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
Chief Scientific Officer
Patrice Hugo, Ph.D. is chief scientific officer of Q2 Solutions, a Quintiles Quest Joint Venture. Dr. Hugo leads the organization’s global scientific strategy and implementation, developing and accelerating strategies to help improve human health through innovation that transforms science and data into actionable medical insights.
Dr. Hugo brings more than 25 years of senior scientific leadership experience with extensive management expertise in laboratory operations applied to diagnostics, therapeutic targets and clinical trials. Most recently, Dr. Hugo was Associate Vice President and Chief Scientist at Laboratory Corporation of America (LabCorp). He has held several other senior leadership positions at companies including LabCorp, Clearstone Central Laboratories, Caprion and PROCREA BioSciences. A noted industry expert, Dr. Hugo has more than 75 scientific publications in internationally renowned journals. He also is active in a number of industry organizations, including his role on the Board of Directors for the non-for-profit Personalized Medicine Partnership for Cancer in Quebec, Warnex offering analytical and bioanalytical services and his role as a Steering Committee Member for the Biomarker Factory.
Dr. Hugo obtained his Ph.D. at McGill University and completed five years of post- doctoral fellowship at the Walter Elisa Hall Institute in Australia, and Howard Hughes Medical Institute in Denver, Colorado.
Senior Director and Global Head, Translational Genomics
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.
Chief Pathologist and Senior Medical Director
Radha Krishnan, M.D., is chief pathologist at Q2 Solutions, a Quintiles Quest Joint Venture. In this role, and in collaboration with the company’s chief scientific officer and chief operating officer, Dr. Krishnan defines the plan for global Anatomic Pathology (AP) service offerings, including instrumentation, technician and pathologists. Additionally, she serves as the scientific advisor for AP services, such as immunohistochemistry (IHC), In-Situ Hybridization (ISH) hematopathology and cytology. This includes the supervision of all assay validation, Pathologist and staff training, proficiency testing, the review and approval of related SOPs, and validations to ensure global harmonization of AP laboratory testing in accordance with applicable regulations governing clinical laboratories.
Dr. Krishnan has more than 22 years of post-specialization experience, with the last seven years in senior leadership roles within Quintiles and Q2 Solutions, including the senior medical director and head of AP for Europe and Asia. Prior to Quintiles, Dr. Krishnan worked as a consultant Pathologist in tertiary referral hospitals and cancer centers and specialized in tumour pathology. Dr. Krishnan has also been in the academia as an Associate professor in Pathology in the Faculty of Medicine at the University Technology MARA in Malaysia, and a lecturer in Pathology at the International Medical University in Kuala Lumpur.
Dr. Krishnan obtained her Bachelor of Medicine, Bachelor of Surgery (M.B.B.S) and her Doctorate in Medicine (M.D., Pathology) from the University of Madras in India. She is also a Member of the International Academy of Cytology (MIAC).