• About
  • Introduction
  • Managing Directors
  • Principals
  • Consulting Staff
    • Senior Consultants
    • Consultants
    • Associates
    • Analysts
    • Interns
• Services
  • Introduction
  • Corporate Strategy
  • Technology Strategy
  • Licensing, Mergers, and Acquisitions
  • Portfolio Optimization
  • Commercialization Strategy
• Clients
• Cases
  • Introduction
  • Case Study 1
  • Case Study 2
  • Case Study 3
  • Case Study 4
  • Case Study 5
• Careers
  • Introduction
  • Benefits
  • How to Apply
• Alumni
• Contact
• Blog

Case Study 02: Target Product Profile and Clinical Development Planning

Situation

A multi-national pharmaceutical company wanted to leverage their technology platform and thus needed to understand the internal and external requirements to compete in the inflammatory bowel disease market (IBD). The client was interested in the clinical thresholds required to successfully enter the market as well as external factors that might impact the global opportunity

Complication/Opportunity

Given the recent and likely future strategic focus of the range of biologic competitors (anti-TNF, anti-integrins), the key question was whether or not a defined market will exist in the future for new therapeutic options and what performance profile is needed to support commercial success. Additionally, the analysis was complicated by the fact that IBD really is two discreet diseases (Crohn’s and Ulcerative Colitis), each at a different stage of evolution with its own set of market, clinical and competitive issues.

Approach and Resolution

Combining a comprehensive secondary research effort with a robust, in-depth primary research methodology, Frankel Group characterized the business case/rationale for each of these opportunities (Crohn’s Disease and Ulcerative Colitis) and integrated the findings into a prioritization framework for the portfolio of R&D investment options for the client.

Ultimately, the client needed to decide between a larger, higher unmet need marketplace with more competitive intensity versus one that was less competitively intense but also smaller in size due to mild and moderate patients being well managed…leaving the opportunity only in the most severe patients. Recommendations were made in a staged fashion since there were many uncertainties at this early stage of product development…focusing on the most immediate decision/investment that needed to be made to get them to the next decision “gate” (e.g. specific pre-clin models to pursue to answer mechanistic questions). The action steps were then prioritized within the context of the broader R&D program investments for the client taking into consideration program valuation, investment required, timing, likelihood of success…among other decision criteria.