Critical Path Institute (C-Path)

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://lnkd.in/gRRfJhwq   #CPath20Years #DrugDevelopment #GlobalHealth #Collaboration #DataSharing #YouTube #Webinars #Interviews

Interested in C-Path updates? Be sure to subscribe at https://lnkd.in/gvUcJDg5 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. #CPath #drugdevelopment #neutral #datasharing #globalhealth #collaboration #regulatoryscience

SAVE THE DATE | We are thrilled to invite you to the 2025 Critical Path Institute Global Impact Conference (CGIC), scheduled for September 9-11, in downtown D.C. at the Washington Marriott at Metro Center. This can’t-miss event will build upon the monumental success of CGIC 2024 and provide a unique opportunity to connect the dots across key initiatives dedicated to accelerating drug development for conditions in neurology, rare diseases, pediatrics, and more. This year’s event takes on special meaning, as C-Path celebrates 20 years of impact. Be sure to join us to discover how C-Path can assist you in addressing challenges in drug development.  Engage with colleagues and advocates from diverse sectors, including industry, regulatory agencies, academia, patient organizations, and our vibrant community of those with living experiences. CGIC 2025 promises a dynamic agenda, bringing together a multitude of voices and perspectives to foster collaboration and open dialogue. Stay tuned for forthcoming communications, including the full conference agenda, featured speakers, and more. Your participation is key to making this event a resounding success! Date: September 9-11, 2025 Location: Washington Marriott at Metro Center, Washington, D.C. Registration: Coming soon, with Early Bird pricing! We look forward to seeing you there! #CPath20Years #Collaboration #DrugDevelopment #DataSharing #GlobalHealth #CGIC

Watch the interviews from the 2024 C-Path Global Impact Conference on our YouTube!  Maaike Everts, Executive Director of the Translational Therapeutics Accelerator program at C-Path, speaks about TRxA. TRxA is a pioneering initiative under the Critical Path Institute aimed at bridging the gap between basic research and clinical drug development. Established to support academic drug discovery scientists, TRxA provides both funding and expertise to navigate the challenging phases of drug development, often referred to as the “Valley of Death.”  Listen to this interview here: https://lnkd.in/g47J2EH8 Save the date for CGIC 2025 which will take place September 9-11, in downtown D.C. at the Washington Marriott at Metro Center.  #CPath20Years #CGIC #DrugDevelopment #GlobalHealth #Collaboration #DataSharing #TRxA

The future of drug development is shifting—away from traditional models and toward approaches that can accelerate timelines, reduce costs, and improve patient outcomes.   C-Path CEO Dr. Klaus Romero contributed to this compelling article, Beyond Animals: Revolutionizing Drug Discovery with Human-Relevant Models, alongside experts from Wyss Institute at Harvard University, Revalia Bio, and industry leaders. The piece explores how cutting-edge in-vitro and computational models are transforming preclinical research, with real-world examples of regulatory progress, such as the FDA's first-ever acceptance of an organ-on-a-chip technology for drug development.   At C-Path, we work at the forefront of these advancements, collaborating with regulators, academia, and industry to pave the way for innovative, patient-focused methodologies in drug discovery. Special thanks to co-contributors and thought partners in this effort: Milad Alucozai, Abi Kulshreshtha, and Megan Sperry. We're grateful for your insights, expertise, and the shared vision that brought this piece to life.   Read the full article below and see how the landscape is evolving. #CPath20Years #Collaboration #DrugDevelopment #GloablHealth #DataSharing #RegSci

New Publication Alert: A Tutorial and Use Case Example of the eXtreme Gradient Boosting (XGBoost) Artificial Intelligence Algorithm for Drug Development Applications is available on American Society for Clinical Pharmacology & Therapeutics. Artificial Intelligence is revolutionizing drug development, and XGBoost stands out as one of the most powerful machine-learning algorithms for predictive modeling. In this tutorial and use case example, the authors demonstrate how XGBoost can be applied to optimize drug discovery, streamline clinical research, and enhance decision-making in pharmaceutical development. Key Highlights: ✅ Step-by-step tutorial on XGBoost implementation ✅ Real-world use case in drug development ✅ Practical insights for data-driven decision-making Read more here: https://lnkd.in/dMuTS-_Y Nick Henscheid, Jagdeep Podichetty, PhD #CPath20Years #DrugDevelopment #XGBoost #AI #Collaboration #DataSharing #GlobalHealth

