Carol Ann Satler
Vice President - Clinical Development Insilico Medicine
Dr. Carol Ann Satler is a physician executive with 20+ years of experience leading global clinical development across top pharma and biotech companies including Pfizer, Sanofi, Takeda, Gilead, and PureTech. She has overseen programs from discovery through commercialization, including multi-billion-dollar launches such as Plavix and Lipitor. Former President and CMO of Respira Therapeutics, she excels at translating scientific innovation into improved patient outcomes. A board-certified pediatric cardiologist and Harvard faculty alumna, she holds an MD-PhD from Case Western and has served on boards including the American Heart Association, Carbon Biosciences, and Vicardia Therapeutics.
Seminars
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?
- Detailing the discovery and development of Rentosertib (INS018_055), a first-in-class small molecule TNIK inhibitor identified through end-to-end generative AI
- Overview of clinical progression: positive safety and efficacy signals from a completed Phase 2a trial, with Phase 2b in the US and a Phase 3 trial underway in China
- Reflections on the integration of AI in early discovery and translational development, and navigating multinational clinical trial strategies for IPF
