Critical Path Institute

02/26/2026

As clinical research evolves, so too must the tools we use to measure outcomes—particularly in neuromuscular disease studies, where patient burden and accessibility remain critical considerations.

Join us for an upcoming webinar, “Meeting Patients Where They Are: Validating Remote Digital Tools for Multi-Indication NMD Research,” featuring Dr. Tina Duong and a panel of experts across industry and regulatory science.

In this session, Dr. Duong will explore the scientific, clinical, and regulatory considerations involved in validating video-based assessments and other digital tools across multiple NMD indications. Through both presentation and panel discussion, attendees will gain insights into how these approaches can:
- Enhance accessibility for patients regardless of location
- Reduce the burden of participation in clinical trials
- Generate reliable, regulatory-grade data
- Ensure innovation remains grounded in patient-centered research

This webinar is designed for stakeholders across drug development, clinical research, regulatory science, and patient advocacy who are committed to advancing more inclusive and effective clinical trials.

Register now to secure your spot and be part of the conversation shaping the future of NMD research: https://f.mtr.cool/xbqdjedeox

02/26/2026

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/cfinrbwawr

02/25/2026

The Critical Path Institute team is pleased to invite you to an upcoming webinar on Wednesday, February 25, at Noon Eastern that brings 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. This “Transforming Drug Development for Precision Medicines” webinar will highlight how precision medicine continues to evolve, this conversation will explore shared challenges and opportunities in creating more predictable, aligned pathways from development through reimbursement.

This expert-led discussion will explore how to bridge evidence generation, regulatory expectations, and payer considerations to create a more seamless path from discovery to patient access.
Featuring insights from:
Kate Dawson, Biogen
Allison Martin, Sanofi
Dan Swerdlow, GSK
Julia Vitarello, EveryONE Medicines

Register now to learn how collaboration across industry and innovation leaders can accelerate precision therapies to the patients who need them most.

Register now: https://f.mtr.cool/drybksxgbj

02/24/2026

The Critical Path Institute team is pleased to invite you to an upcoming webinar on Wednesday, February 25, at Noon Eastern that brings 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. This “Transforming Drug Development for Precision Medicines” webinar will highlight how precision medicine continues to evolve, this conversation will explore shared challenges and opportunities in creating more predictable, aligned pathways from development through reimbursement.

This expert-led discussion will explore how to bridge evidence generation, regulatory expectations, and payer considerations to create a more seamless path from discovery to patient access.
Featuring insights from:
Kate Dawson, Biogen
Allison Martin, Sanofi
Dan Swerdlow, GSK
Julia Vitarello, EveryONE Medicines

Register now to learn how collaboration across industry and innovation leaders can accelerate precision therapies to the patients who need them most.

Register now: https://f.mtr.cool/sdudtaoqfz

02/23/2026

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 engaging discussion from Critical Path Institute’s (C-Path) Global Impact Conference (CGIC) 2025 centers on the modernization of the evidence generation enterprise in drug development, emphasizing the importance of collaboration among regulators, industry, academia, and patient advocacy groups. The panel is led by C-Path CEO Klaus Romero, Revalia Bio Co-Founder and CEO Greg Tietjen, Harvard Business School’s Amitabh Chandra, Takeda Pharmaceuticals Executive Director LaShell Robinson, EMA Head of Regulatory Science and Academia Ralf Herold, and FDA Director Tersea Buracchio.

The session highlights the challenges in neurology drug approvals, noting the need to integrate diverse data types beyond clinical trials—such as biomarkers and model-informed drug development tools—to build a compelling scientific story supporting drug efficacy. The conversation includes the transformative impact of public-private partnerships (PPPs) in closing regulatory gaps, improving clinical trial design, and advancing regulatory science on a global scale. These partnerships enhance the visibility and adoption of drug development tools, which often go unrecognized despite their broad utility.

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

This engaging discussion from Critical Path Institute’s Global Impact Conference (CGIC) 2025 centers on the modernization of the evidence generation enterpri...

02/23/2026

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/qablpiayqe

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.

02/22/2026

Critical Path Institute and the PKD Foundation hosted a webinar to discuss C-Path's Translational Therapeutics Accelerator (TRxA) BRIDGe awards, which provide funding for academic researchers developing new therapeutics.

The Accelerator's Executive Director, Maaike Everts, explained the program's focus on advancing therapeutics in the areas of brain health, pediatrics, and rare and orphan diseases, with a new dedicated track for polycystic kidney disease (PKD) in collaboration with the PKD Foundation.

The webinar detailed the eligibility criteria, funding levels, and the application process for program grants, emphasizing the importance of interdisciplinary teams and clear target product profiles. The session concluded with a Q&A.

Watch the recording now: https://f.mtr.cool/mhhrdnkgdn

02/22/2026

The Critical Path Institute team is pleased to invite you to an upcoming webinar on Wednesday, February 25, at Noon Eastern that brings 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. This “Transforming Drug Development for Precision Medicines” webinar will highlight how precision medicine continues to evolve, this conversation will explore shared challenges and opportunities in creating more predictable, aligned pathways from development through reimbursement.

This expert-led discussion will explore how to bridge evidence generation, regulatory expectations, and payer considerations to create a more seamless path from discovery to patient access.
Featuring insights from:
Kate Dawson, Biogen
Allison Martin, Sanofi
Dan Swerdlow, GSK
Julia Vitarello, EveryONE Medicines

Register now to learn how collaboration across industry and innovation leaders can accelerate precision therapies to the patients who need them most.

Register now: https://f.mtr.cool/qhypwxzoll

02/22/2026

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/tcqleozabl

02/21/2026

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/hsakafoyen

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.

02/21/2026

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

02/21/2026

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

Session 4: Implementation Insights in Rare Disease Clinical Outcome Assessment featured Lindsey Murray, PhD, MPH — Executive Director of the Rare Disease Clinical Outcome Assessment Consortium at Critical Path Institute.

This dynamic panel discussion examined the challenges, key insights, and emerging best practices for implementing COAs in rare disease clinical trials, with a special emphasis on pediatric studies and gene therapy applications.

Panelists included:
Kayci Capps, MEd – Dravet Patient Advocate, Dravet Syndrome Foundation
Lisa Dilworth, BS, MAS – Vice President, Disease Monitoring Program Strategy and Management, Ultragenyx
Diana Rofail, PhD, CPsychol, MBA – Global Head of Patient-Centered Outcomes Research & Digital Health (PCOR-DH), Regeneron
R.J. Wirth, PhD – CEO & Managing Partner, Vector Psychometric Group, LLC

Learn more about our COA program here: https://f.mtr.cool/mpfpjkflyc