Senior Research Scientist
Bristol Meyers Squibb
This spotlight was featured in March 2020.
Bill has been contributed his expertise to the SEND team for over 10 years and served as Team Leader for three years. He currently advises SEND Team Leadership. He lives in New Jersey.
How long have you been volunteering at CDISC?
I started in Jan 2008
What encouraged you to volunteer your time and expertise with CDISC?
Federal Register /Vol. 72, No. 191 /Wednesday, October 3, 2007 announced that the FDA was looking for 5 to 8 organizations to participate in a three-year pilot of SEND. The head of Toxicology at BMS at the time wanted BMS to participate and asked me to join the SEND team.
How did you begin working in clinical research?
I have never worked in clinical research. I’m guessing that you really mean to be asking how I began working in nonclinical research. I was a preparing to graduate with a degree in Physics with plans to go on to graduate school, but decided to delay graduate school to wait for my wife to complete her undergraduate degree. My knowledge of computer programming and science was a perfect match for a position that was open at Bristol-Myers Squibb as a Scientific Computer Programmer supporting their Toxicology area. After working with BMS for a number of years in their computer science department I was invited to move into a Research Scientist role in Toxicology even more focused on SEND development and implementation.
What did you want to be when you grew up?
A research scientist. I thought my skills were best suited for the area of condensed matter physics; but see that they have had an even greater impact in bringing relief and healing to patients needing new medical treatments.
Many consider SDTMIG, CDISC's tabulation standard for human clinical trials, to be our flagship standard, yet SEND is an essential standard as well. Can you tell us why SEND is so important?
Perhaps the greatest value of SEND is that it is enabling more efficient reviews of the final hurdle in drug development before the potential medicine can be administered to humans. There is a very limited amount of time that regulatory health authorities have to review toxicology studies and raise any concerns before humans are impacted. SEND brings standardization of the study data enabling a more complete and effective regulatory review. This standardization has many additional benefits throughout the non-clinical research community:
- Enabling new software for data visualization and analysis to be commercially marketed.
- Enabling consortia to create toxicology data repositories with less effort.
- Which in turn is expected to enable
- optimization of the types of studies required for regulatory approval
- better understanding of impact of rare and incidental findings
- better medicines through improved data based decisions during the drug development process
Please provide a tip that someone would find helpful in working the CDISC Standards.
Keep in mind the needs of the data recipients. CDISC standards permit flexibility which enables you to create datasets that not only conform to the standard but also provide the important information for analysis. If you don’t keep in mind the needs of the recipients, you are likely to have datasets that conform to the standard but lack critical pieces of information.