Drug development is often described in eras: the age of small molecules, the rise of biologics, and then the emergence of cell and gene therapies. Few experts have worked directly through each transition
Meet Alan Boyd. He has spent over four decades in R&D, watching the industry progress from a time when ACE inhibitors and beta blockers represented the cutting edge to a landscape where the central challenge is no longer discovery alone, but the ability to manufacture living medicines at scale, reliably and cost-effectively.
“When I begin working with a client developing a cell or gene therapy, I tell them right from the start that they will face manufacturing challenges,” says Boyd. “It’s important to anticipate these issues and ensure the right expertise is in place to address them.”
In this interview, Boyd – who is today the founder and CEO at consultancy firm Boyds – explores the challenges facing the sector, from understanding manufacturing to surviving a hostile funding environment.
You’ve been working in drug development for 40 years. What have been the most exciting developments you’ve seen in terms of new therapeutics and scientific discoveries?
Over the past 40 years, I have witnessed several distinct eras in medicine. In the late 1960s and 1970s, there was a strong focus on discovering and developing new drugs, particularly those designed to target specific receptors or enzymes. This was the era that gave rise to beta blockers and ACE inhibitors. For instance, the ACE inhibitor lisinopril (marketed as Zestril) was approved in the 1980s for the treatment of cardiovascular conditions. Around that time, when I joined ICI, I worked on developing this third ACE inhibitor that was approved for both heart failure and hypertension.
The 1990s marked the beginning of the next major phase, with the emergence of antibodies and biologics – innovations that went on to revolutionize medicine, especially in fields like rheumatology. By the late 1990s and into the 2000s, this progress expanded to include cell and gene therapies. Also, from the mid-2000s onwards, we saw remarkable growth in immunotherapies.
It is really in the past 20 to 25 years that we have experienced a true revolution in medicine. For the first time, we are moving beyond treating signs and symptoms (as I was originally trained to do) and beginning to achieve actual cures for certain diseases. Gene and cell therapies, in particular, have opened the door to modifying patients’ immune systems to fight or even eliminate disease. This ability to move from treatment to potential cure represents one of the most exciting developments in modern medicine.
How have the challenges around drug development changed?
In the first half of my career, I worked predominantly with new chemical entities, where manufacturing was relatively straightforward. As Head of Medical Research at Zeneca, my department was often the rate-limiting step in getting a new drug approved. Today, however, with the advent of immunotherapies and cell and gene therapies, the rate-limiting step has shifted. It’s now manufacturing.
The key difference is that we are working with biologics that are living organisms rather than stable chemical structures. When I begin working with a client developing a cell or gene therapy, I tell them right from the start that they will face manufacturing challenges. It’s important to anticipate these issues and ensure the right expertise is in place to address them.
Another major challenge is cost. Much of the progress in advanced therapies so far has focused on rare diseases, which makes development and production particularly expensive as the volume of sales is limited. The real opportunity now lies in finding ways to reduce the cost of both development and manufacturing, so these transformative therapies can reach more patients.
You previously spoke to us in 2022 – and you predicted that cell and gene therapy companies may have to fight for funding in the near future. How has the investment landscape for gene therapies fared in 2025?
Securing funding was challenging in 2022, and over the past two to three years it has become even more difficult, particularly in the cell and gene therapy space. It’s not for lack of effort; many companies simply haven’t been able to access the necessary funding. I saw a similar pattern during the 2008 recession. The US continues to lead globally in life sciences investment, but within Europe, the UK remains the frontrunner in attracting the most funding.
What can help make a company stand out from the crowd?
When assessing or conducting due diligence for a company or product, I use what I call the “five Ps”:
People. Who is running the company? What is their experience and track record?
Patent. What intellectual property does the company hold related to its product?
Product. Is there solid data being generated? Can it realistically be developed? Is it druggable, scalable, and capable of being manufactured at the necessary scale?
Profit. Is there a clear path to profitability, and does a viable market exist for it?
PR. How well does the company communicate its progress? Are key milestones, such as clinical trial starts or result announcements, clearly shared to help increase visibility and company valuation?
Your consultancy offers expertise in several areas. What type of advice is in high demand?
While the cell and gene therapy market has slowed, we’ve seen a real resurgence in the development of new chemical entities. It feels as though the focus has shifted back to traditional chemistry, such as small molecules, organic chemistry, and antibody-drug conjugates.
The use of RNA-based medicines also seems to have passed its peak. A few years ago, many companies were moving into RNA or RNA-based therapies, and of course, we saw the success of RNA vaccines. However, that initial excitement has faded, and the spotlight has now returned to other therapeutic modalities.
What other trends in cell and gene are you hearing about from clients?
We led the way with our work with FKD Therapies in Finland on a gene therapy treatment for non–muscle-invasive bladder cancer, Adstiladrin – an 11-year project that ultimately gained approval. There are now thousands of studies focused on gene therapy and approximately two-thirds have focused on oncology indications, but to date, only two gene therapies have been approved for treating cancer.
In this therapy, we used a gene encoding TNF-alpha delivered via an adenoviral vector, which was instilled directly into the bladder. At this stage of cancer, the disease typically affects the bladder wall and produces papillary tumours. The standard treatment is BCG, administered directly into the bladder at periodic intervals. However, many patients eventually relapse, and when the cancer returns, the only curative option is often bladder removal (cystectomy), which has a significant impact on quality of life.
The approach was to administer the gene therapy on a repeated basis after the BCG treatment had failed and this helped reduce recurrence rates significantly. Also, it was the first gene therapy of its kind to be administered on a repeated basis every three months. This is because the adenoviral vector is only active in the body for between 60 to 90 days, allowing for repeated dosing cycles of the gene therapy to be used.
If funding in the sector improves, we’re likely to see developers begin exploring additional indications and diseases with higher prevalence and incidence, expanding the reach and impact of gene therapies.
Where do you think the industry’s priorities need to lie in 2026 to further advance cell and gene therapies?
We need to take a closer look at the manufacturing process and explore how it can be streamlined. There’s been increasing engagement with chemical engineers, which is encouraging and will help improve efficiency and scalability.
When developing new therapies, it’s important to consider not only the health benefits for patients but also the broader economic impact, how these treatments can ultimately save money for health authorities and allow patients to be better supported in the community. I’d also like to see companies begin to think about developing treatments for larger patient populations, rather than focusing solely on rare diseases.
Finally, one concern I have is that cell and gene therapies currently remain largely limited to Western countries. We need to ask how we can use these technologies to address diseases prevalent in developing nations and work towards reducing the inequality of access to these transformative medicines.
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