Critical Path Institute (C-Path)


Critical Path Institute (C-Path) is a nonprofit organization dedicated to improving and streamlining the process of drug development. By fostering collaboration between industry executives, scientists, academic researchers, regulators, and patient groups, C-Path aims to accelerate the development of therapies for people with unmet medical needs.

Critical Path Institute

Critical Path Institute (C-Path)

1840 E River Rd, Suite 100, Tucson, AZ. 85718


What We Do

A quantitative clinical trial enrichment tool to help optimize clinical trial design in the pre-dementia stages of Alzheimer’s disease, using CDR-SB as the primary endpoint.

A clinical trial simulation tool to help optimize clinical trial design for mild and moderate AD, using ADAS-cog as the primary cognitive endpoint.

A model-based clinical trial simulation tool aimed at optimizing clinical trial design of efficacy studies of potential therapies for Duchenne muscular dystrophy (DMD).

A quantitative clinical trial enrichment tool to help optimize clinical trial design in the early-motor stages of Parkinson’s disease, using MDS-UPDRS part III as the primary endpoint.

This quantitative clinical trial enrichment tool helps optimize clinical trial design for therapies to prevent or delay diagnosis of T1D, using islet AAs with other relevant clinical features.

The mission of the PRO Consortium is to establish and maintain a collaborative framework for the qualification of patient-reported outcome measures and other clinical outcome assessment tools.


Digital Health Technologies


Key People

Klaus Romero

Chief Executive Officer, Chief Science Officer

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Cécile Ollivier

Vice President, Global Affairs

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Robert Hemmings

Board Member

Tomas Salmonson

Board Member

Collin Hovinga

Vice President, Rare and Orphan Disease Programs

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Alexandre Bétourné

Executive Director, Rare Disease Cures Accelerator-Data and Analytics Platform

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Ramona Belfiore-Oshan

Executive Director, Duchenne Regulatory Science Consortium

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Cheryl Coon

Vice President, Clinical Outcome Assessment Program

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Sonya Eremenco

Executive Director, Patient-Reported Outcome Consortium

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Maaike Everts

Executive Director, Translational Therapeutics Accelerator

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Nicholas King

Scientific Program Manager, Associate Director, Translational and Safety Sciences Program

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Rick Liwski

Chief Technology Officer, Director, Data Collaboration Center

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Shu Chin Ma

Vice President, Model-Informed Drug Development and Quantitative Medicine

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Terina N. Martinez

Executive Director, Rare and Orphan Diseases

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Lindsey Murray

Executive Director, Rare Disease Clinical Outcome Assessment Consortium

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Diane Stephenson

Vice President, Neurology and Executive Director, Critical Path for Parkinson

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Kanwaljit Singh

Executive Director, International Neonatal Consortium

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Kristen Swingle

President, Chief Operating Officer

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Nadine Tatton

Executive Director, Critical Path for Alzheimer's Disease

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Ramona L. Walls

Executive Director, Data Science

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News & Updates

Scientific Breakthrough Summit

At Critical Path Institute’s Scientific Breakthrough Summit, the organization announced the progression from pre-consortia to consortia for Critical Path to Lysosomal Diseases (CPLD) and Critical Path for Alpha-1 Antitrypsin Deficiency (CPA-1).

Predictive Safety Testing Consortium (PSTC) Milestone

C-Path’s Predictive Safety Testing Consortium (PSTC) achieved a major milestone with the FDA’s support for four new pancreatic injury biomarkers.

Duchenne Regulatory Science Consortium Support

C-Path Receives Letter of Support from EMA on Duchenne Muscular Dystrophy Clinical Trial Simulation Platform.

Transplant Therapeutics Consortium Qualification Opinion

C-Path’s Transplant Therapeutics Consortium Receives EMA Qualification Opinion for iBox Scoring System.

Critical Path for Parkinson’s Support

C-Path Receives Letter of Support from EMA for Parkinson’s Disease Clinical Trial Simulation Platform.

Rare Disease Moonshot Initiative

A new initiative to boost research and development into rare and pediatric diseases was launched at the European Health Summit.