Expedited development: An overview and discussion of how accelerated scenarios impact CMC workflows and strategies

The Development Group's CMC Considerations for Expedited Development Point Share presented a poster at the CASSS WCBP (2018) meeting

The poster summarizes this industry group’s collective thoughts on opportunities and challenges of CMC development under accelerated registration pathways - with a focus on breakthrough therapy designation.

The poster and the clear approach of the combined knowledge of 15 companies was very well received. Encouraged by the feedback received which included comments from the audience: “great to have the information in one place,” “do we have case studies, the strategies are very ‘do-able?” and “could we produce a white paper which could be used as an industry reference?”

Those presenting said that it attracted many inquires for the topic but also interest in BioPhorum, there was a tremendous interest in both the poster and for the white paper.

The team is now gathering further information from member companies on the regulatory feedback and scientific justification and rationale used to justify risks taken and is considering preparing a white paper.