Pharma Unscripted

What can manufacturers learn from the first EU JCA report? The first EU Joint Clinical Assessment report offers an early look at how evidence may be evaluated under the EU HTA Regulation. This episode explores key methodological learnings from the tovorafenib assessment and what they may mean for future submissions, especially in rare diseases. Key Topics: • PICO scope and consolidation • Systemat...

Why is patient-centered evidence critical in oncology?   As oncology treatments become more targeted and long-term, organizations need evidence that captures real-world patient experience. This episode explores how PROs, tolerability, and patient-centered evidence are shaping adherence, evidence strategy, and market access.   Key Topics: Real-world patient experience Tolerability and treatment bur...

This episode is part three of a three-part series featured on Fierce Pharma’s The Top Line podcast. AI is transforming medical communications, but it’s not replacing human expertise. In this episode of Pharma Unscripted , we explore how AI is being used across med comms workflows, from literature review to content creation, and where it introduces risk. Accuracy, context, and scientific integrity...

This episode is part two of a three-part series featured on Fierce Pharma’s The Top Line podcast. Getting a therapy approved is only part of the journey, demonstrating its value is what drives access. In this episode of Pharma Unscripted , we explore how evidence storytelling is becoming critical in biopharma. From real-world evidence (RWE) to health economics and outcomes research (HEOR), organiz...

This episode is part one of a three-part series featured on Fierce Pharma’s The Top Line podcast. What does it really mean to put patients first in biopharma? In this episode of Pharma Unscripted , we explore how patient-centered evidence, including patient-reported outcomes (PROs), is reshaping clinical development, regulatory expectations, and market access. As decision-makers look beyond tradit...