Pressure to assess and approve a growing volume of promising new drugs and biologics in accelerated and compressed timeframes is prompting a major reorganization of the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER). The aim is to help CDER staff deal with a “staggering pace of work,” that involves attention to detail and the need to keep up with emerging scientific advances in genomic medicine, targeted therapy, digital health, drug-device combination and more global drug development, commented CDER director Janet Woodcock. She has been spearheading the initiative for the past year, with an eye on encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
This article highlights the scope for developing therapeutics with new innovative, alternative approaches. The current trillion dollars pharmaceutical industry is in peril where the current drug development pipeline is slow, inefficient and incapable of being extended to multi-combination drug therapies as well as minimally focused on prevention. The complex modeling of diseases and biological functions has been limited because of the inability to integrate large scale molecular pathways.
Watch this Video to understand how recent advances provide breakthrough technology for doing scalable modeling of complex molecular systems to dramatically accelerate drug discovery and development.