Transfer from research/academia to clinical/regulated

Abstract

We focus here on how the interface in academia has adapted in their approach to assessing the PDs of biological agents to better understand mechanisms at an early stage. This understanding enables drugs to be modified early and to be reassessed before progressing to late stage trials. We discuss how these efforts are now being bolstered by a network of consortia involving industry, academia and regulatory bodies, to bring together resources, knowledge and a harmonization in bioanalytical techniques. We highlight how the regulatory guidance still lags behind the rapid advancement in biologicals and associated analytical techniques, especially in immunotherapies and immunological bioassays. Despite this, new collaborative groups are working together to deliver robust and accurate results essential for identifying the most promising drugs to progress from early phase academic research to late phase industry based trials. We show how the relationship between academia and not-for-profit organizations with large pharma and emerging biotech companies has shifted toward a more collaborative effort in bringing new therapies to the forefront.