IQ Consortium Board of Directors Member (2018-2021)
IQ Regulatory Advisory Committee Chair (2020-2021)
IQ Good Manufacturing Practice & Quality Assurance Leadership Group (GLP QA LG) Chair (2012-2017)
IQ GLP QA LG Member (2017-2021)
IQ Quality Leadership Group (QLG) Co-Chair (2018-2019)
IQ QLG GMP QA Focus Group Member (2018-2021)
IQ Symposium Organizing Committee (SOC) Chair (2017)
IQ SOC Member (2011-2021)
Senior Associate Director, GMP QA, Boehringer Ingelheim (Ret.)
Human Physiology, University of California, Berkeley
HOW DID YOU FIRST GET INVOLVED IN IQ?
In 2012 (prior to the formation of the GMP QA LG), IQ was developing a series of papers on GMPs for early development. I was asked to join the team preparing a paper on small molecule specifications to provide a quality perspective.
WHAT WOULD YOU CONSIDER TO BE IQ’S GREATEST ACCOMPLISHMENT?
Among the many accomplishments, the IQ Database stands out most prominently. This tool allows for the sharing of complex data in a blinded fashion to increase the statistical power of the data. On a personal note, I’m proud of the increased relevance of quality (Q) with the formation of the Quality LG (combining the GLP and GMP LGs into one Quality LG) and the formation of the Regulatory Advisory Committee.
WHAT BENEFITS HAVE YOU AND YOUR COMPANY ENJOYED AS MEMBERS OF IQ?
Most of the IQ papers/workshops/webinars and other resources have provided a benefit to BI. Specific examples include the Allotrope Foundation and the Allotrope Data Format, the series of papers on GMP in Early Development (we reference these papers frequently), the IQ Database, and Data Integrity. In addition, the colleagues directly involved in the working groups have benefited through personal growth by their engagement with industry colleagues on topics that are critical to the pharma industry.
WHAT IS IN STORE FOR IQ?
I believe IQ remains uniquely positioned within the pharma industry to bring technical experts together to apply scientific tools and facilitate consideration of key challenges facing the industry. IQ needs to keep up with emerging trends (e.g., new modalities, personalized medicine, increasing risked-based and flexible approaches to drug development) and identify relevant topics where IQ can contribute.