James Cassella
Chief Development Officer Trevi Therapeutics
Dr. James Cassella is Chief Development Officer at Trevi Therapeutics, where he leads clinical development of novel therapies targeting chronic cough associated with idiopathic pulmonary fibrosis. With over 35 years of experience across CNS and innovative drug development, he brings a strong track record of advancing therapies from early research through to regulatory approval.
Prior to Trevi, Dr. Cassella served as Chief Development Officer at Concert Pharmaceuticals, where he led programmes culminating in FDA approval and played a key role in the company’s acquisition by Sun Pharma. His experience spans both scientific and strategic leadership, positioning him to address the significant unmet need of refractory cough in IPF. At this meeting, he brings valuable insight into symptom-focused endpoints and patient-centric therapeutic development.
Seminars
- Comparing commonly used IPF patient-reported outcome measures, including ERS-IPF, K-BILD, cough-specific instruments, and Living with IPF to understand their strengths, limitations, and clinical relevance
- Exploring why PRO use varies across trials, including regulatory expectations, endpoint selection, and differences in therapeutic mechanisms
- Discussing whether the field should move toward standardized PRO frameworks to better capture symptoms such as cough, breathlessness, fatigue, and overall quality of life
- Strategies for testing new investigational agents on top of standard-of-care drugs (Nintedanib, Pirfenidone, Nerandomilast), including selecting appropriate patient populations, managing heterogeneity, and adapting inclusion/exclusion criteria to balance scientific rigor with feasibility
- Evaluating potential pharmacodynamic and pharmacokinetic interactions, predicting additive, synergistic, or antagonistic effects, and translating mechanistic insights from preclinical models into clinical trial design to ensure patient safety while maximizing therapeutic benefit
- Leveraging biomarkers, imaging readouts, and exploratory endpoints to validate mechanism-of-action, identify early signals of efficacy, and design trials that are both regulatory-compliant and clinically meaningful, while learning from existing trials and real-world experience
