Pharmora in Conversation with Industry Leaders: Professor Alan Boyd

Continuing my series of conversations with leaders in our industry, I caught up with Professor Alan Boyd before Easter. Some of you will know him as the former President of the Faculty of Pharmaceutical Medicine, some will know him as the entrepreneur who created “Boyd’s Consultants” and others will know him as an expert mentor, dedicated to training and empowering the next generation of people working in the pharmaceutical industry.

In our wide-ranging conversation we discussed his reflections on 45 years as a medic, his latest crusade, some of the medicines he has helped to bring to patients, and the lessons learned along the way; he revealed his past life as an actor, and some of his work behind the scenes to improve our health.

Happy 45th Anniversary of being a doctor!

Although Alan has spent the past 40 years in industry and people think of him as a business-person, he feels that he is still very much a doctor. He remains registered with the UK General Medical Council (GMC) with a licence to practice, and putting patients first is very important to him.

We talked about how people tend to ask pharmaceutical physicians “don’t you miss patients?” and it’s a long time since he treated a patient (these days just on long haul flights!) Alan reminisced about the intellectual challenge of treating a patient, particularly the very sick patients, with gross heart failure, renal failure, or diabetic crisis, and how satisfying it feels when over the weeks in hospital with you they will become better and go home. But when he stands back he can see that in supporting the development of new medicines he has helped to treat patients on a much larger scale. He knows of around 25 products he that he helped to develop into successful new medicines, some all the way through development, bringing benefits to millions of patients all around the world. This includes novel medicines in the gene therapy space.

Gene therapy: the pioneer of a new era

I was fascinated to discover that Alan’s journey into gene therapy started with losing his job! When AstraZeneca was formed he was the Global Head of Medical Research for Zeneca, responsible for more than 1000 people globally. He was successfully managing a great deal of responsibility, with a big budget. However, in the merger it was decided that R&D would be led by Astra and the commercial roles by Zeneca, making his role redundant. This was a shock at the time but on reflection he said it was probably the best thing that ever happened.

Losing his job gave him the opportunity to pursue his dream and set up the world’s first ever gene therapy company. At the time it had only been about 4 years since the world’s first academic trial with an investigational gene therapy (you may have heard of Asanta Desilva, who lived in a bubble). People thought he was crazy because no one had ever done this before. There was no regulatory guidance to follow, no manufacturing example, and he had to work everything out from first principles.

This did not deter Alan, who could see the potential to help patients with rare genetic conditions. He found 2 experts (in London and Finland) who had been working up these ideas with a small grant and wanted to raise more money. This is where Alan came in as R&D director together with a CEO and a CFO. But they needed a name for their company…

ARK Therapeutics: what’s in a name?

I asked how they came about the name ARK Therapeutics and Alan revealed a funny story. The original name of their company was Eurogene. This was a great name, until they discovered that it was shared with a company specialising in artificial insemination for pigs. They decided to look for a name that would appear near the top of the Financial Times pharmaceutical share price listings and just above a big pharma name, which turned out to be AstraZeneca, and came up with the name ARK. After some checks it became their name.

With Alan as their head of R&D they raised 35 million in Venture Capital funds, then in 2004 floated ARK Therapeutics Ltd in London and raised £55million. This was the biggest biotech funding to date. They needed to build a manufacturing plant, as there was nowhere to manufacture such specialty products at scale, which meant they had the first ever manufacturing licence for these products in the world. In 2006 they submitted the data for one of the products “Cerepro” for use in glioma to the EMA, but the agency did not have sufficient expertise at that time, so this drove the initiation of the Committee for Advanced Therapies (CAT) to oversee reviews of these products.

By 2008 their company had raised £150 million and had grown considerably, now employing 200 people between London and Finland. But disaster was about to strike the markets, and as the world headed into global recession they found that they couldn’t raise any more money, so they were forced to close the company. However, by this time they had proven that you could turn human DNA into a medicine for humans.

The journey continues…Boyd’s Consultancy

Having already set up his own consultancy Alan swiftly transferred his energies into using all of the knowledge, insights and expertise gained from leading a large pharma R&D organisation and building his own gene therapy company, to help other companies create new medicines. As one of the few people in the world with this level of expertise he found himself in great demand, and brought in project managers and medics to help. He now has a team of around 40 people, clients from Sydney to San Francisco, offices in Cheshire, Cambridge, Dublin and Philadelphia.

