Work performed by Clarion, now part of Lumanity
Oncology development strategies have always been unique. The path to market as well as to post-approval expansion reflects both the urgent clinical need for new therapies as well as the complexity of oncology drug development.
This challenge has become exponentially more difficult as we have moved past cytotoxics to targeted therapies and more recently immune-based anti-cancer treatments. Each has and will continue to have an important role in rolling back, managing and now, even effectively curing this devastating disease. Selection of lead and expansion indications, appropriate patient selection, mono/combo selection, and trial design have become enormously more complex and more critical.
Our client, a large multinational oncology innovator, was struggling with exactly this issue for several of its early stage clinical assets. The teams had done an excellent job in identifying compelling drug candidates and had a clear sense for their interplay with cancer biology. What was difficult and more challenging, however, was to answer the question: “Given everything else that is in development, where do we think our candidate is most likely to have a meaningful comparative advantage?” Developing a strong hypothesis for such an advantage is critical for all phases of oncology commercialization–essential to everything from ensuring investigator interest in supporting clinical development all the way through to ensuring appropriate update, pricing and reimbursement.
We designed, orchestrated and led a series of workshops with the Client’s extended development team (our SPARC Process). Through this process, we helped the team critically assess the potential for comparative advantage against the full breadth of competitive programs pursuing the tumor targets of interest. Using a rigorous assessment and characterization methodology, we were able to highlight the tumor targets, patient populations, and best combinations that best capitalized on the relative strength of the client’s data.
Applying best practices in strategy option development and evaluation, we challenged the team to rethink its assumptions, explore creative options and systematically evaluate the merits of each path.
Independent and rigorous fact-base
- Characterization of cancer types based on existing literature as well as the scientific rationale for the product of interest
- Summary views of competitor studies and potential across cancer types
Individual profiles for each cancer type (30+ in total), detailing the evidence for (or against) the product
- Structured framework to capture the scientific, developmental and commercial potential of each tumor strategy
- Sensitivity analysis to understand drivers of value and risk
- Strategic option map
Strategic investment recommendation roadmap
- Recommended prioritization of cancer types, patient populations and combinations for pursuit
- Supporting analysis, including:
- Scientific rationale including new insights from external medical experts
- Business case including assessment of the market size, unmet need, and level of competition
- Staged investment model
The SPARC project helped the clients both to validate indications already being pursued and to recognize new, promising indications for their product, including novel combination regimens to explore. The clinical development and medical affairs strategies were revised, and new clinical trials were initiated.
The cross-functional exercise also strengthened the relationship between the new product strategy and the R&D teams. SPARC was declared a best practice within the organization, and we have since conducted a dozen similar exercises for a variety of products.
Scientific depth and rigor: We have cultivated a team with strong scientific and clinical expertise, which is invaluable for both the independent literature review and the external expert discussions. We can rapidly assimilate large amounts of new data, we know what questions to ask of experts and when and how to dig deeper, and we apply seasoned judgment when evaluating potential indications
Cross-disciplinary capabilities: Integration of science and business strategy is fundamental to SPARC and the quality of the insights and output. Our teams leverage a mix of complementary expertise to achieve seamless and synergistic blending of disciplines
Collaborative commitment: This project had the potential to create tension and defensiveness from the R&D team, but our inclusive approach, helpful engagement, and clear communication led to the opposite outcome. The project strengthened working relationships and generated goodwill and appreciation, which led directly to subsequent collaborations
“This is the best work I’ve seen in my ten years in the industry.”SVP and US Medical Director