Predictive and pharmacodynamic biomarkers are a critical component of today’s progress in immuno-oncology (IO) drug development. While predictive biomarkers can accelerate development by identifying the right group of patients to target and ensuring safety and efficacy of the compound, there are inherent challenges in finding and validating biomarkers that will end as companion diagnostics. Pharmacodynamic markers are very useful in early stages of development to help identify the true mechanism of action in humans. The straightforward approach to find and apply these types of markers is more complex in IO.
Many researchers have complained that use of different local IRBs to review each research site for a multicenter trial is extremely inefficient and leads to additional cost burdens and trial delays. Despite this, many US research sites have been hesitant to use a single, central IRB. Is there a substantive difference, in terms of efficiency and effectiveness, between reviews conducted by decentralized (local) and centralized IRBs? What are the pros and cons of each? Are local IRBs really even necessary, or do they just create bottlenecks in modern clinical trials? The webinar will focus on these issues and look at study startup metrics associated with IRBs.
Clinical supply models need to provide for an adequate supply of patient kits that allow for variations in patient recruitment levels and clinical site activity.
Do you face the challenge of recruiting and retaining rare disease patients for orphan drug clinical trials? Now, discover how you can boost participation, enhance outcomes and speed drug development in this competitive market. Join Dr. Rolando Gutierrez-Esteinou, MD, Vice President, Therapeutic Area Head, Neuroscience Medical and Scientific Services at Covance, for this timely Webinar.
Do you face the challenge of recruiting and retaining rare disease patients for orphan drug clinical trials? Now, discover how you can boost participation, enhance outcomes and speed drug development in this competitive market.
This webinar includes tips to help quality, project management, clinical, and site personnel manage conflicts as well as a review of the applicable regulations and reporting requirements.
In this webinar, the challenge of the prompt reporting of a low or high number of SUSARs to Investigators in global and large-scale clinical trials will be addressed.
In this webinar, Dr. Arun Sanyal will discuss risk factors for nonalcoholic fatty liver disease (NAFLD) disease progression and the implications in clinical development.
In this webinar we will first provide a high level review of the medical underpinnings of the diabetic heart particularly as it relates to heart failure. Understanding the structural, metabolic and functional associations of T2D will help us to better understand how some molecular classes could lead to benefits in CV outcomes while others may be detrimental.
As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, stressing the need to understand this rapidly changing landscape. What is the real potential for clinical and health-economic benefits offered by these agents?
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