Auditing Your Contractor

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.

OpenAI acquired Orchestra Bio to pair AI agents that track drug development timelines with its Rosalind life sciences tools, raising oversight questions for pharma teams.

Germany is home to several prominent pharma companies and more than 1000 innovative biotechs.

BMS-Tempus, Roche-Zymeworks, and LGM-Sannova deals show what AI data, trispecifics, and nitrosamine testing mean for CMC, QA, and development teams.

FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.

Jane Zhang of ETCH Sourcing explains why geopolitics, transparency, and partnership now weigh as heavily as cost and quality when companies choose suppliers, in this episode of Ask the Expert, moderated by Susan J. Schniepp of Nelson Labs.

FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.

Roche-Hansoh, Merck KGaA-Silence, and Lilly-METiS deals show how ADCs, siRNA, and lipid nanoparticles reshape demands on CMC and manufacturing teams.