Critical Path Institute (C-Path)

Have questions about what therapeutic areas C-Path’s collaborations cover? Whether you’re curious about how we collaborate with stakeholders, or how we’re accelerating the development of new treatments, our FAQs section is a valuable resource designed to give you the insights you need. Have a question we haven’t answered yet? Don’t hesitate to reach out—we’re always here to help and provide guidance. You can find more questions and answers on C-Path's website under FAQS: c-path.org/faqs.  #C-Path #FAQs #DrugDevelopment

On Day 2 of C-Path's inaugural #CGIC2024, Former NFL player and ALS patient advocate, Steve Gleason, addressed attendees at the C-Path Global Impact Conference.  Gleason emphasizes the urgency for innovative treatments for ALS and the importance of collaboration among patients, researchers, and regulators. Watch now: https://lnkd.in/gh8NGUuZ #CPath #ALS #ALSAdvocacy #SteveGleason

Interested in C-Path updates? Be sure to subscribe at https://lnkd.in/gWYZwMkk 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

Join us for an insightful panel discussion moderated by Diane Stephenson, Executive Director of the Critical Path for Parkinson's Consortium at C-Path's #CGIC2024. This engaging session delves into how we can adopt a drug development mindset to better characterize conditions, fostering a holistic approach that balances scientific progress with patient welfare. Don't miss out on this opportunity to gain valuable insights from leading experts in the field. 🔗 Watch Now: https://lnkd.in/gtTN3a7R #CPath #Parkinsons #CPP #DrugDevelopment #Innovation #Healthcare #PatientCare

📢 The FDA is hosting a Patient-Focused Drug Development workshop to explore methodological and other challenges related to patient experience data, tomorrow, Dec. 13. C-Path is proud to share that Cheryl Coon, Vice President of our Clinical Outcome Assessment Program, will play a key role in the session on Two Hot Topics: When to Consider Age-Normed Scores and Repurposing COAs for New Uses. Cheryl will deliver a presentation and join the panel, contributing her expertise to discussions on: ✔️ The use of age-normed scores in clinical trials ✔️ Challenges of repurposing clinical care scales for use in clinical trials This session will also feature presentations and insights from various FDA and academic leaders and the panel will be moderated by FDA's Michelle Campbell. 🔗 Register here: https://lnkd.in/eVmveKMa #CPath #FDA #COA #patientfocused #drugdevelopment #datasharing #globalhealth #collaboration

Kidney diseases are silent killers. For many patients, the detection of kidney problems through biomarkers marks the difference between a condition that can be managed versus a life-threatening disease. For instance, chronic kidney disease often progresses silently without noticeable symptoms until it has advanced. Traditional biomarkers such as albumin in the urine or elevated serum creatinine levels allow for the early identification of CKD, giving patients and healthcare professionals the opportunity to implement lifestyle and treatment changes before the disease becomes more severe. For me, a routine employee physical found albumin in my urine when I was 20 years old. This early detection caused me to make diet and lifestyle changes that slowed the progression of my kidney disease. This biomarker data helped prevent the need for invasive treatments like dialysis or kidney transplantation for over 40 years. 👉Read more of Glenda’s Blog Piece here: https://lnkd.in/eY_vkm5d Glenda V. Roberts, Nicholas King, Katrina Peron, MS, RAC #CPath #Biomarkers #PatientPerspective #KidneyDisease #CriticalPathInstitute #drugdevelopment #FDA #globalhealth #datasharing #collaboration

C-Path is proud to welcome uniQure as the newest member of its Huntington’s Disease Regulatory Science Consortium. uniQure is delivering on the promise of gene therapy – a single treatment with curative results – through an innovative adeno-associated virus-based technology platform supported by proprietary commercial-grade manufacturing. The recent approvals of their gene therapy for hemophilia B – a historic achievement based on more than a decade of research and clinical development – represent a major milestone in the field of genomic medicine and usher in a new treatment approach for patients living with hemophilia. They're now advancing a clinical program in Huntington’s disease with a growing list of preclinical candidates. Welcome, uniQure! Learn more about HD-RSC here: https://lnkd.in/epwZHHeX Terina N. Martinez, Ph.D. #CPath #DrugDevelopment #GlobalHealth #Collaboration #HD #GeneTherapy

