Webinar Description:
This webinar will provide an overview of the FDA’s new Biomarker Qualification Program and how, in conjunction with new guidance on Adaptive Trial Designs and coupled with new technologies enabling researchers to measure biomarkers in ways that were never possible previously, pharma and biopharmaceutical companies are accelerating clinical trials, developing safer, more effective drugs, and ultimately can get drugs to patients more quickly and cost-effectively.

Kevin Hrusovsky, Founder of Powering Precision Health, will share his vision for deploying new digital biomarker measurements to disrupt the traditional drug development process. He will draw from a long career commercializing life science research tools and his deep passion for attacking cancer and neurodegenerative diseases to provide a roadmap for researchers, executives, patients, investors alike to change the way healthcare is practiced today. His talk will cover everything from the impact of environmental factors on human health to providing insights into disease progression and accelerating drug development that was never possible before.

Following Kevin's remarks, distinguished researchers Dr. Henrik Zetterberg and Dr. Andrew Nixon will share the ways in which their own labs have been deploying biomarker technology in the areas of neurology and oncology research respectively to deepen the understanding of disease and help accelerate drug development.

Learning Objectives

• Understand how the FDA’s Biomarker Qualification Program can impact drug development timelines
• Review the principles of Adaptive Trial Design and their implications for accelerating drug development
• Understand the role of novel biomarker detection technologies in clinical trial endpoint considerations
• Learn about specific examples in oncology and neurology of utilizing novel biomarker detection technologies to advance the understanding of drug efficacy, toxicity, dosage response, and other parameters

Speakers:

Kevin Hrusovsky
President, Chairman and CEO
Quanterix Corp; Founder, Powering Precision Health

With over 25 years of experience in the life sciences industry, Kevin has dedicated his career to transforming the practices of medicine and health. As the founder of the Powering Precision Health Summit, Kevin spearheaded the creation of an executive think tank of researchers, scientists, physicians and innovators to highlight the latest research on new biomarkers that are transforming healthcare into personalized medicine. With a proven track record for commercializing disruptive technologies, Kevin joined Quanterix in 2014 and currently serves as the President, Chairman and Chief Executive Officer. Kevin also serves on the Board of Directors of several companies shaping the future of precision health, including Quanterix, BioreclamationIVT, 908 Devices and Solect Energy. He also serves on the Educational Board of the Massachusetts Biotech Council, the Advisory Committee for the Center for Biomedical Engineering at Brown University, the Association for Laboratory Automation, the JALA Editorial Board, and the Strategy Committee of Children’s Hospital Boston. Prior to Quanterix, Kevin served as CEO of Caliper Life Sciences, turning the company into one of the fastest growing biotech businesses in the region, leading to a $600-million acquisition by PerkinElmer Life Sciences & Technology. Following the acquisition, Kevin served as President of PerkinElmer. Earlier, he was CEO of Zymark Corporation, President of FMC Pharmaceuticals and International Agricultural Products and held numerous management positions at DuPont. He formerly served on the boards of SeraCare, Caliper Life Sciences, Xenogen – XGEN and Alliant Medical Technology. He is the 2013 Entrepreneur of the Year from Ohio State University and holds an Honorary Doctorate degree from Framingham State University for contributions in life sciences and personal medicine. Kevin holds a B.S. in Mechanical Engineering from Ohio State University and an M.B.A. from Ohio University.

Dr. Henrik Zetterberg
Professor of Neurochemistry and Head of the Department of Psychiatry and Neurochemistry
Sahlgrenska Academy at the University of Gothenburg

With a background in molecular biology and clinical chemistry, Henrik Zetterberg, MD, PhD, has spent the last 10 years focusing on the development of biomarkers for Alzheimer’s disease, Parkinson’s disease and other brain disorders. He has developed new diagnostic tests for Alzheimer’s disease, as well as new preclinical models, and has shown that (i) amyloid pathology precedes tau pathology by around five years during the Alzheimer’s disease process in humans, (ii) altered amyloid homeostasis in the brain is evident already in pre-symptomatic stages of the disease, and (iii) the diagnostic usefulness of Alzheimer’s biomarkers decreases with age due to increased prevalence of preclinical Alzheimer neuropathology.

Dr. Zetterberg has received numerous prizes, including the Erik K. Fernström Prize for Junior Scientists and the Inga Sandeborg Prize for Research on Alzheimer’s Disease. He is professor of neurochemistry and head of the Department of Psychiatry and Neurochemistry at the Sahlgrenska Academy, senior consultant in clinical chemistry at the Sahlgrenska University Hospital, guest professor of neurochemistry at University College London and a Wallenberg Academy Fellow.

Dr. Andrew Nixon, PhD
Associate Professor in Medicine
Member of the Duke Cancer Institute

Andrew Nixon, PhD, MBA (Associate Professor of Medicine) is Director of the Phase I Biomarker Laboratory, which brings together clinical, translational and basic research to pursue the development of novel biomarkers defining mechanisms of sensitivity, resistance, and toxicity to given therapeutic drug classes, particularly anti-angiogenic agents. Additionally, the laboratory has been appointed as a Molecular Reference Laboratory for the Alliance oncology cooperative group, a national clinical trial research group sponsored by the National Cancer Institute. The laboratory has quality control procedures in place to address many of the issues involved in clinical trial research including determination of sample quantity, sample integrity, and sample heterogeneity. We have spent considerable time developing robust assays that utilize limited amounts of specimen while providing high quality data. Multiplex ELISA and gene expression arrays are used to analyze serially collected blood and paraffin samples archived from cancer patient clinical trials. This work has the potential to improve the efficacy and toxicity of current therapies and to guide the development of the next generation of anti-angiogenesis therapies for cancer and other diseases.

Cost: No Cost!