Over the years Alan and Boyd’s have helped over 25 products to be approved as medicines which includes 13 cell & gene therapies. He remembers every one of them, for example he recalled working alongside Spark Therapeutics in the US on what became a 12 year project and worked with the prestigious cancer centre MD Anderson for 11 years.  Although much of their work was initially in cell and gene therapy now Boyd’s are not only focused on advanced therapies, but also cover small molecules (NCEs), biologicals, antibody-drug conjugates (ADCs) and drug-device combinations (as many of the new advanced therapies need specific devices for administration), therefore he employs people who specialise in devices regulations. Half of their work comes from USA.

Tariffs

This led to a discussion about the impact of the new tariffs being imposed by the Trump administration. We both felt it is unlikely the service industry will be impacted (our product is the intellectual support we provide). However, one thing that does concern us is that pharma is a global business, sourcing products from all over the world to manufacture medical products. Many of the active pharmaceutical ingredients (APIs) that go into making medicines are made in China and India. It will be a worry for patients that we may not be able to manufacture the products for them if these APIs become too expensive.

Founding a Faculty

I asked Alan about whether he had any reflections on his time as President of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of London (AKA FPM). Alan reflected on the start of this journey, as he was one of the founders, back in 1989. Membership numbers are now in 4 figures, but he is member number 72.

When he first joined the FPM he was busy and didn’t really get involved, but when working for ARK in London he was much more available to support this important endeavour. Working with other experienced pharmaceutical physicians, including Brian Gennery and Peter Stonier, they asked how can we get the specialty recognised.  Alan was told it was difficult but not impossible as it would need an Act of Parliament. Undeterred the group complied with all of the necessary regulations and in 2002 the Queen signed off an Act to recognise Pharmaceutical Medicine as a specialty in its own right.

Educating Pharma Physicians

Alan then worked hard to set up the educational programme, becoming heavily involved with the UK General Medical Council (GMC) and the 3 Royal Colleges of Physicians (of London, Glasgow and Edinburgh). All Royal Colleges in the UK have Specialty Advisory Committees (SAC), but at that time the FPM were not allowed to have their own and became part of the Clinical Pharmacology and Therapeutics SAC.  Eventually the Joint Royal Colleges of Physicians Training Committee (JRCPTC) allowed the FPM to set up its own SAC for Pharmaceutical Medicine, which he chaired for 9 years, putting the programme in place, including all the “checks and balances”.

Mr President meets Meat Loaf

Between 2012 and 2015 Alan served as Vice President of FPM, and then was voted to be President, where he served between 2015 and 2018.

There is no set job description for a President of a Royal College or Faculty and each new President sets their own strategy and objectives. He was responsible for leading the organisation and putting his own plans and targets in place. He had 3 main aims in mind:

• increase the presence and awareness of pharmaceutical medicine across other medical colleges and the medical profession in general (outward looking)
• continue to develop the specialty internally (the right educational programmes, not just for trainees, for everyone) and expand training opportunities
• broaden the membership beyond medics (setting standards)

Alan succeeded in achieving aims 1 and 2, and then the UK went through Brexit. He is aware that there are a great number of people in industry who are not medically qualified but perform important roles, and he really wanted them to join the work of the FPM in some form. However, there are a number of challenges with bringing non-physicians into a Faculty of a Royal College of Physicians, not least of all because physicians are regulated by the GMC, making it difficult to establish the standards for non-physicians. Brexit also brought numerous challenges for those working in the pharmaceutical industry, and his focus turned to other priorities at that time. But, as the late, great, Meat Loaf said, “2 out of 3 ain’t bad”.

Representing us with the Government

During his time as the President of our Faculty Alan took on other leadership roles around pharmaceuticals. Shortly after the Brexit vote we realised that we needed to make sure Britain could still access medicines. Alan represented the Academy of Royal Colleges and appeared in front of Health Select Committees discussing the impact of Brexit on patients. He made sure we got what we needed in terms of drugs supply across borders and helped to prevent shortages.

