The FDA Modernization Act 2.0 should make it easier for companies to gain regulatory authorization using non-traditional testing methods, like organs-on-a-chip. But biopharma will need to make the leap into technology to help build knowledge and data if the drug development world is to move away from animal testing entirely. 

SIGA provides an update on its monkeypox program, while Massive Bio announces progress on its AI platform for connecting cancer patients to trials, with additional updates from BridgeBio, the Oncology Institute, and CROs Caidya, Charles River Labs, Syneos Health and PPD parent Thermo Fisher Scientific.

Private Company Edition: Arbor is developing drugs based on proprietary gene editors, Acrivon is applying proteomics to precision cancer therapies, and bit.bio is producing differentiated cell products. Also, Marengo launches with $80m, Sanofi invests up to $60m in Gyroscope and Shasqi raises $50m.

Experts share what they believe are the solutions to key manufacturing challenges, such as lowering cost of goods and centralized manufacturing, in the cell and gene therapy sector.