Jeffrey Bornstein
Chief Medical Officer Mediar Therapeutics
Dr. Jeffrey Bornstein is a seasoned biopharmaceutical executive and physician-scientist currently serving as Chief Medical Officer of Mediar Therapeutics, a company pioneering novel therapies for fibrotic diseases. With over 20 years of leadership experience across all phases of drug development, he specializes in translating innovative science into clinical programs for fibrotic disorders.
Previously, Dr. Bornstein served as CMO of Eledon Pharmaceuticals (2021-2023) and held senior roles at Takeda (VP, Head of Clinical Sciences, GI Division), Biogen, and Gilead Sciences, where he led several liver and lung fibrosis development programs. His career spans executive positions at multiple biotechs including Ocera Therapeutics and Tioga Pharmaceuticals, building an exceptional track record in drug development.
Trained in internal medicine with subspecialities in GI and hepatology and with faculty experience at Duke University Medical Center, Dr. Bornstein combines deep clinical expertise with strategic development acumen to advance transformative treatments for fibrotic conditions.
Seminars
Forced Vital Capacity remains the anchor endpoint for pulmonary fibrosis trials and the filed remains split on torn on its value. What’s more the field is evolving to capture a more complete picture of disease progression and therapeutic impact. This panel will dig into FVC and secondary endpoints, the emerging role of quantitative HRCT and other imaging biomarkers, the evidence required for regulatory acceptance, standardization across providers, and the integration of multi-modal endpoints into trial design, all to ensure you leave with a clear understanding of how to design trials that balance traditional FVC measurements with innovative endpoints, enabling robust efficacy assessment, regulatory alignment, and differentiation in an increasingly complex ILD landscape.
- The continued relevance of FVC as a surrogate for disease progression and mortality in IPF and PPF
- How secondary endpoints can complement FVC to reveal meaningful changes in symptoms, quality of life, and disease biology
- Advances in quantitative imaging, including AI-driven HRCT, and the pathway toward regulatory qualification
- Strategies for integrating multi-modal endpoints into trial design without overcomplicating study execution
- Practical considerations for trial sponsors: standardization, subgroup analysis, and managing background therapy
- Has the Approval of New Antifibrotics Fundamentally Changed IPF Trial Design? Exploring whether the introduction of additional approved therapies requires a paradigm shift toward combination trials and active comparators, or whether traditional development approaches remain valid
- Managing Background Therapies in an Evolving Standard of Care Debating strategies for incorporating monotherapy, prior antifibrotic exposure, and real-world combination regimens without compromising interpretability or feasibility of clinical trials.
- Lessons from Other Crowded Therapeutic Areas Considering how fields such as inflammatory bowel disease, rheumatoid arthritis, and psoriasis have continued drug development despite multiple approved therapies, and whether ILD should follow a similar path.
- Designing Future Trials as the Pipeline Expands Anticipating how additional approvals may influence eligibility criteria, stratification strategies, and expectations for head-to-head or combination studies.
