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.

Now enrolling! Advance your expertise at the intersection of science, policy, and innovation at the University of Arizon...
06/23/2026

Now enrolling!

Advance your expertise at the intersection of science, policy, and innovation at the University of Arizona.

The Graduate Certificates in Health Law & Policy at the University of Arizona offer professionals the opportunity to deepen their understanding of the legal and regulatory frameworks that shape healthcare and drug development—while earning a recognized credential.

Courses are taught by leading experts, including contributors from Critical Path Institute, bringing real-world perspective to topics like regulatory science, clinical research, and data-driven decision-making.

Whether you’re in industry, research, or policy, these certificates are designed to help you navigate an evolving healthcare landscape and drive meaningful impact.

Learn more and apply: https://f.mtr.cool/prfkygbjbu

06/22/2026

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/zfzcjslhkl

As BIO 2026 approaches, Critical Path Institute is looking forward to connecting with colleagues across industry, academ...
06/22/2026

As BIO 2026 approaches, Critical Path Institute is looking forward to connecting with colleagues across industry, academia, patient advocacy, investment, and regulatory science.

BIO is always a valuable opportunity to listen, learn, and explore where collaboration can help address persistent challenges in drug development.

This year, we’re especially interested in conversations around:
➡️ Strategic partnerships that support shared priorities across the biomedical ecosystem
➡️ Translational therapeutic programs and what they need to move toward IND readiness
➡️ Emerging pathways for advanced therapies, including gene, cell, siRNA, A*O, and individualized medicines
➡️ Collaboration with patient advocacy groups and disease foundations to ensure patient needs remain central
➡️ Regulatory science, evidence generation, and collaborative infrastructure that can help reduce development uncertainty

We’re looking forward to thoughtful conversations in San Diego about how partners across the ecosystem can work together to accelerate therapies for patients with unmet medical needs.

If you’ll be attending BIO 2026, we’d welcome the opportunity to connect through the BIO Partnering App.

ICYMI | What does it mean to dedicate your career to accelerating drug development, while also living with the very dise...
06/21/2026

ICYMI | What does it mean to dedicate your career to accelerating drug development, while also living with the very diseases you're working to fight?

This Critical Path Institute® podcast episode explores exactly that. In this deeply personal and inspiring conversation, C-Path CEO Dr. Klaus Romero sits down with two members of our own team: Hailey Davenport, Type 1 Diabetes Consortium Project Manager, and Alex Diegel, Communications Assistant Director. Hailey lives with Type 1 diabetes (T1D), and Alex was recently diagnosed with IgA nephropathy, a form of chronic kidney disease (CKD). Together, they open up about their diagnoses, the daily challenges of managing chronic conditions, and how their lived experience fuels their work at C-Path.

🔗 Listen & subscribe now:
Apple: https://f.mtr.cool/qsfpjgalpi
Spotify: https://f.mtr.cool/gghqcjsfbb
YouTube: https://f.mtr.cool/dghsltzqxw

06/21/2026

Day 1 of the 27th NIH Tissue Chip Consortium Meeting + CIVM Qualification Framework Public Workshop: An Aging Alveolar Lung Model in Microgravity

Shrike Zhang from Harvard Medical School presented an advanced project focused on developing a physiologically relevant distal lung model, emphasizing the alveolar region rather than the conventional upper airway models. Collaborations with UCLA and Space Tango focus on integrating organoid-derived multiple cell populations, including epithelial, endothelial, and immune cells, into a miniaturized, space-ready platform. The project plans to launch these lung models to the International Space Station for experiments, leveraging automated systems and sensor modules, including oxygen sensing, to monitor function.

Watch the recording here: https://f.mtr.cool/wqgrrkvalv

When rare disease data are collected across patient populations, the question that matters most is: how do we maximize t...
06/21/2026

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.

Early bird pricing closes June 30. Register today and save: https://f.mtr.cool/odusaecbli

Dive into the world of solutions for Drug Development with C-Path's YouTube channel! Subscribe now for access to on-dema...
06/21/2026

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/wbyabazuxb

Interested in C-Path updates? Be sure to subscribe at https://f.mtr.cool/xwsomzbapb For 20 years, C-Path has been provid...
06/20/2026

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

06/20/2026

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

One of the standout discussions at the 2026 COA Annual Meeting explored a critical question: How can we move beyond simply "checking the box" and meaningfully incorporate the patient voice into clinical trial design?

Moderated by Nicki Bush (OPEN Health), the session brought together experts from industry, regulatory agencies, and patient advocacy organizations, including representatives from Sanofi, Takeda, the U.S. Food and Drug Administration, Italfarmaco, the International Rare Disease Research Consortium, and the International Rett Syndrome Foundation.

Panelists shared insights on how patient engagement can strengthen patient-focused medical product development, improve clinical research practices, and help ensure that studies are designed around outcomes that matter most to patients. The discussion highlighted both strategic and practical approaches for engaging patients throughout the clinical development process, as well as regulatory perspectives on integrating patient input into trial design.

A key theme throughout the session was that meaningful patient engagement requires ongoing collaboration among sponsors, regulators, researchers, and patient communities not as a one-time activity, but as a foundational component of clinical development.

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

06/20/2026

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/ghfztifvps

Address

1840 E River Road Ste 100
Tucson, AZ
85718

Opening Hours

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

Website

Alerts

Be the first to know and let us send you an email when Critical Path Institute posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Shortcuts

Share