Sudhir Sivakumaran, PhD

"For every biomarker, we need to ask ourselves the question, ‘How can this biomarker help optimize drug development?’”

There are several biomarker tests that are used for research on Alzheimer disease (AD) and related dementias. Changes in the brains of individuals with these disorders may begin many years before memory loss or other symptoms appear, and utilizing these biomarkers may help detect these changes and thus better identify people who may develop these diseases and may be eligible for treatment options.

Biomarkers such as neurofilament light chain, amyloid-beta, tau, and the radiotracer flurodeoxyglucose have all gained traction in recent years. While clinicians typically have agreed on several biomarkers that have clinical relevancy in AD, finding the gold standard biomarker—if one exists for AD—is still an ongoing process. The Critical Path for Alzheimer’s Disease (CPAD) consortium, an organization that promotes data-sharing among drug development stakeholders, has embarked on a new initiative since 2019 to acquire fluid and imaging biomarker-rich data sources that will hopefully assist in developing novel tools to quantify disease progression better.

Sudhir Sivakumaran, PhD, vice president, Neuroscience Program, and Executive Director, CPAD, and Klaus Romero, MD, MS, FCP, chief science officer, CPAD, recently sat down with 

to discuss the thought of prioritizing specific biomarkers. The duo claimed that the consortium does not limit itself to a single biomarker focus, but rather any biomarker that correlates with disease progression and helps improve clinical trial efficiency.

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The duo from the Critical Path Institute detailed the thought process behind evaluating the importance of specific biomarkers and their relation to disability progression in Alzheimer disease. 

Identifying Impactful Biomarkers of Alzheimer Disease: Sudhir Sivakumaran, PhD; Klaus Romero, MD, MS, FCP

"From our perspective, we use those data to generate quantitative tools and solutions, where the clinicians can get a better understanding of how these models convey information with regard to a particular biomarker or end point.”

The Critical Path for Alzheimer’s Disease (CPAD) is a public-private partnership aimed at creating new tools and methods that can be applied to increase the efficiency of drug development in neurodegenerative diseases that progress to dementia with the shared characteristics of Alzheimer disease (AD). In August 2018, CPAD celebrated its tenth anniversary of the original formulation of the of the Coalition Against Major Diseases (CAMD)—the founding consortium.

2021 Alzheimer’s Association International Conference

, July 26-30, members including Sudhir Sivakumaran, PhD, and Klaus Romero, MD, MS, FCP, shared an update on CPAD’s database and reemphasized the primary objective of the consortium. As of October 2020, CPAD’s database contained 41 studies, standardized to the AD Clinical Data Interchange Standards Consortium (CDISC) standards, of which 3 datasets were used to generate analysis subsets. Serving as a neutral third party, CPAD provides a safe harbor for individual organizations to share data in a pre-competitive environment.

Sivakumaran, vice president, Neuroscience Program, and Executive Director, CPAD, and Romero, chief science officer, CPAD, sat down with 

to discuss the advantages this consortium brings to clinicians within the AD community and why the trough of data will lead to greater clinical trial success.

The duo from the Critical Path Institute discussed how CPAD is revolutionizing data collection within the Alzheimer disease community and the advantages it brings to clinicians. 

Sudhir Sivakumaran, PhD

Articles

Identifying Impactful Biomarkers of Alzheimer Disease: Sudhir Sivakumaran, PhD; Klaus Romero, MD, MS, FCP

Advantages of CPAD Consortium: Sudhir Sivakumaran, PhD; Klaus Romero, MD, MS, FCP