Focus Area Evidence generation

Work performed by Clarion, now part of Lumanity

Challenge

A mid-size pharmaceutical company had an approved and commercially available therapy in its portfolio, used in a highly competitive market, with several additional indications in late-stage clinical trials. As the organization and the brand’s strategic priorities evolved, the client needed a long-term, comprehensive evidence generation strategy to effectively address existing and anticipated market questions. More specifically, the client was seeking to understand which evidence generation opportunities would yield the greatest impact for the brand and the disease space more broadly to appropriately allocate investment in these impactful areas.

Solution

We partnered closely with the client to develop a formal, prioritized three-year evidence generation plan that addressed strategic opportunities in the current on-market and pipeline indications. As part of the effort, we worked collaboratively with medical leadership to collate and define an extensive set of evidence generation opportunities, rooted in strategic rationale and desired objectives of each effort. Thereafter, we conducted external market research with leading key opinion leaders (KOLs) to gather insights regarding evidence gaps, areas of interest, and impact on patient care. After synthesizing these discussions, we workshopped the extensive list of opportunities with the client team, refining and prioritizing a critical set of evidence generation topics for pursuit over the next several years.

Define evidence generation opportunities

  • Reviewed existing insights regarding opportunities, stakeholder needs, and interests to identify key gaps in existing evidence base
  • Developed a framework by which the team organized key objectives and strategic rationale for evidence generation opportunities
  • Defined the range of potential evidence generation topics for consideration, including strategy rationale and potential avenue(s) for collection

Gather and synthesize insights from KOL discussions

  • Developed guide for market research discussions and conducted series of conversations regarding areas of interest for industry exploration and potential impact of various data on patient care
  • Analyzed and synthesized findings from discussions, developing readout materials for client review and conversations with various internal partners

Develop prioritized evidence generation plan

  • Incorporated insights from KOL discussions into draft plan, revising opportunities and adding additional ideas
  • Conducted prioritization exercise based on feasibility, investment, and impact of each potential evidence generation effort, identifying a subset of high priority opportunities
  • Compiled recommended plan into presentation for leadership team review and sign-off, along with broader organization rollout

Impact

We partnered with the client to develop their first comprehensive evidence generation plan, aligning medical research priorities with the overarching asset strategy to address key gaps, needs, and opportunities. Ultimately, implementation of this plan allows for intentional, targeted exploration and education in the space, positioning the client as a leader in research and patient care while also demonstrating the product benefits in relevant, highly-impactful ways.

Expertise utilized

  • Scientific & Medical Rigor: Our deep scientific expertise offers insights and perspectives across a range of therapeutic areas and modalities, crafting impactful strategies and approaches that are relevant to a variety of complex markets
  • Cross-Disciplinary Expertise: Extensive experience across key commercial and clinical functions allows us to effectively engage a range of stakeholders, understand and address their needs, and incorporate their perspectives into the final approach and materials
  • Perspectives Across the Life Cycle: Expertise ranging from early-stage R&D to late-stage lifecycle management enables us to approach strategic questions with a well-rounded perspective and deep understanding of considerations along the broader commercialization pathway