Importance of Early Integrated Evidence Strategy for Cell & Gene Therapies

The healthcare ecosystem is a complex network of stakeholders that requires a focused engagement strategy to navigate the evolving landscape. Traditional clinical development is primarily focused on meeting evidentiary needs for regulatory authorities and does not necessarily meet the needs of the broader network of diverse stakeholders, each with their own engagement preferences and evidence needs. An integrated, cross-functional evidence strategy can ensure that the right processes, tools, culture, governance and training are available to support evidence generation and evidence dissemination activities. Many organizations already work in a cross-functional manner to address their evidentiary needs; however, the critical next step is truly integrated thinking around value creation as well as a refined strategy to generate and disseminate the right evidence to the right stakeholders at the right time. Integrated Evidence Strategy represents the next generation of clinical development and could be particularly important for companies developing cell and gene therapies (CGT), for whom the complexities of CGT have introduced new uncertainties among stakeholders across the healthcare ecosystem. For example, as a result of the high upfront costs of CGT, payers are beginning to introduce Outcomes-Based Contracts, which stipulate that the amount a health plan pays for a therapy depends on how effective the therapy is at treating the condition. An Integrated Evidence Strategy can address these evolving payer dynamics to ensure a successful product launch and lifecycle while also protecting companies from risk by proactively anticipating and meeting critical evidentiary needs in a timely manner. Register for this webinar and find out through case studies and panel discussion, the value of defining an Integrated Evidence Strategy early on in cell and gene therapy development.