Deborah Driscoll

Deb Driscoll is Vice President of Quality Assurance at Merck Research Labs. In February of 2014, heads of quality from large and small biopharmaceutical companies were asked to gather and discuss challenges facing the industry when it came to quality. Deb Driscoll spent time identifying the root cause and found that many of us were trying to implement ICH Q10 in clinical trials, which is a pharmaceutical quality system developed for Good Manufacturing Practices (GMP). She was also looking to follow other international standards, such as ISO methodology.

Deb Driscoll developed the following problem statements: How do we improve quality in clinical trials in a quality system framework that would improve efficiency for sponsors? How do we do that in an effective way that is voluntarily applicable to any company size, large or small? Those questions spearheaded exploratory work through funding, guidance, and oversight from TransCelerate.