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Stacking the odds in your favour with landscape analysis

November 21, 2024 | HCPs, landscape analysis, strategic analysis 

By James Aird and Jess Choi

- PMLiVE

In many pharma companies, progression of a product (or asset) through development is gated by a series of governance checkpoints – internal decision stage-gates where senior management approve or deny progression.

Think back to the last asset you took through governance – why was it green-lighted for approval?

Was it because you presented a clear opportunity and plan that was evidence based, aligned with organizational priorities, and included a clear pathway of downstream activities? Sure, that probably helped. But the real reason was likely not your plan per se – a handful of slides are rarely enough, no matter how well crafted.

The gold dust that organizations crave and the real reason for progression is certainty. If your asset progressed, it is likely because you conveyed a sufficient level of certainty that there is a strong business case with good potential for return on investment (ROI). Yes, we want assets that will benefit patients, we want assets that offer something different, but we also want assets with strong ROI. If your asset has all three, chances are you have a strong business case. Convey a sufficient level of certainty around this and you will be in a good place come governance.

So how does one build certainty, especially at the early stages when little is known and we are normally dealing with imperfect information? The answer is to gradually reduce uncertainty, and this is where landscape analysis comes in.

Landscape analysis, the Swiss Army Knife™ of brand planning … helpful in many different ways when used correctly (but when used incorrectly it is easy to get hurt!). If you want to stack the odds in your favour at the next governance cycle, build certainty and secure funding for the next stages, this humble tool can be worth its weight in gold!

In this post we draw on our experience to look at what landscape analysis is, when to do it, how to do it and common pitfalls to avoid. We also highlight a case where we have successfully used landscape analysis to create certainty, build asset value and gain that all-important governance rubber stamp!

Landscape analysis 101 – what is it?

As we’ve previously discussed, we extol the virtues of early strategic thinking, and good landscape analyses are a key part of that.

Early in development (and indeed all the way through to launch and beyond), you are making big, important strategic decisions based on your belief of what is best for your product. But this product-centric view can sometimes be inward-looking – to be good decisions they must be cognizant of the external environment (or market) in which your product will be competing. So how do we gain that external insight? Large primary market research programmes certainly have their place, as do advisory panels, but the first, and often the fastest and best value, steer is a landscape analysis.

There are so many big questions where a good landscape analysis can help; all of which have relevance for asset governance, for example:

Q) Where do we focus our new products/portfolio? Which therapy areas, which target patients, which unmet needs?

Do you want to better understand unmet needs, target patient characteristics, cohort size and corresponding disease burden? A landscape analysis looking at market reports, industry trends, scientific literature and credible online sources can yield significant clarity on these matters, helping to develop hypotheses and insights for downstream external testing.

Q) We have just acquired an asset in a competitive space, what should our positioning and go-to-market strategy be?

A good landscape analysis can inform on the competitive landscape, potential target product profiles, differentiating characteristics, positioning and product strategy, helping to identify the white space where your product can win.

And there are many other aspects where landscape analysis can be beneficial to inform key development, commercialization and communication decisions, not least:

  • Informing clinical trial design through an understanding of competitor endpoints, comparators, dosing, eligibility criteria, recruitment, regulatory expectations, label implications etc
  • Stakeholder mapping: understanding key opinion leaders (KOLs), physicians, trialists, nurses, patients, payers of potential interest etc
  • Evidence-/data-generation plan: eg considering the landscape of post-marketing surveillance, confirmatory trials, real-world studies and more
  • Scientific communications: eg understanding competitor messaging and channels, or understanding the disease awareness landscape

For this blog we are focusing on pre-launch assessments informing product/portfolio strategy and commercialization, but many of the principles discussed will apply to a broad range of assessments, regardless of focus and scope.

Landscape analysis 101 – when to do it

The pharma planning cycle tends to operate around governance schedules – these are the meetings where the big decisions are made and working backwards from these can help drive your timing.

For example, if you know you’ll need to present your assessment of a potential opportunity at a governance meeting next October, you want to start thinking about the landscape analysis piece at least 6–9 months beforehand. Partner selection, project scoping, sign-off and kick-off could easily take 2–3 months. Running the analysis typically takes 2–4 months depending on scope. Processing and integrating the analysis into your strategy and plans can then take another month or two; 9 months can go very quickly! If primary market research is needed, you can easily add on another 2–3 months (of course, there are always options to have a ‘quick look’ if accelerated timelines are needed, but a robust analysis usually takes time and planning).

Other factors to be aware of that can influence timelines include the following:

  • Breadth and depth: how many markets/therapy areas? Top-level analysis versus deep dives? Make sure you are clear on your priorities and goals for the analysis
  • Stage of asset and data sources: a later-stage asset will require a greater level of rigour (and time) and will typically lean more on primary market research than secondary research. For an early-stage asset, secondary research alone may be adequate (that said, a small number of qualitative/semi-quantitative expert interviews can add significant value at a relatively low cost, but can add a month or two to timelines)
  • Stage of thinking: an initial assessment will typically take longer versus a refresh (say 18 months, or as internal/external milestones dictate)
  • Size of project team: cross-functional involvement is important to help shape the analysis and gain buy-in with the approach, process and outputs, but larger teams tend to mean slower projects. If in a rush, keep the team tight

Landscape analysis 101 – how to do it

It all starts with a process: a lot of the success in running a good landscape analysis comes from defining a process that is appropriate for the goals. If you are using external partners, look for experience of running impactful assessments ahead of therapy area expertise. Yes, experience in the therapy area can help, but a team that can define a strong, efficient and fit-for-purpose process will get you a lot further than one with therapy area expertise alone.

