Professor Alan Boyd, Founder and CEO of Boyds, has played a pioneering role in the cell and gene therapy industry. He led the development of Ark Therapeutics’ Cerepro, the first gene therapy submitted to the EMA for approval. Whilst Cerepro was not ultimately approved, it paved the way for future gene-based therapies and demonstrated the potential to turn DNA into an approvable medicine.
In 2005, he founded Boyds to support the translation of early-stage scientific concepts into viable medicinal products and treatments. His work has contributed to the development and approval of multiple therapies across a wide range of indications. Of the 33 approved cell and gene therapies currently available across the US and Europe, Boyds has been involved in 13 of them at some stage of their development.
In this article, Professor Boyd shares insights and key lessons gained over the past two decades – lessons that can help guide the next generation of scientists, clinicians, and innovators as they shape the future of drug development.
Reflections on two decades of progress
As I reflect on the 20th anniversary of Boyds and my 40-year journey in drug development, I’m reminded of how far the field has progressed, and how much further we still have to go. Over the decades, I’ve had the privilege of contributing to some of the most transformative developments in pharmaceutical medicine, from the early days of gene therapy to the continued professionalisation of our industry.
My move from big pharma to co-founding Ark Therapeutics – the world’s first dedicated gene therapy company – was driven by vision and perseverance.
When we first proposed using DNA as a therapeutic agent, the idea was considered radical. But our willingness to challenge conventional thinking laid the groundwork for what has now become the gene therapy revolution. One of our most important decisions was to invest early in the first commercial gene therapy manufacturing facility. This helped establish quality and compliance standards and paved the way for market readiness.
Patients at the heart
Although I’m often regarded as a businessman, I’ve always identified first and foremost as a doctor. That medical foundation informs every decision we make at Boyds. Strategic, scientific, and commercial choices are all grounded in a single guiding principle: how does this benefit the patient?
This approach not only ensures we act with ethical integrity. It also supports long-term success. Having medically trained professionals in leadership roles helps align our business priorities with patient needs and promotes more responsible innovation.
Indeed, whenever we face high-stakes decisions, whether this be to pursue a risky therapeutic avenue or to invest in a novel technology, I always reframe the decision through the lens of patient impact. This clarity has guided both our scientific and commercial strategies.
High-performing team
The creation of the Faculty of Pharmaceutical Medicine in 1989 was a landmark step in establishing a clear framework for the training and accreditation of pharmaceutical physicians. This formalisation has elevated standards across the industry and continues to do so.
Our in-house expertise at Boyds enables us to tackle complex development challenges through a multidisciplinary lens that combines regulatory, clinical, and scientific perspectives.
We also encourage a culture of continuous growth. Team members are supported in their professional development, and we work to foster an environment that enables career progression. This helps us attract and retain top talent whilst empowering individuals to contribute strategically – not just technically.
Our patient-centric ethos shapes our approach across every stage of development, from regulatory strategy to clinical trial design.
Lessons and learnings from the last 40 years
Drawing on my experience, here are some key pieces of advice I would offer to drug developers:
- Navigating regulatory challenges
The regulatory environment for advanced therapies is continuing to evolve, particularly in the wake of the COVID-19 pandemic. Agencies such as the MHRA, EMA and FDA are demonstrating more flexibility and openness to alternative approaches.
Drug developers should engage in open and proactive dialogue with regulators. When randomised controlled trials are not feasible, propose alternatives like single-arm studies – backed by strong data and ethical rationale. Engage advisory boards, clinicians, and patient advocates to build consensus and support. This kind of collaboration can unlock regulatory flexibility and accelerate the approval of promising therapies.
- Embracing innovation in clinical trial design
As treatments become more targeted and patient populations more specific, traditional trial models are becoming less practical. Regulatory authorities are increasingly open to alternative designs, provided they are scientifically robust and ethically sound.
Design your trials with real-world patient needs in mind. In rare or high-risk conditions, traditional comparators may not be feasible. Explore non-traditional endpoints or historical controls and involve clinical experts and patient advocates early to help validate your approach and build regulatory trust.
And importantly, share what you learn. Publishing trial designs and outcomes, including imperfect results, helps move the field forward and establishes new benchmarks for others.
- Tackling the manufacturing bottleneck
In advanced therapy development, manufacturing has become one of the most significant barriers to progress. It is no longer something to address midway through development – it needs to be considered from the outset.
Start early. Don’t wait until late-stage clinical trials to solve manufacturing challenges. Secure scalable, compliant facilities and develop robust analytical and quality control methods in parallel with your production processes. Staying ahead of regulatory expectations and engaging in industry consortia can ease the regulatory path and accelerate time to market.
- Learning through failure
Behind every approved therapy are numerous failed attempts. These are not wasted efforts – they are essential learning experiences.
Here at Boyds, we conduct thorough reviews of every unsuccessful project to understand what went wrong and share those insights across the organisation. We celebrate learning, not just success. Documenting both wins and losses builds institutional knowledge that informs better decision-making and reduces risk in future projects.
Looking to the future
Drug development is evolving rapidly. New frontiers, from plant-based biologics to gene editing and synthetic biology, are creating exciting opportunities in the sector.
Breakthroughs often come from unexpected places. But it is important to be realistic – meaningful innovation takes time, often decades. And above all, embrace cross-disciplinary collaboration. The intersection of biology, data science, and engineering will define the next chapter in medicine.
The last 20 years at Boyds, and my 40 years in drug development, have been defined by innovation, perseverance, and transformation. Ideas that once seemed radical are now changing lives. I hope the lessons I’ve shared provide guidance and encouragement to those navigating the path ahead.
The future of medicine is bright. Let’s shape it together – and always with patients at the heart.
Boyds marks 20 years
Earlier this year, we celebrated 20 years of Boyds. Read more about our milestone moments here.