James is interested in the full medicinal product development life cycle, and is committed to facilitating the advancement of innovation into clinical benefit. He believes that at the interface of industry and academia, he can have the greatest impact in doing so. The first part of his thesis focusses on intellectual property, which is a cornerstone of life science research and development. At a practical level, he believes that by improving landscaping practices, individuals and organisations will be able to make better informed decisions about their research. In the second part of his thesis, James is attempting to create a machine-learning based model to improve our ability to predict the marketing authorisation of new compounds, and therefore reduce attrition rates in drug development – one of the largest and largest problems facing healthcare.
James also has active research interests in advanced therapies. Prior to and during his DPhil, he was Programme Coordinator and Research Associate of the CASMI Translational Stem Cell Consortium, where he is responsible for leading and conducting research into and review of various aspects of advanced commercialization. He received a research scholarship to Harvard University, where he investigated scale-up costs of exosomes under the supervision of Prof Jeff Karp and Brock Reeve.
Before moving to the field of healthcare translation, he worked in the R&D department of an integrated supplier of micro-ingredients for animal feeds, AB Vista, where he gained experience applying advanced statistical methods to commercial and scientific problems.
James holds an EU Regulatory Affairs Certification (RAC, EU) and sits on the Publications Advisory Committee and is the lead author of several chapters published by the Regulatory Affairs Professionals Society. He has also contributed to publications in several high impact academic journals, management journals and bioprocessing trade magazines on a range of topics. He has authored or co-authored several poster presentations, and regularly is regularly invited to speak at a variety of international conferences.
James holds a First Class Degree in Biological Sciences from the University of Oxford, where he was an academic scholar at Worcester College.
Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan
Halioua C. et al, (2017), YALE JOURNAL OF BIOLOGY AND MEDICINE
A quantitative, multi-national and multi-stakeholder assessment of barriers to the adoption of cell therapies
Brindley DB. et al, (2017), Journal of Tissue Engineering
Evidence of insufficient quality of reporting in patent landscapes in the life sciences
Brindley DB. et al, (2017), Nature Biotechnology
Conditional Approval Pathways: The "Special" Case of Global Regenerative Medicine Regulation.
Smith JA. and Brindley DA., (2017), Rejuvenation Res, 20, 1 - 3
The Magnitude and Temporal Changes of Response in the Placebo Arm of Surgical Randomized Controlled Trials - A systematic review and meta-analysis.
Wartolowska K. et al, (2016), Trials, 17, 589 - 589