SEP 11: Biological Clocks and Other Biomarkers of Aging in Regulatory Development

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The Role of Biological Clocks and Other Biomarkers of Aging in Regulatory Development

About this Event

The explosion of research and development of biological clocks and other biomarkers of aging is beginning to guide an array of activities from drug discovery to medical care to personal wellness to the commercialization of nutritional supplements. Despite their recent perfusion into numerous fields, aging biomarkers have yet to play a meaningful role in regulatory development. Key reasons for this include the fact that aging is not currently a disease or condition within the purview of the FDA and that the elevation of biomarkers to surrogate markers that can support registration typically takes decades of emerging scientific consensus. Particularly in the case of aging biomarkers, very large, very long validating clinical trials may be necessary. However, cross-silo attention on validating aging biomarkers could accelerate the development of agents that prevent or delay chronic diseases associated with aging.

Join our "dream team" expert panel, consisting of the discoverer of the DNA methylation epigenetic clock, developer of a biological clock that supports commercialization of an anti-aging supplement, one of the top thought leaders from the FDA, the chief scientist for an AI-based company commercializing aging and longevity clocks, and the Scientific Director from the National Institute on Aging as they discuss the history, current status and future directions of biomarkers of aging as well as their potential role in regulatory development of interventions for the prevention or delay of chronic diseases and the extension of healthspan.

About the Speakers

Steve Horvath, PhD, ScD, is a Professor in Human Genetics and Biostatistics Departments of the Geffen School of Medicine at UCLA. His research draws from numerous fields, including epidemiology, epigenetics, and systems biology, to develop novel approaches to researching a broad spectrum of age-related diseases like cancer, neurodegenerative disease, and cardiovascular disease. An acknowledged leader within genetics and biostatistics fields, Dr. Horvath developed the epigenetic clock, a versatile biomarker that utilizes DNA methylation levels to measure biological age across multiple DNA sources. Dr. Horvath also developed the weighted gene co-expression network analysis, a data mining technique used especially in studying biological networks.

Morgan Levine, PhD, is a Professor within the Department of Pathology at the Yale School of Medicine. Her work incorporates multiple theories and methodologies from statistical genetics, computational biology, and mathematical demography to uncover measures for aging as well as risk stratification for major chronic diseases such as cancer and Alzheimer’s. Dr. Levine also serves as the Head of Bioinformatics at Elysium Health, a company that incorporates recent scientific developments in aging into its production of dietary supplements. In this capacity, she led the development of Elysium’s Index, an at-home test that measures an individual’s cumulative rate of aging.

Robert Temple, MD, currently serves as Deputy Center Director for Clinical Science at the FDA’s Center for Drug Evaluation and Research (CDER) as well as Senior Advisor in the Immediate Office of the Office of New Drugs (OND). A long-time member of the FDA, Dr. Temple has held numerous positions within the agency spanning back to 1972, including a 23-year tenure as the Acting Deputy Director of OND’s Office of Drug Evaluation-I, which regulates cardiovascular, renal, neurological, and psychiatric drug products. Dr. Temple’s primary interests lie in the design and conduct of clinical trials, as he has written extensively on topics relating to study enrichment and issues related to study design and interpretation.

Polina Mamoshina, PhD, is chief scientist at Deep Longevity, a spin-off of AI leader Insilico Medicine, that develops and commercializes aging and longevity clocks. She previously served as a Head of Biomarker Development at Insilico Medicine. Dr. Mamoshina’s primary research interests lie in artificial intelligence, deep learning, and biomarkers of aging, disease, and drug responses. Her expertise has led to her involvement in multiple deep learning projects with Insilico’s Pharmaceutical Artificial Intelligence Division such as the development of their drug discovery engine as well as biochemistry, transcriptome, and cell-free nucleic acid-based biomarkers of aging and disease.

Luigi Ferrucci, MD, PhD, currently serves as the National Institute on Aging’s Scientific Director and Chief of the Longitudinal Studies Section as well as Director of the Baltimore Longitudinal Study on Aging. Prior to his current positions, Dr. Ferrucci served as an Associate Professor of Biology, Human Physiology, and Statistics at the University of Florence in addition to Director of the Laboratory of Clinical Epidemiology at the Italian National Institute on Aging. Dr. Ferrucci’s research primarily focuses on the causal pathways leading to progressive physical and cognitive decline in the elderly population. He has made major contributions to the implementation of various epidemiological studies conducted in both the U.S. and in Europe.

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