Camilla Graham
Senior Vice President, Medical Affairs PureTech Health
Seminars
- A moderated discussion between PureTech and Vitalograph about the common challenges that clinical trials face and practical strategies to overcome them
- Puretech review how they designed and conducted their Phase 2b IPF study to maximise data quality
- Key learnings PureTech are taking into their Phase 3 preparations
- A study coordinator’s perspective on how sponsors can further support teams at sites to improve patient experiences and ease of trial conduct is shared
With Nintedanib and Pirfenidone approaching patent expiration, the IPF treatment landscape is at a pivotal moment. The industry is now exploring next-generation therapies, combination strategies, and novel mechanisms of action to address the remaining unmet needs in fibrosis progression and lung function preservation. However, as new therapeutic approaches emerge, challenges arise in clinical trial design, endpoint selection, and regulatory pathways.
This panel will examine the evolving IPF treatment paradigm, discuss the role of combination therapy, and explore how the
upcoming shifts will influence drug discovery, clinical development, and patient outcomes.
Discussion Points:
- What impact will the upcoming patent expirations of Nintedanib and Pirfenidone have on innovation and investment in IPF drug development?
- How are combination therapy strategies shaping the future of IPF treatment, and what are the key scientific and regulatory hurdles to address?
- What lessons can we learn from the development of past fibrosis treatments to optimize clinical trial design, including endpoints beyond FVC?
- With new mechanisms in development, what biomarkers and surrogate markers can better predict treatment efficacy and guide future therapeutic strategies?
- How do we ensure that novel therapies advance patient outcomes while maintaining accessibility and regulatory compliance in an evolving landscape?
- How evolving payer expectations around value, outcomes, and cost-effectiveness should inform early clinical trial design in IPF to support future market access, especially as next-generation therapies and combination strategies emerge
FVC remains the gold-standard endpoint for IPF clinical trials, but its variability can undermine trial reliability, increase costs, and complicate regulatory approval. As the field moves forward, there is growing recognition of the need to refine endpoints by integrating additional, more predictive measures. This interactive workshop will spotlight innovative strategies for endpoint selection— drawing lessons from other respiratory diseases and leveraging data-driven approaches to boost trial sensitivity and efficiency.
Key discussion points:
Addressing the Limitations of FVC
- Exploring the variability of FVC and its implications for trial design
- Identifying complementary or alternative measures to improve accuracy and enhance trial success Learning from Composite Endpoints in Pulmonary Arterial Hypertension
- Assessing how composite endpoints—such as six-minute walk distance, respiratory hospitalizations, and imaging biomarkers—can provide a more holistic measure of efficacy Advancing Clinical Trial Desig
- Harnessing quantitative, data-driven approaches to develop novel composite endpoints that increase sensitivity, facilitate regulatory approval, and reshape the future of IPF clinical research
- Overview of the clinical development journey of deupirfenidone, including key learnings from the Phase 2b study and plans for advancing to Phase 3
- Discussion of trial design rationale, patient population, endpoints, and positioning within the current IPF treatment landscape
