COMMERCIALISATION
measurements and metrics. It’s hard enough to keep one organisation fully aligned on these dimensions: keeping multiple organisations with different timelines and expectations aligned presents an additional challenge. On the flipside, partnerships can result in learnings that can be mutually beneficial.
What would be your main tips for streamlining sourcing approaches? I’ve found throughout my career that, when it comes to sourcing, there are several key areas to consider as a company thinks about placing work externally. The sourcing process ranges from the early stage of request for information (RFI), which involves learning about a company’s capabilities, to request for proposals (RFP), where you have a specific programme in mind with desired timelines and clear deliverables. With respect to RFI, I’ve found that, historically, there’s a lot of exhaustive information gathering that is burdensome for the company that needs to conduct outsourcing, as well as the companies providing services. One thing I have done with my teams is to determine upfront what critical information is needed, versus an exhaustive list of everything you could imagine wanting to know. My specific area of expertise is in clinical phase drug product manufacturing. In that space we’ve narrowed
14 | Clinical Trial Supply Handbook
down must-have information to a few key areas, including geographic location of work, because that can be an important variable in our scientists’ ability to connect as well as the impact of material movements. Another thing to consider is a supplier’s regulatory status for markets where we plan to conduct clinical trials. From the beginning, our suppliers need some experience providing clinical trials to North American and EU markets. Without that ability as a starting point, creating a plan for clinical development is very difficult for a company having global reach. Of course, we also need to assure that the expertise, equipment, and scale of operations, as well as downstream capabilities (such as release testing), all come into the equation. We also look for high-level, non-confidential cost estimates, as it’s nice to get a basic idea of service cost consumptions. And we utilise a variety of high- level stability measures for our suppliers, such as regulatory status and publicly available financial indicators. An additional key thing we look at is responsiveness of the supplier during the RFI process – we’ve found this can be predictive of how the eventual relationship will work. All in all, taking a streamlined approach can be beneficial for both customer and provider as long as the ‘must have’ information requested is carefully selected.
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