A leader in the biopharmaceutical industry, Navidea develops novel radiopharmaceutical imaging agents for precision diagnostics.
Jamie Wilson, Associate Director, Global Quality Assurance, attended the 2013 PharmaLink Conference anticipating discussions on supplier management best practices with industry leaders and FDA officials. She and her team also came away with a long-range action plan based on a deeper understanding of the FDA Safety and Innovation Act.
“Insights we gained from Ryan Long, Congress’ Chief Health Counsel for the Energy and Commerce Committee, and Steve Solomon from the FDA helped us develop action plans to improve our Global Management and Supplier Qualification Program,” says Wilson. “Major benefits included removing barriers so we could get products to market faster.”
As the new program was being implemented, Wilson and her team returned to PharmaLink in 2014. They heard Russ Wesdyk, FDA Scientific Coordinator, and Jim O’Reilly, Professor, University of Cincinnati, explain what the FDA is looking for in metrics and how the industry should be involved.
“We then reassessed how we identify leading and lagging metrics, and analyzed unintended consequences from ourselves and our suppliers,” says Wilson. “It allowed us to structure management meetings in an entirely different way, monitoring specific metrics from our suppliers.”
Navidea has seen continued improvement in consistent and reliable quality performance from its contract suppliers due to the changes. In addition, Wilson now leads an industry-wide Pharmaceutical Quality Metrics Initiative, in cooperation with Xavier Health, working to identify metrics that are critical to ensuring the reliability of product quality.