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.

Be part of the global conversation shaping the future of drug development.  The Critical Path Institute’s Global Impact ...
04/20/2026

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.

Register now during early-bird pricing: https://f.mtr.cool/nsastjakob

Now Available on Demand! Catch up on every moment of the 2025 C-Path Global Impact Conference! All sessions are now stre...
04/19/2026

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 panel from Critical Path Institute’s (C-Path) Global Impact Conference 2025 (CGIC), is led by C-Path Vice President, Global Affairs, Cécile Ollivier, FDA Director Lynne Yao, Johnson & Johnson Senior Director of Child Health Innovation and Leadership Sumati Nambiar, and Hôpital Necker-Enfants Malades Professor, Guillaume Canaud. This discussion focused on advancing pediatric drug development, particularly in the context of rare diseases, through enhanced collaboration among regulators, industry, healthcare professionals, and patient communities.

The speakers emphasized the complexities and unique challenges in pediatric therapeutics, including the need for global regulatory alignment, leveraging public-private partnerships (PPPs), and improving evidence generation and data sharing. Key themes included the importance of viewing pediatric drug development as a lifelong process impacting children into adulthood, the critical role of innovative regulatory science and tools, and the need for education and engagement of all stakeholders including physicians, legal experts, investors, and people living with unmet medical needs, worldwide.

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

C-Path's Global Impact Conference 2025: Future of Public-Private Partnerships in Peds/Rare Diseases

Be part of the global conversation shaping the future of drug development.  The Critical Path Institute’s Global Impact ...
04/19/2026

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.

Register now during early-bird pricing: https://f.mtr.cool/jkoqtphzwo

Dive into the world of solutions for Drug Development with C-Path's YouTube channel! Subscribe now for access to on-dema...
04/19/2026

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/yigplucvug

Now enrolling! Advance your expertise at the intersection of science, policy, and innovation at the University of Arizon...
04/18/2026

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/eihhrfbywx

C-Path's Rare/Orphan and Pediatric Disease Programs hosted a special webinar showcasing six years of achievements from t...
04/18/2026

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/vwebmnqyyc

Interested in C-Path updates? Be sure to subscribe at https://f.mtr.cool/iaqyjlpdhy For 20 years, C-Path has been provid...
04/18/2026

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

04/17/2026

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/sqlnrgcrxj

Be part of the global conversation shaping the future of drug development.  The Critical Path Institute’s Global Impact ...
04/17/2026

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.

Register now during early-bird pricing: https://f.mtr.cool/vdvzkrsjps

Now Available on Demand! Catch up on every moment of the 2025 C-Path Global Impact Conference! All sessions are now stre...
04/16/2026

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 is led by moderator Terina Martinez, C-Path's Executive Director C-Path's Rare Neurodegenerative Diseases (CP-RND) Consortium, FDA Associate Director, Office of Therapeutic Products Gumei Liu, CortexBio Founder & CEO Dima Martini-Drew and CND Life Sciences CMO Todd Levine. The panel dives into the complexities and advancements in mechanism-based drug development, particularly for rare pediatric and adult neurological diseases. The conversation emphasizes the importance of understanding disease biology to guide rational drug design and clinical trials, moving beyond trial-and-error approaches. Panelists representing diverse perspectives—including clinicians, researchers, regulators, and patient advocates—highlight the critical role of diagnostics, biomarkers, and patient engagement in developing effective therapies.

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

1 like. "C-Path's Global Impact Conference 2025 : Mechanism-based Drug Development in Rare/Orphan Diseases"

Now enrolling! Advance your expertise at the intersection of science, policy, and innovation at the University of Arizon...
04/16/2026

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/qxssfilvdd

Be part of the global conversation shaping the future of drug development.  The Critical Path Institute’s Global Impact ...
04/15/2026

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.

Register now during early-bird pricing: https://f.mtr.cool/qxxyjdxggd

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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

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