Cellular & Genetic

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Decentralized manufacturing methods for cell and gene therapies will be critical for improving patient access to treatments, but sponsors must prepare to demonstrate “comparability” with centralized manufacturing.

Exosome-based treatments hold promise, but their reality has not yet materialized in the form of compelling clinical data. Belgian biotech Exo Biologics’ CEO Hugues Wallemacq believes his company can help move the field forward, both through its own clinical programs and by offering high-quality exosomes to others in the field.   

“Proper medicine driven by data” is how C4X Discovery Holdings’ CEO Clive Dix sees the future now that his immuno-inflammation focused company has been able to identify IBD genetic response signatures in patients treated with vedolizumab.

Stakeholders looking to gain deeper insights into potential cell and gene therapy candidates and optimize R&D strategies can employ several strategies to inform portfolio management decisions.  

President Joe Biden signed an executive order the White House said represents the most comprehensive executive action to date on improving women’s health. The move follows the president’s call during his State of the Union for Congress to invest $12bn in women’s health research.

This week, the US FDA labelled several recalls class I, approved an at-home diagnostic for chlamydia and gonorrhea, and announced the expansion of its TAP pilot program. Guardant Health also announced it would appeal a verdict in a patent suit against the company and AdvaMed voiced its continued support for pending breakthrough device legislation.

Legislation introduced in the US Senate by Wisconsin’s Tammy Baldwin would beef up the nation’s flu preparedness by investing in new technology for vaccine and diagnostic development as well as treatments.

Having led the way to regulatory approval for Kymriah and now Ebvallo, Atara CEO Pascal Touchon reflects on the evolution of cell therapy and what his company is doing differently.

Welcome to In Vivo’s new AI-focused blog, BioBytes, providing news and insight on the growing role of artificial intelligence in biopharma. In this post, Illumina’s new large language model-based gene analysis tool could help drive uptake of its products.