This year has brought a range of challenges for biopharma companies and their leaders, including on-and-off tariff threats and President Donald Trump’s arm-twisting around overseas drug spending. New data reveal that these regulatory and policy disruptions are significantly hampering strategic planning and operational execution within the industry. Biopharma executives report heightened uncertainty, which complicates decision-making processes and resource allocation.
The implications of these findings are profound. As regulatory environments shift and policies evolve, companies must adapt quickly to maintain compliance and competitiveness. This ongoing turbulence may lead to increased operational costs and delays in drug development timelines, ultimately affecting market access and patient care. Stakeholders across regulatory, QA/QC, CMC, sourcing, and portfolio management must collaborate to navigate these challenges effectively, ensuring that their organizations remain resilient in an unpredictable landscape.
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