The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
News|Videos|October 16, 2026
PharmTech Weekly Roundup—October 16, 2026: Rare Diseases, CMC, and AI Accountability
Author(s)Susan Haigney
AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
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This week on PharmTech.com, the FDA moved to shorten first-in-human (FIH) timelines and bring rare disease chemistry, manufacturing, and controls (CMC) review into a risk-based framework, while artificial intelligence (AI) moved deeper into discovery, manufacturing, and evidence generation. The common question across the week is who signs off, on what data, and whether quality systems can keep up with the pace.
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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.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
Sanjay Konagurthu, PhD, senior director of Science and Innovation at Thermo Fisher Scientific, explains what teams need to do to ensure the usefulness of AI and what strides have been made with AI in regulatory submissions.
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.
Vivek Gupta of Duquesne University explains at AAPS PharmSci 360 why device decisions can't wait and why excipient makers must test beyond drug molecules.
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