The pharmaceutical industry continues to face enormous pressures from increasing payer demands, and a constantly changing regulatory landscape has forced all companies to identify processes to increase productivity and decrease attrition. However, success rates for candidate drugs moving from Phase I to market have remained relatively steady at ~7% for the last several years. There have been numerous attempts to understand the reasons for failure and many have offered suggestions that have promised to decrease attrition, but these have mostly met with marginal success.
In this webinar, our featured speakers will cover clinical attrition, discuss a number of factors associated with trial endpoint success and explore specific strategies related to effective trial amendments. For trial success, the speakers will look at several aspects of trial design that are associated with increased likelihood of trial endpoint success, including the application of specific types of biomarkers in different phases and therapeutic areas.
The speakers will also discuss how protocol amendments are a time-consuming and costly endeavor. In this discussion, they will examine how amendments impact budget planning, patient enrollment, and increased cycle times. The speakers will also address ways to incorporate strategies to reduce the number of amendments and when amendments are required, how to make them more effective.
Dr. Richard K. Harrison, Chief Scientific Officer, Clarivate Analytics
Dr. Richard K. Harrison is the Chief Scientific Officer at Clarivate Analytics. He has over 30 years of experience in the life sciences industry. His career has focused on all aspects of preclinical drug discovery. During this time, he has held positions of increasing responsibility at Aventis, Merck, DuPont and Wyeth Pharmaceuticals where he delivered numerous clinical candidates and worked on several marketed drugs. In addition, he served as a founding scientist in two successful venture-funded computational and structure-based drug design companies. Dr. Harrison has authored over 40 peer-reviewed publications and book chapters in all areas of drug discovery and has presented over 50 invited lectures on these subjects. He earned his Ph.D. in Biophysical Chemistry and Enzymology and currently serves as an adjunct professor at several universities.
Gavin Coney, Head of Clinical Products, Clarivate Analytics
Gavin Coney is the Head of Clinical Products for Clarivate Analytics. In this role, he manages a portfolio of products dedicated to supporting decision making by professionals within life science organizations who are interested in gaining intelligence relating to clinical development, clinical operations and competitive intelligence. Gavin has worked within informatics for 17 years and within the life sciences for the last 8 years.
Teresa Fishburne, Head of Clinical and Regulatory Professional Services, Clarivate Analytics
Who Should Attend?
Senior professionals from biopharmaceutical companies working within:
Chief Scientific Officers
Drug discovery / R&D scientists
Translational research scientists
Presidents, CEOs, CFOs, COOs
Managing Directors, Heads of Business Development
What You Will Learn
- What the latest trends are in clinical success and phase attrition
- The scenarios in which biomarkers contribute most to trial endpoint success
- How can you inform critical decisions relating to trial amendments