In early February, Cello Health Consulting’s Carl Engleman moderated another lively panel discussion with senior biotech leaders at the LSX World Conference. The panel discussed the commercialization journey for biotech companies bringing their first asset to market and the need to bring a commercial perspective earlier into the development process.

Panel: Steven Powell, CEO, eTheRNA Immunotherapies; Denise Scots-Knight, CEO, Mereo BioPharma Group; Erik Van den Berg, CEO, AM-Pharma

“It may have previously been the norm to focus on clinical development and to leave commercial thinking to a bigger partner. However, as more and more companies choose to go it alone, or to do later stage deals, there is a need for asset owners to have a more granular understanding of their target market, the needs of their stakeholders, and the evidence required to ensure successful uptake and long-term differentiation.” 

Carl Engleman, Cello Health Consulting

The panellists represented a range of perspectives, therapy experiences and commercial backgrounds, and over the course of the discussion they identified a number of factors critical to successful commercialization.

Clarity of vision

The panellists discussed the shift towards going it alone, and the consequences for commercial strategy. “In the previous scenario we didn’t have to worry too much about commercialization aspects in the early stages. These days however, larger sums of investment and an increased opportunity for biotechs to commercialize alone means that a different mind-set is needed. In our situation this has meant for example, a much closer look, in Phase 2 (and 3), at a number of important commercial drivers such as length of hospital stay, reduction in mortality, quality of life.”

“It’s starting with the end in mind – the end is the market you will launch into, which means much more than simply great science. Ultimately, it’s the process of planning and commercial thinking that delivers most value.  It allows you to learn, remain agile and adapt to new challenges or opportunities.”

Examples of the need to generate value by introducing commercial thinking earlier in the clinical development process were varied and compelling, often fuelled by the complexity of today’s market – one biotech CEO used the example of the rapid shifts in the immune-oncology market over the past 5-10 years. “These days we need to consider and plan for what the standard of care is likely to be in the future, not just how it is today.  Then, how we will weave our product into that future treatment regimen. It’s never enough to focus on clinical attributes if the commercial lens isn’t applied early. What will be relevant in 5 years’ time? For us, it’s also been critical to think about how the standard of care and treatment regimen will vary between different geographies. There can be major differences across oncology markets. These considerations all need to happen at the early TPP stage.”

Early stakeholder insights are critical to shape future commercial success

An area the panellists were keen to highlight was the early synchronisation of clinical and commercial development strategy around the Target Product Profile (TPP). The TPP is not simply about the product, it is a description of the clinical and commercial needs of the different stakeholders. The TPP should evolve over time as the understanding of the product increases, but also, and importantly, as the understanding of these stakeholders and their needs increases. 

It’s not only about marketing, changes to the TPP and usage expectations can have significant implications for manufacturing and supply for example, and especially where these are complex or constrained. “We start with the TPP at pre-clinical stage. An important factor to build in is the volume, dosing and capacity needs. For us, the manufacturing requirements and regulatory considerations are key to the success of the asset. The TPP will change and become more detailed over time of course, but we know it can’t only be about the science at the early stage.”

The discussion then turned to the need to bring stakeholders to the table early. “We start payer discussions early, which generally has an impact on guiding requirements for phase 3 studies.  This early engagement allows us to make important tweaks around those drivers I mentioned earlier - length of hospital stay, reduction in mortality, quality of life.  If you don’t bring in the patients, payers and other stakeholders early on you risk making the wrong choices – you may have a very successful trial program but ultimately you’ll struggle to have a commercially viable and differentiated product.”

One panellist built on this and talked about different portfolio assets entering their phase 2b/3 study. “Common to all assets was the need to engage very early on with physicians, payers and patients in something we call the ‘3 petal model’. For example, we’ll have patients come to the practice and talk about the impact of the disease. We will make sure there’s patient representation at regulatory meetings. You gain insights about the disease you didn’t previously know. And from physicians and payers - new insights on the treatment paradigm.  All of these fresh insights then feed into your TPP, trial endpoints, and pricing model and justification”.

Focusing again on immune-oncology and regulators, one of the panellists spoke of the challenge presented though new mRNA technology. “Different formulations require different data packages from a safety perspective. So data requirements around the formulation vary significantly in different geographies. This active dialogue is so important across different regulatory agencies and of course with physicians - we have to understand the difference in the uptake of new therapies in a particular indication for various geographies. We have to be able to show how we fit with other cancer vaccine modalities, checkpoint inhibitors and drug combinations and this has implications for the data we need”.

Assigning commercial responsibility 

The panel was in agreement on the need to have a commercial voice or champion to guide their transition from a clinical development company to a commercial entity. This might come through recruitment of specific roles, such as CCO or VP Marketing, or from effective use of board-member experience.

‘’Bringing in or recruiting commercial experts early also allows you to better manage the investor discussions. You don’t need a huge headcount early on but you need that voice and perspective.”

“Sometimes you don’t yet have the commercial people in place in a smaller biotech. It’s lacking this commercial input and multi-stakeholder perspective that means the clinical development plan can lack those criteria that will have a huge impact on future success. Comparative elements of the product might easily be missed, which is why biotechs need to really accelerate their evolution from a pure research organisation early on.’’

Improved commercial awareness supports deal-making

When the panellists considered their approach to partnering or going it alone, they emphasized the importance of having a clear initial plan informed by a solid understanding of the commercial and clinical requirements for success. It was also agreed that these plans would rarely develop as expected, but that the investment in early planning allowed them to be more responsive to change and to have greater confidence in their decision-making.

“When you look at the immuno oncology landscape and what’s required from a clinical perspective as well as for a sizeable population, it was clear we had to go down the partnering route. The other key factor was a need to manufacture a complex product. We sought a strategic partner that could manufacture at scale, which in turn led to a commercial partner for a specific geography. The supply chain challenge also sharpens the mind and feeds back into the development program – it becomes a key part of the commercial differentiation potentially.”

Other panellists shared their journeys, and how they evolved from their early vision. “Initially we thought we had our large pharma partner and believed we could gain their investment and input into phase 3 during phase 2. In the end the deal wasn’t exercised so we had to finance the phase 3 study ourselves. We are now building our own commercial infrastructure - but are looking at other partnering for geographic reach and scale.”

“With our rare disease programmes we intended to raise the capital to fund phase 3, maintain our global rights and self-commercialize.  As things progressed, one of our stakeholders became nervous around the trial endpoints.  We were confident however and evolved our strategy to co-commercialize.  We still retain some commercial rights but our partner is responsible for all the costs of global development though to filing. The biologic manufacturing investment is also there so this was a great outcome.  It’s not how we set out, but if we didn’t have the original vision of being a commercial company and retaining rights from the get go – we wouldn’t have been able to secure this deal.’’

At Cello Health Consulting we work with 24 of the top 25 biopharma companies, and in the last 2 years alone we have worked with over 100 biotech and start-up companies. For over 30 years we’ve been helping our clients to address some of the most challenging problems in our industry. We are expert navigators, with a blend of experience built in the biopharma industry, in strategy consulting, and in academic research.

Contact us today if you would like to hear more about how we could help you to realize the full value of your asset.