Critical Path for Parkinson’s Celebrates Foundational 10-year Milestone
Critical Path Institute’s Critical Path for Parkinson’s consortium is celebrating a significant 10-year milestone today. The g
CPP is a global public-private partnership initiated in 2015 consisting of industry, multiple nonprofit organizations, academic partners, and advisors (FDA, EMA, NIH, and people living with Parkinson’s), with the goal of accelerating the path to approval of therapies that improve the lives of people with Parkinson’s.
Parkinson’s affects over 10 million individuals worldwide, but there is currently no cure and only limited treatments to manage its progression, which impacts both motor and nonmotor functions. This wide range of manifestations makes it difficult to both fully capture the real-life experiences of individuals living with Parkinson’s and to measure the efficacy of drugs in clinical trials in this heterogeneous population.
Existing approaches and measures used to evaluate Parkinson’s fail to capture the aspects of the disease that hold genuine significance for people living with Parkinson’s and their care partners. Thus, there is an urgent need to redefine and expand our understanding of the early stages of Parkinson’s.
The focus on the impact of early-stage Parkinson’s Disease (PD) will enable us to reach a greater number of individuals affected by the disease and effectively address their specific needs, ensuring improved outcomes and a better quality of life.
The goal of the CPP Consortium is to broadly advance the drug development landscape for Parkinson’s prevention and treatment by working collaboratively with the Parkinson’s Disease global community to share data, knowledge, and resources towards the development and regulatory endorsement of novel drug development tools.
We do this by prioritizing efforts focused on broadening populations for trial recruitment, collecting, understanding, and sharing real-world data, and by leveraging innovative technologies to capture what truly matters.
With a focus on the “right drug, right patient, right time” approach, CPP streamlines regulatory processes to optimize drug development with greater efficiency in advancing data-driven solutions for clinical trials. CPP aims to align with regulatory strategies spanning from model-informed drug development, patient-focused drug development, digital heath technologies, biomarkers, and real-world data.
Regulatory endorsement relieves trial sponsors of the burden of having to convince the regulators that methods are reliable and reproducible and could accelerate effective patient treatments. Tools endorsed by regulators save time and money, which incentivizes more trials, which results in increased chances of getting more Parkinson’s disease treatments approved.
2022 – EMA issues Letter of Support for Parkinson’s Disease Clinical Trial Simulation Platform
2018 – EMA issues qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms
2016 – EMA issues Letter of support for molecular imaging of the dopamine transporter biomarker as an enrichment biomarker for clinical trials for early Parkinson’s disease
2015 – FDA issues Biomarker Letter of Support for an exploratory prognostic biomarker for enrichment in Parkinson’s (PD) trials
The database includes integrated and standardized data from both PD observational studies and randomized clinical trials and contains thousands of participants’ data, anonymized and deidentified. The database covers over 600 variables, such as demographic information, clinical measures, medication usage data, dropouts, and more.
The CPP integrated database is rich in patient-level outcome measures and includes item level patient level data. It contains limited biomarker and genetics data and does not include data collected using digital health technologies. In accordance with the Data Contribution Agreements between CPP and data contributors, CPP is obligated to protect the identity of the individual datasets and provides access to the datasets in aggregate with masked study identifiers.
We would like to thank our collaborators for their generous contributions to the CPP integrated Parkinson’s Database. View acknowledgements.
This quantitative clinical trial enrichment tool helps optimize clinical trial design in the early-motor stages of Parkinson’s, using MDS-UPDRS part III as the primary endpoint. For scientists and clinicians of all backgrounds, a cloud-based graphical user interface (GUI) has been developed, which allows a user-friendly experience to perform simulations based on the model.
CPP is proud to work with those who have been diagnosed with PD, as we all work together to advance treatments for People with Parkinson’s.
Critical Path for Parkinson’s (CPP) is proud to share the following story, featuring John Crawford, a biotechnology executive, avid hiker, and a person with Parkinson’s. His contributions to innovative wearable technologies for self-management of Parkinson’s is one of the many reasons sharing John’s story on behalf of CPP. Read more about how John has contributed to the work of CPP and his outstanding achievements, including completing the entirety of the Pacific Crest Trail (a 2,650-mile through hike).
Dr. Soania Mathur and Dr. Kevin McFarthing are patient advocates and individuals living with Parkinson’s. Our partner, Parkinson’s UK, interviewed these two powerful storytellers to share more on the needs of Parkinson’s patients and the sense of urgency felt within the Parkinson’s community. Their reflections illustrate the importance that the Critical Path for Parkinson’s Consortium places on listening to the voice of the patient in every aspect of our work.
Laura Gaetano, PhD
3DT Member Co-Director, Novartis
Gennaro Pagano, PhD
Member Co-Director, Roche
Diane Stephenson, PhD
Executive Director, Critical Path for Parkinson’s Consortium
Klaus Romero, MD, MS
Chief Executive Officer, Chief Science Officer
J. Rubin Abrams, PhD
Quantitative Medicine Scientist
Roopal Bhatnagar, MS
Data Analyst II, Data Collaboration Center
Laura Carrillo, MPH
Project Manager, Critical Path for Parkinson’s Consortium
Kimberly Collins, PhD
Senior Quantitative Scientist, Pharmacometrics
Shasta Jorgensen, MPH
Senior Project Manager
Grace Lee, PhD, PhD
Quantitative Medicine Scientist
Erin Lowry
Senior Project Coordinator, Critical Path for Parkinson’s Consortium
Martijn Müller, PhD
Senior Scientific Director, Critical Path for Parkinson’s Consortium
Albert Barrera, M.H.Sc
Data Collaboration Center
Sakshi Sardar, PhD
Quantitative Medicine Scientist, Quantitative Medicine
Robert Stafford, MA
Data Manager, Data Collaboration Center
For more information on the Critical Path for Parkinson’s (CPP) Consortium, please contact CPP Executive Director Dr. Diane Stephenson at DStephenson@c-path.org.