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 International Neonatal Consortium invites you to contribute to an important project led by its Real-World Data/...
01/11/2026

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/dzlvmrgfcc

Dive into the world of solutions for Drug Development with C-Path's YouTube channel! Subscribe now for access to on-dema...
01/11/2026

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/amamkgkkhl

Interested in C-Path updates? Be sure to subscribe at https://f.mtr.cool/gxckvnqwmv For 20 years, C-Path has been provid...
01/10/2026

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

01/10/2026

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

Session 1: Current thinking on the accessibility and burden of eCOA & DHT system use. This session captures a rich panel discussion focusing on the burden, accessibility, and evolving use of electronic clinical outcome assessments and digital health technologies in clinical trials. The session aims to address how technological advancements can improve patient data collection while minimizing participant burden and enhancing inclusivity for diverse populations, particularly those with impairments or disabilities. Moderated by Scottie Kern – Executive Director, Electronic Clinical Outcome Assessment Consortium, C-Path, with presenters Lee Aiyegubsu, MBChB, PhD – Associate Professor and Deputy Director, Centre for Patient-Reported Outcomes Research, University of Birmingham, UK,Alisa Heinzman, MFA – Senior Project Manager, Electronic Clinical Outcome Assessment Consortium, Critical Path Institute, and panelists featuring Katy Benjamin, SM, PhD – Senior Principal Scientist, Patient Centered Endpoints and Strategies (PaCES), Merck & Co., Inc., and Ian Pallett, BSc, HNC – Sensor Solutions Director, Parexel.

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

On Demand Now | Watch the Biomarker Data Repository Team's inaugural virtual workshop titled: BmDR: A New Collective Res...
01/10/2026

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 will 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/gtvewectyk

Now Available on Demand! Catch up on every moment of the 2025 C-Path Global Impact Conference! All sessions are now stre...
01/09/2026

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 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/ialoegxvtp

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 hosted a special webinar showcasing six years of achievements from t...
01/09/2026

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/wzrqlhxlxs

Register now for the 27th NIH Tissue Chip Consortium Joint Meeting with the Critical Path Institute's Complex In Vitro M...
01/08/2026

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/ajgcbudlpg

C-Path's Translational Therapeutics Accelerator is launching its 2026 Request for Proposals.Join our upcoming webinar to...
01/06/2026

C-Path's Translational Therapeutics Accelerator is launching its 2026 Request for Proposals.

Join our upcoming webinar to learn about funding scope, eligibility, and how TRxA supports projects beyond the bench.
📅 January 27th, 2026 10AM ET
👉 Register: https://f.mtr.cool/oyaljvbkzx

Not all translational funding programs are the same. TRxA supports investigators at critical development milestones with both funding and strategic expertise. Learn how the 2026 RFP works during our upcoming webinar. Registration is still open for the TRxA 2026 RFP Webinar.

If you’re considering applying this cycle, this session will help you understand expectations, timelines, and next steps. Don’t miss it!

Now Available on Demand! Catch up on every moment of the 2025 C-Path Global Impact Conference! All sessions are now stre...
01/05/2026

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 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/cpfkqdpats

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, ...

C-Path's International Neonatal Consortium invites you to contribute to an important project led by its Real-World Data/...
01/04/2026

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/pqiawxrcpz

Dive into the world of solutions for Drug Development with C-Path's YouTube channel! Subscribe now for access to on-dema...
01/04/2026

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/khoodnqrxl

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1840 E River Road Ste 100
Tucson, AZ
85718

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Monday 8am - 5pm
Tuesday 8am - 5pm
Wednesday 8am - 5pm
Thursday 8am - 5pm
Friday 8am - 5pm

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