Overview: With more than 80% of oncology therapies in development being precision medicines, the demands for data and evidence to support clinical development and commercialization have changed. We are seeing new challenges across the development lifecycle, including clinical trial site selection and recruitment and finding the right real-world data to support various evidence needs. With testing often limited to known and actionable biomarkers, there are additional hurdles to bring these drugs to patients once approved. In this session, we would like to discuss the era of precision oncology: testing practices, development needs, data hurdles, and how we can overcome these obstacles.

The IQVIA Institute will assemble a mixed panel to give a holistic view from the perspective of patient, pharma (large/small) and regulator. This interactive discussion will explore the challenges, key levers, and scenarios for precision oncology trials to find the right data for the right decision at the right time, thus ensuring all patients benefit from precision therapies. The panel will seek to address these topics:

• Precision medicine—is the hype too good to be true or is this the future?
• How do testing requirements impact a patient’s ability to participate in a clinical trial?
• Given the complexities and additional burden, how do we communicate the importance of precision medicine trials and ensure prioritization by stakeholders?
• Do we need to challenge the current data access/usage approaches to support evidence generation from trials that support drug launches? Is there a need for ‘co-opetition’?