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.

Critical Path for Rare Neurodegenerative Diseases will host a virtual public research update on Friday, June 5, from 9am...
06/02/2026

Critical Path for Rare Neurodegenerative Diseases will host a virtual public research update on Friday, June 5, from 9am – 12pm ET.

Critical Path Institute's Critical Path for Rare Neurodegenerative Diseases consortium, will convene partners from the U.S. Food and Drug Administration, National Institutes of Health, Foundation for the National Institutes of Health, and the amyotrophic lateral sclerosis lived experience community to discuss progress under the public-private partnerships established under the Accelerating Access to Critical Therapies for ALS Act. Additional details will be posted as they are confirmed.

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

06/01/2026

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/jmicjlvppy

Be part of the global conversation shaping the future of drug development. The Critical Path Institute’s Global Impact C...
06/01/2026

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/ydskcfxynu

As BIO 2026 approaches, Critical Path Institute is looking forward to connecting with colleagues across industry, academ...
06/01/2026

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...
05/31/2026

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/nvjdgegigk
Spotify: https://f.mtr.cool/lnykbywqjs
YouTube: https://f.mtr.cool/xyavunydmf

05/31/2026

Day 1 of the 27th NIH Tissue Chip Consortium Meeting + CIVM Qualification Framework Public Workshop:

The presentation introduces the Center for the Advancement of Science in Space (CASIS), a non-profit organization that manages research projects aboard the International Space Station (ISS) National Laboratory. CASIS’s mission is to support U.S.-based researchers and companies by leveraging the unique microgravity environment of space to accelerate drug development and enhance translational science. The ISS has been continuously inhabited since 2000 and designated as a National Lab by Congress in 2005. CASIS has managed the allocation of research resources on the ISS since 2011, fostering collaborations among principal investigators, platform developers, and commercial service providers to improve microphysiological systems (MPS) and tissue chips. These systems are used to model human diseases and biological processes under microgravity, offering novel insights into aging and disease progression.

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

Critical Path for Rare Neurodegenerative Diseases will host a virtual public research update on Friday, June 5, from 9am...
05/31/2026

Critical Path for Rare Neurodegenerative Diseases will host a virtual public research update on Friday, June 5, from 9am – 12pm ET.

Critical Path Institute's Critical Path for Rare Neurodegenerative Diseases consortium, will convene partners from the U.S. Food and Drug Administration, National Institutes of Health, Foundation for the National Institutes of Health, and the amyotrophic lateral sclerosis lived experience community to discuss progress under the public-private partnerships established under the Accelerating Access to Critical Therapies for ALS Act. Additional details will be posted as they are confirmed.

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

At Critical Path Institute, collaboration, innovation, and sustainability aren't conference themes, they're how we work ...
05/31/2026

At Critical Path Institute, collaboration, innovation, and sustainability aren't conference themes, they're how we work every day.

Through global public-private partnerships, we bring together industry, regulators, academia, and patient communities to accelerate the development of safe and effective therapies. From advancing regulatory science and data standards to developing tools that improve clinical trial design and decision-making, C-Path's work reflects the same principles driving dialogue at DIA 2026 collaboration that leads to real impact for patients.

Looking forward to engaging with partners at and continuing to move drug development forward, together. Don't miss the opportunity to connect with us at our posters and featured session:
1. Tuesday, June 16 | 111AB | 4:15 PM ET | SESSION "Operationalizing Large Language Models in Drug Development"
2. Wednesday, June 17 | 11:30 AM | POSTER "Glutamate Dehydrogenase (GLDH) as a Safety Biomarker: Applying a Regulatory Science Framework for Drug Development Tools"
3. Wednesday, June 17 | 11:30 AM | POSTER "Privacy-Preserving Federated Analysis Enables International Rare Disease Evidence Generation"

Be part of the global conversation shaping the future of drug development. The Critical Path Institute’s Global Impact C...
05/31/2026

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/lnmfgdejyf

Dive into the world of solutions for Drug Development with C-Path's YouTube channel! Subscribe now for access to on-dema...
05/31/2026

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/vauocmzgwa

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