Increasing Interaction Between Product, Process and Regulation

David Brindley, Director of Alliances, SENS Research Foundation

Video Overview

SRF Director of Alliances, David Brindley, considers the unique regulatory challenges associated with regenerative medical therapies and the potential of new expedited approval pathways – such as FDA Breakthrough Therapy status – to overcome those challenges. Although such pathways have had a clearly positive impact on the rate of innovation, David cautions that their requirement for greater interaction between researchers and regulators throughout the development process will demand a new emphasis on translational studies within academia.