Optimizing probability of success in developing a new pharmaceutical

ISEA supported a pharmaceutical startup company in finding its position within a specific therapy area and helped it optimize the probability of a successful development of a new medicine.

Situation

A small size pharmaceutical company emerging from academia was in need pharmaceutical industry development experience and expertise. The assignment demanded specific therapy area knowledge and involved the development of a project plan as well as a business plan for raising funds for the work to be done. In addition, support in regulatory agency interaction and negotiations with potential partners were requested.

Approach

The ISEA assignment was to work on a long-term basis to contribute to the various tasks emerging during the course of the development. Several of the tasks have been thorough analysis and evaluation of different development options for the project. The assignment has also included a interim role as Project Director in the project management process.

Result

The output from the work has generated a defined way forward to optimize the probability to create a new pharmaceutical for a disease with high unmet need. The work has focused on the important questions to generate valuable data for informed decisions. Additional funding has also been applied for and approved.

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