AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
News|Videos|October 26, 2026
PharmTech Weekly Roundup—October 23, 2026: CMC Considerations, Rare Disease Development, Standards Harmonization
Author(s)Susan Haigney
This week on PharmTech.com, experts discussed E&L suitability standards, rare disease treatment development, sourcing ingredient suppliers, the use of AI in quality control, and more.
Advertisement
Advertisement
The use of artificial intelligence (AI) is all aspects of pharmaceutical development and manufacturing was once again a hot topic on PharmTech.com this week, with both headline news and our experts weighing in on the technology’s progress. AI factored into a common theme of “keeping things on schedule”, from FDA’s expedited pathways and new approvals to AI agents built to keep drug programs on track. But to keep up the pace, manufacturing must be able to scale new modalities, analytical data labs must be able to trust data, and quality teams must be ready for new tools.
Related to this article
Shubhajit Paul, a senior research fellow in Boehringer Ingelheim’s Department of Material Analytical Sciences, spoke with PharmTech at AAPS PharmSci 360 to explain how tabletability prediction can be improved for roller-compacted formulations.
Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Boyang Wang, Immortal Dragons, discusses how the FDA’s Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
Boyang Wang, Immortal Dragons, explains how FDA’s Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China’s 818 Decree.
Advertisement
Advertisement