Podcast

Delphi Methodology: Turning Expert Judgment into Actionable Evidence

How can Delphi studies address critical evidence gaps?

When traditional evidence is limited or unavailable, Delphi methodology offers a structured way to turn expert judgment into credible, actionable insights.

In this episode, Ashwathi Menon and Mark Price discuss when to use Delphi research, what rigorous study design looks like, and how findings can support publications, regulatory submissions, HTA, and market access strategy.

Key Topics

The First EU JCA Report: Methodological Learnings and Implications for Future Submissions

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
• Systematic literature review expectations
• Indirect treatment comparisons
• Single-arm evidence in orphan diseases
• Future JCA submission planning

AI in Medical Communications: Why Human Expertise Still Matters

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 remain critical, making human oversight essential in an AI-driven environment.

Key Topics:

From Approval to Value: Evidence Storytelling, HEOR & Market Access

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), organizations must translate complex data into clear, decision-relevant insights.

Putting Patients First: Patient-Centered Evidence & PROs in Biopharma

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 traditional endpoints, understanding the real patient experience, quality of life, treatment burden, and daily impact, is becoming essential.