?” and “Should I be talking with my healthcare provider about biomarkers?” Well, the answer is yes, you should, and we are here today to help you get started!