Principal Consultant S-cubed ApS
I joined S-cubed in January 2018. After working for Roche Diagnostics and travelling to their offices in Lucerne, Switzerland, I knew I wanted to work in Europe. The position at S-cubed came at just the right time, as my daughter had moved out and my wife, Karla had retired, so it seemed like a natural step and a real opportunity.
Working in Clinical Research
When I was at college, I was enrolled on the Pre-Med course and I double majored in biology and chemistry. I thought I was going to be a doctor. But once I got talking to my professors, I realized my love of mathematics and statistics was really important to me. So I decided that I wanted to be an epidemiologist which would combine my passion for math and science. I went on to do my Masters in Epidemiology and worked in that field for 12 years. It was while I was involved with case control studies and longitudinal studies that I developed an interest in clinical trials. In fact, I was involved with the development of the first two drugs for Alzheimer’s which is amazing when I think about how many are now available.
Numbers and SAS
When I consider what has kept me interested in my work, it always comes down to the numbers! I get real satisfaction out of sitting at a computer and creating code. I have seen some huge changes in the way we work. Perhaps the biggest change has been in SAS procedures. It used to be hard to produce good output and SAS is now much better at producing reports, such as summary tables and graphs. And another significant change: data standards. Before it was like the wild west with everyone doing things in completely different ways, making it almost impossible to compare or combine data sets. Now CDISC Standards should make creating datasets and producing reports easy, when done correctly!
Science and Regulation
Science and regulation should be in a symbiotic relationship, but sometimes it feels like the science is driven by the regulators. Recently, the medical device CDISC team that I co-founded was reviewing a Therapeutic Area User Guide (TAUG). They were proposing to use a DTC (date time of collection) variable for a device domain in a way that was not originally thought about by the team, when we put the implementation guide together. Usually, the DTC variables are associated with dates of collection, but this new use case fit the standard definition in the medical device implementation guide, which can be the date of the device setting and not just the date of collection. Thus, the new use case met the needs of the people working on the TAUGs. This is a good example of how science should get it’s say on standards.
Challenges for the Future
I’d say the biggest challenge of the next 5 years is to get companies to use the TAUGs. They have been a huge amount of work for CDISC and yet their use seems to be low. Companies need to be good at developing a company specific implementation of CDISC standards (perhaps based on the TAUGs). It often appears that raw data is thrown at CROs to implement SDTM but the data and what the sponsor gets back from the CROs is not consistent. You end up with different implementations of SDTM and the question then arises, are we really getting standardized data at all? It would be great, if say you are doing a cardiovascular study, that you use the TAUG to make it work for you at the start of the trial not just throw it over the fence to the CRO.
I have personally seen an example of a sponsor that gave two CROs the task of implementing SDTM and ADaM and what they got back from the two CROs was so different that integrating the data for an ISS/ISE was not possible. The raw data from one CRO had to be passed to the other CRO and run through their processes to produce SDTM and ADaM that could be integrated.
There have been many things in my life that I am proud of but really, the most important is from my childhood. As a child, I was diagnosed with a neurological disability, ‘minimal cerebral palsy’. Developmentally I was behind other children my age and so I went to a boarding school in San Francisco for children with my condition. When I arrived, I did not speak very well, and that year changed my life completely. At the boarding school, I received speech therapy. Now, it makes me smile when I consider that I have had many awards for speeches and presentations. In my time at the school, I went from reading on a third-grade level to a seventh-grade level in one semester. They also discovered that I was actually quite good at math.
My first job was not the least inspiring. I was a pot washer at a local hospital and for four hours a day I cleaned the huge pots. It was a terrible job! We had to empty them into the garbage disposal, spray them and scrub them. It was all manual; there were no dishwashers then! However, it was during the summer break from High School and it funded activities like going to watch my beloved San Francisco Giants play baseball. I still go and see them, whenever I am back in the States.
Plan for retirement
My wife and I have always been a part of our local church and we used to put aside time to work with people in our community. We supported those who need a helping hand, like single moms and children that needed support. In fact, our daughter was a teenager, when she came to live with us. I always thought she would gravitate towards spending most of her time with Karla. I was delighted and surprised that we spent hours chatting together. It’s made me reflect on how I want to use my time in retirement. I really want to support young adults and help them get a good start in life. One of the advantages of working with younger people is they keep me young. I truly enjoy taking some of these youngsters out and about to baseball games, car shows and theme parks, things they wouldn’t experience otherwise. As it turns out, I absolutely love rollercoasters!
Karla and I love to walk, and we have Fælledparken on our doorstep; it’s a beautiful place to take a stroll. We love dogs and, although people say that the Danes are reserved, once you ask them about their dog, they don’t stop talking! If I am not walking, I like to read, particularly mystery/whodunnit and crime fiction stories. I am currently reading Frederik Forsyth, The Avenger but I equally enjoy, Ruth Rendell, Agatha Christie or PD James. Of course, I love travelling. I have visited all 50 US states and 17 countries around the world. Travelling equals adventure and I have been lucky enough to see three of nature’s amazing displays: The Perseid Meteor Shower, a total solar eclipse in Oregon (which I photographed) and the Northern Lights in Trømso, Norway.
The best thing about S-cubed is the people. It was such a change for me going from 50 – 60 hours per week with 3 hours commuting a day, often with no holiday to being where I can relax and enjoy my life. The staff here are so helpful. I am always happy to get out of bed, go to work and meet my colleagues.
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