Zeist, 7 November 2019 – Science CRO Julius Clinical has appointed Billy Franks, PhD, to cement the organisation’s position as a leader in the upcoming step-change from real-world data to real-world evidence in drug development programmes.
Billy brings over 14 years’ experience in supporting clinical development, medical affairs and real-world research in various leadership roles in the pharmaceutical industry. He joins Julius Clinical from Astellas Pharma, where he was the Global Head of Analytics responsible for a team of statisticians, epidemiologists and medical coders in Chicago, Leiden, London and Tokyo.
The use of real-world evidence is growing fast in clinical drug development. This is because real-world evidence (RWE) is increasingly recognised as essential to determining the risk/benefit balance of treatments in routine clinical practice across populations and geographic regions. The result will be improved patient outcomes.
As the company’s first Head of Data Science, Billy will lead the Julius Clinical team of statisticians and statistical programmers and further build the company’s presence and capabilities in the highly promising field of RWE.
Holder of a Doctor of Philosophy degree in Statistics from Florida State University, Billy has spent much of his career providing statistical support for clinical trial design, analysis and reporting for phase 1 through phase 4 trials. He is an expert in that setting on advanced statistical issues such as trial design, sample size and power estimation with a strong interest in non-standard designs including adaptive clinical trials. He pivoted towards RWE in support of medicals affairs, pharmacovigilance, HEOR, and commercial analytics and has developed a deep appreciation of the complexities and strategies in working with messy observational data. During his career he has supported clinical and real-world research in cardiology, oncology, urology, infectious disease, nephrology, neurology and dermatology.
With Billy’s interest in RWE study and the recognition of increasing overlap between traditional clinical trials and RWE, it was the opportunity to do more in this exciting area that led him to join Julius Clinical: “I saw that Julius Clinical was using its academic foundations to innovate regarding clinical trial data and RWE. They are uniquely positioned to get to real-world data sources that were unreachable from my past experience. That really appealed to me and was something I wanted to be a part of.”
The crucial difference is that pharma companies must generally obtain individual patient consent to track results as part of a drugs trial. “The difference with RWE is that most of the information is already held in existing systems, which pharma companies, for obvious reasons, are not allowed to directly access,” Billy says. “Because Julius Clinical, as a scientific CRO, does not manufacture or market drugs, we can more easily work with doctors to transform existing patient notes and information into data for research. This addresses a pharma company limitation, but which I think is very much the future of drug research, development, and commercialization.”
Billy adds: “What excites me about RWE is that there is no real ‘recipe’ for how to use the data you develop to create an insight you can trust. You have to be a bit of a detective to uncover weaknesses and then create something robust. It’s the pioneering aspect, and I think Julius Clinical provides the right environment for me to do this.”
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