How to identify 505 (b)(2) drug product development opportunities- An Innovation Management Case Study

​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.

Results Dashboard:

• LCM opportunities were identified for 10 products which would be developed using the 505 (b) (2) pathway.
• The management decided to select 3 out of the total 10 opportunities, to initiate the program. Balance 7 opportunities would be worked upon in a tiered fashion once funds accrue.
• The team building campaign was a super success. Output from this campaign fetched the CRO immense intellectual property which they would capitalize in due course.

Following three patent inventions involve 505 (b) (2) pathway product development-

1. Modified release mucoadhesive formulation of Clopidogrel bisulphate (Appl 2162/ MUM/2012)
2. Novel pharmaceutical composition of Argatroban (Appl 2713/ MUM/ 2011).
3. Novel formulations of Tetrabenazine (Appl 2716/ MUM/ 2011).

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​​Keywords and Tags:
#ContinuousImprovement   #Innovation