Problem:

Presidio Global undertook a three-step process to address GeneCo’s R&D challenges and generate a prioritized set of growth options.

       GeneCo, an international biotechnology company, was falling short of its goal to bring two blockbuster NMEs (new molecular entities) to market each year. An analysis of its development pipeline suggested that these challenges would likely continue, and might worsen, due to a dearth of projects in early stage (pre-IND/Phase I) development.

       GeneCo needed a new R&D strategy that would make the most of its investment dollars while addressing some critical gaps in the pipeline. The company had a relatively extensive R&D project portfolio consisting of 31 projects targeting more than a dozen indications. The lack of projects in early-stage development was due primarily to a number of projects falling through at the same time, not a lack of expertise; GeneCo’s R&D process was driven by some of the most prolific scientists in their fields. But the R&D process lacked significant input from other critical functions like sales, marketing, and managed care.

       Management was concerned about achieving its aggressive growth objectives in light of these significant pipeline challenges. Presidio Global was asked to assist GeneCo with designing a new growth strategy and addressing the R&D challenges.

Approach:

Presidio Global undertook a three-step process to address GeneCo’s R&D challenges and generate a prioritized set of growth options.

• Assessment of current R&D process strengths and weaknesses
• Perform competitive and best practices analysis
• Incorporate cross-functional input
• Develop implementation plan and set clear go/no go hurdles

• Conduct risk-adjusted market analysis of projects under development
• Portfolio analysis of markets/therapeutic areas covered
• Prioritize innovation options
• Identify gaps by market, size, and timing

• Utilize identified gaps in pipeline as starting point
• Identify and evaluate external growth opportunities
• Licensing, commercialization, acquisition targets
• Prioritize and execute opportunities based on NPV

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Recommendations:

Using the above approach, Presidio Global made the following critical recommendations to GeneCo.

• Cross-functional management of R&D projects to inject commercial insights into the development process
• Enables design of clinical trials with critical endpoints that correspond to unmet nees and will drive desired buying behavior

• Focus/Invest in identified critical therapeutic areas where GeneCo has a proven track record of success and market experience
• Follow established go/no go hurdles for development projects in order to maintain efficient use of resources

• Acquire licenses for promising new IP from university/government labs who are in need of revenue but lack expertise or resources to commercialize their technological developments
• Targeted licensing endeavors to fill pipeline gaps in critical therapeutic areas

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