Portfolio management has been embraced by the pharmaceutical and biotech industries because of the unique characteristics of drug development, huge investments, long development timelines, extremely high risk, and need for several products in the pipeline. Portfolio management is about selecting which projects should be funded, how they should be funded, and which should be killed.


Start-up pharmaceuticals and biotechs develop their first products with a laser-like focus, making whatever decisions are in the best interests of each product in isolation. As these companies grow, they continue making product decisions in isolation, unaware of the implications for their other products. Portfolio management is the idea that projects must be valued consistently, allowing investments to be aggregated across the portfolio or compared against each other on an “apples-to-apples” basis.


Regulatory Compliance Associates® Inc.’s Portfolio Management services for the Pharmaceutical industry include:


  • Needs Analysis, i.e., Therapeutic Areas and Product Strategies
    • Portfolio Diversification Across Therapeutic Areas
    • Portfolio Diversification Across Technologies
  • Asset Evaluation Process
    • Current Situation Assessment
    • Strategic Alternatives
    • Technical and Cost Analysis
    • Commercial Analysis
  • Risk Reduction via Strategic Alliance and Partnerships
    • Use of Discovery Alliances
    • Use of Development Alliances and Partnering Arrangements
  • R&D Portfolio Prioritization
    • Near-Term, i.e., <5 Years and Long-Term, i.e., <5 Years, Launch Targets
    • Development Strategy
      • Internal vs. Outsourced Development
      • Acquisition vs. In-Licensing
  • Stage-Gate Governance
    • Aligning Product Development with Available Resources
    • Monitor Progress Against Deliverables
    • ROI Accountability

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