PharmTech Highlights Industry Advances and Regulatory Updates

This week on PharmTech, Merck expanded its pipeline, while the United States Pharmacopeia (USP) emphasized the importance of supply chain security in the pharmaceutical industry. The platform also explored the use of AI systems in drug development and featured previews of upcoming presentations at key industry events like CPHI Milan and AAPS PharmSci 360.

Earlier in September, PharmTech covered a range of topics, including the fundamentals of digital pathology in drug development and the role of AI in pharmaceutical advancements. Additionally, regulatory actions impacting the industry were discussed, providing insights into the latest developments shaping the sector.

Dr. Aleksandra Zuraw, a senior veterinary pathologist at Charles River, shared an introduction to digital pathology in drug development, highlighting its growing significance in the field. Meanwhile, Bram Baert and Sandrine Picco from Capsugel argued that setting scientifically justified, risk-based limits for nitrite in pharmaceutical excipients is more practical than aiming for zero.

Ron Scarboro of Azurity Pharmaceuticals emphasized the need for drug reformulation to remove patient barriers while preserving efficacy, advocating for early cross-functional team alignment. He also discussed the importance of incorporating real-world usability into product definition and using post-launch feedback to guide drug formulation.

Regulatory updates included the FDA opening an expedited Investigational New Drug (IND) pilot, tightening scrutiny of foreign trial data, and finalizing a rule recognizing non-animal testing methods. In Europe, the European Medicines Agency (EMA) advanced pharmaceutical legislation reform, restricted two legacy products, and initiated a safety review of injectable iron.

Ronald Piervincenzi of USP discussed the need for a system approach to drug supply resilience, covering everything from procurement benchmarks to regulatory capacity building.