C-Path’s Executive Director of Neuroscience, Diane Stephenson, moderated a session at #CGIC2024 on Characterizing Conditions with a Drug Development Mindset: Biological Staging. Panelists included Pavel Balabanov, Teresa Buracchio, MD, Steven Hersch, Geoffrey Kerchner and Ken Marek. "Having well-defined biologic-based definitions of diseases are really critical to our work." -Dr. Burrachio. #CGIC2024 #DrugDevelopment #CPath #neutral #datasharing #globalhealth #collaboration #regulatoryscience #biologicalstaging #NeurodegenerativeDisorders
Critical Path Institute (C-Path)
Research Services
Tucson, AZ 8,017 followers
Advancing Drug Development. Improving Lives. Together.
About us
Critical Path Institute (C-Path) is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDA’s Critical Path Initiative. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.
- Website
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http://www.c-path.org/
External link for Critical Path Institute (C-Path)
- Industry
- Research Services
- Company size
- 51-200 employees
- Headquarters
- Tucson, AZ
- Type
- Nonprofit
- Founded
- 2005
- Specialties
- creating collaborations with regulators, patient advocacy groups and the regulated pharmaceutical industry, accelerated development of safer, new medical products, faster, safer, and smarter medical product development, and public private partnership
Locations
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1840 E River Rd # 100
Tucson, AZ 85718, US
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Barbara Strozzilaan 201 1083 HN
Amsterdam, NL
Employees at Critical Path Institute (C-Path)
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Deb Discenza (she/her/hers)
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Thomas Morel
Global Patient-Centred Outcomes Research & Policy Lead at UCB
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Huong Huynh Reagan
Regulatory Director | Regulatory endorsements of drug development tools | Cross-functional collaborations | Diverse disease portfolio | Lead people;…
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Hannah Blau
Data Scientist ∙ ML / NLP Engineer ∙ Listener Extraordinaire ∙ She who does not let stuff fall through the cracks
Updates
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#CGIC2024, FDA Commissioner Dr. Robert Califf reflected on the early days of Critical Path Institute, nearly 20 years ago, "There's a whole list of achievements from this public-private partnership...part of the Critical Path Initiative and the Critical Path Institute has been the development of the methods and the playbook," he said. C-Path’s CEO Klaus Romero, was also joined by FDA members Peter Stein, and Celia Witten, plus European Medicines Agency member Spiros Vamvakes (virtually) to discuss the impact of global public-private collaborations on drug development. Public-private partnerships are critical to modern drug development because of: 1. Neutrality to focus on addressing unmet needs in the process. 2. Scientific and clinical trust in the tools generated. 3. Global collaboration that can de-risk the process overall. #CPath #CGIC2024 #FDA #DrugDevelopment #neutral #datasharing #globalhealth #collaboration #regulatoryscience
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The FDA encouraged scientists and drug developers to use the alpha-synuclein seed amplification assay (αSyn-SAA) biomarker, discovered in 2023, for research and clinical trials in a “Letter of Support” issued late Summer 2024. The Letter of Support follows multi-stakeholder collaboration amongst The Michael J. Fox Foundation for Parkinson's Research and the Critical Path Institute, with both organizations supporting use of the biomarker for clinical trials and advancing new drugs for Parkinson’s disease. 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 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. “This FDA Letter of Support is a transformative moment for the field, promising to speed clinical trial design in Parkinson’s and related disorders,” said Diane Stephenson, PhD, executive director, CPP, C-Path. “The cross-collaboration among patients, researchers, clinicians, regulators and patient advocacy organizations demonstrates the critical role every player holds in moving today’s achievement forward. Now, we’re closer than ever to better treatments, and perhaps one day, preventing people from developing the symptoms of these diseases altogether.” Full details, here: https://lnkd.in/gqhuVqnW #CPath #MJFF #FDA #Parkinsons #PD #Biomarker #drugdevelopment #diseaseprevention #datasharing #globalhealth #collaboration
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Looking forward to kicking off C-Path's Global Impact Conference tomorrow, September 9! The day is packed with insightful sessions and discussions on the impact of global public-private collaborations on drug development. We're especially honored to have FDA Commissioner Dr. Robert Califf joining us, alongside experts like Klaus Romero, Teresa Buracchio, MD, Amit Khanna, and many others. They’ll be covering critical topics ranging from biological staging in drug development to the role of digital health technologies and AI in advancing treatments. With thought leaders from the FDA and industry pioneers on board, this event promises to be a powerful platform for shaping the future of drug development. See you there! #CPath #CGIC24 #DrugDevelopment #GlobalImpact #Collaboration #pediatrics #neurology #raredisease #collaboration
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Interested in C-Path updates? Be sure to subscribe at https://lnkd.in/gdme7CP2 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
