SOURCE: Xtalks

Xtalks Webinars

May 26, 2016 07:00 ET

Upcoming Xtalks Webinar to Examine Pursuing Accelerated Approval in Oncology Indications: Is Your Asset the Right Candidate

TORONTO, ON--(Marketwired - May 26, 2016) - In this webinar the presenters will review a number of the benefits and considerations related to pursuing accelerated approval; offer advice on how to access the applicable expedited program, effectively interact with the Agency, follow the regulatory pathway most expeditiously; and highlight examples that illustrate both the advantages and challenges of pursuing Accelerated Approval.

Learning Objectives:

  • Understand expedited development/review options in the U.S. and EU
  • Identify potential benefits and risks of pursuing accelerated approval in oncology indications
  • Learn about the planning process for pursuing accelerated approval
  • Learn about how to execute trials designed for the accelerated approval pathway

The live broadcast takes place on Thursday, June 16, 2016 at 11am EDT (4pm BST/UK), featuring a panel of experts from inVentiv Health.

About the Accelerated Approval Process in Oncology Indications:
Sponsors in the US, the EU, and in some select cases Japan, are able to apply for Accelerated Approval from regulators based on a surrogate endpoint, using less clinical data than would typically be required. This approach is intended to speed products to market that treat serious or life-threatening conditions -- like cancer -- and that offer a benefit over current treatments. As a result, patients have benefited from earlier access to critical medications, and sponsors have enjoyed the accompanying market advantage.

The pursuit of the Accelerated Approval development path are not without risk, however, and the decision to seek this program should be made carefully with a complete understanding of the regulatory, medical and logistical implications. The greatest risk for sponsors in seeking Accelerated Approval using a surrogate endpoint is that the confirmatory clinical trial might fail to confirm the intended clinical benefit or reveals a new safety issue not detected in the earlier smaller trial population. Challenges in population selection, endpoint selection, diagnostic assay and trial design can all be barriers to success for a promising asset in successfully achieving Accelerated Approval. Even after Accelerated Approval is achieved, full marketing approval remains a challenge as confirmatory trials compete with a newly marketed agent.

To learn more or register for this complimentary event, visit: Pursuing Accelerated Approval in Oncology Indications

About inVentiv Health
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 14,000 employees and the ability to operate in more than 90 countries, we enable clients to successfully navigate an increasingly complex environment. For more information, visit

About Xtalks
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, health care 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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