Best Practices for Integrating Biomarkers across the Drug Development Continuum
Join us from 11am-12pm EDT
About This Event
The use of biomarkers throughout all phases of the drug development process plays an increasingly important role in the drug approval process. Biomarkers used in early discovery stages of drug development enable companies to identify the most promising drug candidates in preparation for preclinical studies. Preclinical studies enable drug developers to characterize the safety, efficacy and toxicity of the early drug candidates.
The value of a well-designed biomarker strategy then extends to first-in-human studies where the drug’s activity, mechanism of action, safety, and proof of concept are tested. Once a drug candidate- enters phase II studies, the use of biomarkers shifts to identifying subjects that may have better responses to the drug, safety, decisions on dosing, as well as prognostic purposes. A well-designed biomarker- strategy is the cornerstone for utilizing precision medicine in a study and determining the right treatment for the right patient. Biomarkers that demonstrate usefulness in patient selection or patient responsiveness may be utilized in further phase III studies and ultimately may lead to diagnostic markers.
This webinar will present the important concepts of biomarker usage throughout the drug development process and provide case studies that demonstrate the value of biomarkers.
Key learning objectives –
- How to optimize biomarker selection to accelerate the drug development process
- Effective biomarker implementation strategies
- Evolving a biomarker into a diagnostic
Immunology; Chief Scientific Officer
Dr. Patrice Hugo obtained his Ph.D. in Experimental Medicine/Immunology at McGill University and completed 5 years of post-doctoral fellowships in Immunology at the Walter Elisa Hall Institute in Australia, and at the Howard Hughes Medical Institute in Denver, Colorado. He then became a Principal Investigator leading the T-lymphocyte Unit at the Montreal Clinical Research Institute with academic appointments at McGill University and Montreal University. Throughout his academic work, Dr. Hugo focused on T-lymphocyte differentiation, self-tolerance induction, and leukemogenesis. He worked at PROCREA BioSciences and Caprion as Chief Scientific Officer and Executive Vice President R&D, respectively. Dr. Hugo was assigned as Chief Scientific Officer at Clearstone Central Laboratories later acquired by LabCorp and became Associate Vice President and Chief Scientist at LabCorp/Covance Central Laboratories Division. Dr. Patrice Hugo joined Q2 Solutions as Chief Scientific Officer where he currently leads the global scientific strategy and is responsible for the medical affairs and scientific activities of the Central Laboratories, and the Specialty Testing Centers of Excellence worldwide including Expression Analysis Genomics, Vaccine, Biomarkers and BioAnalytical/ADME laboratories. Dr. Hugo has more than 75 peer-reviewed scientific publications. He also played an active role in a number of industry organizations, including being a member of the Board of Directors for Personalized Medicine Partnership for Cancer in Quebec, and the Steering Committee for the Biomarker Factory. He is also a member of the American Society of Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (SITC).
Patrick Hurban, Ph.D. is senior director and global head of Translational Genomics at Q2 Solutions. In this role, he is responsible for the identification and implementation of new genomic capabilities, encompassing bioinformatics and wet-laboratory methods, as well as the development and validation of genomic assays to support research and clinical programs. These include broad-based screening assays, such as exome and RNA sequencing, to highly focused expression, genotyping and sequencing assay panels that target a smaller number of genes.
Dr. Hurban has more than 25 years of experience in molecular genetics, including more than 18 years in positions of increasing responsibility in high-profile genomics-focused organizations. His research interests have focused on the genetic control of gene expression and have spanned diverse fields such as toxicology, developmental, and cancer biology.
Following a Bachelor’s degree in Biology from the University of North Carolina at Chapel Hill, he earned his Ph.D. in Human Genetics from the University of Utah in Salt Lake City before serving as a postdoctoral research fellow of the American Cancer Society in the Department of Developmental Biology at Stanford University.