Indication and Asset Planning Foundations
Our client had recently acquired a small biotech company, adding a new therapy to their late-stage clinical portfolio for multiple rare disorders. The client was anticipating quick succession of two commercial launches in different therapeutic areas, both in about three years’ time. When Clarion was engaged, the client was seeking support to better understand the current situation in both indications, including strategic opportunities and challenges to address in launch preparations. Additionally, the client needed an overarching asset strategy to tie together various indications, disease-specific commercialization strategies, and a roadmap to guide the team’s preparation for successful launch in the U.S. and international markets.
Clarion partnered with the client to develop robust fact base documents, an overarching asset strategy, indication-specific strategies, and operational plans to underpin commercialization efforts over the following three years. The fact bases captured detailed information about the disease state and current management, market dynamics and unmet needs, external stakeholder perspectives, and key gaps in current understanding. Leveraging the foundational fact base documents, Clarion then partnered closely with client to develop the commercialization strategy for each indication, and an overarching asset strategy that set the strategic focus across disease states. Finally, Clarion created cross-functional plans, rooted in the commercialization strategy for each indication, outlining critical workstreams and activities leading up to commercialization.
Develop foundational fact base for each disease state
- Collect and analyze existing materials, market research, and secondary information regarding the therapy and each indication / market
- Synthesize and collate all available content into disease-specific fact base document, inclusive of key information such as market dynamics, competitive landscape, and clinical milestones
- Identify key gaps in understanding of current and future situation that require near-term attention
Craft working commercialization strategies
- Develop indication-specific commercialization strategies for three years pre-launch, to be updated at regular intervals as new information is available
- Define the overarching asset strategy to guide launch planning and execution across a multi-indication brand
Create cross-functional operational plans
- Develop cross-functional operational plans that outline the way in which key gaps and/or opportunities will be addressed in the years preceding launch
- Define organizational and capability requirements to successfully execute against the operational plans
Clarion rapidly developed a deep and nuanced understanding of the client, product, and market situation at a critical time in the organization’s growth, setting the foundation for subsequent strategy and tactical execution. This foundational framework for launch readiness planning enabled the client to articulate the evolving market situation, define the key differentiating features of the therapy, and identify relevant stakeholder groups to engage with externally. By defining an overarching asset strategy, Clarion helped the client establish a consistent framework and approach across all current and future disease states in the product pipeline.
In parallel, Clarion identified key gaps and critical opportunities to address in the pre-launch period, helping to prioritize high-impact efforts in line with strategic priorities. Overall, Clarion developed a single source of truth, integrated strategies, and cross-functional plans that amplified cross-functional alignment and ensured the client planned to appropriately address all relevant market and product activities as they worked toward commercialization.
The Clarion Advantage
- Products & markets: Clarion’s range of therapeutic area expertise including immunology, specialty, oncology, and rare diseases provides the perspective and confidence to guide organizations and individuals in identifying and overcoming challenges, regardless of their nature
- Strategic & medical insights: Deep commercial and scientific expertise enables the Clarion team to offer insights and perspectives, forming impactful strategies and approaches that are relevant to a variety of complex disease areas and markets
- Organizational impact: Clarion’s ability to work cross-functionally and employ its expertise across the client organization, including with clinical, medical, and commercial stakeholders, enables the team to bring together perspectives and ensure alignment across the business
- Commercialization planning : Clarion’s expertise in building the foundational commercialization preparation framework enables teams to effectively shape the product and market for success