Alan got on well with the other Presidents of Faculties and Royal Colleges, and was invited to advise them at times. For example, the President of the Faculty of Obstetrics and Gynaecology (RCOG) asked whether it would ever be possible to obtain oral contraceptives over the counter.  They discussed what it would take for reclassification of oral contraceptives from prescription-only medicine to a general sales or pharmacy medicine. It involved making an application to the Medicines and Healthcare products Regulatory Agency (MHRA) to change the classification, supported by the right data. As this is not in the RCOG’s realm of experience Alan helped to make the application and found a French company manufacturing oral contraceptives that was willing to help. He discovered that according to UK law, the Royal Colleges can make a formal request to MHRA directly for such reclassifications. This led to the first oral (progesterone only) contraceptive being made available for people to buy over the counter in the UK!

Alan achieved a great deal in his time as the VP and President of the FPM, and continues to support the government when they need an expert in pharmaceutical medicine.

Future and ongoing challenges for the FPM

Being a Faculty that clinical medics don’t often hear about we have a reputation for being small, but Alan points out FPM is bang in the middle of the 30 physician specialties in terms of size, with the number of members matching other more well-known specialities such as neurology and rheumatology.

Pharmaceutical Medicine is a growing specialty, now with at least 600 people who, like me, have achieved the Certificate of Completion of Training (CCT). FPM have advertised the annual call for nominations to become a Fellow of the Faculty. This time of year always makes Alan really busy, supporting the applications for Fellowships for people like me, as he is a “Fellow of good standing”. I’m hoping my application is successful!

At the moment Alan describes himself as on a “crusade” for those with membership of the Royal College of Physicians (MRCP) to become Fellows (FRCP). He has put several people forward recently, including Karen Mullen, the Chief Medical Officer for Boyd’s, and Sheuli Porkess, the current President of the Faculty, all of whom have been successful, and he encouraged me to consider this too.

The medical “Hunch” factor

Alan reflected that one of the advantages of being an Independent Consultant is that we have a great deal of experience as we have supported many different types of clients, giving us the benefit of observing many different situations. Alan feels we have a view like a Regulator, as we can give advice on the basis of this extensive experience. We can’t tell you why we are giving that advice, but trust that we have seen it before.  The Regulators have seen it all, therefore if they give you some guidance you are well advised to take it!

However, this experience comes from taking on new activities and learning as we go. Alan told me of a saying I had never heard before that chimes with me completely: experience is something you have 2 minutes after you needed it!

This made me reflect on the approach taken by a former EU QPPV and world-leader in Patient Safety, Barry Arnold, who has since retired but has had a profound effect on my work. Dr Arnold talked of the “Hunch factor”, because as a medic you have experience of dealing with patients in many situations, in addition to your experience as a pharmaceutical physician, which sits quietly in the background and just gives you a “hunch” as to the right answer, even when you were not consciously aware of the reasons why you felt this way. I asked Alan for his thoughts on the changes in the MHRA (Dame June Raine retired and we have a new Chief Executive Officer [CEO]: Laurence Tallon). Alan commented that this is not the first non-medically qualified CEO of MHRA and we are watching with interest to see what he plans to do with the agency.

Interviewing and being interviewed

Alan mentioned that he has been asked to speak on the radio about what it is like to run a business. During the discussion he revealed 2 surprising facts:

• He is a patron for his local radio station Crewe and Nantwich: The Cat
• He almost missed out on studying medicine to become an actor!

Alan likes to support local organisations and has been supporting The Cat for many years now. This year is the 20th birthday of Boyd’s and The Cat want to learn from him what it is like to sustain a business and help it to grow and expand. I did not wish to step on their toes so we did not dwell on this topic.

Then Alan revealed that he used to be an actor. He grew up in Blackpool, playing all the parts in the local plays and really enjoyed this. When he was deciding where to pursue his further education he was choosing between medicine and drama school. It was Alan’s father who we have to thank because he pointed out that Alan could always become an actor later, whereas medicine was a solid profession with more chance of providing an income! This explains why Alan likes talking and interviewing people and is such an engaging public speaker!

Super-networker status!

Alan left me with the following thought: there are 3 levels of networking:

• meet up with another person, with the idea that we may do something together
• do something together with another organisation
• bring together two people or organisations that you have nothing to do with – also known as being a super networker!

Alan is now at the stage where he is bringing together people and organisations that can help each other, with nothing in it for him or his organisation, but often with the ultimate goal of improving the situation for patients, which he finds really satisfying.

So our conversation ended and we went on with our respective days.

Thank you Alan for your time and insights. I really enjoyed it and have much food for thought!

Dr Stephanie‑Jayne Jones, CMO, Pharmora