- Client: Global biopharmaceutical company
- Therapy Area: Oncology
- Geographical Scope: Global
A franchise team within a global biopharmaceutical company was interested in qualifying the future need for a new treatment for a niche oncology indication. The team wished to understand (1) how the treatment landscape could evolve in the short- and medium-term, (2) whether their developmental products could bring benefit to any specific patient segments, and (3) what clinical development options existed for selected patient segments.
We kicked off with a meeting with the client team to understand their latest thinking and refine the project goals and agree steps in the project process.
groupH conducted extensive secondary research to identify clinical trials with the potential to impact Standards of Care (SoC). We then interviewed leading TAEs (therapeutic area experts) to understand how these trials could shape the treatment landscape, patient segments and unmet needs. Based on this TAE input, the groupH team built schematics to illustrate how key clinical trials could impact first-line and relapse/refractory SoC in the short- and medium-term.
groupH then designed and facilitated two 1-day workshops with cross-functional members of the client franchise team, with the following objectives and outputs:
- Day 1: the teams reviewed key trials and the models of future SoC to understand the evolving treatment landscape, future patient segments and unmet needs. We reviewed how each trial could advance the SoC in each line of therapy and patient segment, and what unmet need would remain if the trial was successful. We then identified patient segments in each line of therapy likely to have remaining unmet needs. For each segment, the teams set future aspirational SoC efficacy and safety guidance for TPP development
- Day 2: based on the guidance developed on day 1, each team focused on a specific patient segment and developed TPPs that described the product efficacy and safety and multiple options for clinical development (including trial design, timelines, and likely data requirements of regulators and payers). Fast-to-market and conservative clinical development options were developed.
The workshop outputs were documented by groupH in a concise PowerPoint deck for use by the teams.
The workshop process helped the different teams within the franchise (brand teams, and commercial and clinical organisations) to reach a shared understanding of the evolving treatment landscape. The workshop report captured these changes to the treatment landscape, and how patient segments, unmet needs and SoC benchmarks could evolve.
As a result of the work stream, we identified patient segments with likely remaining future unmet need, and developed a view of what would be required to be successful in these segments.
After the project, the franchise team evaluated the commercial case for these patient segments, and considered the clinical development options that had been proposed.