What was your biggest professional highlight of the past 12 months?
Taking a company that was on a Refusal to File from the FDA – deeply in trouble, in a very difficult position – and turning it around. The company had spent millions of dollars on regulatory advice from established advisors but had received an RTF and was then left struggling to attract further investment to recalibrate its course. When we came in, we identified and addressed a number of major issues across verticals that had not previously been surfaced, engaged productively with the Agency – in a fraction of the time and at a fraction of the cost – and raised capital for them in short order. The lesson, which we see repeated constantly across the industry, is that development failures very often are not about the molecule, but rather are about decision-making processes and eventual decisions made that make an asset hit the wall. Get those right, and the situation often looks very different.
Where is the biopharma industry making real progress that isn’t getting enough attention?
The quality of the companies that have survived the funding drought. The narrative is still largely about how difficult the market is, and that is true given macro allocation of risk capital to other industries than biotech. But what gets missed is that the companies that are still standing today, have been through a genuine natural selection process. At JPM this year, the level of scientific and commercial rigour we saw from the “surviving” biotech management teams was markedly higher than even two years ago. Clear target product profiles, articulated competitive positioning, realistic development budgets – the bar has been raised, and that is genuinely encouraging.
The other area that is underappreciated is what is happening in Korea. Roche’s sub-billion-dollar investment into the Korean biotech ecosystem is, in my view, one of the smartest strategic moves of the last twelve months, and it has received little coverage or acknowledgement by industry stakeholders relative to its significance.
What is the biggest bottleneck slowing progress in drug development – and how do we fix it?
Drug development experience at the decision-making level. The complexity of bringing a drug to market has increased enormously, and the competitive landscape – especially from South-East Asia – has intensified exponentially. But too many boards and C-suites are still operating as though what worked five-to-ten years ago still works today. It does not. You cannot hand a programme to a CRO and expect that everything will be taken care of strategically. The CRO will execute your study. They will not tell you it is the wrong study. The competition for capital is more fierce than it has ever been, and the investors who are deploying it can now compare your program against a Chinese company that achieved proof of concept for a fraction of the cost and in a fraction of the time. Boards that do not understand this are the single biggest hindrance to their own companies getting funded.
What’s one widely held belief in your field that you disagree with – and why?
That drugs fail. They don’t, at least not most of the time. Management fails. We review hundreds of situations every quarter where clinical programs are going or have gone wrong, and in the overwhelming majority of cases the molecule was not the problem. The study design was wrong, the comparator was wrong, the endpoints were not commercially relevant, or nobody had assessed whether the competitive landscape would still support the product by the time the data arrived. Our analysis of 1,200 Phase II and III studies found that 80 percent contained at least one material design error. Only 5 percent of the companies had a commercial target product profile relevant at time of launch. These are not scientific failures. They are operational and strategic failures made by the ecosystems around the asset, and they are largely preventable.
How can the pharmaceutical industry become more resilient in an increasingly uncertain world?
By treating commercial strategy as a design input, not an afterthought. The most resilient companies we work with are the ones that ask, before a single patient is enrolled, whether the evidence they are generating will be sufficient, relevant, and timely enough to support a commercially viable product in the market that will exist when they get there. That sounds obvious. It is astonishing how rarely it happens. The other dimension is operational speed. Not speed for its own sake, but the ability to make decisions faster and revisit them dynamically as the landscape changes. The world is more uncertain than ever – regulatory, geopolitical, competitive. Static development plans written three years ago and followed without deviation are a recipe for failure.
If you could introduce one policy change to accelerate progress in drug development, what would it be – and why?
Mandate that CROs provide an independent strategic assessment of the study they are being asked to run, separate from the commercial pitch to win the business. At the moment, the incentives in the outsourcing industry are structured around executing whatever the client brings to them as efficiently as possible – and with the industry having a large-pharma outsourcing legacy, that is understandable where “no questions asked” is usually the customer’s prerogative. Nobody is incentivised to say: this is the wrong study. But with biotech on the one hand being one of – if not the most – critical source of large pharma’s future blockbusters beyond their current patent cliffs, and on the other hand notoriously being short of capital and expertise, the approach needs to be different. If a structural separation existed between the advisory function and the operational delivery function – within the same organisation – but both were mandated to be included, we could see a meaningful reduction in avoidable clinical failures. The automotive industry does not allow the manufacturer to certify its own safety. Drug development market practice should not allow the service provider to leave unvalidated the strategic rationale of the program it is commercially incentivized to execute. For the time being, the buck stops with management and boards – whilst investors lean back asking companies to show them how their path to commercial success is more financially attractive on a risk-adjusted basis than running a similar program through a Chinese competitor.
What will look completely different about drug development in 10 years?
The geographic centre of gravity. Within a decade, I expect the majority of early-stage drug development – from target identification through to human proof of concept – will be conducted in Asia. Not because of lower costs alone, but because the operational model emerging there is simply more efficient and more commercially disciplined. Western pharma will remain dominant in later-stage development, regulatory navigation, and most importantly commercialization in the major markets – which is where a large portion of value is being captured and humongous investment is required to build a presence. But the notion that innovation originates in Boston and Cambridge and is then licensed globally will be inverted. The BMS-Hengrui deal is not an outlier. It is the beginning of a structural pattern. The companies and advisors that understand this will thrive. Those that are still treating it as a curiosity will find themselves checkmated.
Do you think your younger self would be surprised to see the career you’ve had?
Astonished. I started as a biochemist looking at the chemical pathology of breast cancer, graduated as a clinician from St Mary’s 31 years ago, and assumed I would spend my life practising medicine. I still practise acute care, which I love and which keeps me grounded in what actually matters – patients. But the journey from the lab bench to Goldman Sachs to Blackstone to building Treehill was never a plan. It was a series of moments where I realized that the problems I found most compelling sat at the intersection of science, medicine, strategy, and capital … and as we built the firm, we realized yet more vantage points needed to be included, and have acted accordingly. The thing that would genuinely surprise my younger self is that after all of it, the most impactful work we do at Treehill is still fundamentally about the same question I was asking as a student: how do we get better treatments to patients faster? And how do we make those involved talk to each other? We have just found a different way to answer it.
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