Process follows purpose: is this work to inform a business development opportunity? In which case, a process that generates results quickly might be needed. Or is this to support an early-development stage gate such as progression to first-in-human trials or indication prioritization for label expansion? In this instance, a more thorough process would be better suited, such as a 4-month assessment coupled with primary market research and external expert input.

Shared decision-making helps navigate the sea of uncertainty: embarking on a landscape analysis is very much like going on a voyage where to begin with, or even along the way, you are not completely sure of the destination. You know what you want to achieve by the end, but until you have all the information it will never be 100% clear where it will take you and where the endpoint is. This explorative element is something to be embraced – enjoy the learning moments it creates and share these with the cross-functional team. Taking the full team on the journey with you can be hugely valuable and may yield novel perspectives or ideas for new research avenues while fostering shared decision-making and buy-in.

A word on AI: the use of AI in landscape analysis is increasingly gaining traction – and judicial integration of AI tools can indeed be beneficial, speeding up certain elements such as foundational research in the early stages of an assessment. But for tasks requiring the layering-on of complex context, or for obtaining a deeper understanding of implications, current AI tools fall short; these are aspects where the human touch still has the upper hand. That said, this area is fast-moving and we look forward to assessing and integrating the best aspects from new AI tools as they become available.

- PMLiVE

Common pitfalls and mistakes to avoid

In no particular order, the biggest destroyers of value in a landscape analysis tend to be the following:

Trying to answer too many questions at once: chase two rabbits at the same time and you will catch neither. Big questions need breaking down into digestible chunks, and often prioritization will be needed within assessments. You don’t need to answer everything at once, and often what you learn in the early stages will inform later direction and approach. If you rush at the whole thing at once, you risk missing the rabbits!

Expecting perfect information: you need to be comfortable not having all the answers, and you need to make sure the whole cross-functional team is on board with this ethos. Encourage moving forwards based on what you do know rather than getting too hung up on what you don’t know. By all means acknowledge the gaps, then try filling them with assumptions while considering certain scenarios. Then comes the important (and sometimes overlooked) part – prioritize spending time considering the implications of these scenarios on the asset, rather than fixating solely on the gap itself

Not bringing in the right stakeholders at the right time: bringing in important stakeholders late on can cause disruption. Potential misalignment on scope, approach, interpretation and more, late in an assessment, can be a huge headache and one that is usually avoidable by involving key stakeholders earlier on

Not staying decision-focused: to continue the rabbit theme, landscape assessments are riddled with rabbit holes. Take a peek down as many as you wish, but keeping sight of the key objectives and decisions will help stop you going too deep!

In different ways, all of these pitfalls can slow down the process, reduce quality of outputs and undermine confidence in the foundational assumptions for your governance review. Being aware of them is the first step to avoiding them.

- PMLiVE

Case study of where landscape analysis helped support a positive governance outcome

Recently we’ve been partnering with a client to assess a wide range of preclinical opportunities to inform a portfolio expansion strategy. We’ve conducted an extensive series of landscape assessments to better understand pathophysiology, epidemiology, unmet needs, key target patient groups and burden across a broad range of infectious diseases.

Each assessment was based on secondary research alone, took 2–3 months to complete, focused on key markets only and involved a cross-functional team of commercial, medical, access, clinical development and business insights. A key aspect was to not only consider each area in isolation, but rather in the context of the nascent asset target product profile (TPP). This ensured our work stayed focused on what is relevant for the product concept at hand and allowed our findings and recommendations to directly feed into key asset decisions, shaping the TPP as it evolved.

This programme of work allowed our client team to go into mid-year governance well prepared, with clear and strong business cases developed for the priority opportunities. The outcome was a success, with approval of the two lead assets for progression into clinical studies, and budget secured for the next wave of early-stage assessments.

The foundational thinking developed from our assessments was instrumental in framing, explaining and sizing these opportunities, and zoning in on priority indications and target populations for both launch and downstream lifecycle management. We acknowledged knowledge gaps, considered alternative scenarios, gave suggestions for next-steps research, and gave recommendations for TPP and programme development. The end effect was our client not just conveying knowledge to the governance board, but also confidence that we had a plan that was well thought through and was grounded in evidence and insights.

AMICULUM landscape assessments have successfully shone a light on many big questions (here’s another article we’ve published, answering some of pharma’s big questions to drive brand strategies), helping to align products with patient needs and market opportunities, and successfully shape business cases while offering that vital degree of evidence to back up decisions and convey that all-important certainty to senior management during governance reviews.

We have completed a wide range of landscape analysis projects looking at the disease and treatment landscapes, competitor landscapes, payer/access landscapes, market trends, value drivers, opportunity assessments, portfolio assessments and more, across multiple therapy areas spanning primary and specialist care, for the world’s top 10 global pharma companies and smaller start-up biotechs.

 

At AMICULUM, we relish the opportunity to support our clients with impactful landscape analyses that provide a solid, confidence-building foundation for governance meetings, and downstream product and portfolio decisions. If you have a governance meeting on the horizon and want to build a strong foundation for your asset we would love to hear more! Please reach out to James Aird at james.aird@amiculum.biz to start the conversation. For more insights, visit the AMICULUM News and Insights page.

This content was provided by Amiculum

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