Topic

Articles

Quantum chemistry is accelerating drug discovery AI by providing physics-based, reproducible, and scalable data that encodes molecular reality.

How Quantum Chemistry Fills the AI Gap

Bristol Myers Squibb collaborates with Anthropic to accelerate drug development, manufacturing quality systems, and regulatory documentation via AI integration.

BMS-Anthropic Signals AI Move in Drug Manufacturing Quality Systems

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Videos

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust out-of-specification procedure. 

Ask the Expert: Enhancing Out-of-Specification Procedures

Nicholas Richardson is vice president of clinical development at Precision for Medicine.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients. 

Patient Access to Radiopharmaceuticals, Part 1

Deborah Smook is co-founder and co-owner of TurboFil Packaging Machines.

Deborah Smook, co-founder and co-owner of TurboFil Packaging Machines, explains some of the challenges involved with prefilled syringe manufacturing. 

Overcoming Challenges in Prefilled Syringe Manufacturing

The FDA replaced acting heads of its drug and biologics centers, deepening leadership instability that raises concerns for pharmaceutical developers.

Everything to Know about FDA's Personnel Shifts

This week, the industry saw rapid technological integration on the factory floor, a strategic shift toward globalized development networks, and leadership upheaval at the FDA. 

PharmTech Weekly Roundup-May 15, 2026

Senior Content Associate For Pharmaceutical Commerce

FDA Commissioner Marty Makary resigns amid agency turmoil, staff exodus, pressure over vaccines, rulings on abortion pills, and vaping rules.

FDA Commissioner Marty Makary Resigns Following Industry Pressure

Dennis Cantellops is an independent GMP and data integrity consultant and a former consumer safety officer for the US Food and Drug Administration.

This article evaluates a structured, risk-based framework for the development, execution, and life cycle governance of master production and control records and batch production and control records systems aligned with current good manufacturing practice requirements and internationally harmonized pharmaceutical quality system guidance.

Risk-Based Life Cycle Management of Master Production and Control Records to Strengthen Data Integrity and GMP Inspection Readiness Part 1: Regulatory Framework, Inspectional Findings, and Documentation System Evaluation 

This week's roundup features coverage from Excipient World and INTERPHEX, including discussions on proactive risk management, the rise of advanced modalities, and the integration of flexible, tech-enabled infrastructure.