Opposing were Martin Landray, professor of medicine and epidemiology, at the University of Oxford, in the U.K., and Bettina Ryll, the Uppsala, Sweden-based founder of Melanoma Patient Network Europe.
countered that the current problems arise from an absence of or inadequate engineering.
cast poor interpretation and misapplication of regulations and an overly cautious approach to technology as the "enemies of innovation.
argued for a quality-by-design approach to clinical development, which builds on a culture of critical thinking, focusing efforts on essential activities and focus on errors that matter, while building broad stakeholder engagement.
All of these are principles of engineering design, he
"Our failure has been to apply those principles closely," he
"It's not overengineering is the problem - it's forgetting to engineer is the problem."
defended regulators, who have made valuable inputs into new development approaches, such as quality by design, risk-based management and risk-proportionate studies "All these things come out of working with regulators," he
"We agree that trials are too expensive, too slow, highly wasteful and do not address the questions we want," Landray
"That's not overengineering - that's insanity."
By the close of the debate, Landray
and Ryll had managed to shift the audience significantly.