ISPE President and CEO John Bournas welcomed attendees and thanked both the companies participating in Wave 1 of the ISPE Quality Metrics Pilot Program for their expertise and enthusiasm and the ISPE Quality Metrics Task Force for their hard work.
“It is exciting to finally have a dedicated conference for quality metrics,” said Diane Hagerty, Vice President, Genentech Inc., and Task Force co-chair. “We are also excited about sharing outcomes of the pilot program and getting the data to industry.”
Hagerty introduced Willie A. Deese, Executive Vice President, Merck & Company, who told attendees that Merck has spent the last five years improving quality through metrics and laid out some of the programs and steps Merck has taken to achieve higher corporate quality. “What is it like to be a patient?” asked Deese. “We have all been a patient or know someone who has been a patient. At the end of the day, what really matters is delivering what the patient needs when it is needed.” Deese discussed four elements employed at Merck – compliance, reliable supply, strategy, and budget.
“The first two are the most important,” he said. “We never make decisions based on budget. We link people to targets and make sure that everyone knows what we are measuring and why.” Ashley Boam, acting director, FDA/CDER/OPQ/OPPQ, spoke on how data from metrics may be used by the FDA in establishing quality standards and expectations for industry and helping to make “robust analyses” of industry. “If you can’t measure it, you can’t manage it,” said Boam, who also noted that it is important to develop quality metrics that are useful for both products and sites.
Boam suggested that quality metrics can reduce recalls and drug shortages, which are FDA goals for the industry. She thanked ISPE for their efforts in carrying out the Quality Metrics Pilot Program and noted that the effort has the potential to better protect the drug supply.
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