Critical Path Institute

02/02/2026

Now Available on Demand! Catch up on every moment of the 2025 C-Path Global Impact Conference! All sessions are now streaming on our YouTube channel — watch, learn, and share.

Check out the opening session of , where C-Path CEO Klaus Romero leads off with a welcome to the attendees, before diving into our first session, “Accelerating Therapies for Disease Modification and Interception: Removing Barriers, Realizing Impact."

Klaus leads this engaging discussion with Julia Vitarello, co-founder of Mila’s Miracle Foundation, European Medicines Agency (EMA) Chief Medical Officer Stephen Thirstrup, Sanofi Head of Science Policy Chris Woolston, Director, and FDA Director Dionna Green.

Key Insights from this session include:

- C-Path's strategic partnerships have been foundational in transforming drug development paradigms.

- Data integration across heterogeneous sources is C-Path's core competency

- Julia’s lived experience highlights the human urgency behind scientific discussions. ss heterogeneous sources is C-Path's core competency.

- Data privacy and sovereignty present significant barriers to data sharing, despite patient willingness.

Watch the video on C-Path's YouTube channel here: https://f.mtr.cool/outkdbjnzu

Critical Path Institute advances drug development through global partnerships, data integration, and innovative approaches, focusing on individualized medici...

02/02/2026

We are pleased to invite you to register now for Critical Path Institute's 2026 Clinical Outcome Assessment Program Annual Meeting, taking place April 16–17, 2026, at the Washington Marriott at Metro Center in Washington, D.C.

This year’s meeting will once again bring together leaders from across industry, regulatory agencies, academia, patient organizations, and technology and allied service partners to advance the science and application of COAs in medical product development. Building on the strong engagement and momentum from last year, the 2026 program will feature deep-dive sessions, case studies, and multi-stakeholder discussions on pressing issues in the field, including:
- Using patient experience data to inform value assessment for access decision making
- Pulling back the curtain: Multi-stakeholder insights on electronic clinical outcome assessment implementation
- Incorporating the patient voice into clinical trial design: More than just checking the box
- From meaningful aspect of health to metric to endpoint: How multidisciplinary teams form a comprehensive approach to digitally-derived endpoints
- Revisiting meaningful change: Current thinking on establishing and applying benchmarks
- Addressing challenges in rare disease clinical trials: Methodological case studies

Register Now: https://f.mtr.cool/owqzsdswuv

We look forward to sharing a more detailed agenda as it becomes available and welcoming you in April for another engaging and collaborative Annual Meeting.

02/01/2026

C-Path's International Neonatal Consortium invites you to contribute to an important project led by its Real-World Data/Real-World Evidence Workgroup.

The workgroup is dedicated to advancing the development of cell & gene therapies for neonates and infants. Insights gathered through this survey will contribute to a publication aimed at identifying and characterizing registries that include infants and children under the age of 24 months.

The survey should take approximately 10 minutes to complete. Participation is voluntary, and no compensation is provided. Completion of this survey implies consent for us to retain and use your responses. Your input is invaluable in shaping the future of neonatal Cell & Gene Therapy research. Thank you!

Take the survey now: https://f.mtr.cool/xbfamrxxkf

02/01/2026

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!

SUBSCRIBE to C-Path's YouTube Channel Now ►► https://f.mtr.cool/ncdgqfooqw

01/31/2026

We are pleased to invite you to register now for Critical Path Institute's 2026 Clinical Outcome Assessment Program Annual Meeting, taking place April 16–17, 2026, at the Washington Marriott at Metro Center in Washington, D.C.

This year’s meeting will once again bring together leaders from across industry, regulatory agencies, academia, patient organizations, and technology and allied service partners to advance the science and application of COAs in medical product development. Building on the strong engagement and momentum from last year, the 2026 program will feature deep-dive sessions, case studies, and multi-stakeholder discussions on pressing issues in the field, including:
- Using patient experience data to inform value assessment for access decision making
- Pulling back the curtain: Multi-stakeholder insights on electronic clinical outcome assessment implementation
- Incorporating the patient voice into clinical trial design: More than just checking the box
- From meaningful aspect of health to metric to endpoint: How multidisciplinary teams form a comprehensive approach to digitally-derived endpoints
- Revisiting meaningful change: Current thinking on establishing and applying benchmarks
- Addressing challenges in rare disease clinical trials: Methodological case studies

Register Now: https://f.mtr.cool/vfdcwfmkgo

We look forward to sharing a more detailed agenda as it becomes available and welcoming you in April for another engaging and collaborative Annual Meeting.

01/31/2026

Interested in C-Path updates? Be sure to subscribe at https://f.mtr.cool/wqsawnasxv 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.

01/31/2026

Relive the best moments of the 2025 C-Path Clinical Outcomes Assessment Program Annual Meeting. Watch the session recordings anytime, anywhere now!

In this session, Sonya Eremenco, MA — Executive Director of the Patient-Reported Outcome Consortium at the Critical Path Institute — shares insights from the Consortium’s 16-year journey in shaping patient-focused drug development.

Her presentation highlights how the PRO Consortium has set a high bar for clinical outcome assessments, working through robust public-private partnerships that bring together regulatory agencies, patient advocacy organizations, academia, and CROs.

