Critical Path Institute

Be part of the global conversation shaping the future of drug development. The Critical Path Institute’s Global Impact Conference 2026 brings together regulators, industry leaders, scientists, clinicians, those with lived experience, and advocates for three days of high-impact dialogue and collaboration, all focused on accelerating better treatments for patients worldwide.

This is more than a conference — it’s a working forum where ideas turn into action. Join us as we redefine the evidence-generation enterprise for drug development in the 21st century. Through dynamic plenaries and interactive sessions, you’ll engage directly with leaders across the ecosystem on the most pressing challenges and opportunities, including:
- Innovative approaches to patient identification, enrichment, and stratification
- Bridging the gap between drug development and clinical care
- Advancing truly patient-centric clinical trials
- Leveraging real-world data to generate decision-ready evidence
- Integrating novel methodologies to support faster, more effective regulatory decisions

Each day is designed to move beyond discussion, culminating in clear priorities and actionable next steps that continue long after the meeting concludes.

If you are committed to advancing therapies and improving outcomes for patients, CGIC 2026 is where you need to be. Don’t miss your opportunity to connect, collaborate, and help shape what comes next.

Room Block closing August 28! Register now: https://f.mtr.cool/sxoaverred

Evidence Generation for Scalable Advanced Therapies: A focused half-day convening from One to Millions | Thursday, Sept. 17 | 8 a.m. - 1 p.m.

This dedicated half-day program will spotlight the forward trajectory of C-Path's One to Millions initiative. This session will provide updated scientific direction, highlight meaningful progress, and explore key areas of momentum across the collaboration.

Designed as an interactive forum, the session will engage KOLs, advisors, members, and interested stakeholders in shaping the next phase of this global effort. This session offers an opportunity for deeper engagement beyond the core Global Impact Conference agenda.

Room Block closing August 15! Register now: https://f.mtr.cool/wnqfyhcvum

CGIC 2026: Evidence-Driven. Patient-Focused. Future-Ready.

As you've come to expect from previous years, CGIC 2026 will offer the chance to collaborate on the next wave of innovative therapies, discuss the latest initiatives, network with colleagues, and drive progress for those who need it most — people living with unmet medical needs.
If you're part of the movement to improve drug development with accelerated timelines and patient-centered therapies, this is the event you can't afford to miss. You'll have two full days to engage in inspiring conversations, discover the latest developments in neurology, rare diseases, and pediatrics, and explore the newest tools and collaborations C-Path has to offer.

This year's program gets right to work on Day One with a session that goes to the heart of one of drug development's most persistent challenges: Fixing the Front End of Drug Development: Why Target Selection Is Foundational to Evidence Generation

Despite significant advances in clinical trial design, real-world evidence, and regulatory science, late-stage attrition remains stubbornly high, often due to insufficient biological confidence in therapeutic targets. This session tackles that challenge head-on, examining target selection as a critical but underrecognized component of the evidence-generation continuum.

Panelists will explore how weak or siloed target validation can cascade uncertainty through every stage of development, increasing patient burden and system-wide inefficiency. The discussion will spotlight emerging pre-competitive, collaborative approaches to building target confidence before first-in-human studies, grounded in shared learning, disease-agnostic principles, and patient relevance.

Featured Speakers:
• Chris Chen, VP of Research Programs, Polycystic Kidney Disease Foundation
• Rita Cowell, Professor, University of Alabama at Birmingham
• Maaike Everts, Executive Director, Translational Therapeutics Accelerator, Critical Path Institute
• Alexis Hoffher, Head of Cardiorenal Development, AstraZeneca
• Robert Schuck, Deputy Director, Division of Translational and Precision Medicine, Office of Clinical Pharmacology, CDER, FDA

This session is just one example of the cross-sector, pre-competitive collaboration that has defined C-Path's approach for the past 20 years, and a preview of the conversations that will shape the future of drug development for the next 20.

Room Block closing August 28! Register today to secure your place at CGIC 2026: https://f.mtr.cool/evipgucval

One Biomarker, Multiple Uses: Connecting Safety and Disease Applications | Wednesday, Sept. 16. | 9-10 a.m. ET | Grand Ballroom

Every biomarker provides information on a biological process. But how relevant such information is to inform specific types of decisions in the evidence generation process for new drugs varies. A tool built to flag drug-induced organ injury can also help characterize disease progression. A safety signal in one program can become a disease marker in another. The question is whether the field is set up to make those connections, or whether each program is left to rebuild the case from scratch.

The session opens with an update on C-Path's Biomarker Data Repository, followed by a multi-stakeholder panel of industry, clinical, bioanalytical, modeling and regulatory experts. The discussion will cover real-world use cases, measurement considerations in clinical trials and opportunities to align biomarker efforts across C-Path consortia to maximize impact.

Room Block closing August 15! Register today: https://f.mtr.cool/kvnzolhtwm

ICYMI | The Critical Path Institute Podcast: Connecting the Dots with the Data Collaboration Center

This Critical Path Institute podcast episode provides an in-depth exploration of one of C-Path's core competencies: the Data Collaboration Center. Led by Ramona Walls, Director of the DCC, and Rick Liwski, Prior Chief Technology Officer, Rick and Ramona join C-Path CEO Klaus Romero to discuss how data drives C-Path’s efforts to accelerate drug development.

The podcast explains the types of data integrated by DCC — including clinical trial data, electronic health records (EHR), imaging, digital device data, and preclinical findings—and how the team manages complex challenges of data acquisition, standardization, privacy, and accessibility. DCC emphasizes Findable, Accessible, Interoperable, and Reusable data principles and implements rigorous curation to ensure data quality and regulatory compliance. The episode highlights DCC’s pivotal role in assembling large, integrated datasets crucial for developing drug development tools, especially in challenging areas such as rare and orphan diseases where patient populations are limited. The conversation also outlines the distinctions and interplay between data management, data engineering, and data science within C-Path, as well as the evolution of the Data and Analytics Platform, which securely hosts and facilitates collaborative research on over 700,000 patient datasets spanning 450+ studies. Looking to the future, the leaders share a vision emphasizing federated data access across multiple platforms and the integration of artificial intelligence and machine learning to enhance data processing, curation, and analytical efficiencies.

The episode wraps up by reinforcing the DCC’s critical mission to convert complex data into actionable insights that move drug development forward and facilitate regulatory review.

🔗 Listen & subscribe now:
Apple: https://f.mtr.cool/nlmlqcnwvd
Spotify: https://f.mtr.cool/krzajvazrs
YouTube: https://f.mtr.cool/dzemcukgaz

The Critical Path Institute Podcast: Connecting the Dots with the Data Collaboration Center This newest Critical Path Institute (C-Path) podcast episode provid...

Data: What's Overused and Underused? | Sept. 16 | 8:30-9 a.m. ET | Grand Ballroom

C-Path Chief Data and Technology Officer Chris Lunt sits down with Janet Woodcock, former acting FDA commissioner and longtime director of the Center for Drug Evaluation and Research, for a direct look at which data approaches actually move drug development forward and which add complexity without insight.

Room Block closing August 15! Register today: https://f.mtr.cool/jomfaoddgl

Dive into the world of solutions for Drug Development with C-Path's YouTube channel! Subscribe now for access to on-demand content including meetings, webinars, interviews, and more. Stay informed, stay inspired!

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Interested in C-Path updates? Be sure to subscribe at https://f.mtr.cool/ggglpzllbr For 20 years, C-Path has been providing vital infrastructure to generate a neutral environment for everyone working in drug development to collaborate, not compete. Let's improve lives, together.