Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.
Biopharmaceutical experts Stephen Perry, CEO of Kymanox, James Blackwell, principal consultant with The Windshire Group, and consultant Mike Ultee, share best practices and musts to avoid in biopharmaceutical technology transfer. Some crucial takeaways? Share all data (especially data on failed runs in the past), and include clear instructions for sampling. In addition, aim for reproducibility.
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Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.