Pharma Unscripted

About Pharma Unscripted

Pharma Unscripted explores how evidence is evolving across the biopharma landscape—and what that means for patients, access, and decision-making. Through expert-led conversations, the series examines how organizations are generating and applying evidence to bring meaningful therapies to the people who need them most. From patient-centered outcomes and real-world evidence to value demonstration and AI in medical communications, each episode breaks down the trends shaping how therapies move from development to real-world impact.

Publisher

RTI Health Solutions

Category

science · technology

Language

en

Explicit

No

First episode

8 May 2026

Latest episode

2 Nov 2026

Latest episodes

7 episodes in the feed.

1. 

   2 Nov 2026

   JCA for Vaccines: Preparing Today for 2030

   How can vaccine manufacturers prepare for EU JCA in 2030? Vaccines are expected to enter the EU Joint Clinical Assessment (JCA) framework in 2030, but evidence decisions are being made now. This episode explores why vaccines pose distinct assessment challenges, where clinical development may leave comparative evidence gaps, and how manufacturers can begin preparing while vaccine-specific expectations continue to evolve. Sandra Talbird and Lacey Lopez join host Peter Wirth to discuss early evidence planning, scientific consultation, and the connection between EU assessment and national vaccine decisions. Key Topics EU JCA for vaccines and the 2030 timeline Comparative evidence gaps and duration of protection Real-world evidence, modeling, and indirect comparisons Joint scientific consultation and national vaccine decisions Early evidence planning and alignment across teams Continue Exploring Vaccine Evidence Planning Read the companion article, “Preparing Vaccine Evidence for EU JCA in 2030 (https://www.rtihs.org/resource/insight/vaccine-evidence-access-european-jca),” for practical priorities to guide your next evidence planning discussion.

2. 

   31 Aug 2026

   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, 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 Continue Exploring Delphi Methodology Get a practical, step-by-step approach to designing, conducting, analyzing, and reporting a rigorous Delphi study. Download the Delphi methodology guide (https://go.rtihs.org/GuideToDelphi)

3. 

   10 Jul 2026

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

4. 

   3 Jun 2026

   The Patient Experience: Evaluating Tolerability in Oncology Treatments

   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 (https://www.rtihs.org/resource/insight/tolerability-strategic-differentiator-oncology)

5. 

   8 May 2026

   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: 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

6. 

   8 May 2026

   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. 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

7. 

   8 May 2026

   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. 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

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