Principal Scientist, Nonclinical Drug Safety
How long have you been volunteering at CDISC?
I attended my first SEND face-to-face meeting in 2006 in downtown Washington D.C. This was when individual companies were hosting CDISC SEND volunteers to develop what would eventually become SENDIG v3.0. I have been participating in various CDISC roles and on sub teams ever since.
What encouraged you to volunteer your time and expertise with CDISC?
As a college student and throughout my career I was always motivated by establishing clear, logical guidelines and procedures that could be easily followed. My experience working in the pathology laboratories on nonclinical safety assessment studies and managing the associated data collection systems led to my company selecting me to help out on this team from CDISC that was developing standards for exchanging nonclinical data. At the time, I had no idea that I was signing up for a career-long commitment to developing and maintaining the standards. Having the support of my company allowing me to spend time volunteering over the past 16 years has been a significant motivating factor. At this point, I can’t really imagine my day job without having SEND and the new possibilities it has enabled.
How did you begin working in clinical research?
I was interested in the Pharma industry while studying in college. After graduating, I reached out to a family friend who was currently working in the industry. I was inspired by his passion for helping ensure that medicines were safe for patients. Not long after that, I began my career working with that family friend at MERCK. It is hard for me to believe that I have now spent 25 years at MERCK in nonclinical safety assessment. I suppose time moves quickly when you are engaged in meaningful work.
What did you want to be when you grew up?
I am a bit embarrassed to admit that I wanted to be a professional athlete; however, the lessons I learned being part of a team and dealing with both failure and success at a young age were beneficial when that aspiration ended. I then thought I wanted to work in construction, but that soon faded after experiencing the summer heat for five years while in high school and college. That experience did prepare me to eventually do much of the work building my own house.
As a scientist with a background in pathology, and from your perspective representing a sponsor organization, what kind of improvements in research are you hoping for as you lead the team in developing new functionality in SEND?
The ultimate hope would be to reduce the time it takes to get life changing medicines and treatments to patients while ensuring they are safe and effective. The hope is that having more nonclinical data in a standardized format will enable quicker review and analysis of nonclinical data. I am energized by the thought that my CDISC standards work is helping enable cross submission analysis to provide deeper learning from the enormous amount of data that will be produced in the future. In the spirit of full transparency, the procedural side of me also wants to eliminate work by reducing variability and harmonizing industry work processes wherever it makes scientific sense.
Please provide a tip that someone would find helpful in working with CDISC Standards.
When creating SEND datasets for a General Observations Findings class domain, make sure to think about the plan (e.g., protocol) vs. the result to ensure variables are used correctly according to the variable’s definition. The other helpful thing I ask myself is “What is the question being asked?”. As a rule of thumb, this should be the TEST.