As a member of the PMO office you will see many new products claiming to enhance the company’s products and portfolio. Using a series of metrics and personal intuition, it is your responsibility to act on behalf of the corporation to vet these proposals for their potential success or failure.
Below is an example of a new product development cycle for pharmaceuticals after the completion of the basic research phase. Knowing that new products are the lifeblood of a pharmaceutical corporation, consider the information below.
Basic Research Preclinical Testing Phase 1 Phase 2 Phase 3 FDA Review Market Entry
Avg. Duration (yrs.) 6 2 2 2 2 2
Avg. Compounds per/yr. 10 6 4 2 2 1
Ag. Cost of compound in $ (Mill.) 20 25 30 60 120 80
Your office is asked to provide initial feedback to senior management regarding the project’s viability. Using the guiding questions below, develop a 2-3 page summary report. Your report should include at least 3 references and follow the CSU-Global APA guidelines for APA formatting and style.
1. The ability of the effort to succeed
2. Difficulties you envision in the project and why
3. The average total value of this project
4. Consider the average output rate out of the FDA review. If there are 200 projects in the pipeline for basic research, how does this project fare?
5. What kind of performance is required to warrant a financial investment