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Today, September 7, we acknowledge World Duchenne Muscular Dystrophy Awareness Day and extend our deepest gratitude to the Duchenne community and C-Path’s Duchenne Regulatory Science Consortium members for their tireless dedication to advancing treatments for DMD. To combat the many challenges posed by this disease, D-RSC has created an integrated database of patient-level clinical data from DMD studies, and several drug development tools available to the Duchenne community with permissions. Established by C-Path and Parent Project Muscular Dystrophy, D-RSC, in partnership with CDISC, has also developed standard terminology and authored the Duchenne Muscular Dystrophy Therapeutic Area User Guide and the Cardiac Imaging Supplement currently out for public review until September 30. We are proud to continue this work and are grateful for the community’s ongoing collaboration. For more information, visit c-path.org/programs/d-rsc. To view the Cardiac Imaging Supplement, visit: https://lnkd.in/g8ujGTsV Ramona Belfiore-Oshan, Pat Furlong #CPath #DMDawareness #WDAD2024 #musculardystrophy #raredisease #drugdevelopment #datasharing #globalhealth #collaboration #CDISC
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REGISTRATION NOW OPEN: eCOA Clinic #2 - BYOD - The Sequel! Join us for the next offering in the eCOA Consortium’s eCOA Educational Series, entitled eCOA Clinic #2: BYOD – The Sequel! Revisiting the lively topic of BYOD, this event offers attendees a further chance to pose any questions that were unaddressed at the first eCOA Clinic or the recent collaborative webinar delivered by the eCOA Consortium and PRO Consortium entitled “BYOD: A Guide for Successful Implementation.” Submit your questions live (or in advance via the registration form) for our expert panel to discuss. 📆 Wednesday, September 25 ⏰ 10 - 10:55 a.m. Eastern (US) Register here: https://lnkd.in/dshmzPFF Chris Barden Kelly Dumais Karl McEvoy Florence Mowlem, PhD Scottie Kern eCOA members, include: ActiGraph Evinova Clario ICON plc Inspired Health IQVIA Kayentis Koneksa Mapi Research Trust Medable, Inc Medidata Solutions Medrio ObvioHealth Parexel Red Nucleus RWS Group Signant Health Suvoda TransPerfect Life Sciences uMotif WCG YPrime #CPath #eCOA #DHT #clinicaltrials #DCT #PRO #BYOD #COA #drugdevelopment #datasharing #globalhealth #collaboration
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C-Path is proud to announce the addition of significant new data sets from the Cystic Fibrosis Therapeutics Development Network, coordinated by Seattle Children's, to the Rare Disease Cures Accelerator-Data and Analytics Platform. This marks a major milestone in the collaborative efforts to enhance cystic fibrosis research and the development of effective therapies. Integrating this data with RDCA-DAP furthers the shared mission of accelerating research and therapeutic development for CF and other rare diseases. RDCA-DAP offers a cohesive and standardized infrastructure that supports, among other things, the rigorous conduct of natural history studies and provides a comprehensive, integrated database and analytics hub for clinical trial design and regulatory review. “We deeply value the collaboration with the Cystic Fibrosis Therapeutics Development Network and Seattle Children’s,” said RDCA-DAP Executive Director Alexandre Bétourné, PhD, PharmD, PMP. “Enhancing our collective capabilities to tackle CF and reinforcing our platform’s role in accelerating new therapies stands as a pivotal development in our partnership. Integrating these and future datasets into RDCA-DAP marks a crucial advancement in our efforts to effectively combat rare disease.” Read the full details, here: https://lnkd.in/gkass5yn #CPath #CysticFibrosis #datasharing #drugdevelopment #collaboration #globalhealth #raredisease #SeattleChildrens
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REGISTER NOW 📆 C-Path's Predictive Safety Testing Consortium is delighted to announce its second public workshop on evidentiary considerations for regulatory assessment and qualification of complex in vitro models - CIVMs. Health authorities, academia professionals, model developers, and representatives from the pharmaceutical industry are encouraged to participate in this workshop. It offers a valuable platform for attendees to engage in discussions and deliberations regarding the evidentiary considerations essential for regulatory assessment and qualification of CIVMs. Through collaborative efforts, attendees will strive to reach a consensus on the standards and features necessary to enhance the performance of CIVMs as a reliable tool for drug development and regulatory assessment. The meeting agenda features sessions led by key opinion leaders, who will address general considerations for qualification. Additionally, interactive breakout sessions will concentrate on various organ systems and disease models. During these breakouts, participants will actively engage in discussions and deliberations to explore the evidentiary considerations crucial for regulatory assessment and qualification of complex in vitro models. Join us September 26 - 27, 2024 in Bethesda, Maryland. Register now: https://lnkd.in/gKTA5H3X #CPath #PSTC #CIVM #workshop #drugdevelopment #datasharing #regulatoryscience #collaboration #globalhealth
LinkedIn
web.cvent.com
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It’s #PKDAwarenessDay and a great time to thank C-Path’s PKD Outcomes Consortium members and its co-directors Ronald Perrone, Frank Czerwiec, and the PKD Foundation’s Susan Bushnell. A collaboration between leading academic medical centers, pharmaceutical companies, patient organizations, and international regulatory agencies, PKDOC members work together to develop tools and processes that advance research aimed at improving the lives of those living with polycystic kidney disease. Learn more about PKDOC’s mission and history of impact in the PKD space here: https://lnkd.in/gnPtErSg. Sorin Fedeles, PhD, MBA Wendy Vanasco, MLS #CPath #PKD #kidneydisease #raredisease #drugdevelopment #datasharing #globalhealth #collaboration