C-Path effort to help develop Parkinson's disease gender-equitable...

The Critical Path Institute (C-Path) is launching a new initiative to advance research on how Parkinson’s disease impacts women and people across the gender spectrum.

The goal is to develop treatments and technologies that take into account each person’s unique experience with the disease, leading to more equitable approaches for detecting, managing, and treating it.

Launching next year, the initiative is called Gender Equitable Medicines for Parkinson’s Disease (GEM-PD). It will partner and build on years of research from the C-Path’s Critical Path for Parkinson’s (CPP) Consortium.

“The launch of GEM-PD is a major step in addressing the gaps in Parkinson’s research,” Diane Stephenson, PhD, CPP’s vice president of neurology and executive director, said in a C-Path press release. “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.”

CPP is a public-private partnership launched in 2015 that’s been working to boost the development of new therapies and prevention strategies for Parkinson’s. It has developed an integrated database that contains thousands of patient data points that cover both clinical and medication data, along with demographic information, to help determine how certain factors, including biomarkers and genetics, influence disease outcomes.

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Addressing ‘unique experience’ with Parkinson’s

Like other disease consortiums under C-Path, it relies on collaborative work from diverse stakeholders, including regulatory authorities, industry leaders, and patient advocacy organizations, to streamline patient-focused drug development.

“For nearly 20 years, C-Path has served as the worldwide leader in developing partnerships with a proven impact in accelerating drug development in neurological indications,” Klaus Romero, MD, C-Path’s CEO, said. “GEM-PD will further catalyze our efforts to address unmet need in Parkinson’s disease therapies.

“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 said.

CPP has already contributed to seven regulatory milestones, including the first biomarker certified by the European Medicines Agency for use in clinical trials for early-stage Parkinson’s, according to the press release.

“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,” Sarah Zenner-Dolan, a C-Path advisor, said. “This initiative gives me hope that future therapies will better address the specific challenges women face with Parkinson’s.”

C-Path said it’s eager to establish collaborations with regulatory agencies, patient organizations, disease foundations, and pharmaceutical companies to further advance the initiative’s goals.