By Dr. Neal Hansen, expert-trainer of the Late Stage Pharma Lifecycle Management course.
Most biopharma companies have come to realise that the future for their business will be driven as much, if not more, by better management of the assets they already have than by the fruits of their new product development.
Many companies face up to the harsh reality that it is now time to engineer processes that can reliably deliver what they are ultimately looking for: the ability to optimise assets throughout their lifecycles within the context of the evolving portfolio needs. Good lifecycle management is not rocket science, but it is also not easy to accomplish in the real world, with competing priorities and challenging organisational dynamics.
Building from experiences in working with teams of all shapes and sizes and with brands at every phase of the product lifecycle, LCM expert Dr. Neal Hansen has developed a working list of 10 critical success factors that form the basis of good process development. These are by no means the answer to every company’s challenges, but they provide a common foundation from which individual success can be built.
Companies that truly integrate LCM into strategy are those with a commitment to planning for the mid-term and where resources are allocated to LCM as a core activity, not an add-on. Evidence of this commitment can be found in organisational structures (dedicated LCM functions or roles within brand/therapeutic teams), annual brand planning activities (where LCM is a key focus, not just a tick box exercise) and the behaviours of senior management at key decision points (where the value of LCM is understood, prioritised and challenged if absent).
This may sound simple, but in many cases it is at this stage that an LCM program falters, with senior management not ready, willing or in some cases able to effectively support brand needs. Often the first key step is to identify an LCM project sponsor at the senior management/executive committee level – someone who will act as a key advocate for LCM activities and ensure projects receive the appropriate time and focus in decision processes.
It may sound obvious, but if a team does not have the time to think about the future, how can they be expected to deliver a plan that will best position the brand to succeed? It is completely understandable and essential to drive short term growth, but too many teams find themselves 3-5 years past launch with a gap in their LCM activities, resulting from the lack of focus in that critical early period.
One of the biggest drivers of LCM failure is the fact that LCM is probably one of the most cross-functional activities within the pharmaceutical industry. Building a successful LCM plan will commonly require input from medical, marketing, clinical development, technical development, market access, regulatory, legal, finance, communications, supply chain and manufacturing teams. It will also require input from regional and local teams.
Alongside the creation of LCM organisational structures that enable cross-functional working, the development or refinement of LCM processes that drive effective, rational and aligned decision-making is a key step. Such processes must integrate market insight with brand needs, include idea generation from both within and outside the organisation and deliver plans that are cross functionally aligned and primed for senior management review and investment.
A critical driver of success for any strategic plan in today’s world is alignment with market need. A deep understanding of what drives decision making, where there are unmet needs and opportunities and/or threats to address is the foundation from which strategy should build, and in this context LCM is no different from short term brand planning. However, the key differentiating factor for LCM is the need to not just understand the issues in today’s world, but to anticipate the future market environmental drivers and resistors and to understand what will shape success or failure in the next lifecycle stage.
While an analogue approach can help us to address the potential impact of a future event, a key challenge that remains is uncertainty – will the events happen or not? What else might happen to shape the market? The future is by no means certain and as we look to longer timeframes for decision making we have to recognize and deal with this uncertainty as effectively as we can.
’Putting strategy at the heart of LCM planning’ may sound like stating the obvious - after all, who wouldn’t do that? The reality however for many companies is that LCM planning too often starts with idea generation (either from internal sources or from market pull) without the time or focus on understanding what the strategy underlying ideation and tactic selection should be.
Our penultimate critical success factor addresses a challenge at the heart of much of pharma today – innovation. Building creativity into a lifecycle management process is essential, driving teams to consider different approaches to dealing with common issues, reflecting potentially different timescales, geographic applicability, costs and probability of success.
The average lifecycle of team members is often much shorter than that of the brand, so identifying the best way to pass on the learnings of previous LCM exercises to new generations is critical. After all, if the first LCM plan has been well designed and justified, why reinvent the wheel?