C-Path expands its worldwide leadership in accelerating drug development in neurology; seeks additional collaborators to broaden impact.

TUCSON, Ariz., Nov. 13, 2024 /PRNewswire/ -- Critical Path Institute (C-Path) today announced a landmark initiative, Gender Equitable Medicines for Parkinson's Disease (GEM-PD), dedicated to globally advancing actionable research on how Parkinson's disease uniquely impacts women and individuals across the sex and gender spectrum.

"For nearly twenty years, C-Path has served as the worldwide leader in developing partnerships with a proven impact in accelerating drug development in neurological indications," said C-Path CEO Klaus Romero, M.D., M.S., FCP. "GEM-PD will further catalyze our efforts to address unmet need in Parkinson's disease therapies."

GEM-PD aims to accelerate the development of more personalized treatments by leveraging diverse data and innovative technologies, such as artificial intelligence and digital health technologies. The initiative seeks to generate drug development solutions that will lead to more equitable approaches to detection, disease management, and therapies for all individuals living with Parkinson's.

"As someone living with Parkinson's, I'm hopeful that through a better understanding of how the disease affects women uniquely — from disease onset to clinical diagnosis and treatment response — we can develop treatments that truly reflect each person's unique experience," said Sarah Zenner-Dolan, Parkinson's patient, and C-Path advisor. "This initiative gives me hope that future therapies will better address the specific challenges women face with Parkinson's. It's encouraging to see this focus on what matters most to us."

GEM-PD will partner with and build upon the achievements of C-Path's Critical Path for Parkinson's (CPP) Consortium, a global public-private partnership committed to accelerating the development of therapies that improve the lives of those with Parkinson's. With 10 million people worldwide living with Parkinson's — the fastest-growing degenerative neurological condition — collaboration and data sharing are crucial to driving innovation. CPP's global integrated database and digital tools have already demonstrated impact in drug development, by enabling the quantification of how factors such as biomarkers and genetics shape the living experiences of those with Parkinson's.

In the past decade, CPP has achieved significant success, including seven regulatory milestones, including the first biomarker qualified by the European Medicines Agency for use in clinical trials targeting early-stage of disease. Beyond Parkinson's, C-Path's drug development solutions have contributed to the first-ever approvals of disease-modifying treatments for Alzheimer's disease, Friedreich's ataxia, polycystic kidney disease, and the first new treatments for tuberculosis in over 50 years. In partnership with CPP, C-Path's GEM-PD initiative seeks to further accelerate progress and develop more tailored, equitable solutions for the Parkinson's community.

"The launch of GEM-PD is a major step in addressing the gaps in Parkinson's research," said Diane Stephenson, Ph.D., Vice President of Neurology, and Executive Director of CPP. "By focusing on women's distinctive experiences, we're filling a critical need for more personalized approaches to treatment. This initiative not only strengthens our existing tools and databases but also creates new opportunities for innovation."

"Integrating sex and gender into actionable drug development tools enables us to utilize our core competencies in data sharing, advanced analytics, biomarkers, clinical outcome assessments, and regulatory science, to develop solutions that will accelerate drug development for everyone affected by this condition," Romero added.

C-Path welcomes additional partnerships and resources to build on the initial support that launched this multi-year program. We look forward to collaborating with regulatory agencies, the pharmaceutical industry, and other stakeholders to advance the goals of GEM-PD. To learn more about the initiative or explore partnership opportunities, visit c-path.org or contact us at [email protected].

About Critical Path Institute

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 in Tucson, Arizona and C-Path's Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.

Media Contacts:

Roxan Triolo Olivas
C-Path
520.954.1634
[email protected]

Kissy Black
C-Path
615.310.1894
[email protected]

SOURCE Critical Path Institute