Accelerating the path to a
healthier world


Critical Path Institute, or C-Path, is an organization that brings together biopharmaceutical firms, universities, patient groups, and regulatory agencies from around the world to improve public health. Together, these stakeholders work to identify or create tools that can accelerate the drug development and regulatory review process.

Critical Path Institute, Ltd, is a wholly owned subsidiary based in Ireland to facilitate the work of C-Path in the European Community.


Shortly after its founding in 2005, Critical Path Institute began forging relationships with European entities. In 2007, C-Path’s Predictive Safety Testing Consortium (PSTC), which counted among its members European pharmaceutical company Novartis AG, was the first collaboration to use the Voluntary Exploratory Data Submission review process, which allowed them to submit qualification plans for seven kidney safety biomarkers to FDA and EMA simultaneously. In 2011, C-Path signed a Memorandum of Understanding (MoU) with the European Union’s Innovative Medicines Initiative (IMI) to further the missions of both organizations. Marking C-Path’s 10th anniversary in 2015, founder and former CEO Raymond Woosley, MD, PhD, reflected, “C-Path, because of its founding principles of trust, collaboration, and outstanding science, has become an internationally respected leader in advancing the innovative methods that are fundamentally changing the way new medicines are being developed.”

Core Competencies

Critical Path Institute (C-Path) serves as a neutral third party to enable multiple stakeholders across the spectrum of...


Breadth of Expertise

C-Path’s staff possess a wide range of scientific, medical, regulatory, technical, and business expertise...


European Collaborators by Consortium

Critical Path For Alzheimer’s Disease


Critical Path For Alzheimer’s Disease(CPAD)

  • Alzheimer’s Research UK
  • Biomarkable
  • Boehringer Ingelheim
  • Roche
  • Roche, UK

Duchenne Regulatory Science Consortium


Duchenne Regulatory Science Consortium(D-RSC)

  • Leiden University Medical Center

Type 1 Diabetes Consortium


Type 1 Diabetes Consortium(T1D)

  • University of Leuven

Critical Path to TB Drug Regimens


Critical Path to TB Drug Regimens(CPTR)

  • Alere
  • Amsterdam Institute for Global Health and Development
  • Cambridge University
  • Certara
  • Dutch National Institute for Public Health and the Environment
  • EMA
  • Forschungszentrum BorstelGlaxoSmithKline
  • Innovative Medicines Initiative
  • InterTB/ St George’s University of London
  • Janssen
  • Johnson & Johnson
  • London School of Hygiene and Tropical Medicine
  • Medical Research Council, UK
  • Medicins Sans Frontiers
  • Nanopore Technologies
  • Otsuka
  • Qiagen
  • Radboud University
  • San Raffaele Scientific Institute
  • Sanofi
  • The Union
  • Thermofisher
  • University College LondonUniversity of Brescia
  • University of Liverpool
  • University of Munich (LMU)
  • University of OxfordWHO
  • bioMerieux

Polycystic Kidney Disease Outcomes Consortium


Polycystic Kidney Disease Outcomes Consortium(PKD)

  • ADPKD Paediatric Registry
  • Bambino Gesù Children’s Hosp
  • European Medicines Agency
  • Istituto Mario Negri
  • PKD Charity
  • University of Leuven
  • University of Sheffield

International Neonatal Consortium


International Neonatal Consortium(INC)

  • ANSM, France
  • Baxter International
  • Brighton and Sussex Medical School
  • Chiesi PharmaceuticalsChildren’s Memorial Health Institute
  • City University, London
  • Cordelier Research Ctr
  • Diderot University Paris
  • EFCNI (Consultants)
  • European Medicines Agency
  • French NIH & Medical Research (Inserm)
  • Graham’s Foundation
  • Great Ormond Street Hospital
  • Highbury Regulatory Science Ltd
  • Imperial College London
  • Inserm, France
  • Johnson & Johnson
  • Karolinska University Hospital
  • King’s College, London
  • Lilly
  • March of Dimes
  • NANN
  • NEC Society
  • Neonatal Nurses
  • Novartis
  • P. Stradins Clinical University Hospital (Latvia)
  • PDCO
  • Pfizer
  • Preemie Parent Alliance
  • Queen Mary University of London
  • Robert Debré Hospital, Paris
  • S. Paris U. Hospitals
  • Saint-Pierre University Hospital
  • Sanofi
  • Shire
  • Sophia Children’s Hospital (the Netherlands)
  • St. Anna Hospital
  • Therabron
  • Thomson
  • University College Cork
  • University College London Hospital
  • University Medical Center Freiburg
  • University of Birmingham
  • University of Gothenburg
  • University of Leuven
  • University of Liverpool
  • University of Lübeck
  • University of Siena, Italy
  • University of Tartu, Estonia
  • University of Ulm

Critical Path for Parkinson’s


Critical Path for Parkinson’s(CPP)

  • Cure Parkinson’s Trust
  • GSK
  • Ixico
  • Lundbeck
  • Newcastle University
  • Parkinson’s UK
  • UCB
  • University of Cambridge
  • University of Glasgow
  • University of Oxford

Predictive Safety Testing Consortium


Predictive Safety Testing Consortium(PSTC)

  • AstraZeneca
  • EMA
  • Johnson & Johnson
  • NMI
  • Novartis
  • Otsuka
  • Roche
  • Sanofi
  • Signatope

Multiple Sclerosis Outcome Assessments Consortium


Multiple Sclerosis Outcome Assessments Consortium(MSOAC)

  • European Medicines Agency
  • Imperial College London
  • Italian Multiple Sclerosis Society (AISM)
  • Premier Research
  • Scientific Institute H.S. Raffaele, Milan
  • University College London
  • VU Medical Centre Amsterdam