Gil Roth, president of the Pharma and Biopharma Outsourcing Association (PBOA), delivered a stark assessment of the uncertain regulatory and trade environment facing US drug manufacturers under Donald Trump's administration at CDMO Live 2025.

In a presentation characterised by its unflinching candour, Roth outlined the key challenges confronting contract manufacturers, from rapidly changing tariff policies to mass layoffs at the FDA. His central message was bracingly simple: "Nobody knows anything. You need to be focused on flexibility and optionality."

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