Tomorrow! Register now for, The Power of Data Sharing and Collaboration Across LGMDs in a Pre-Competitive, Neutral Environment. 📅 Thursday, December 12 | 11 AM ET This event will feature Dr. Volker Straub, a renowned neuromuscular genetics expert and Director of the John Walton Muscular Dystrophy Research Centre @ Newcastle University. Dr. Straub will provide an overview of Limb-Girdle Muscular Dystrophies and highlight critical unmet needs in the field. He’ll be joined by a panel of experts: Douglas Sproule (ML Bio Solutions) Jennifer Levy (Coalition to Cure Calpain 3) Kat Bryant Knudson (Speak Foundation) Sophie Olivier (Atamyo Therapeutics) Cécile Ollivier (C-Path) Together, they’ll explore how the launch of the LGMDs Task Force aims to foster data sharing across LGMD subtypes, drive innovation in drug development, and inspire new researchers to enter the field. What you'll gain: ▶ Learn about cutting-edge initiatives to address challenges in LGMD research. ▶Hear diverse perspectives from advocacy leaders, industry stakeholders, and leading scientists. ▶Discover how collaboration in a pre-competitive, neutral environment can accelerate progress for LGMDs. Don’t miss this opportunity to be part of a conversation that could shape the future of LGMD drug development. 🔗 Register now: https://lnkd.in/d5EkhkPT Collin Hovinga Alexandre Bétourné, PhD, PharmD, PMP Ramona Belfiore-Oshan Heidi Grabenstatter #CPath #RareDisease #LGMD #limbgirdle #musculardystrophy #drugdevelopment #datasharing #collaboration #taskforce #globalhealth

C-Path's Duchenne Regulatory Science Consortium is excited to announce the publication of the Cardiac Imaging Supplement to the Duchenne Muscular Dystrophy Therapeutic Area User Guide v1.0, developed in partnership with CDISC. The user guide includes new controlled terminology, and SDTM and ADaM examples for several cardiovascular tests (i.e., basic systolic function, late gadolinium enhancement, parametric mapping and circumferential and longitudinal strain). We are grateful to all D-RSC members including industry members, academic and clinical advisors, government and regulatory advisors, patient advocate advisors, and C-Path staff who contributed to this wonderful effort. Follow this link below to access the cardiac supplement: https://lnkd.in/eSvhcuB3 #CPath #DMD #Duchenne #CDISC #cardiacevent #globalhealth #datasharing #drugdevelopment Ramona Belfiore-Oshan, Diane Corey, Rebecca Baker, Jon Neville, Jonathan Soslow, Kan Hor, Chet Villa, Karin LaPann, Alana St. Clair, Paige Martin Lysandra Gomez Stacy Owen, Collin Hovinga, Eric Camino, Pat Furlong, Heather Fitzpatrick Medlin, Abby Bronson, Joanne Donovan, Dania D'Achille Porco, Divya Reddy, Sara Cazzaniga, Yoichi Egawa, Jane Larkindale, Jennifer Hibma, Qi Shen, Nidal Boulos, PhD, CCRP, Naz Dastgir, Christian De Ford, Maitea Guridi Ormazabal, Alex Murphy, Nadya Masloboeva, James Richardson, Phil Larimer, Tina Liu, Asif Paker, Mark Peterson, Yiting Wang, Arpeat Kaviya, Daniel Paulson, Yetrib Hathout, Hank Mayer, Christopher Spurney, Carol Gregorio, Larry Markham, FAAP, FACC, Karim Wahbi, Beth Kaufman, PhD, Brenda Wong, Erik Henricson, Stefania Mondello, Mindy Cameron, Ryan Russell PhD Adith Thummalapalli, Colin Werth

Have questions about how C-Path is structured? Whether you’re curious about how we collaborate with stakeholders, or how we’re accelerating the development of new treatments, our FAQs section is a valuable resource designed to give you the insights you need. Have a question we haven’t answered yet? Don’t hesitate to reach out—we’re always here to help and provide guidance. You can find more questions and answers on C-Path's website under FAQS: c-path.org/faqs. #C-Path #FAQs #DrugDevelopment