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CMO 2016

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TECH TRANSFER Outsourcing LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016 20 edge of at least one's own facilities and equipment — his company shares a "guidance policy" with clients. He says that when CMOs clearly detail the aspects and their methodology of tech transfers at the different stages, it helps ensure both sides understand the experiences of the other and also helps in setting realistic goals. "It's not that we have to do every- thing our way or even a certain way," concludes Advant. "But at the end of the day, the CMO is expected to deliver to the customer. And that starts right off the bat with the project transfer working out." SIZING UP YOUR PARTNER Hank Stern, VP CMC, Alexo Therapeutics, says it's difficult to determine whether one organization does tech transfer bet- ter than another. However, he lets us in on some telling research regarding the potential costs of a commercial-scale project, which may help inform a spon- sor on technology-transfer discussions and decisions. Stern puts that in perspective. "If you ever went to a CEO at a smaller pharma company and said, 'We need 40 FTEs to do a tech transfer,' it's just not going to happen. All sponsors, particularly smaller pharma or virtual companies, need to ask: 'How do I fully leverage the systems and processes at my CMO?' You may feel like you lose some control, but you can effectively minimize resources and gain the full experience of your partner manufacturer." The key here, of course, is to make sure sponsors have strategies but, more importantly, who has the most experience." Besides his general tenet regarding the primacy of experience, Advant suggests a specific approach to more effectively transfer product into any facility: Scale-down models should be performed to gain a deeper understand- ing of challenges before proceeding to the desired scale up within the CMO's manufacturing format. "Of course the client has to agree to the strategy, and be a willing partner in these activities," says Advant. That final comment on client accep- tance can be the most difficult part of the equation, according to so many I've talked to over the years at CMOs and from some personal experience. It's the sponsor's project. They are paying, and they often feel they know what's best in the transfer process. Advant says that to help gain acceptance — or recognition of experience and knowl- hat ongoing challenge has increasingly led to another question, this one posed in more hushed tones (and some conspiratorial drama): "Do you think the CMOs have developed strate- gies for tech transfer that may be superior to pharma's own?" Here's what some professionals have to say. EXPERIENCE TRANSFERS WELL "One of my first projects years ago was perceived as a straightforward com- mercial tech transfer from a customer," recalls Siddharth J. Advant, president — Biologics, Kemwell Biopharma. "We thought, 'It's a set commercial product, so what's the big deal?' But as many now know, when you have to fit a process into a new facility, not everything performed in the original location is going to work in the next one. I've learned it's not a matter of who has the best tech transfer An exasperated pharma veteran publically voiced a widely shared concern via an open question: "Our industry's been engaged in tech transfer for some 30 years, so why haven't we gotten really good at it?" "It does make me wonder," replied a second industry executive at the same forum. "I've seen tech transfer at Big Pharma continue to pose problems through this decade, including between internal sites. It remains a challenge." T By L. Garguilo WHO'S GOT THE BEST TECH TRANSFER PROTOCOLS? Who's Got The Best Tech Transfer Protocols? L O U I S G A R G U I L O Executive Editor, Outsourced Pharma @Louis_Garguilo

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