Bing Cai, PhD, is acting director, Division of Liquid-Based Products at FDA’s Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research.

Mahmood Majeed, ZS, explains why measurable AI outcomes in pharma supply chain and manufacturing jumped from 29% to 53%, and how GMP limits and GxP validation shape adoption.

Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.

Mahmood Majeed, ZS, explains why measurable AI outcomes in pharma supply chain and manufacturing jumped from 29% to 53%, and ...

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 ...

In the October 2026 episode of PharmTech’s Ask the Expert video series, Jane Zhang, co-founder and co-CEO of ETCH Sourcing, joins Susan J. Schniepp, distinguished fellow at Nelson Labs, to answer the ...

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

Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice. Ahead ...

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

Jaenisch, Muraru, and Pandey discuss new skills for QC and regulatory teams, plus patient trust, as new approach methodologies reshape pharma. As new approach methodologies (NAMs) and non-animal ...