BMS’ director, hub unit manager Regional Clinical Operations on the need for excellence in clinical research
What is your current role and background?
Currently I work at Bristol-Myers Squibb and head up the Clinical Operations team for UK, Ireland, Belgium and Netherlands. I have been at Bristol-Myers Squibb for 14 years in a number of different roles, all in Clinical Operations. Prior to BMS I had roles at SmithKline Beecham (that ages me), and Novartis.
What does your day-to-day work involve?
My team are responsible for delivery of clinical trials phases I to III predominantly in oncology. I am fortunate as my role is very varied.
I am involved in team management, one-to-one meetings, resourcing, performance reviews, succession planning etc. At the moment I am also involved in Brexit planning and risk mitigations, CAPA actions following an MHRA inspection, external engagements with sites and partners, mentoring and various project working groups. I also sit on the UK and Ireland leadership team which provides a fantastic insight to other parts of the business. On this group I represent the voice of the Clinical Operations team but also the wider business.
What do you find the most exciting aspect of your role?
To see people grasp an opportunity with both hands and build on it, to witness people developing their careers and their skillset is the most exciting part of my role.
What is a key frustration?
Email overload! Email has made it so easy to share information which, I believe, has led to oversharing. It is easier to send to all, rather than to think who really needs to be made aware. This in turn can lead to a lack of clarity on who is the decision-maker. Of course email has a place but if not used wisely it can become a huge productivity drain.
What are the main challenges in moving forward healthcare innovations in the UK?
While we must work in a robustly regulated environment, we need to ensure this is performed in a transparent, rapid and streamlined way. Over engineering processes across all parts of clinical research to fit the UK structure, with its numerous stakeholders, will result in a slow, labour intensive environment that is not globally competitive. We must continually look to other countries to understand what they are doing well and take learnings.
Do you think open innovation is the way forward for pharma? Does the traditional R&D model still have a place?
I think open innovation definitely has a place. To ensure we get medicines to the patients that need them as soon as possible we should ensure all focus is on the right area, the product rather than the process. Trancelerate and Biocelerate are great examples of this. In addition open innovation is critical for development in high risk areas, i.e. in Alzheimer’s where a huge need for innovation exists, but the costs and the risks are high. Co-development, sharing the skills, the resources and the risks would seem to be a logical solution.
An area I see benefit in my day-to-day work is working for a company with a rich oncology pipeline where a goal of targeted medicines is a must. There is not enough time or resources to sequentially work though product by product and combination by combination so working with physicians and academics on shared areas of interest enables more rapid development decisions.
At this time traditional R&D does still have a place, although there is a commitment to continue to adapt, to continually look at how we can increase the speed of development while driving down the costs of commitment.
What does the future hold for clinical research?
The need for ever-increasing speed will see further development of flexible trial design. Combine this with the need for individualised treatments will mean drugs and diagnostics being co-developed as standard.
Continuing enhancements in wearable and mobile technology combined with patent centricity may be the biggest opportunity and challenge to come. The ability to have immediate data and in huge volumes may make it harder to be focused and efficient.
Drug approvals will become a new start point of research, as the availability of big data to continually validate the risk benefits to patients, combined with the payers need to manage drug spend, could see the lifespan of a marketed product ever reducing.
You sit on the steering group for the PharmaTimes International Clinical Researcher of the Year competition – what do you gain from this role?
On the steering committee I get to interact with like minded individuals that care passionately about our industry and its future. It’s a great forum to have helicopter view on the industry, i.e. when we are discussing what categories should be in the competition and what the questions should be, it highlights the hot topics across the industry.
As part of the steering group I get to sit on a judging panel for the singles finals and also help out at the team finals. To see first-hand the global talent, energy and enthusiasm that exists in our industry is incredibly satisfying.
Why is it necessary to reward excellence in this field?
At the core of clinical research is a need for excellence. The impact of not working to the highest standards is hugely significant and could bring down a development programme or impact the patients involved. As such those performing at the highest level should be held up as role models and rewarded for their abilities.
What would you say to any clinical researchers considering taking part in the competition?
Go for it! The competition offers such a great opportunity to challenge yourself and to validate your experience and skills against a wide group. I can see from members of my team that have entered how it has enabled them to demonstrate their passion and commitment to furthering their careers.
What are your passions outside of work?
I find sport a healthy balance to my work schedule and have access to a gym and personal trainer at work, so I try to get to circuits during the week. I have recently gone back to playing hockey after a 20+ year break and I am thriving in the team dynamic. I also ski and try to get a couple of trips in a year. If that didn’t keep me busy enough this year I have added road cycling to the list and will be taking part in a sponsored ride this September, from Tours in France to Uxbridge over three days, raising money for Cancer52. I also have a passion for red wine and chocolate so just as well I enjoy the sport.
What keeps you awake at night?
I’m a wife and a mother to a ten and a seven year old, like most working mums I struggle to know if I’m getting the balance right. I choose to focus on the positives and hope that I can demonstrate to them the importance of hard work, independence and sexual equality.
What advice would you give to those considering a career in pharmaceutical research?
It is incredibly rewarding to have a career where every day you can relate your work to a genuine need. To work in an industry that is dynamic and where you are truly accountable forces you to continually develop your skillsets. My experience on the UK & Ireland leadership team has opened my eyes to many other areas of the business which in turn have given me greater insights in to my role and how my action impact those around me and vice versa. My advice to anyone going into the industry is to build yourself a solid base of cross functional experience. The wider your base the greater it will support you as you progress in your career.