Leveraging post-marketing regulatory requirements to drive commercial value

While long-term surveillance and ongoing studies are inevitable for certain products and approvals via accelerated pathways, this regulatory requirement also represents an opportunity to substantiate product value.

With the FDA’s recent black box mandate, we use the CAR T product class as a working example to explore opportunities for evidence generation beyond required safety and efficacy data to support all stakeholders, including HCPs, payers and patients.

In this webinar, hosted by Endpoints News, Parexel’s regulatory, access, and real-world research experts will focus on value creation through an integrated evidence approach, including:

• Regulatory expectations and acceptability during clinical development, marketing application and post-marketing stages
• Best practices for real-world evidence generation in the context of long-term population surveillance
• Strategies for generating evidence on long-term effectiveness to support product value
• How this approach can support reimbursement and value-based pricing models