Imagine a world where our loved ones are no longer affected by diseases like Parkinson’s, Alzheimer’s, diabetes or rare diseases like ALS and Duchenne. Today’s drug development process can take up to 10 or 15 years, posing a significant hurdle. For 20 years, Critical Path Institute (C-Path) has brought together experts in patient advocacy groups, those with firsthand experience with these conditions, and leaders from regulatory agencies, medical research, and the pharmaceutical and biotech industry. Together, we accelerate the drug development and approval process to advance therapies and cures, ultimately improving lives.
C-Path’s aim is to address unmet medical needs and cut drug development costs through the creation of novel tools, distinct collaborations, and robust data strategies to improve the scientific assessment of new therapies’ effectiveness and safety. These shared standards and methods, also known as drug development tools (DDTs), are developed by our collaborative teams. Each one undergoes a rigorous regulatory review process to ensure they’re valid for specific situations.
Our impact goes beyond creating tools: We are an independent nonprofit catalyst that generates a unique, neutral ecosystem in drug development. We convene and manage diverse stakeholders critical to the process and combine intellectual and financial resources to generate actionable solutions that facilitate the development of safe and effective treatments across a multitude of diseases.
C-Path actively builds consensus across all these stakeholders. We share ideas, we share data and we share risks and costs to move the science forward, all with patients at the heart of it all.
“Critical Path Institute is smoothing the regulatory pathway and emphasizing what is important to the patient.”
C-Path is making meaningful advancements every day in medical innovation and regulatory science — breakthroughs that make a difference for patients and their families in clinical trials, at the pharmacy, in the doctor’s office, and at home.
Alzheimer’s Disease: A Case Study
Recent estimates indicate that the number of people living with dementia worldwide is expected to rise to 139 million cases in 2050. Alzheimer’s disease (AD) accounts for an estimated 60% to 80% of dementia cases and total costs for AD care in the U.S. are estimated to increase to more than $1 trillion by 2050. However, estimating the economic burden of AD is difficult as many patients living with AD remain undiagnosed and estimates do not include the burden of informal caregiving by a patient’s family and friends.
Critical Path for Alzheimer’s Disease (CPAD) team demonstrated the usefulness of an imaging biomarker to optimize clinical trial patient selection, helping sponsors to determine which participants are likely to develop AD dementia. CPAD developed an innovative solution enabling researchers to simulate clinical trials with and without the use of this imaging test, which can accelerate the time to test new drugs.
CPAD continues to streamline drug development for AD and Alzheimer’s related dementias, by transforming data into actionable insights that make drug development more efficient. For instance, at the 2021 Alzheimer’s Association International Conference, a pharmaceutical company presented data on their anti-amyloid investigational drug. The company weaved their data into a disease progression model of mild to moderate AD built on patient-level control data from the CPAD database, to demonstrate that reduction in amyloid and tau-burden is likely to result in slowing cognitive decline. As of January 2022, the CPAD clinical trial simulation tool, based on CPAD’s mild to moderate AD progression model, has been accessed by 140 approved users.
The development of these tools requires integration of information from diverse data sources. As of January 2022, CPAD has aggregated data from 57 clinical trials and natural history studies, containing 38,894 patient level records. Recently acquired AD datasets contain extensive biomarker information, which are key pieces to continue generating actionable solutions and advancing drug development. These learnings have a direct impact on patients and their families by providing them with new medicines developed in a smarter way.
As C-Path continues to build its strategic partnerships, the organization is looking to the future and building support for its continued pathways to help millions of people affected by disease. Sound like something you want to be a part of it? Reach out to become a partner today.
“The campaign will advance drug development for therapies and cures for a multitude of diseases by using innovative tools, enhancing collaborations and accelerating regulatory approvals.”
– Daniel Jorgensen, M.D., M.P.H., M.B.A. – C-Path Chief Executive Officer