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Phase 2 trials: A pivotal moment for launch success

Hassan Choudhury, Head, Early-Stage Strategy; Genevieve Ball, Head, Go-to-Market Strategy; and Gary Choy, Senior Consultant | 9/25/2023

In accelerated launch timelines and highly competitive oncology landscapes, a successful launch requires a different approach. Biopharmaceutical manufacturers are rethinking Phase 2 trials to infuse the clinical strategy with commercial thinking to drive value for stakeholders across the product life cycle.

In 2022, more than 700 oncology products were in the late stages of the development pipeline—an increase of 60% over the previous decade. The rise in competition—fueled in part by scientific advancements and treatments targeting smaller patient populations—has created a complex environment for stakeholders to navigate as they work toward improving patient outcomes. These stakeholders include policymakers, healthcare professionals, and patients, along with regulators and payers, with nuanced needs to be considered from an early stage to ensure success later on.

Launch challenges are heightened in accelerated environments, where timelines for new oncology products are shorter than in traditional trial protocols and regulatory bodies are putting pressure on biopharmaceutical organizations to improve the data available at the time of accelerated approval.

To be successful, biopharmaceutical manufacturers are rethinking their approach to early-phase clinical trials, applying a commercial lens to maximize value across the product life cycle, including exploring how technology could help improve product development.

Competing in a constantly evolving oncology landscape

The crowded, rapidly evolving, and personalized oncology space creates challenges and opportunities for developers of new therapeutics.

As a result, manufacturers are looking for innovative approaches for speed to market while also being mindful of commercial value and competitive differentiation as the market evolves.

Key considerations affecting the complex oncology landscape include:

  • Greater complexity within a crowded marketplace
  • An increased emphasis on highly targeted patient subpopulations
  • More sophisticated study design
  • Increasingly personalized therapies
  • A continuously evolving regulatory landscape

Each trend requires a rethink of the clinical trials to deliver evidence beyond the scientific benefits, ensuring value is crystalized for a range of stakeholders so they are better equipped to make critical healthcare decisions.


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