A strategist who can define the pathway. A CEO who understands the commercial stakes. A board that can challenge decisions with technical insight. Project leadership, resilience and hands-on execution to carry the work through. When these capabilities are present, commercialisation accelerates. When they are missing, even strong innovations fail.
Commercialisation in biotech rarely breaks down in a single dramatic moment. More often, it slows quietly as decisions are delayed, risks go unchallenged and momentum begins to drift. The science may be sound, yet progress stalls because the organisation lacks the capability to translate ambition into disciplined action. By the time the problem becomes visible, time and capital are already under pressure.
One commercialisation expert sees this pattern far too often and knows how it ends.
“You might have great research, but you also need a commercially feasible product, funding, and the right people. You need a development mindset, not just a research mindset,” says Rosalie Cull, PhD GAICD, CEO of The Adjutor Group.
At its core, this is a capability issue. Not whether you have people in place, but whether you have the right people, at the right time, making the decisions that matter. If you don’t, you’re on the fast track to failure.
A strategist who can define the pathway
Most organisations understand that, as Rosalie puts it, “every commercialisation starts with a really good strategy”. The difference is in execution. Those that move forward are the ones who appoint a strategist capable of translating that principle into a clear, workable route to market.
“It has to be a holistic view of what is this route to market – not just what is the biggest market – and that works overall for your particular product,” she says.
Too often, organisations default to the US without considering whether that is the fastest or most effective entry point. In practice, a more targeted approach can accelerate progress and strengthen the financial foundation of the business.
“China is a huge market. South America is a huge market. Europe is a big market as well. Each market has its own reasons why a particular product might not work there, but if you carefully consider these you might be able to get to market a lot quicker somewhere else,” Rosalie says.
“You can’t just copy what somebody else has done in terms of the commercial strategy. It has to be bespoke to your product.”
That early positioning has direct implications for funding. Generating income sooner can provide the capital to sustain development, extend intellectual property and expand into more complex markets.
“If you can generate an income stream, that gives you more money to feed back into R&D to go into some other market,” she says.
A strong strategist also ensures that everything is interconnected and decisions across regulatory, clinical, manufacturing and funding are aligned from the outset. At the same time, they make sure it is not a one-off exercise. Because as development progresses, plans need to evolve.
“You’d be surprised how many people do a project plan and then it gets thrown in the cupboard… then they look at it five years later and realise they went on a completely different tangent,” Rosalie says.
“A project plan is a living document… it has to be kept up to date, and new information has to be fed into the plan so it can evolve throughout development.”
A commercially minded CEO
Even with a strong strategy in place, commercialisation often breaks down at leadership level.
It’s a common scenario in biotech: a technically brilliant founder tries to take a product to market, only to find that the role demands a completely different skill set. Suddenly they’re outside their comfort zone, engaging investors, making commercial decisions and defining a clear product pathway.
“I once spoke to a CEO who had led the fundamental research on a compound with potential across multiple diseases,” Rosalie explains.
“When I asked what indication they wanted to pursue, the answer kept shifting and the conversation kept going back to the technical detail. After several hours, I still couldn’t get a clear answer on what the product was or which disease they were targeting.
“That’s when you know the company is not set up to succeed as it stands.”
In many cases, separating the roles is more effective, allowing the founder to focus on R&D, while appointing a CEO with the commercial experience to take the product forward.
A board that can challenge decisions
Leadership gaps do not stop at the CEO. Boards are often built around governance – legal, financial and operational oversight – but lack the technical expertise needed to interrogate development decisions.
“They need to ask the right questions, but if you don’t have technical expertise, you might not know what questions to ask,” Rosalie says.
Without that capability, issues can go unchallenged for too long.
“I’ve seen plenty of examples where a product was going nowhere, but the board didn’t know because there was no-one with that technical expertise to tell them that they should have moved on six months ago.”
Hands-on execution
Even with the right leadership in place, execution remains a critical pressure point.
Working for a start-up is not for everyone. Biotech operates under constant constraints including limited capital, tight timelines and high uncertainty. Progress depends on having people who can navigate that environment, respond to setbacks and keep momentum when things go wrong – because they will.
“In biotech, you’re operating in a pressure cooker. It’s a stressful environment, and things don’t go to plan. No matter how good your strategy is, there will be curve balls,” Rosalie says.
That requires resilience and adaptability at every level of the organisation.
“You need the resilience to respond, to step back, assess what’s happened and decide whether to change course or investigate further. It requires flexibility and honesty. I often liken it to NASA, because when something goes wrong, you either identify and fix the problem quickly or find a more radical solution, on the fly.”
This mindset has to be set from leadership and carried down to the team they build. Without it, even well-designed strategies can stall under pressure.
A solid pipeline of expertise
Finding this mix of capability is not straightforward, particularly in smaller markets.
“We’re probably not training enough people and giving them real-world experience to be able to get up to speed quickly and be useful to a biotech company,” Rosalie says.
Broad, cross-functional understanding is particularly valuable.
“Even if you’re in finance or manufacturing, for example, it’s important to understand regulatory, because everything ultimately leads to that dossier being submitted for approval,” Rosalie says.
This is where larger organisations have an advantage. Big pharma has the scale to train people across functions, giving them exposure to the full development pathway. Ideally, these are the individuals that can then move into biotech with a broader perspective and make a meaningful impact.
“I’d like to see more of that – more internships, more movement between roles – so people don’t just become specialists in one area, but develop a view across the whole process,” Rosalie says.
This is where it can also pay to consider external expertise. Because if you don’t fancy paying a regulatory specialist to read a book for six months while they wait for the regulator to review a dossier, then it’s time to consider whether hiring in-house is what you need.
“This is where a lot of companies fall down, because they will start with a core team and decide they’re going to take that team all the way through. But they have to realise that at different points of development, they’re going to need specialised skills. Those people are hard to find, expensive, and at times are going to be twiddling their thumbs,” Rosalie says.
“So this is where you can bring in external consultants on an as-needs basis. It makes sense to have those flexible resources that are going to cost you less having someone permanently on staff – if you are able to hire them at all”
When it comes to commercialising innovation, most organisations know these roles exist. The question is whether they have them in place now or not. Every month spent with the wrong capability in place compounds. Decisions slow or remain stuck in silos, risks go unchallenged and opportunities begin to narrow. By the time the impact is visible in timelines and budgets, the cost of correcting it is already significantly higher. By then, the organisation is no longer building momentum but trying to recover it.
This is why the right expertise and resourcing is not something to be put in later in the commercialisation process. The strategy needs to be built in from the start and reviewed regularly to ensure the team remains aligned and relevant to the stage of development.
About Hunton Executive
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