Today, the Consortium includes 25 member firms — among them 15 of the world’s top 20 pharmaceutical companies — all committed to advancing the role of the patient voice in medical product development.

Learn more about our COA program here: https://f.mtr.cool/qwreyhyixj

01/31/2026

On Demand Now | Watch the Biomarker Data Repository Team's inaugural virtual workshop titled: BmDR: A New Collective Resource to Drive Improvements in Kidney Health!

This workshop featured presentations on BmDR strategy, a clinical Chronic Kidney Disease patient story, an overview of what datasets and biomarker information are available, example analyses that have been performed, and a panel discussion on the value of data sharing and what this means to kidney disease patients and the community.

Watch here: https://f.mtr.cool/rbmbvilgdz

01/30/2026

Now Available on Demand! Catch up on every moment of the 2025 C-Path Global Impact Conference! All sessions are now streaming on our YouTube channel — watch, learn, and share.

In the final session of Critical Path Institute’s (C-Path) Global Impact Conference (CGIC) 2025, C-Path CEO Klaus Romero is joined by NCCHD Director for Clinical Research and Development Hidefumi Nakamura, FDA Director of Strategic Coalitions Amy Comstock Rick, Sanofi Regulatory Science and Policy Director Pujita Vaidya, and EMA Head of Regulatory Science and Academia Ralf Herold.

The conversation highlights the importance of incorporating the patient voice throughout the drug development lifecycle, emphasizing a shift from patient-focused to patient-informed development. The panel makes a call for a holistic integration of innovation—linking AI, digital health, real-world evidence, novel endpoints, and biomarkers—across the entire medical product ecosystem, rather than isolated silos. This conversation underscores the need for robust data generation, validation, sharing, and quality assurance as foundational to leveraging advanced tools like AI effectively.

Watch the video on C-Path's YouTube channel here: https://f.mtr.cool/ocbvmbtimq

In the final session of Critical Path Institute’s (C-Path) Global Impact Conference (CGIC) 2025, C-Path CEO Klaus Romero is joined by NCCHD Director for Clin...

01/30/2026

C-Path's Rare/Orphan and Pediatric Disease Programs hosted a special webinar showcasing six years of achievements from the Rare Disease Cures Accelerator–Data and Analytics Platform.

Over the past six years, RDCA-DAP has built a foundation for progress by:
• Promoting data sharing to expand a growing, open-access rare disease database
• Fostering a collaborative data ecosystem with external partnering platforms
• Supporting drug development through our public data and analytics portal

This session demonstrated how data sharing can move mountains for rare disease research — with real-world examples of data-driven solutions and collaborative task forces that address unmet needs, streamline development, and advance regulatory-grade tools. The presentation concluded with a panel discussion featuring diverse stakeholders sharing their perspectives on why data sharing remains essential to progress in rare diseases.

Watch Now: https://f.mtr.cool/rofwvlzkwu

01/29/2026

Register now for the 27th NIH Tissue Chip Consortium Joint Meeting with the Critical Path Institute's Complex In Vitro Model Qualification Framework Public Workshop on March 5-6, 2026.

Over the past 13 years, the NIH has brought together members of the NIH Tissue Chip Consortium, including funded academic investigators, members of the pharmaceutical industry, and government agencies to accelerate the use, adoption, and ultimately dissemination of tissue chip technology across the United States.

This year, NIH has partnered with C-Path's Predictive Safety Testing Consortium, a recognized global leader in drug development, to put together a joint meeting at no registration cost focused on accelerating the employment of tissue chips within the drug development pipeline. Day 1 (March 5th) will focus on Contexts of Use for Today and Tomorrow and Evidentiary Considerations for MPS, while Day 2 (March 6th) will focus on Integration of In-Silico NAMs, including tissue chips.

Register now: https://f.mtr.cool/xrmbydarum

01/26/2026

Now Available on Demand! Catch up on every moment of the 2025 C-Path Global Impact Conference! All sessions are now streaming on our YouTube channel — watch, learn, and share.

This engaging discussion from Critical Path Institute’s (C-Path) Global Impact Conference (CGIC) 2025, focuses on the future of regulatory science, drug development, and the role of collaboration between public and private sectors to accelerate biomedical innovation. This session, led by Consilium Salmonson & Hemmings Partners and C-Path Board Members Tomas Salmonson and Robert Hemmings, C-Path Senior Scientific Director Smith Heavner, FDA Senior Advisor Marie Bradley, EMA Head of Regulatory Science and Academia Ralf Herold, and Senior Medical Director at Biogen, Angela Paradis, emphasizes the importance of speeding up drug development to benefit patients faster and at lower costs.

The conversation highlighted the need for better tools, frameworks, and guidance to facilitate the appropriate use of external control arms. Key points include the current regulatory uncertainty, the evolving nature of methodological standards, and the necessity of early engagement between sponsors and regulators to improve study designs and regulatory acceptability.

Watch the video on C-Path's YouTube channel here: https://f.mtr.cool/rdnlrbduqj

This engaging discussion from Critical Path Institute’s (C-Path) Global Impact Conference (CGIC) 2025, focuses on the future of regulatory science, drug deve...