BioPharm Associates LLC
Biopharmaceutical Project Management Solutions
Success Stories


Development of a Global PM Department

Opportunity – A mid-size pharmaceutical company expected tremendous growth in their portfolio over a 3-year period.  Along with the need to conduct global studies there was a need to develop its Project Management Department to meet this expected growth.

 Solution – Implemented a global PM department by developing roles and responsibilities, identifying new business processes, and developing the organizational
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Implemented A Global Enterprise Management System

Opportunity A pharmaceutical company was having difficulty in managing their portfolio.  Timelines/baselines/stage-gate milestones were decentralized and it was difficult to assess project performance and potential NDA/MAA submission dates.  Also there were times where opportunity was lost for high priority projects because activities timelines were decentralized.

Solution Interviewed key stakeholders to conduct a user-owner-stakeholder analysis followed by a gap analysis.  An enterprise project management system was implemented with inputs from 3 regions (US, EU, Japan) resulting in one official timeline and project performance objectives.  Value to the company was to properly assess future resource requirements, identify competing studies, access delays to potential submission dates, and collection of study metric data for process improvements.

 

Regulatory Agency Marketing Authorization

Opportunity An emerging biotechnology corporation was preparing to submit their first major BLA/MAA and needed expertise in the planning and execution of the submissions. The target was to submit the BLA/MAA 3 ½ months after database lock.

Solution Working with the global project team developed a plan, assessed resource requirements, developed document work flows, and implemented project management tracking tools successfully submitting the BLA/MAA in 3 months.  As a result of the aggressive submission plan and priority approval the product was launched 4 months earlier than planned with $25 million in unplanned revenues.

 

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