PDA Letter Article

Can ICH Q12 Unlock Manufacturing Innovation?

by Ursula Busse, PhD, Novartis, and Melissa Seymour, Biogen

June 2018

Human medicine has come a long way in the last 100 years. Paradigm-changing therapies have made their way into the clinic since the end of the last century, nurtured by better understanding of the underlying causes of various diseases. These 21st century cures entail personalized therapies using genomics, targeted tumor therapies using antibody–drug conjugates along with cell and gene therapies, just to name a few. These therapies are giving hope to millions of patients. In addition, they profoundly impact multiple stakeholders in the healthcare sector, including the pharmaceutical industry.