DOUGLAS KELLER, PhD
IQ Board of Directors Member (2011-2020)
IQ DruSafe (2011-2020)
Global Head for Development Projects, Preclinical Safety, Sanofi (Ret.)
PhD, Toxicology, Duke University
DESCRIBE THE COLLABORATIVE SPACE IN THE AREA OF INNOVATION AND QUALITY IN PHARMACEUTICAL DEVELOPMENT IN 2010, WHEN IQ WAS FORMED.
A lot of new technologies were coming into vogue around 2010, and the time was ripe for collaboration. Companies understood that they could benefit from these collaborations and save time and money, as well as improve their technologies. Many of the IQ leadership groups (LGs) were able to become active very quickly, and the environment allowing to publish and comment was better than it had been in PhRMA. This enabled LGs to get visibility and recruit new companies. The LGs and working groups rapidly expanded over 10 years—IQ now has over 100 working groups!
HOW DID IQ MEET SOME OF THE MAIN INDUSTRY CHALLENGES AT THAT TIME?
In the early years of IQ most of the members were large pharmaceutical companies. We needed to be purposeful in creating an environment where experts from large companies made space for experts from smaller companies to engage fully in IQ’s efforts. Good leadership has ensured that every IQ member company, regardless of size, can play a meaningful role and contribute to the consortium.
NAME A FEW OF IQ'S GREATEST ACCOMPLISHMENTS, AND WHAT MAKES YOU MOST PROUD.
While the pharmaceutical industry has played a role in the development and advancement of regulatory science for a long time, IQ has taken this role to a greater level. When IQ first started, convincing FDA to interact with IQ was easy, since they understood the need to have a relationship with industry scientists and knew that IQ was becoming an important and unique forum for this collaboration. The publications and presentations by IQ members have influenced regulations. IQ members have a forum to share information and take this back to their companies. The frequency of meetings and information sharing is much greater than what other forums had provided. This turned out to be beneficial for everyone. I am very proud of IQ’s contributions to regulatory science.