ProPharma Group has launched a “Meet the Expert” series to introduce you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support clients’ complex challenges throughout the complete product lifecycle.
Meet the Expert: Tom Oakley, Head of Regulatory Sciences, Southwood Research
Can you tell us what you do?
I am Head of Regulatory Sciences at Southwood Research – part of the ProPharma Group of companies. I head up our regulatory team, help develop our consulting business and get involved in consulting projects for our clients – most often helping US biopharma companies bring their medicines to EU patients. My career started out as a bench scientist, where I spent 4 years getting a doctorate in cancer research – studying mechanisms of genome integrity in budding yeast. Since then, I’ve moved into regulatory affairs, and worked for a number of companies (including Celgene, Amgen, Takeda and United Therapeutics), helping to develop cancer medicines.
What do you like best about working with clients?
Being involved in some genuinely cutting-edge science and helping companies navigate the EU regulatory environment! The development activities which our clients are pursuing are highly scientific and its great being involved in some translational science projects that would have been almost unthinkable even 10 years ago. Its fascinating to see such an expansion of truly targeted medicines entering the clinic and becoming available to patients. We’ve been able to support a number of EU approvals in recent years, and its hugely satisfying being part of this process.
What are the biggest challenges on the horizon for our industry/for our clients?
Navigating a regulatory environment which is constantly evolving to adapt to the advances that are being made in translational medicine.
What do you like to do in your free time?
Train for a return to taking part in triathlons! Over the years I have completed a number of events, including the London Olympic distance triathlon. Being a dad to two small children has been awesome, but has curtailed my training activities somewhat – as they’ve grown up a bit, I am now able to spend a bit more timing training! Recently, a team from Southwood Research completed a sprint triathlon as a team event to raise money for a local charity (Rennie Grove Hospice Care), so I am looking forward to doing more events like this.
In your opinion, what value does a client gain by working with ProPharma Group’s regulatory development experts?
Access to a group of very experienced, very enthusiastic and highly scientifically literate development experts. Much of the consulting work we do is in areas where the science is significantly more advanced than the prevailing guidelines. We’ve often been able to help companies to come up with innovative approaches to the challenges facing them, by having a very strong understanding of the science and data behind their medicines.