New Outcomes, Old Measures; New Measures, Old Outcomes: Integrative Strategies for Optimizing Biomarkers in Clinical Trials of Neurodegenerative Disease

Presenter: John Seibyl, M.D. | Distinguished Scientist, Invicro

This talk provides a broad overview of novel approaches to making effective use of imaging and non-imaging biomarkers in multi-center trials in neurodegenerative disease. These biomarkers should meet the many needs of studies from cohort enrichment, increasing diagnostic certainty, assessing target engagement, monitoring natural progression of disease and evaluating efficacy of treatment. New developments in signal processing, novel targets, advances in image processing, improvements in fluid markers, etc. offer new possibilities for the rational, integrative use of biomarkers to improve clinical trial design, shorten time to study completion and improve confidence in the research findings.   

During this webinar, the presenter will discuss:

  • The different applications of biomarkers in drug development clinical research of neurodegenerative diseases
  • The concept of integrative use of biomarkers and the on-going evolution of strategies for optimizing the practical uses of these tools for drug development
  • The appreciation of the regulatory dialogue around biomarker use regarding standardization, validation and implementation in late-stage drug development trials

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Distinguished Scientist, Invicro

Dr. Seibyl is an international expert on PET and SPECT imaging for neurodegenerative disorders. He is the past President of the Brain Imaging Council of the Society of Nuclear Medicine. Dr. Seibyl is dually-boarded in Nuclear Medicine and Psychiatry and has twenty years of experience in clinical studies. He has made significant contributions to development of visual and quantitative analysis for PET imaging in neurodegenerative and neuropsychiatric disorders. Along with Invicro's Distinguished Scientist, Dr. Ken Marek, he has directed and continues to direct several international multi-center imaging studies. Dr. Seibyl is an author on 100+ publications on CNS imaging.