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How Involved Should Biopharma CEOs Be In Outsourcing Activities?

When outsourcing drug development and manufacturing, how involved should the CEOs of emerging biopharma be in the requisite day-to-day activities and processes? Louis Garguilo interviews James Mackay, CEO of Aristea Therapeutics to answer this question within his article How Involved Should Biopharma CEOs Be In Outsourcing Activities?

Extract:

How Involved Should Biopharma CEOs Be In Outsourcing Activities?

When outsourcing drug development and manufacturing, how involved should the CEOs of emerging biopharma be in the requisite day-to-day activities and processes?

Now that’s a good question.

James Mackay, CEO of Aristea Therapeutics, and independent board member to emerging biopharma, says when he’s advising new CEOs, he answers by first informing them “at some point along the way, normally something in your CMC activities becomes problematic.”

And thus: “The CEO is likely to be the ultimate decision-maker on more activities related to outsourcing than they might expect.”

Mackay, who earlier in his career at AstraZeneca helped guide six drugs to commercial approval, outlined the role of an independent board member for emerging biopharma in our earlier conversation.

Here he’ll turn specifically to our leading question.

CEO In The Weeds

For an example of “normal” but “problematic CMC challenges” that can pop up for a CEO, Mackay uses his own situation at Aristea, where he is “living and breathing this right now.”

He describes the attempted nano-milling of an intermediate that “works beautifully on small scale, but not so well moving to large scale.”

CEO-level concern? Mackay thinks so.

But first, he says, it’s important – even at “virtual” start-ups – the CEO has at least a core team in place. That team can include an independent advisor suggesting approaches to the challenge; consultants and SMEs, who in this case, for example, can help the CEO better understand particle[1]size distribution, impacts of adjusting speeds, or the time of milling.

Next, as Mackay puts it, the CEO must recognise the people at the CDMO know their equipment and technology better than anybody. “They’ve seen more projects than we have,” he says. “Working with them as part of your team is critical.”

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