September 20, 2023 @ 3:00 PM – 5:00 PM
CASSS DC Discussion Group is hosting a panel discussion on the role of platform technologies in biotherapeutic development:
After the rapid development of COVID vaccines and biotherapeutics, industry members and regulators are turning to platforms as a means to facilitate accelerated development and time to market. This is not to say that platforms are new to the biologicals community, but instead that their potential has not been fully tapped for the benefit of patients in need. Neither is this a novel paradigm with breakthrough therapies and the PRIME initiative already in action. But while these more recent initiatives have been successfully employed to help fulfill an unmet medical need, acknowledgment of biological platforms which have heretofore been mostly ignored or underutilized are beginning to gain attention.
Monoclonal antibody therapies and protein subunit vaccines are developed today using the same technologies and measured using the same methods over the last several decades. Thus, there is an immense body of prior knowledge about these platforms which offer a head start, and perhaps more efficiency when introducing a new product into the pipeline. With prior knowledge comes more careful attention to information management and advanced data and analytics tools which facilitate product and analytical development, as well as communications to global regulatory authorities.
This session of the CASSS DC Discussion Group will bring together a panel of industry, government, and regulatory leaders to discuss the why’s, the hows, and the hurdles to developing and utilizing platforms. Participants are expected to engage the panel to learn about and to challenge current practices and the pathways to successful application of biological platforms.