The company believed they needed to develop a level of internal capability to effectively deal with scheduling challenges, IP control, technology transfer and life cycle management. The company was proposing to invest $33-39MM to build a process development centre to develop drug substance/product for small molecules and biologics.
Many options were considered over three years, but could not be agreed on to develop a sound business case for the management team.
Within a very tight timeline PA achieved:
• agreement on the capabilities and functions to be housed in the facility to manage knowledge internally and with vendors across the portfolio and pipeline
• development of a sound business case that provided best fit with the space plan, maturity/evolution of the company and the projected pipeline
• consensus from a diverse group of stakeholders not used to working with one another to generate a proposal for the management team with a level of detail not previously achieved.
PA provided a business case that contained a consistent data-set, an understanding of the risks and alternatives and a proposal that makes sense given the client constraints. The proposal was approved by the management team and a site study was initiated.
To find out more about how PA can help you with process development, please contact us now.
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