Drug Information Association Logo

DIA to Host Webinar in Collaboration with Cytel to Provide Insight into Planning and Conducting CV Outcomes Studies

WASHINGTON — Oct 14, 2013

DIA today announced the next in its Solution Provider educational webinar series – this one being held in cooperation with Cytel.  On October 22, DIA will host: Planning and Implementing Large Cardiovascular Outcomes Studies: Opportunities & Challenges.

Cytel is collaborating with DIA to participate in its newly-created Solution Provider Webinar Program. DIA’s educational collaboration with Cytel brings together leading scientists and thought leaders from industry who will host this webinar.  

Register today for the no-charge October 22 webinar to learn from experts:

Paul Strumph, MD, Lexicon Pharmaceuticals', Vice President, Clinical Development

Zoran Antonijevic, Cytel Senior Director, Adaptive Implementation, Strategic Consulting

All Solution Provider webinars are free to DIA customers and will feature topics including oncology, strategies for late phase development, biomarkers and technology as an enabler of clinical development services.

Susan Cantrell, Director, North America at DIA said, “We are excited to host what will prove to be an insightful and in depth discussion.  Today, international regulators are calling sponsors to increasingly conduct CV outcomes studies. The costs necessitated by the additional research will be measured in the $100’s of millions of dollars per program.  The full impact to be felt by every sponsor, of any size engaged in therapeutic areas where cardio-related events are a concern.”

Cytel’s Senior Director of Adaptive Implementation, Zoran Antonijevic said, “We are pleased to work with the DIA to share the recent experiences with managing larger CV Outcomes trials.  Our goal is to help sponsor organization begin to formulate responses to critical questions -- How to best assess necessity, choose the design strategy, and determine timing?  Which development path is optimal: add-on studies or a more parallel approach? Do we choose a non–inferiority approach for approval? A non-inferiority trial in a post-marketing setting?”

 

 

###

ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.

ABOUT CYTEL: The clinical development of drugs and devices is a crucial contribution to human welfare. We stand committed to improving the success rates of the clinical development process through the application of statistical science and innovative technology.

All 25 leading global pharmaceutical, biotech and medical device companies rely on Cytel when planning and implementing their clinical studies. Pioneers in adaptive trials, every adaptive design submitted for regulatory review has been deemed acceptable.