Simulations Plus

Are you a whistle-blower? Or do you cringe just to read those words? According to Margaret Heffernan* (links to a dead link) in a 2012 TEDTalk, most whistle-blowers are good guys. A whistle-blower can provide constructive conflict, which is vital for success. Heffernan says that great research teams, relationships, and businesses allow people to deeply disagree. When we are afraid of conflict, our doubts remain hidden. But when we dare to break that silence – when we dare to create conflict – we enable ourselves and the people around us to do our very best thinking.

Reviews of new drug applications by regulatory authorities worldwide grow ever more rigorous. I think that one reason for this heightened scrutiny is that reviewers have, over the last 10 years, read many submissions containing results of pharmacometric modeling and simulation analyses. With the use of modeling, explorations of the determinants of drug efficacy and safety are more thorough, and the analyses provide solid support for dose recommendations and labeling content. In short, I think that model-based analyses have raised reviewers’ expectations.

Brené Brown is a researcher at the University of Houston who studies vulnerability, courage, authenticity, and shame.* She speaks to many different audiences, including corporations and universities. Often, the person arranging a presentation timidly suggests that it might be better if she does not mention vulnerability or shame in her presentation. When asked what they want to hear about, the reply is “innovation, creativity, and change.” Her emphatic retort is that, “vulnerability is the birthplace of innovation, creativity and change!” To learn more, watch her second TEDTalk, Listening to Shame, here: