Critical Path Institute

04/11/2026

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/oqmjidcxmy

04/11/2026

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/iefsotgmjj

04/11/2026

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

04/10/2026

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/lqhwykyfns

04/10/2026

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/aylmiyiaaw

04/09/2026

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.

In this session from Critical Path Institute’s Global Impact Conference PreemieWorld Foundation Executive Director Deb Discenza shares her raw, emotional story of her daughter Beck’s premature birth and the challenges of fragmented neonatal care. She is joined by moderator Kanwaljit Singh, Executive Director of C-Path's International Neonatal Consortium, Board Member and NICU Advocate, GLO Preemies Christina Gagnon, It’s a NICU World! Patient Advocate Ashley O’Neil, FDA Director Lynne Yao, and Hope for HIE Executive Director Betsy Pilon.

Kanwaljit explained the “therapeutic orphans” status of neonates due to decades of off-label drug use without approved neonatal medications, while Betsy recounted her son Max’s HIE diagnosis, emergency hypothermia treatment, and her advocacy work to advance HIE drug development.

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

In this session from Critical Path Institute’s (C-Path) Global Impact Conference (CGIC) PreemieWorld Foundation Executive Director Deb Discenza shares her ra...

04/09/2026

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/hgswyaxmtu

04/08/2026

We are pleased to invite you to register now for Critical Path Institute's 2026 Clinical Outcome Assessment Program Annual Meeting, taking place April 16–17, 2026, at the Washington Marriott at Metro Center in Washington, D.C.

This year’s meeting will once again bring together leaders from across industry, regulatory agencies, academia, patient organizations, and technology and allied service partners to advance the science and application of COAs in medical product development. Building on the strong engagement and momentum from last year, the 2026 program will feature deep-dive sessions, case studies, and multi-stakeholder discussions on pressing issues in the field, including:
- Using patient experience data to inform value assessment for access decision making
- Pulling back the curtain: Multi-stakeholder insights on electronic clinical outcome assessment implementation
- Incorporating the patient voice into clinical trial design: More than just checking the box
- From meaningful aspect of health to metric to endpoint: How multidisciplinary teams form a comprehensive approach to digitally-derived endpoints
- Revisiting meaningful change: Current thinking on establishing and applying benchmarks
- Addressing challenges in rare disease clinical trials: Methodological case studies

Register Now: https://f.mtr.cool/dlecsevrqm

We look forward to sharing a more detailed agenda as it becomes available and welcoming you in April for another engaging and collaborative Annual Meeting.

04/08/2026

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/fkjnubieul

04/07/2026

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/xjqejucqxq

04/06/2026

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/pwhymytpjb

04/06/2026

As precision medicine continues to evolve, so too must the frameworks we use to evaluate benefit–risk, especially for patients facing severe, rare conditions with limited or no treatment options.

Join us on April 8 at noon (Eastern) for a timely and important discussion: Scalable Approaches to Patient-Centered Benefit–Risk: Defining Patient-Focused Drug Development in Precision Medicine

This session will feature patients and families sharing real-world experiences that are shaping how benefit–risk is understood in the context of individualized medicines. Their perspectives will provide critical insight into how decisions are made when stakes are high and options are limited.

Together, we will explore:
- 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
- As traditional population-based models are increasingly challenged, this conversation will highlight how incorporating patient experience can help inform more responsive and scalable approaches to drug development.

Register now to be part of this important discussion: https://f.mtr.cool/lwuvbcosrt