Critical Path Institute

Critical Path Institute The Critical Path Institute (C-Path) is an independent, non-profit organization established in 2005.

Critical Path Institute (C-Path) is a nonprofit, public-private partnership with the Food and Drug Administration (FDA) created under the auspices of the FDA’s Critical Path Initiative program in 2005. C-Path’s aim is to accelerate the pace and reduce the costs of medical product development through the creation of new data standards, measurement standards, and methods standards that aid in the scientific evaluation of the efficacy and safety of new therapies. These pre-competitive standards and approaches have been termed “drug development tools” (DDTs) by the FDA, which established a process for official review and confirmation of their validity for a given context of use. C-Path orchestrates the development of DDTs through an innovative, collaborative approach to the sharing of data and expertise. We build consensus among participating scientists from industry and academia with FDA participation and iterative feedback. The process culminates in a formal application to FDA for official “qualification” of the DDT for a given use in product development. Qualified DDTs then become open standards for the scientific community which, in turn, may be assured both of the scientific rigor under which they were developed and of the FDA’s understanding and acceptance of their validity.

C-Path's Rare/Orphan and Pediatric Disease Programs invites you to a special webinar showcasing six years of achievement...
11/19/2025

C-Path's Rare/Orphan and Pediatric Disease Programs invites you to 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 will demonstrate 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 will conclude with a panel discussion featuring diverse stakeholders sharing their perspectives on why data sharing remains essential to progress in rare diseases.

Don’t miss this opportunity to see how collaboration and shared data are shaping the future of rare disease drug development.

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

Celebrating 20 Years of the Critical Path Institute: Accelerating Drug Development and Advancing Better Treatments for P...
11/18/2025

Celebrating 20 Years of the Critical Path Institute: Accelerating Drug Development and Advancing Better Treatments for People Worldwide. This year marks a special milestone for C-Path- 20 years of growth, innovation, and an unwavering commitment to our mission. As we celebrate this journey, we reflect on the moments, people, and breakthroughs that have shaped our of success.

2020: C-Path lead's its first medical device collaboration in pediatrics and joins ERA4TB. FDA issues contracts to support outcomes work in asthma, and model-informed drug development in neuroscience. Through the Cure Drug Repurposing Collaboratory, C-Path contributes real-world data solutions during the COVID-19 pandemic.

Your donation today will inspire hope and advance C-Path’s life-changing efforts to accelerate drug development. Help transform the next generation of medical breakthroughs with your contribution. Support C-Path today!

Keep Us going for 20 more by donating to C-Path: https://f.mtr.cool/qgrtwazlku

Now Available on Demand! Catch up on every moment of the 2025 C-Path Global Impact Conference! All sessions are now stre...
11/17/2025

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 session from Critical Path Institute’s (C-Path) Global Impact Conference (CGIC) provides an expert panel discussion focused on the development, qualification, and application of biomarkers in progressive diseases, specifically autosomal dominant polycystic kidney disease (ADPKD) and Alzheimer’s disease (AD). The conversation is led by C-Path CEO Klaus Romero, Executive Director of its Polycystic Kidney Disease Outcome Consortium (PKDOC) Sorin Fedeles, Eisai Senior Vice President of Clinical Research Michael Irizarry, Mayo Clinic Rochester Professor of Medicine and Senior Associate Neera Dahl, and Hyman, Phelps & McNamara Director James Valentine.

The conversation begins with a detailed overview of the journey to qualify total kidney volume (TKV) as a prognostic biomarker for ADPKD, highlighting its significance in clinical practice and drug development. The panel then draws parallels between the TKV biomarker story in kidney disease and the evolving role of imaging biomarkers, particularly tau PET imaging and amyloid PET, in Alzheimer’s disease.

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

This session from Critical Path Institute’s (C-Path) Global Impact Conference (CGIC) provides an expert panel discussion focused on the development, qualific...

C-Path's International Neonatal Consortium invites you to contribute to an important project led by its Real-World Data/...
11/16/2025

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/eutqkyjzzw

Dive into the world of solutions for Drug Development with C-Path's YouTube channel! Subscribe now for access to on-dema...
11/16/2025

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/djcgrtqnpt

Interested in C-Path updates? Be sure to subscribe at https://f.mtr.cool/mjohbpzynj For 20 years, C-Path has been provid...
11/15/2025

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

11/15/2025

Happy 20th Anniversary, C-Path! 🎉

Join us in celebrating two decades of innovation, collaboration, and impact! In this special video, C-Path staff, friends, and stakeholders from around the world share their heartfelt congratulations and reflections on 20 years of advancing drug development TOGETHER.

