BioPharm - 4

BioPharm May eBook - Outsourcing

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Page 26 of 42 May 2017 BioPharm International eBook 27 Outsourcing Resources Tech Transfer Getting Biopharmaceutical Tech Transfer Right the First Time Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure. Agnes shAnley T echnology transfer is essential to any innova- tor's success, but even the best science or the most innovative technology can be derailed by simple human failures (e.g., inadequate or infrequent communication, or reliance on approaches that reflect individual preferences or corpo- rate cultures, rather than a clear focus on what is needed to advance the project). The most effective tech trans- fers eliminate personalities and focus on data and clear communication, so that the right people are in touch about the right issues at the right time. In this arti- cle, Stephen Perry, CEO of Kymanox; James Blackwell, principal of The Windshire Group; and Michiel Ultee, principal of Ulteemit Bioconsulting, share some of the lessons they've learned to help prevent overruns and wasted time, and ensure that biopharmaceutical tech- nology transfers succeed. Mistakes in tech transfer BioPharm: From what you've seen, what are the biggest mistakes that companies make when they're working on tech transfer for biologics? Blackwell (Windshire): All too often, processes are sim- ply thrown over the wall to scale up and manufactur- ing. Sometimes a tech transfer team will have to deal with a poorly characterized process, in which process Dmitry Kalinovsky/

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