Camilla Graham

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?

• 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
• How payer perspectives can and should influence clinical trial design earlier in development to support future reimbursement and access