Learning Lab: How COVID-19 is Redefining Drug Development and Manufacturing

Watch this Learning Lab video presented by Chris McPherson, Principal Scientist, DS Manufacturing, Samsung Biologics, which details how CDMOs have reacted to the challenging ‘Black Swan’ event that is the COVID-19 pandemic by initiating ‘Green Swan’ thinking that is optimising timelines via agile execution, transparent communication and teamwork, and innovative regulatory strategy and support.

Within the presentation, McPherson makes the distinction between ‘Black Swan’ events -- unexpected, hard-to-predict events that result in extreme, unintended consequences – and the ‘Green Swan’ concept which is a positive market and value development once deemed highly unlikely, if not impossible.

“With the emergence of the COVID-19 pandemic, the pharma and biotech industry has been hit by a Black Swan, and globally, 335,000 ongoing clinical trials have either been cancelled or significantly slowed,” he says. “Yet there we could also find Green Swans take off in cross-pharma collaboration, accelerated drug development, and approvals.”

He says that looking at the Green Swan concept from the CDMO perspective, technological innovation has enabled overall time saving by agile execution through predefined platforms at each phase and process, expedited batch processing with close communication with clients and successful regulatory submission with strong IP protection.

With typical pre-COVID tech transfer timelines of at least six months, McPherson also explains how Samsung Biologics, as part of its COVID-19 response, set about reducing its tech transfer to as little as three months from kick-off to Out of Freeze for the first ‘at scale’ run.

To watch the Learning Lab, click here