CBI’s 2nd Annual Forum on Investigator Initiated Research Studies

Jun. 8, 2009-Jun. 9, 2009
Courtyard Philadelphia Downtown
Philadelphia, PA
https://www.cbinet.com/show_conference.cfm?confCode=PC09147

Description:

Tim Dietlin, Vice President in our Clinical Development Practice, will present a session on minimizing risk and identifying opportunities through strategic planning.

Abstract:

Minimize Risk and Identify Opportunities Within Strategic Planning

IIS enables data to be generated on additional uses for pharmaceutical products. This can be extremely important to companies with products in complex specialty markets, since those companies often do not have the resources to pursue registration strategies for every potential indication. IIS provides companies the opportunity to stretch their R&D budgets, while simultaneously educating physicians. However, pursuing IIS comes with considerable risk. Companies have no control over the design or conduct of IIS, nor the data that comes about as a result. Obviously, this could provide substantial risks to the commercial viability of any product. Any company seeking the benefits of IIS must adopt a careful and strategic approach that balances risk with reward. This session helps attendees answer several important questions including:

  • Why are IIS programs so critical to some products?
  • What are the risks involved with pursuing IIS?
  • What are the key challenges to address when evaluating IIS opportunities?
  • What are some best practices that companies can use when pursuing IIS?

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