The field of human therapeutics has evolved from small molecules to complex biologics with tremendous acceleration in innovation of new modalities and drug delivery technologies. These innovations have led to corresponding therapies seeking regulatory approval globally. The accelerated growth in innovative therapies represent challenges for sponsor and regulatory agencies. This talk will briefly cover the innovative modalities and drug delivery, current CMC guidance for mAb like therapies and propose recommendations from an industry perspective to make sure innovation and regulation are not out of sync. It is critical for industry and health authorities to work together towards a confluence of innovation and regulation to accelerate access of life-saving therapeutics to patients globally.
Twinkle Christian, Process Development Scientist, Drug Product Technologies Group , Amgen