Dr Stuart Mair, medical director, Quotient Clinical, Nottingham and Edinburgh
What do you do? and what is a typical week for you?
I am the medical director at Quotient Clinical, a leading early phase scientific contract research organisation (CRO) where we conduct phase I/II clinical trials and pharmaceutical development. In any given year we conduct around 30 to 40 different studies and dose around 1500 subjects with new investigational medicinal products (IMPs) for a range of biotech and pharmaceutical companies (our clients). We cover all therapeutic classes including molecular targeted oncology drugs and all routes of administration. All studies are approved by the Medicines & Healthcare Products Regulatory Agency (MHRA) and independent ethics committees. I lead a team of 11 medical doctors and act as a principal investigator (PI) on selected studies including first-in human (FIH) studies.
In a typical week, I may support busineess development discussions for one or more potential new studies, review emerging data from live studies and prepare interim summary reports for a dose escalation decision meeting. I also provide advice and support for the other doctors in the studies they are working on.
What qualifications and experience do you have?
I qualified in medicine (MBChB) from Aberdeen University in 1990 then completed vocational training in general practice. I left the NHS in 1996 and have worked in early drug development ever since. I didn’t necessarily plan this outcome but developed an interest in clinical pharmacology and studied for a diploma in clinical pharmacology (DCPSA) in 1999. I then became a PI for FIH studies and a medical director in 2008 with overall responsibility for all studies conducted in the organisation. I am also a member of the FPM and a member of the ABPI Experimental Medicine Expert Network committee.
What’s the most interesting aspect of your job?
There are several different aspects to the job I do. I am involved in business development discussions with potential new clients and it is always rewarding when a new study is won and you played a role in that. I also play an important role in study design and protocol development particularly for first in human studies where it is important to understand the preclinical pharmacology and safety data in order to select an appropriate safe starting dose, appropriate dose range and maximum dose and exposure. Again, it is rewarding when agreement is reached and protocols attain approval form the MHRA and ethics committees. It is also good when a study progresses as planned and the outcomes are favourable in terms of safety (few adverse events), pharmacokinetic and pharmacodynamic which provides a clear signal for progression to the next study. Lastly, I play an important leadership role in the management and development of the medical team and support developing doctors in their training both inside and outside the organisation eg. Pharmaceutical Medicine Specialty Training (PMST) and the diploma in pharmaceutical medicine exam.
What are your research interests?
I have a particular interest in the design and delivery of FIH studies and am one of two qualified FIH PIs in the organisation. In an average calendar year Quotient Clinical conducts around 4 to 5 FIH studies each year, very often in combination protocols incorporating single and multiple doses, different dosing regimens, different formulations and also patient cohorts for the target indication. Over a 21-year career, I have acted as either a co-investigator or PI on over 100 of these studies and around 40 as a PI.
To be a PI on a FIH study you need to have a thorough understanding of the IMP in terms of the preclinical pharmacology (in-vitro and in-vivo), the dose response curve and the toxicology in animal species and preclinical PK. This information is usually summarized in a document called the Investigator’s Brochure which is owned by the client or sponsor company.
What one piece of advice would you give to someone seeking a career in clinical pharmacology?
I would advise someone to complete basic general medical training first and if you have an interest in how drugs work and how they are developed to give it a go. Most medical careers are flexible and if you decide to try a role in industry – perhaps as clinical research physician in an early phase CRO then it should always be possible to re-enter clinical medicine if you want to do that. I know several of the doctors I have appointed have done this while others have moved on to roles in the wider pharma industry. Either way, the experience will be of value as the development of new and better drugs is a key element in the advancement of medical practice.