“Understand not only what your CMO can do, but how they can get it done,” was Baxter’s message during a speech at the year’s Interphex in New York.
Raul Soikes, senior director of program management, R&D for the organisation told attendees the most crucial element to a project’s success is creating joint assessments between businesses and service providers.
He said that by forming service agreements with the CMO (contract manufacturing organisation)–allowing for an understanding of what is expected from each party early on in the process – firms may eliminate waste of the most important resource for drugsmakers; time.
“Sometimes if you miss the delivery of something the company misses the window in which they can sell the product,” he said.
Soikes added the most important part of the service agreement is risk assessment.
He said: “Both the client and the CMO work together to understand and it becomes a joint plan. If something happens – and Murphy’s Law things will happen – you already have a pathway set out.
“You don’t have to stop and make a decision. You don’t have to waste time trying to pull the next step together.”
Those CMOs with a team of risk assessment experts for each part of the process – QA (quality analysis), manufacturing, regulatory and an over-all project manager – rather than one do-it-all person, are the ones Soikes heralded as the most successful.
“The nice thing about this risk assessment is that you are able to have your clients do specific parts of the process expert with your subject expert.
“It helps understanding about how the process in your plant works, helps the client share information they may not have known,” he said, citing an instance with a Baxter client in which neither party realised their valves were situated in a different place on the machinery prior to assessment.
“Small things like this can mean big implications,” said Soikes.
He urged companies to constantly work with risk management teams, involving as many people in the process as possible.
“If you can manage a risk, get more data, information, get more people involved there are bound to be fewer issues and thus lest cost.”
He warned: “Risk assessment is a living document and you have to monitor it at least once a month so it will be effective.”