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

In this episode, Ash 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

• When Delphi methodology is appropriate
• Panel and questionnaire design
• Consensus thresholds and iterative rounds
• CREDES and ACCORD reporting standards
• Regulatory, HTA, and market access applications

Get a practical, step-by-step approach to designing, conducting, analyzing, and reporting a rigorous Delphi study.

Download the Delphi methodology guide

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

Guests:
• Caroline Ling, Vice President, Health Outcomes – Europe
• Vijay D’Souza, Associate Director, European Value and Access

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 burden
• Patient-reported outcomes (PROs)
• Patient-centered evidence strategy
• Adherence and market access

Guests:

• Ari Gnanasakthy, Principal Scientist, Patient-Centered Outcomes Assessment
• Dawn Odom, Vice President, Biostatistics

Learn more about tolerability research

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:

• AI in medical communications
• Scientific accuracy and governance
• Risks and limitations of AI-generated content
• Role of human expertise

Guests:

• Margaret Mathes, Director of Medical Editing
• Gabby Dardis, Senior Integrated Evidence Strategist
• Frances Ramsey, Manager of Library Services

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.

As payers and HTA bodies demand stronger value demonstration, how you communicate evidence can directly impact patient access.

Key Topics:

• Evidence storytelling in biopharma
• HEOR and real-world evidence (RWE)
• Value communication for payers and HTAs
• Market access strategy

Guests:

• Kate Lothman, Director of Medical Writing & Publications
• Sara Musetti Jenkins, Principal Medical Writer
• Jason Crouch, Graphic Designer

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.

Key Topics:

• Patient-reported outcomes (PROs)
• Patient-centered evidence generation
• Clinical trial design and endpoints
• Market access and patient experience

Guests:

• Ash Menon, Sr. Medical Affairs Lead
• Mark Price, Head of Expert Perspectives