JOHN BURKHARDT, PhD, DVM
IQ Board of Directors Member (2018-2021)
IQ Preclinical Safety Leadership Group (now DruSafe) Chair (2016)
IQ DruSafe Member (2012-2021)
Senior Vice President - Global Head, Drug Safety R&D, Pfizer
PhD, Pathology and Toxicology, Purdue University
WHAT ARE THE BENEFITS OF IQ MEMBERSHIP?
IQ has a unique ability to aggregate blinded data across many companies and to derive insights from those data sets. I'm not aware of any other entities able to do that within the pharma space. The data insights go on to form the basis for discussions with Health Authorities and often result in impactful, peer-reviewed publications that inform and influence key audiences.
FROM YOUR PERSPECTIVE, WHAT ARE IQ'S GREATEST ACCOMPLISHMENTS?
IQ has accomplished so much that it can be difficult to specify the "greatest”, but I'll give it a try! IQ has been able to share data, to bring insights and external influence, in a way that seemingly no other entity has been able to do. Some resultant preclinical safety examples include publications on preclinical to clinical correlations and interspecies sensitivity to convulsive effects of compounds. The data sharing database capability is a major strength and will serve us well as we continue the powerful data sharing initiatives.
REGARDING YOUR ENGAGEMENT IN IQ, WHAT MAKES YOU MOST PROUD?
At an annual face-to-face meeting with Pharm/Tox supervisors at FDA, we unlocked a level of engagement and honest, interactive discussion (on the topic of NOAELs in toxicology studies) that seemed to change the trajectory of these meetings for the future. Today, we have hugely valuable interactions at the annual meetings, including engaging breakout discussions.