SOURCE: Xtalks

Xtalks Webinars

June 02, 2017 07:00 ET

The Evolving Utilization of Specific Biomarker Roles Within Trial Design, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - June 02, 2017) - The live broadcast takes place on Thursday, June 15, 2017 at 10am EDT (3pm BST/(UK).

There is a lot of discussion across biopharma about the increasing complexity in the design and management of clinical trials. Recent estimates suggest the cost of bringing a drug to market is as high as $3 billion, and only 1 in 10 drugs successfully navigate the process and make it to market. These trends are not sustainable, and the use of targeted clinical strategies are being seen as a critical step towards improving success rates.

Historically, drug approvals sought to maximize the potential market opportunity both in the initial indication and later line extensions. The rising average duration of trials suggests that a change in strategic approach is valuable, particularly after the recent successes with drugs like Imatinib and Keytruda. Keytruda developed by Merck is indicated for patients with metastatic or advanced non-small cell lung cancer who test positive for TPS>1% PD-L1 expression and negative for EGFR and ALK mutations. This new drug has a mechanism of action that is so tightly understood and critically linked to a clear biomarker strategy that development professionals had the confidence to carefully select patients from specific sub-groups from the earliest trials and demonstrate efficacy from the earliest opportunity, leading to a uniquely accelerated approval and ultimately benefiting both patients and Merck with the granting of a Marketing Authorization.

To determine whether these celebrated successes reflect the beginning of a new stage of therapeutic evolution, we wish to understand how deep the shift has occurred towards personalized therapies and how widespread such an approach is across the therapeutic areas within clinical development. By comparing the two periods, 2007-2011 vs. 2012-2016, we can identify a number of trends in the application of specific biomarker roles (therapeutic effect marker, toxic effect marker, disease marker) within active clinical trials. The speakers demonstrate an increase in both the application of specific biomarker types and also highlighting some areas where there are opportunities to increase our knowledge of the underlying biological mechanisms.

To learn more about this event visit: The Evolving Utilization of Specific Biomarker Roles Within Trial Design

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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