Pharmaceutical Regulatory Affairs

Biography

Biography: Michael Drues

Abstract

Description: Pharmacogenomics, also known as personalized medicine, has received increased attention in recent years. But what is pharmacogenomics and is it really a new idea? Pharmacogenomic ideas and technologies have the potential to impact numerous areas of medicine including clinical trials, new product development & manufacturing and the practice of medicine. And with the recent deaths due to fungal meningitis from the New England Compounding Center, what will be the ramifications not just on traditional compounding, but more importantly on pharmaceutical and medical device manufactures now and in the future. Appreciating what the future may hold will better prepare us for what has yet to come. During this presentation, participants will be exposed to a broad mix of pharmacogenomic ideas and applications currently on the market, under development, on the drawing board and beyond. See ‘Pharmacogenomics may change the way medicine is practiced’ for more. Goal(s): “Simply put… the goal of this presentation is to get people to think! To purposely provoke them, to look at the way we develop and manufacture medical products today and ask does it make sense? Regrettably, far too few seem to be willing to do this. Many seem to be content with the status quo; to continue to do what we have been doing in the past for no other reason than that’s the way we have done it, OR that’s the way others do it, or worse, that’s what is required. Using many real case studies, I try to teach people how to think not what to think. This is all too uncommon in medical technology. My mantra is simple: if you always do what you always did, you’ll always get what you always got. Alternatively, if you always think the way you always thought, you will also always get what you always got. It seems this happens all the time. The problem is if everyone thought this way, we would still be living in caves in medical development, in medicine in general and in life, we must always question the status quo. We can and should do better! Th at’s the takeaway from this workshop.” – Dr. Michael Drues.