Innovation Management Case Study:
Problem: A Global Pharmaceutical Contract Research Organization (CRO) wanted to start a new division that could develop products via the 505 (b)(2) pathway. They had three main requirements- Create appropriate team, Identify 505 (b) (2) product development opportunities and develop the identified products within best possible time line.
Due Diligence: A due diligence of CRO’s capabilities such as human capital, machinery, facility engineering, marketing plans, logistics, budget etc. was done. It was decided that existing scientific talent (rather than new recruits) shall be trained for this venture. A team Director shall be recruited who could provide leadership to the innovation program.
Solution: Innovation strategy was designed for team building and training of existing employees to prepare them for this new initiative, allocate space for conducting research work, set up budget etc . Appropriate product Life Cycle Management (LCM) opportunities were identified via Brainstorming, mind-mapping and Pareto tools.
How to identify 505 (b)(2) drug product development opportunities- An Innovation Management Case Study
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