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 sc

ientific 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.

08/31/2026

ICYMI | C-Path's team hosted a webinar bringing together drug development leaders for a practical, collaborative discussion on evidence needs, data strategies, platform opportunities, and approaches to regulatory engagement for individualized and small-population therapies.

The “Transforming Drug Development for Precision Medicines” webinar highlighted how precision medicine continues to evolve and explored shared challenges and opportunities in creating more predictable, aligned pathways from development through reimbursement.

This expert-led discussion covered:
- Evolving evidence needs for individualized and small-population therapies
- Data strategies that support regulatory and payer decision-making
- Framework and infrastructure opportunities to improve predictability and efficiency
- Practical approaches to early and ongoing regulatory engagement
- Clear next steps for organizations navigating precision medicine development today

If you missed it, you can access the recording here: https://f.mtr.cool/nx1w4ih5tz

The AI Trust Gap: If We Don't Trust AI, How Can We Use It to Create Evidence? | Sept. 15 | 3-4 p.m. ET | Jr. Ballroom - ...
08/31/2026

The AI Trust Gap: If We Don't Trust AI, How Can We Use It to Create Evidence? | Sept. 15 | 3-4 p.m. ET | Jr. Ballroom - Salon 1

Artificial intelligence is reshaping drug development. But most AI models never make it into decisions that matter. The barrier is not technical capability. It is trust.

On Sept. 15 at the C-Path Global Impact Conference in Washington, D.C., a session titled "The AI Trust Gap: If We Don't Trust AI, How Can We Use It to Create Evidence?" will examine the conditions under which AI can produce evidence of efficacy and safety that is credible, transparent, and usable in practice.

"AI has the potential to fundamentally change how we generate and interpret evidence of efficacy and safety, but only if we can answer the trust question first. That means building systems that are not just accurate, but explainable, auditable, and fit for the decisions they are meant to support." — Chris Lunt, Chief Data and Technology Officer, Critical Path Institute

This session is one of many reasons CGIC 2026 is the meeting drug developers, regulators, researchers and patient advocates cannot afford to miss.

Register today: https://f.mtr.cool/4uozjz5ilm

ICYMI | The Critical Path Institute Podcast: Electronic Clinical Outcome Assessments in Oncology ResearchThis panel disc...
08/30/2026

ICYMI | The Critical Path Institute Podcast: Electronic Clinical Outcome Assessments in Oncology Research

This panel discussion, hosted by C-Path's Electronic Clinical Outcome Assessment Executive Director Scottie Kern and features experts from industry and academia Bill Byron, Principal of eCOA Science at Signant Health, Melissa Mooney, the Director of eCOA, Solution Engineering at IQVIA, Thomas Moll, Senior Scientific Advisor at Clario, Devin Piper, Professor of Health Outcomes Research and 125th Anniversary Chair at the University of Birmingham. The conversation explores the evolving role and strategic integration of Clinical Outcome Assessments, particularly electronic ones, in oncology research. The episode highlights historical context, regulatory insights, practical implementation challenges, and future directions for clinical outcome assessments use in oncology clinical trials.

🔗 Listen & subscribe now:
Apple: https://f.mtr.cool/dm8zztzagy
Spotify: https://f.mtr.cool/spvamq3x2a
YouTube: https://f.mtr.cool/bu9nhdoyag

Digital health technology development depends on clinicians, engineers, researchers, data scientists and measurement exp...
08/30/2026

Digital health technology development depends on clinicians, engineers, researchers, data scientists and measurement experts working from the same playbook. Too often, they are not. The same term can mean very different things across disciplines, and that ambiguity slows down development, evaluation and understanding of digital measures before a study even begins.

On Sept. 15 at the C-Path Global Impact Conference in Washington, D.C., a session titled "A Thesaurus for Digital Health Terminology: A Resource to Aid the Field in Finding Common Language to Bolster Collaboration" will introduce C-Path's DHT Thesaurus, a new cross-functional resource built to align terminology across the digital health development pipeline. The session will open with a live demonstration of the thesaurus in action, followed by a panel discussion on language and terminology in digital health.

This session reflects C-Path's broader work to remove the barriers, technical and otherwise, that slow the development and adoption of better evidence. Aligning vocabulary early is a small thing to fix and a hard thing to work around, and it is exactly the kind of bottleneck C-Path exists to solve. It's one more example of how CGIC 2026 goes beyond presenting research to giving drug developers, regulators, researchers and patient advocates tools they can put to use right away.

