Scaling-Up from Lab to Commercial Scale

Insilica's Dr Thomas Luechtefeld argues process traceability, not benchmark accuracy alone, determines whether AI toxicology decisions can be trusted.

Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.

Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains where cold-chain planning still breaks down and why biopharma supply chain leaders should use AI to act on data sooner, with humans making the final call.

Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains what is driving biopharma reshoring, how USMCA uncertainty complicates sourcing for biologics, and where cold-chain visibility still breaks down.

At PharmSci 360, Insilica CEO Thomas Luechtefeld will present on auditable agentic AI systems and how they are expanding computational toxicology beyond single predictive models.

Emily Heffernan, director of new process technologies at Arcadis, explains what it takes to design a facility that can produce both lentiviral vectors and mRNA-LNPs, and how in vivo platforms change QC release testing.

BMS's Dr Nathan Pennell outlines how biomarker testing barriers and trial diversity affect patient access to targeted oncology drugs.