12 Questions with Graham Belgrave

Graham Belgrave is Senior Vice President, Head of Global Medical and Regulatory Affairs and Managing Director Europe at Advanced Clinical. He has over 39 years of experience successfully leading pharmaceutical development across Clinical Operations (Phases I-IV), Outsourcing & Contract Management, and Project, Program, and Vendor Management. He has held senior management roles for global top pharma and biotech companies.

Belgrave is an active member and Honorary Fellow of the Institute of Clinical Research UK (ICR), a Fellow of the Royal Society of Medicine, a Chartered Scientist, Member of the Institute of Biomedical Science, and Chartered Manager and Companion of the Chartered Management Institute.

What are the main responsibilities of your current role? I have the privilege of leading the Medical and Regulatory Affairs groups, which includes all Medical Services, Consultancy, Medical Monitoring, Medical Feasibility, Medical Writing, Regulatory Intelligence, Global Study Start-Up, Clinical Supply Management, and Pharmacovigilance. I also serve as the Managing Director for Europe, which includes nine legal entities.

What is your background prior to this role and how did it prepare you for the work you do now? I have spent over 30 years in mainstream Pharmaceuticals and Biotechnology companies, starting life as a CRA in the early 1980s, progressing through many roles in Clinical Development, Clinical Outsourcing, Vendor Management, and thereafter leadership positions at some large pharmaceutical companies. I have also worked as a consultant for a number of organisations focusing on restructuring, process improvement, and implementation of new functions. The last seven years have been in the fast-paced CRO world, which has provided me with the fantastic opportunity to take on more projects at any given time.

What are some of the biggest ongoing challenges in your work? During the COVID times, many clinical research professionals took the opportunity to re-think what they wanted to do and where they wanted to be based (most now prefer home-based roles). Some took the opportunity to leave the life sciences and this has impacted the industry as a whole. At Advanced Clinical, because we are highly selective in only hiring new colleagues that have the desired blend of experience and interpersonal skills that match our culture, sometimes this means we have to search for longer than in the past for the best new hires.

What motivates you about working in pharma? Although this might sound ‘trite’, it is the ability to work on compounds that make a real difference to patients’ lives, be that a new chemical entity (NCE), new formulations, or delivery systems. I have had the opportunity to work on some ground-breaking projects that have gone on to save lives, improve symptoms - and in some cases - markedly extend lives. I have had the pleasure and privilege of working with some amazing surgeons, physicians, nursing staff, pharmacists, and patient advocacy groups during my almost forty years and have learned so much from them all. There are not many roles in any industry that provide this opportunity!

What do you see as the biggest challenges facing the industry right now? I see these as multifactorial. COVID had a dramatic effect on the willingness and ability of sponsor companies to continue or even start their trials. Some CROs managed to navigate the required changes to decentralised clinical trials (DCT) and remote monitoring modalities and the willingness of several Regulatory Agencies to accept these methodologies was somewhat hindered by Industry's ability to help demonstrate the efficacy of new drugs. Currently, and probably for another year, the financial situation globally and inflationary pressures will at best delay recommencement of clinical studies and at worst cause the cancellation of many trials, with a knock-on effect to potential patients, as well as on the finances of both sponsor and service companies.

What excites you most about current industry trends? What really excites me is the willingness of many companies to embrace the technology that has become available in the last five years, which made dramatic steps forward during the ‘COVID years’. I am thinking particularly of DCTs, remote monitoring, the use of AI to guide patient identification, eSource, and ePRO/eCOA. Regulatory Agencies are now far more accepting of these new technologies, if not universally so just yet. I believe that the current financial strictures will actually encourage more precise and focused research projects with tighter endpoints. The ability of feasibility assessment continues to grow, which is helping with the identification of patients, investigational sites, and geographies that were until recently ‘untapped.’ These are all exciting opportunities.

How do you promote patient-centricity in your workplace? It has been fascinating and heartening to see patient-centricity become more prevalent since the mid-nineties. What we do within our organisation is to encourage the involvement of patient advocacy groups and if these do not exist, we connect with individuals and seek their input to both protocol design and data capture methods. After all, we can design a scientific and medically sound protocol, but if patients or the parents of patients are unwilling to participate in the clinical trial, it can fail before it starts. We get great input, which often allows a trial to be modified and thus can greatly increase recruitment efforts.

What has changed most about the industry since the start of your career? When I started in 1984, Good Clinical Practice (GCP) existed, typically per country, trials were designed with often single endpoints, and data was exclusively recorded in paper 3 part NCR (No carbon required paper). It was not until 1996 that the ICH-GCP first came to fruition and, consequently, studies have increased in complexity, scope, and geographical coverage, while the number of orphan and ultra-rare trials has dramatically increased since the early 80’s. Last but not least, both the cost of running clinical trials, as well as time before a drug goes to market, have increased markedly!

What do you think pharma will look like in 15 years? 50 years? I have wanted to see personalised medicine for all become a true reality. While it exists in some settings, it doesn’t in others – and we have such great opportunity, being able to identify and treat genetic abnormalities as early as either in-utero or postpartum. We will also be able to eradicate diabetes, heart failure, and many forms of cancer (with treatments such as CAR-T being one amongst others). Many of the ultra-rare and rare diseases will be identified early and treatments will be developed (a particular passion of mine) and my fervent hope is that we will be able to ensure these treatments (preferably prophylactically) be available in the poorer and most disadvantaged parts of the globe.

What are your hobbies? What do you do in your free time? I am re-learning the piano after a 46-year hiatus; it surprises me how much knowledge comes back with regular practice, even if the fingers are not quite as limber as they once were. I also enjoy clay pigeon shooting and introducing and training others in this sport.

If you could have any superpower, what would it be? I am sure I am not alone in this but “Prescience” - the ability to foresee the future. Imagine how much quicker we would be in developing new drugs if we already knew which would not work as predicted!

If you could have any job other than the one you have now, what would you choose? I was fortunate to be honoured by PharmaVoice in 2021 as one of the 100 Most Inspirational Leaders in the Pharmaceutical Industry, in the Mentor category. If I was to do anything else (and I am not planning to do so), I would enjoy coaching and mentoring as a career, something I already do voluntarily with people from a number of different industries.

Connect with Graham Belgrave on LinkedIn.