Early strategic planning: how to get ahead of the curve
March 21, 2024 | Strategic planning, drug development, medical affairs, novel therapeutics
By James Aird and Sarah Theobald
According to a 17th century proverb, ‘early to bed and early to rise makes a man healthy, wealthy and wise’. We say the same about strategic planning in drug development. The sooner you start, the better your chances of success – but what do we mean by this? Strategic planning is the series of decisions that set the vision and direction for your product, guiding all downstream actions as you move through development towards the market.
We advise on strategic planning across the drug development pathway and have seen significant advantages for those who set out a clear vision early, galvanizing the organization towards a shared goal and building a solid foundation for future growth. The clarity drives alignment across functions and provides a guiding light as you progress towards commercialization and as you hit the inevitable roadblocks along the way. When lost, look for the light! But if you don’t have a light or leave it late to set an overarching strategic direction, your choices can be limited, your organization can become misaligned, functions can waste time and energy re-inventing the wheel, and your response to challenges will likely be reactionary and suboptimal. This post will expand on some of these themes.
You can’t plan your route without knowing the destination
You wouldn’t set out on a road trip without knowing where you want go. Knowing your destination allows you to select the best route while planning for any potential diversions along the way. Drug development is no different – you need to know your aspirational outcome to be able to make good decisions from the outset.
In the case of new medicines, this is about being clear on the unmet need you’re going to address and focusing efforts where you have the best chance of filling the gap. Defining this strategic vision and ‘target product profile’ as early as possible allows you to break your journey down into stages. At each of these stages, you can stop, review your plans and the changing landscape, and reroute if needed, but still with the same destination in mind.
Why is directional strategic planning often left till late?
There are many valid reasons why strategic planning is often left late, including:
- Money: early in development, budget is often allocated to data generation ahead of strategic planning
- Silos: responsibility for product development typically transfers between teams at key milestones, creating disconnects that affect long-term planning
- Processes: annual planning frameworks can constrict thinking and dilute decision making
- People: teams are often stretched and will focus their energies on already-launched products ahead of an asset that is years away from launch
While these are all common reasons for delaying strategic planning, the benefits of getting it right from the start have the potential to more than outweigh the risks.
Navigating forks in the road
Decision making is at the heart of strategic planning, and every decision you make is a fork in the road. Many of us prefer to deal with hard evidence, but in early-stage strategy, we need to be comfortable working with imperfect information.
For example, an early decision on your lead indication enables a clear and focused communication plan and early stakeholder engagement. When it comes to evidence generation, understanding what your trials need to deliver for regulators and payers in priority markets is vital but can only be achieved if you know what those markets are upfront. Late decisions run the risk of data gaps or an evidence base that may not support submission in key countries.
There are many forks in the road, thus it is vital to collaborate across functions and work towards the common strategic goal, enabling your whole organization to go on the same journey without diverging. Of course, you can’t guarantee that you’ll choose the right path, but plotting a clear course from the outset will allow you to take an agile approach and collectively renavigate if necessary.
Mitigating roadblocks through early planning
All the strategizing in the world can’t prevent roadblocks from cropping up along the way. There are many possibilities, and we can’t plan for them all, but the more aware we are and the more agile we’re prepared to be, the better we can adapt.
Some of the many roadblocks that could be mitigated with early planning include:
- Changes in corporate strategy or priorities or restructuring – may put your asset in the spotlight or on the backburner
- Mergers, acquisitions or licensing – may provide challenges in terms of knowledge transfer and alignment; may bring time pressure to key decisions
- Challenges with stakeholder alignment – functions may not be united behind the overarching strategic direction; new hires may have different perspectives
- Lack of insight/market understanding – do you really understand what matters to clinicians and patients and how they perceive your asset?
- Data surprises – your trials or competitor trials may throw up unexpected results (positive or negative) that you have not planned for
- Development challenges – trial design may not be aligned with regulatory and/or reimbursement priorities, or may not be optimized for commercial success
- Regulatory challenges – different authorities may have different data requirements; your label may not be as anticipated
- Access challenges – reimbursement may be in a restricted population only; data requirements will differ across markets; competitor moves may surprise you (eg an unexpected head-to-head trial)
Hopefully, these give a flavour of the challenges that could occur, that could significantly limit the potential of your brand, and where early planning would help. While we can stand on our soap box, extolling the virtues of early and adaptive planning, we know that in the real world, things will get in the way.
We are not here to judge but to encourage. A little planning can go a long way, and an agile approach means that you can always refine downstream. This is as much about a mindset of planning as it is about the tools and processes.
Drug development is hard – what can you do to map the best route to success from the start?
Think of early and adaptive planning as filling up a series of buckets with information, whereby the amount of information in each bucket grows over time as more is learnt about the market, the asset and the opportunity. You are unlikely to have any full buckets early on, but you don’t need them. Your team needs to become comfortable with not knowing everything.
Rather, what you need is enough information to make priority decisions so that you can move forward, and this is where having an organization that is unified behind a single strategic direction (not disconnected and pulling in different directions) will reap huge rewards. In our experience, considering the following six elements will help:
1) Create a business case to support strategic thinking
Good, clear thinking at the start can yield big rewards later. You don’t need all the answers initially, but you do need to consider all ‘buckets’ and understand what you know (and don’t) about each one
2) Ask ‘big questions’ from the start; think about the big picture
Who are your target patients and prescribers? What is your basic value proposition and positioning? What are your price benchmarks? Have you considered the approval and reimbursement requirements of key markets? What do you know and not know yet about the big picture questions?
3) Establish a strong decision-making framework
Who will be making decisions? How will they be made and when? What information is needed? What governance is required?
4) Engage cross-functionally to agree priorities and embed early and adaptive planning
Include all relevant functions from the outset. Build in measures that can drive decision making; use data analytics to ‘fail fast’ and redirect
5) Plan ‘stop-offs’ to adjust
Define checkpoints, allowing for structured redirection as necessary (while also remaining agile to adapt rapidly when needed)
6) Work with great consulting and communication partners!
At AMICULUM, we look forward to the opportunity to support our clients with early strategic planning. It’s where we can have the greatest impact and help best shape the path for great products and patient impact.
Download the full article
This blog has been adapted from the First Word article, ‘Getting ahead of the curve: early strategic planning for novel therapeutics’.
Click here to download the full article.
If you’re embarking on this journey, we would love to hear more! Get in touch at sarah.theobald@amiculum.biz. For more insights, visit the AMICULUM News and insights page.
This content was provided by Amiculum
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