Webinar highlights
While considered a relatively novel term in research, biomarkers and diagnostics have been extensively used in the pre-clinical and clinical research and diagnosis arena for many years. Their magnitude in positively influencing the medical community’s ability to accurately diagnose and treat human conditions, although still undefined, seems limitless. Currently, a renewed focus is being placed on healthcare outcomes, and the containment of medical cost, diagnostics, biomarkers and personalized medicine are fostering better outcomes and savings.
In this webinar, our speakers discuss how the need for more clinical applications for diagnostic biomarker testing is expected to have an explosive growth among several disease categories in the five years. They also explain how the operational execution of biomarker and diagnostic research varies greatly from traditional clinical research, while looking at the unique requirements and challenges.
This webinar covers:
- Evolution of diagnostic product development
- Current environment and trends: regulatory requirements
- Execution of population-based studies
- Establishing value for diagnostic and biomarker in a real-life setting
- Operational implementation and management of patient studies
About the speakers:
Dr. Jerome Wilson is Senior Medical Director, Late Phase Services at PRA. As the lead epidemiologist, he is responsible for providing consulting services and developing post-marketing strategies for marketed products. Dr. Wilson has more than 15 years of scientific management experience in the pharmaceutical industry, and has broad administrative and research management experience in all phases of drug development, pharmacoepidemiology and health outcomes research.
Dr. Wilson served as Senior Interdisciplinary Scientist and Team Leader for Anthrax Therapeutics in the Office of the Assistant Secretary Preparedness and Response at the U.S. Department of Health and Human Services (HHS) in Washington, DC. He received his A.B. Cum Laude from Dillard University in New Orleans, his A.M. from Harvard Medical School, and his Ph.D. from the University Of North Carolina School Of Public Health.
Kathleen Kushner has managed several post-marketing safety surveillance programs (including PASS). Her professional research career has almost exclusively been in the area of late phase development within global CROs, specializing in large national and international post-marketing diagnostic, safety and registry programs in a number of therapeutic areas.
Prior to joining PRA, Ms. Kushner worked for a company solely dedicated to the strategic design and implementation of late phase studies, where she directed all operational aspects of late phase programs including clinical operations, data management, pharmacovigilance, biometrics and external vendors.
Who should attend?
- Regulatory Affairs
- Head of Clinical Research
- Epidemiologists
- Benefit/Risk Management
- Medical Affairs