As we move through Q2, now is a good time for launch teams to pause and ask some difficult, but important, questions.
Not because a launch is off track. But because strong launches depend on continuously challenging and updating the assumptions that their launch is based upon before risks become critical.
Here are 4 key questions ( each with their own sub questions!) every launch team should be asking right now:
1. Are the assumptions we based our launch strategy on still valid?
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- Is our planned launch sequence still the right one in light of latest developments in Global pharmaceutical trade policy, pricing regulations and geopolitical risk?
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- Have we selected the optimum Regulatory, Pricing and Reimbursement strategies to balance timely access to medicine for patients with longer-term value?
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- Has the current and future Therapeutic landscape changed in light of latest publications and presentations at key congresses such as ASCO, and have we updated our strategy with any new implications for indication sequencing or lifecycle management?
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- Have there been any changes, or are there planned changes to National / Sub-National reimbursement mechanisms since we created our strategy that could change our assumed timelines for commercial launch in key markets?
Frequent reassessment of situational analyses and strategies has never been more important than now, amid heightened global political and economic uncertainty.
2. Is our timeline for launch still realistic?
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- Have we updated our strategy, project plans and colleagues in light of all of the previous questions about strategy re-validation and any resultant changes?
- Have we updated all internal and external stakeholders about these changes?
Plans created months ago may no longer reflect today’s reality. Delays, new dependencies, or the shifting of pipeline priorities can quietly impact the feasibility of original predictions for launch timelines.
Launch project plans need continual updating to understand any changes and newly documented risks to launch dates, then those updates need communicating and ‘signing off’ so that the whole Organisation is aligned.
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3. What’s our biggest unspoken risk?
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- Is there any internal risk causing us concern that we haven’t yet articulated and discussed as a team ?
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- What can we do to quickly acknowledge and address the problem to reduce the risk to the quality and success of our launch?
Sometimes the most significant risks are known but haven’t been openly discussed. Obvious risks related to data or external factors are easier to discuss than those stemming from internal factors e.g. a lack of cross-functional communication, resource constraints, or a lack of transparency between Alliance partners hindering co-commercialisation progress.
4. Are decisions being taken quickly enough?
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- Do we have a documented escalation and communication pathway agreed for when we need to respond quickly to change?
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- Are all matrix launch team members communicating the same outcomes from decisions ( have we agreed the elevator pitch?)
Delayed decisions can create uncertainty, re-work, and inconsistent communication from the launch team around the Organisation.
A lack of documented decision-making thresholds for the launch team are common reasons for hesitancy and not acting quickly and decisively on the latest information.
In Summary
The strongest launch teams aren’t necessarily the ones with the fewest challenges.
They’re the ones who have anticipated the need to constantly re-validate their strategy and plans, act on the very latest information available, and have agreed upon decision -making and escalation pathways ahead of time.
They are willing to ask honest questions early enough to respond effectively to maximise the potential of every launch and strengthen launch operations for future success.

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