Critical Path Institute

Critical Path Institute

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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

06/08/2026

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/ucqsygzkmc

Photos from Critical Path Institute's post 06/08/2026

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.

06/08/2026

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/ypojgnbsop

06/07/2026

ICYMI | The Critical Path Institute Podcast: Connecting the Dots in Rare and Pediatric Disease

In this episode of the Critical Path Institute© Podcast, C-Path Vice President of Rare/Orphan and Pediatric Disease Programs Collin Hovinga, joins host and CEO Klaus Romero to discuss the current landscape of rare diseases, the unique challenges and opportunities they present, and how C-Path is uniquely positioned to accelerate drug development for these conditions. This podcast highlights how rare diseases collectively represent a vast and complex group with about 10,000 known rare conditions and numerous subtypes. These differences present challenges, but also opportunities due to shared underlying disease mechanisms.

C-Path’s approach to advancing drug development centers on collaboration among regulators, industry, patient advocacy groups, and researchers, ensuring that patient voices are integral to drug development. A key resource in this ecosystem is the Rare Disease Cures Accelerator-Data and Analytics Platform, a hub that aggregates, standardizes, and curates' diverse data sources such as registries, clinical trials, and natural history studies. The platform enables data reuse to avoid redundant research, supports innovative clinical trial designs, and facilitates regulatory decision-making by providing tools such as trial simulations and alternative control models.

🔗 Listen & subscribe now:
Apple: https://f.mtr.cool/siqcyjnymn
Spotify: https://f.mtr.cool/pgmrmemjml
YouTube: https://f.mtr.cool/vhwambucem

06/07/2026

Day 1 of the 27th NIH Tissue Chip Consortium Meeting + CIVM Qualification Framework Public Workshop: Brain-muscle microphysiological system enabled extracellular vesicle network for understanding aging in space

This presentation, delivered by Mei He from the University of Florida and Dr. Luke Lee, focuses on a cutting-edge multidisciplinary project investigating the role of extracellular vesicles (EVs) and microphysiological systems (MPS) in understanding brain and muscle physiology, particularly under microgravity conditions. The collaboration includes expertise in spaceflight hardware compatibility, regenerative medicine, and molecular analysis, positioning this initiative at the forefront of space biology and translational medicine.

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

Photos from Critical Path Institute's post 06/07/2026

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"

06/07/2026

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/fjvomcowkm

06/07/2026

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/ptayoevfof

06/06/2026

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

06/06/2026

Day 1 of the 27th NIH Tissue Chip Consortium Meeting + CIVM Qualification Framework Public Workshop: Assessing Effects of Microgravity on Cardiovascular Aging with AI and 3D Organoids

Joseph Wu from Stanford presented his collaborative project that addresses critical spaceflight health hazards, with a particular focus on microgravity’s impact on cardiovascular physiology, inflammation, and accelerated aging. Three case studies are discussed that demonstrate the pipeline from molecular insights to clinical trials.

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

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Location

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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