Planning the Pivot: Onshoring Pharma/Biotech Manufacturing in a Brave New World

Starting with tariffs and Executive Orders, there are myriad incentives – some would say imperatives – for pharma and biotech companies to increase and expand manufacturing in the US.  But this is a classic “easier said than done” situation, for a number of reasons.  Sally Gu and Chris Middendorf, drug manufacturing and quality experts and leading members of the Hogan Lovells Pharma/Biotech Regulatory Compliance and Enforcement Practice, join Phil Katz to dive into one particular set of issues – those related to the technical, logistical and other practical considerations of manufacturing these products.  Drawing on their years of experience advising and advocating for product sponsors, manufacturers, and others on how to efficiently and compliantly manufacture or source drug and biotechnology products, Sally and Chris tackle the challenges in adding or changing manufacturing sites.  They bring an integrated and strategic approach, and discuss how companies can (and should) do the same.