#ParkinsonsAwarenessMonth | Critical Path Institute’s Diane Stephenson, Ph.D., Vice President of Neurology, and Executive Director of its Critical Path for Parkinson’s Consortium recently appeared on the The Xtalks Life Science Podcast. Hosted by Ayesha Rashid and joined by Digital Medicine Society (DiMe) Research Lead Sarah Averill Lott, MPH, CPH, this episode discusses the collaboration between DiME and C-Path in advancing research and care in neurodegenerative disorders such as Alzheimer’s and Parkinson’s diseases. The conversation highlights how these organizations work together to create resources that allow for better utilization of digital measures in clinical trials, aiming for improved patient outcomes. Key issues addressed include the barriers to adopting digital health tools, the importance of early intervention, and the potential for improved patient empowerment through technology. Both speakers emphasize the need for public-private partnerships and collaborative efforts across various stakeholders to overcome challenges facing Alzheimer’s and Parkinson’s research. You can watch the episode on Xtalks’ YouTube page, or on the Xtalks blog: https://lnkd.in/e4cpGi8b #CPath20Years #Collaboration #DrugDevelopment #ParkinsonsResearch #AlzheimersResearch #DataSharing #GlobalHealth #DHT

Exciting News! C-Path has launched The Critical Path Institute Podcast! 🎙️ This isn't just another podcast—it’s a front-row seat to the groundbreaking work shaping drug development, clinical science and public health. Hosted by C-Path CEO Dr. Klaus Romero, each episode will bring expert insights, real-world impact stories, and a deep dive into the innovations that drive patient-centered solutions. What you’ll gain: ▪️ Insider knowledge on regulatory science & drug development ▪️ Expert perspectives on transforming healthcare ▪️ A deeper understanding of collaborative innovation 🔗 Listen & subscribe now: Podbean: https://lnkd.in/g4Mbpdeq Apple: https://lnkd.in/gPhcjGqP Spotify: https://lnkd.in/gCAaiKnJ YouTube: https://lnkd.in/gtTjrZ8S Join us on this journey—because when we connect the dots, we accelerate change. #CPath20Years #CPathPodcast #DrugDevelopment #DataSharing #HealthcareInnovation #Collaboration #globalhealth

April is #ParkinsonsAwarenessMonth, and Critical Path Institute honors the millions of people worldwide living with Parkinson’s Disease. We also recognize the dedication of researchers, clinicians, and advocates working to advance urgently needed treatments. This week, C-Path’s Diane Stephenson, VP of Neurology and Executive Director of the Critical Path for Parkinson’s consortium, will present “Regulatory letter of support for the application of CSF α-synuclein seeding assay for use in clinical trials focused on early intervention” at the AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases. This poster represents a global, pre-competitive effort undertaken by CPP's Biofluid Biomarker Work Group to advance a novel biomarker for the sensitive detection of misfolded alpha-synuclein in biofluids for use in PD in clinical trials. In August 2024, the FDA issued a Letter of Support for use of α-syn SAA in CSF in clinical trials, bringing researchers closer to targeted solutions for PD. The FDA letter of support is aimed to encourage the use of promising biomarkers, and the new PD letter of support follows 10 others across many disease areas led by C-Path consortia. Because the tool can objectively detect early biology related to Parkinson’s and related diseases, including dementia with Lewy bodies, even before any symptoms emerge, trials using the biomarker are better positioned to identify participants with relevant biology and test therapies that aim to delay or even prevent the onset of disease. The use of the tool also enables research toward tailored therapies to treat individuals at all stages of these diseases. By supporting the development of tools to improve early intervention, we move closer to transforming the landscape of Parkinson’s research and treatment. Read the press release here: https://lnkd.in/e5VrHS8D Learn more about the CPP consortium, here: c-path.org/CPP #CPath20Years #Collaboration #DataSharing #GlobalHealth #DrugDevelopment #ParkinsonsDisease #AlzheimersDisease #PDResearch

THIS WEEK: The #ADPD2025 meeting will highlight the efforts of Critical Path Institute’s Alzheimer’s consortium in a plenary session entitled: Assessing Pathological Tau in AD: From Disease Biomarker to Reasonably likely Surrogate Endpoint?    Diane Stephenson, VP of Neurology at C-Path will participate in a session chaired by Reisa Sperling aimed at reviewing the remarkable progress emerging in TauPET neuroimaging methodologies and the role of CPAD in advancing harmonized methodologies. The role of collaboration, data sharing and regulatory science will be key themes in advancing the use of TauPET  to optimize decision making in AD drug development. C-Path's CPP and CPAD team will be on-site at ADPD2025. CPP and CPAD will be presenting these posters on April 4 & 5:  CPAD (Poster #264): "Reviewing Scientific and Regulatory Aspects of Tau PET Implementation as a Surrogate Endpoint in Alzheimer's Disease Clinical Studies"  CPP (Poster #957): "Regulatory letter of support for the application of CSF a-synuclein seeding assay for use in clinical trials focused on early intervention" Learn more about CPAD here: c-path.org/CPAD Learn more about CPP here: c.path.org/CPP #CPath20Years #Collaboration #Biomarkers #Alzheimers #GlobalHealth #DataSharing #DrugDevelopment