Toronto, Canada (PRWEB) June 24, 2014
Much conversation and excitement have been generated since the introduction of a Breakthrough Therapy Designation (BTD) and oncology therapies have become an area of focus for this designation. With many questions surrounding the topic, this webinar will first provide an introduction to the criteria and process for obtaining FDA’s BTD, including a working understanding of the use of the BTD in cancer therapies. Next, the role of timely and robust health economic and outcomes research (HEOR) data will be examined, reflecting how evidence can be generated to support a product with BTD.
Join speakers Jay Jackson, Vice President of GHEOR, and Kasia Puto, Associate Director at Xcenda, for an informative session using a case-study approach to demonstrate how quickly evolving data can affect timelines and impact HEOR initiatives in these scenarios.
Key take aways include:
- Knowledge of the key components of FDA’s BTD
- Familiarity with the qualifying criteria for expedited programs
- Ability to discriminate between different pathways to FDA expedited drug development
- Awareness of products (oncology and non-oncology) that have been granted BTD status
- Recognition of HEOR opportunities and challenges specific to preparing and supporting a value story for a BTD product
- Expertise to apply these learnings to the development and commercialization of future BTD products
For more information or to register for this webinar, visit: Breakthrough Therapy Designation: Oncology Lessons.
Xcenda is a strategic consulting firm with 20 years of experience applying real-world expertise in health economics and outcomes research, reimbursement, health policy, market research, and market access strategy. As part of AmerisourceBergen Corporation, a leading global healthcare solutions company, Xcenda supports global pharmaceutical companies as well as emerging pre-commercialization phase firms with challenges such as developing an evidence package to optimize access in key global markets, predicting product performance, and identifying reimbursement strategies and programs to maximize patient access. From development through market maturity, Xcenda helps manufacturers identify, demonstrate, and deliver their brand’s value proposition to key healthcare stakeholders. For more information visit http://www.xcenda.com/.
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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