Areas of Expertise

Protocol development

 

How many great advances have been felled by poorly designed protocols? Framing the question properly makes all the difference. Understanding the pluses and minuses of any new drug, device, or combination product begins with developing a protocol focused on efficient and appropriate questioning.

Medical monitoring

 

A good medical monitor can make or break data collection and interpretation. Simple jobs, done correctly, have an elegance. Done incorrectly, they only serve to confuse and manipulate. Being open to what the data is telling you and knowing where to focus limited resources are the heart of proper medical monitoring.

KOL interactions

 

There are many places in the development of a product where key opinion leaders contribute. Having friends and colleagues across different therapeutic areas, and with differing skill sets, helps to keep the interactions stimulating, informative, and relevant.

Data interpretation

 

It’s a common phrase in medical training: “when you hear hoofbeats, look for horses, not zebras.” A proper sense of what the data is telling you is critical to understanding results. But knowing context is everything: the same datapoint in different patients and different circumstances could be completely normal or indicative of a problem. Keeping a close eye on the literature, understanding the statisitics, and having the right clinical background can mean everything.

Publications

 

There is so much literature out there - how can we apply a finite resource to a near-infinite stream of knowledge? “Write what you see” is a quote from Dr. Patrick Walsh (and many others, I’m sure), an important figure in my Urology training. With over 100 publications, book chapters, and abstracts, I can think of no greater mandate - transparently sharing information makes us all better informed, and can be a cornerstone to a successful medical and commercial strategy.