Challenge: A European company focused on the development of oncology vaccines needed assistance in planning for a U.S. IND, as well as a global Phase II clinical program.

Beaufort Solution: Beaufort designed an IND strategy that addressed the challenges facing an oncology vaccine, while taking into consideration the problems faced by other companies with similar compounds.  Beaufort provided CMC support for the client’s manufacturing efforts.  In addition, Beaufort consulted on and prepared the pre-IND package for the FDA.  The client received such a clear positive response to the package that a meeting with the agency was deemed unnecessary.  This process facilitated the near-term development of its compound and led the way for the international Phase II program.

Date posted: October 27, 2011

Categories: Case Studies Clinical Research Regulatory Affairs