Critical Path Institute

12/20/2025

In 2025, C-Path proudly celebrates 20 years of impact. Take a look back at the highlights and the incredible individuals who made it all possible. Here's to the next chapter of innovation!

For the past 20 years, Critical Path Institute has led collaborations that accelerate drug development and advance better treatments for people worldwide. C-Path orchestrates the development of these actionable solutions through an innovative, collaborative approach to the sharing of data and expertise. C-Path builds consensus among participating scientists from industry and academia with regulatory participation and iterative feedback. Such consensus provides the mechanism to generate the necessary confidence to assure the adoption of the medical product development solutions by sponsors and regulators. Examples of pathways through which this confidence is achieved include informal and formal regulatory pathways. Through these various mechanisms, sponsors can confidently adopt the solutions generated through C-Path’s collaborative approach, thus ensuring the continuous optimization of the medical product development process.

Check out our 20 milestones for 20 Years here: https://f.mtr.cool/zhpoibbecn

12/20/2025

Relive the best moments of the 2025 C-Path Clinical Outcomes Assessment Program Annual Meeting.

C-Path's Cheryl C**n closed the COA Annual Meeting with a heartfelt address, underscoring the importance of integrating the patient voice into drug development. She expressed sincere gratitude to all attendees for their engagement and contributions, highlighting the renewed energy and shared commitment that resonated throughout the event.

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

12/20/2025

Our 20th anniversary is not only a moment to reflect; it is a call to action.

For two decades, C-Path has served as a neutral, trusted convener, helping accelerate drug development through collaboration and innovation in regulatory science. As the complexity of diseases grows and patient needs evolve, this role has never been more critical.

As part of our anniversary year, we invite you to consider a year-end gift to support C-Path’s mission. Your contribution helps:
• Support precompetitive collaboration across global stakeholders
• Advance innovative drug development tools and data platforms
• Ensure patient perspectives remain central to scientific drug development and regulatory decision-making
• Build the foundation for the next generation of regulatory science

Every gift, large or small, helps strengthen our ability to deliver impact where it matters most: to people with unmet medical needs.

Donate now: https://f.mtr.cool/mlwsqnoyhu

12/19/2025

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.

The panel discussion from Critical Path Institute’s (C-Path) Global Impact Conference (CGIC) 2025 is led by C-Path Vice President of Rare/Orphan and Pediatric Diseases Collin Hovinga, who is joined by FDA Associate Director for Pediatrics Najat Bouchkouj, Novartis Pediatric Center of Excellence’s Ki Lee Milligan, Director for Clinical Research and Development at NCCHD Hidefumi Nakamura, Eli Lilly Senior Research Advisor Mary Short, Solid Bioscience Head of Clinical Science Patrick Gonzalez. The conversation centers on the development, regulatory considerations, and clinical trial design of pediatric gene therapies, with a focus on cell and gene therapy approval processes, patient inclusion, and long-term follow-up.

The session highlights the complexities and challenges in bringing gene therapies to pediatric populations, emphasizing the importance of early patient inclusion, collaboration across stakeholders, and innovative trial designs.

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

The panel discussion from Critical Path Institute’s (C-Path) Global Impact Conference (CGIC) 2025 is led by C-Path Vice President of Rare/Orphan and Pediatri...

12/19/2025

On Demand Now! C-Path's TRxA unveiled the 2025 global Request for Proposals (RFP) webinar. This year, TRxA has merged its efforts to support both biologics and small molecule therapeutics under a single, unified RFP.

This webinar covered:
🔺An overview of the new combined RFP, encompassing both large and small molecules;

🔺Detailed information about the types of projects eligible for funding, including those for novel protein-based therapeutics, gene-based therapies and small molecule lead optimization, through IND-enabling studies;

🔺Eligibility criteria and application procedures for this funding opportunity;

🔺Insights into how TRxA supports projects through the drug development valley of death to enhance licensing prospects.

The session included a live Q&A to address questions and provided further clarity on how to make the most of this unique opportunity. Don't miss this chance to learn how TRxA’s 2025 RFP can support your innovative research and propel it towards impactful therapeutic solutions.

Watch here: https://f.mtr.cool/tufpzfwptb

12/18/2025

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/bkqctqfllz

12/16/2025

Celebrating 20 Years of the Critical Path Institute: Accelerating Drug Development and Advancing Better Treatments for People Worldwide. This year marks a special milestone for C-Path- 20 years of growth, innovation, and an unwavering commitment to our mission. As we celebrate this journey, we reflect on the moments, people, and breakthroughs that have shaped our of success.

2024: C-Path hosts inaugural Global Impact Conference, receives $1.5M Niemann-Pick grant, unveils effort in imaging method, makes Duchenne trial simulator widely available, and receives landmark funding to convene the Global Evidence in Medicines for Parkinson’s Disease initiative.

Your donation today will inspire hope and advance C-Path’s life-changing efforts to accelerate drug development. Help transform the next generation of medical breakthroughs with your contribution. Support C-Path today!

Keep Us going for 20 more by donating to C-Path: https://f.mtr.cool/cmaiurdpcz

12/15/2025

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/tamnnecjmg

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

12/14/2025

C-Path's International Neonatal Consortium invites you to contribute to an important project led by its Real-World Data/Real-World Evidence Workgroup.

The workgroup is dedicated to advancing the development of cell & gene therapies for neonates and infants. Insights gathered through this survey will contribute to a publication aimed at identifying and characterizing registries that include infants and children under the age of 24 months.

The survey should take approximately 10 minutes to complete. Participation is voluntary, and no compensation is provided. Completion of this survey implies consent for us to retain and use your responses. Your input is invaluable in shaping the future of neonatal Cell & Gene Therapy research. Thank you!

Take the survey now: https://f.mtr.cool/utzkntrowm

12/14/2025

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/fkhzwbgoci

12/13/2025

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

12/13/2025

Happy 20th Anniversary, C-Path! 🎉

Join us in celebrating two decades of innovation, collaboration, and impact! In this special video, C-Path staff, friends, and stakeholders from around the world share their heartfelt congratulations and reflections on 20 years of advancing drug development TOGETHER.