Register today: https://f.mtr.cool/aueacl5giy

Dive into the world of solutions for Drug Development with C-Path's YouTube channel! Subscribe now for access to on-dema...
08/30/2026

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/uiq3iu1i24

Interested in C-Path updates? Be sure to subscribe at https://f.mtr.cool/3qgn9xqlqy For 20 years, C-Path has been provid...
08/29/2026

Interested in C-Path updates? Be sure to subscribe at https://f.mtr.cool/3qgn9xqlqy 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.

08/29/2026

2026 Clinical Outcome Assessment Program Annual Meeting Recordings are now live on YouTube!

The 2026 Clinical Outcome Assessment Annual Meeting opened with an inspiring welcome from C-Path CEO Klaus Romero and former Vice President of Clinical Outcome Assessments Cheryl C**n, who set the stage for a dynamic and collaborative gathering of global stakeholders.

In their opening remarks, they highlighted the critical role of clinical outcome assessments in advancing patient-focused drug development and underscored the importance of collaboration across industry, regulatory agencies, academia, and patient communities. They emphasized the need to continue innovating and working together to develop fit-for-purpose measures that capture outcomes that matter most to patients.

Their message reinforced a shared commitment to advancing Clinical Outcome Assessment science, fostering meaningful dialogue, and accelerating the development and implementation of tools that support better decision-making throughout the medical product lifecycle.

As the meeting gets underway, attendees are poised to engage in important discussions, share emerging research, and explore new opportunities to advance the science and application of clinical outcome assessments worldwide.

Access the full collection of session recordings here: https://f.mtr.cool/vyl1la08m4

08/29/2026

ICYMI | As precision medicine advances, approaches to benefit–risk must evolve beyond traditional models designed for large, repeatable populations. This webinar brought together patients, families, regulators, and industry to explore how benefit–risk is understood, weighed, and acted on in the context of highly individualized therapies. Through real-world perspectives, panelists examined what outcomes matter most, how risk is navigated under uncertainty, and what it means to make truly informed decisions.

Building on C-Path’s February webinar on transforming drug development for precision medicines, which explored evidence generation, data strategies, and regulatory pathways, this session advances the conversation by centering the patient voice and highlighting the shift toward more coordinated, patient-centered approaches in benefit–risk decision-making.

What We Covered:

- How traditional development models translate to personalized contexts
- Patient and family perspectives on real-world benefit–risk decisions
- How benefit–risk evolves as new therapies become available
- Opportunities for collaboration across patients, regulators, and industry

If you missed it, you can access the recording here: https://f.mtr.cool/7apiw3zhsg

When rare disease data are collected across patient populations, the question that matters most is: how do we maximize t...
08/29/2026

When rare disease data are collected across patient populations, the question that matters most is: how do we maximize the value of such data?

On Sept. 16 at the C-Path Global Impact Conference in Washington, D.C., a session titled "Leveraging Rare Disease Data to Inform Drug Development Tools for Rare Neurodegenerative Diseases" will address exactly that, from theory to regulatory action.

Presenters Alexandre Betourne and Mingyuan Wang, joined by Mark Gordon of Arvinas and Mohamed Hamdani of Larimar Therapeutics, will walk through how C-Path's Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP®) is helping reshape how clinical trials for rare neurodegenerative diseases are designed and measured.

Session highlights include:
• Advanced analytics: An update on a pioneering computational model to optimize trial design for Friedreich’s ataxia, currently under FDA review
• Patient-focused drug development: Analysis of how different versions of the progressive supranuclear palsy rating scale predict survival and track disease progression
• Data sharing and integration: A look at how integrated rare disease datasets can address longstanding challenges in drug development
• Actionable impact: Discussion of how these approaches could extend to rare dementias and similar diseases where gaps in trial design and outcome measurement persist
This is evidence-generation work with direct implications for patients, researchers and regulators alike, and a concrete example of the paradigm shift C-Path is driving across the drug development landscape.

Register today: https://f.mtr.cool/9o3r3o4bsn

Be part of the global conversation shaping the future of drug development. The Critical Path Institute’s Global Impact C...
08/28/2026

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/m306xwztbz

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