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Case Study

Therapeutic Area Entry Strategy

Multinational pharmaceutical company preparing to enter the Oncology Market.

A multinational pharmaceutical company with a robust pipeline of oncology therapies was seeking product development, clinical development, and market development for its lead oncology compound. The product had met Phase I requirements and was moving into Phase II. It would be the second market entry in the class and would be competing against a well established brand. Given this situation, the company needed to prioritize potential indications and find the optimal route for clearing FDA registration hurdles.

To facilitate successful clinical development, launch, and market penetration of the lead oncology compound.


Because of the uncertainty of clinical development, we conducted an evaluation of existing and prospective diagnostic and treatment pathways. This approach allowed us to determine future unmet needs and patient accrual across multiple indications. ISA’s scientific experts created a Claims Map that defined the variables affecting approval of future indications and the resulting regulatory and competitive positioning across multiple market scenarios. These scenarios helped us formulate a set of commercial priorities and action plans.

Senior leadership of the company’s Oncology therapeutic area reviewed the Claims Map with ISA’s project team. Based upon that evaluation, the company restructured its allocation of resources for its entire oncology portfolio. This included re-sizing the sales force and restructuring the organization's commercial and clinical teams. ISA’s risk-adjusted view of the market environment helped the client better define a funding request from global senior management. This assessment focused on the product’s best chance for a favorable development outcome and balanced that against the need for a positive return-on-investment.

Sample Results:
  1. Creative Trial Designs
  2. Strategy Algorithm
   

 

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