- Arm yourself with insights
- Use more than just secondary data to predict the fullest possible understanding of the future market and competitive landscape for potential lead indications.
- Build an overarching set of market assumptions, and consider the scenarios that could play out, built from potential opportunities and risks.
- Develop future market hypotheses and agree a cadence for ongoing validation and adaptation, leveraging congress insights, and triangulating competitive intelligence regularly with regions.
- Predict future market unmet needs and how the product profile could satisfy these.
- Identify opportunities for disruption
- Compare the indication, efficacy, safety, dosing, and method of administration with the existing standard of care and most likely future comparator. Determine comparable asset strengths and weaknesses to strengthen your pivotal trial design or integrated evidence generation plan (IEGP).
- Consider which patient populations or profiles may benefit most and how to substantiate this through clinical development. Ensure these aspects are factored into the programme’s data collection parameters.
- Map a futuristic patient journey from diagnosis through treatment, exploring sources of growth and leverage points for disruptive tactics.
- Develop robust foresights through early external stakeholder engagement to tailor the value proposition and shape the market.
- Develop a compelling brand vision
- Devote sufficient cross-functional collaboration to ‘asset visioning’, going beyond the target product profile and articulating the asset’s potential to patients and stakeholders.
- Along with the lead indication, the overall brand vision must be applicable to all potential follow-on indications, albeit with variations in positioning across therapy areas or as part of the lifecycle strategy.
- Construct your core commercial claims
- Evaluate the predicted label and anticipated claims. Determine your aspirational claims, informed by future unmet needs, competitors, target patient populations and asset differentiators.
- These claims should underpin clinical development and integrated evidence planning. They must be closely linked to regulatory label and reimbursement submission strategies to ensure the evidence package is truly differentiated. This will help ensure the evidence supports more than cost-of-entry claims.
- Engage cross-functionally
- Prioritise effective early commercial engagement with clinical development, medical, health outcomes and market access colleagues; this can alter the development path, pivotal trial design and data communication strategy. By highlighting programme limitations early, you could potentially mitigate issues via a well-thought-through and comprehensive IEGP that encompasses phase 3b studies.
- Consider whether your early data disclosure plan timings will generate maximum impact.
- Get your ducks in a row
- Prioritise a full commercial assessment for lead indications, evaluating early and peak indication revenues, optimising price across markets and incorporating a full understanding of commercialisation costs, probability of technical, regulatory and reimbursement success, and any potential for existing portfolio cannibalisation.
- Use this to determine the best indication and market launch sequence for your asset, being mindful that some of these may be beyond your control. This is where a patient and organisational mindset is required. You may need to consider external perception and reputational impact.
- Create your gated plan
- You can now map your high-level critical path to launch and where formal governance go/no-go decision gates will be required. This will be fundamental to agility and ensuring adequate resourcing.
- Categorise key elements as time sensitive, cost sensitive, or stage gated. Determine when commercial resources require allocation based on data read-outs, market dynamics and existing disease area and launch capabilities.
In our experience, innovative global brand leaders following this ‘clairvoyant commercialisation’ process have successfully navigated through a complex web of uncertainty, maintained focus on the big picture and synthesised different technical expertise to develop and drive a brand strategy that will maximise an asset’s global potential.