Case Study - Developing Pharmaceutical Strategy

Challenge -  Find a development strategy for a molecule that was languishing or agree to stop further development

Situation - With several drugs in the same class already on the market it was unsure that an additional molecule in the class would provide significant additional benefit to patients.  Based on preclinical data, a number of small trials had been conducted but a coordinated strategy had not been developed.

Solution - After assembling a team that included key functions, all available data (preclinical and clinical) were reviewed and a list of potential indications developed based on the molecule’s mode of action and disease biology.   A comprehensive review was conducted for each indication on the list including 

  • current standard of care, 
  • level of unmet medical need and 
  • potential regulatory, operational, competitive and pricing and reimbursement challenges

Conversations with internal stakeholders then provided important perspectives on the molecule and indications.  The list was refined and indications prioritized based on all of the inputs to this point.  Preliminary clinical programs were designed for selected indications to understand resource needs and potential approval dates.  Based on the entire data package, the proposed strategy was presented to senior management where the path forward was agreed.

Outcome - Five years after the agreement on the development strategy the molecule was approved in both the US and EU.

How S3B assists you to develop or optimize a pharmaceutical strategy?  A team that augments and collaborates with your internal resources and needs will be assigned.  Working together, an optimal development strategy will be identified as well as the optimal execution strategy that will balance scientific questions to be answered, time and cost.

Know the indications but need to identify the optimal strategy to execute?  S3B will work with you to identify the regulatory, operational, competitive and pricing and reimbursement challenges and then help create the optimal development and execution strategy.