Quality Metrics and CMO Agreement

The proposed $700 million, 700,000-square-foot space will support the companies’ future joint portfolio of next-generation obesity medicines.

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

The pandemic made it daunting for companies to retain talent and then find it anew, but just as that cloud is lifting and workforce diversity is being embraced, AI beckons as a new challenge.

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.