Toby Maher
Professor of Clinical Medicine University of Southern California
Toby Maher is Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles.
Dr Maher has spent over 20 years specialising in the management of interstitial lung disease. Since June 2020 he has been Director of ILD at Keck Medicine of University of Southern California. His research interests include; biomarker discovery, cellular senescence in the pathogenesis of IPF and clinical trials. He has been involved in >100 trials in fibrotic lung disease from phase 1b through to phase 4 and including those assessing IPF, sarcoidosis, scleroderma, rheumatoid arthritis and inflammatory myositis. He is an associate editor for American Journal of Respiratory and Critical Care Medicine. He has authored over 400 papers on pulmonary fibrosis.
Seminars
Imaging offers a direct window into disease progression, but its role in predicting treatment response and improving trial design remains uncertain. While AI-driven imaging shows promise, regulatory acceptance and standardization are key challenges. This panel will explore how imaging can enhance clinical trials and accelerate drug development.
Key Discussion Points:
- What role can imaging play as a surrogate or co-primary endpoint? How close are we to standardized, validated imaging biomarkers, and what can be learned from oncology or neurology?
- How should the field approach integration of patient-reported outcomes and real-world evidence to reflect lived patient experience?
- What are the key regulatory considerations in validating novel endpoints, whether AI-derived, biomarker-based, or functional? How can stakeholders proactively align on evidentiary standards?
- How can trial sponsors, academic experts, and regulators collaborate to build a more flexible, data-driven framework for endpoint selection in future studies?
With new therapies on the horizon, the IPF treatment landscape is evolving. This panel brings together leading clinicians and academics to explore how emerging drugs will fit into current treatment paradigms. Experts will discuss the clinical decision-making process for first-line therapy, balancing efficacy, safety, and patient-specific factors.
A well-designed clinical trial can make or break a promising therapy. This session will explore how trial design choices, endpoints, patient selection, and statistical power, have influenced past outcomes.
- Endpoints & Study Duration: Were phase 2 trials too short or underpowered to detect meaningful effects? Did reliance on FVC as the primary endpoint contribute to misleading signals?
- Patient Selection & Inclusion Criteria: Did we include the right patient populations, or was disease heterogeneity overlooked? Were exclusion criteria too broad or too restrictive?
- Statistical Pitfalls & Misleading Readouts: How often have positive phase 2 results been driven by outliers? Could alternative trial designs, such as adaptive approaches, improve decision-making?
