In May 2024, the International Council of Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a final draft of the newly developed scientific guidance on drug-drug interaction (DDI) studies, ICH M12, that will be adopted by ICH-abiding regulatory agencies (FDA, EMA, Japan). Read on to discover what is new about this DDI guidance…
Madelyn Huang
Cell therapy development faces significant challenges on the path from concept to clinical application. From navigating the regulatory landscape to ensuring product consistency and standardization, the initial phases of developing cell therapies require careful planning and close collaboration among cross-functional teams. In this blog, we explore the complexities of early cell therapy development, with a…
Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. The Cell and Gene Therapy (CGT) field has unprecedented potential to effectively treat and/or cure genetic-based rare and orphan diseases and expand the reach of personalized medicine. This blog will…