11/15/2025

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

Cheryl D. C**n, PhD — Vice President of the Clinical Outcome Assessment Program at Critical Path Institute — closed day one of the meeting by thanking attendees for their active participation and encouraging continued engagement as the conversations move forward.

Learn more about the COA programs here: https://f.mtr.cool/oflsvfihoc

Now Available on Demand! Catch up on every moment of the 2025 C-Path Global Impact Conference! All sessions are now stre...
11/14/2025

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 comprehensive session, held during the 10-year anniversary of the Critical Path for Parkinson’s (CPP) initiative, focused on addressing the long-overlooked topic of Parkinson’s disease (PD) in women. This C-Path Global Impact Conference (CGIC) 2025 panel included CPP Executive Director Diane Stephenson, UnshakeableMD Patient Advocate Soania Mathur, Michael J. Fox Senior Vice President, Clinical Research, Catherine Kopil, University of California, San Francisco, Professor Caroline Tanner, and Panoramic Digital Health CEO Derek Hill, who share perspectives of women living with Parkinson’s on key gender differences in disease presentation, treatment response, and lived experience.

The discussion underscored the urgent need for s*x and gender-specific research, patient-centric approaches, and innovative tools to better understand and treat Parkinson’s in women. Key points included the biological and clinical differences between men and women with PD, the gaps in research studies largely dominated by male participants, and the importance of incorporating patient voice and digital health technologies in research and clinical trials.

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

This comprehensive session, held during the 10-year anniversary of the Critical Path for Parkinson’s (CPP) initiative, focused on addressing the long-overloo...

C-Path's Rare/Orphan and Pediatric Disease Programs invites you to a special webinar showcasing six years of achievement...
11/12/2025

C-Path's Rare/Orphan and Pediatric Disease Programs invites you to 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 will demonstrate 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 will conclude with a panel discussion featuring diverse stakeholders sharing their perspectives on why data sharing remains essential to progress in rare diseases.

Don’t miss this opportunity to see how collaboration and shared data are shaping the future of rare disease drug development.

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

Celebrating 20 Years of the Critical Path Institute: Accelerating Drug Development and Advancing Better Treatments for P...
11/11/2025

Celebrating 20 Years of the Critical Path Institute: Accelerating Drug Development and Advancing Better Treatments for People Worldwide. This year marks a special milestone for C-Path- 20 years of growth, innovation, and an unwavering commitment to our mission. As we celebrate this journey, we reflect on the moments, people, and breakthroughs that have shaped our of success.

2019: C-Path opens European headquarters in Dublin, launches the Friedreich’s Ataxia database with FARA and begins a biomarker project with Japan’s PMDA. A global transformative effort for data integration for rare and orphan conditions launches: The Rare Disease Cures Accelerator-Data and Analytics Platform initiative.

Your donation today will inspire hope and advance C-Path’s life-changing efforts to accelerate drug development. Help transform the next generation of medical breakthroughs with your contribution. Support C-Path today!

Keep Us going for 20 more by donating to C-Path: https://f.mtr.cool/nkjidxudua

Now Available on Demand! Catch up on every moment of the 2025 C-Path Global Impact Conference! All sessions are now stre...
11/10/2025

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 discussion from Critical Path Institute's (C-Path) Global Impact Conference (CGIC) 2025 is led by C-Path T1D Consortium Executive Director Joe Hedrick, University of California, San Francisco, Professor Caroline Tanner, FDA Associate Director Kevin Krudys, Breakthrough T1D Senior Director Joshua Vieth, Georgetown University Adjunct Professor Jiri Aubrecht, and Berry Consultants Senior Medical Scientist Mike Krams.

The conversation centers on the transformative potential of pre-symptomatic intervention, or “interception,” in chronic degenerative diseases such as Parkinson’s disease and type 1 diabetes (T1D).

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

This discussion from Critical Path Institute's (C-Path) Global Impact Conference (CGIC) 2025 is led by C-Path T1D Consortium Executive Director Joe Hedrick, ...

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