But what defines a good contract partner is the way that companies deal with these deviations and manage uncertainty and risk, experts told attendees at InformEx in New Orleans.
Tony Wiederhold, joint process team leader for API manufacturing at Eli Lilly, said that CMOs often have a tendency to label deviations as mistakes rather than trying to understand “why the system was allowing human judgment to be a major safeguard.”
“Relationships are best when CMOs don’t have an aversion to telling us bad news,” Wiederhold said, noting that partnerships often work best when both companies come together earlier to resolve issues.
And although Big Pharma companies won’t have an integrated relationship with every supplier, both the supplier and its partner should lay out their assumptions and set up the language in master service agreement, he added.
Tony Treston, director of manufacturing at Unither Virology, a small early stage development company, offered a different perspective from the side of the CMO, noting that CMOs should “err on the side of over-reporting” as companies often “need to know in advance if something is going wrong.”
Treston gave the example of an early stage development of a batch that once came out an odd green color that was clearly different from previous batches though the company moved the material onto the next stage, only to realize what they feared earlier: out of specification test results.
“We need to encourage over-reporting even if there’s little understanding of what it is,” Treston said.
Wiederhold added that CMOs need to get over the fear of looking incompetent, adding that the three poisons of a bad partnership are aversion, attachment and ignorance.
Eli Lilly, however, looks to minimize its issues with suppliers by adopting global standards for safety and quality, as well as its supply chain partners. “We apply the same standards to everyone we work with and if they’re going to work with us, they’re going to have to meet those standards,” Wiederhold said.
But smaller CMOs and developers have a different set of problems, Treston added. “Large companies have a lot of clout and it’s very different for a smaller company,” which often times have only “one shot” to move a compound forward. “It’s tougher to recover if you’ve only got one project – the slightest failure becomes a company issue,” he said.