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Multidisciplinary Team Advances Immuno-Oncology Development

Developing a product from concept to commercialization is a multi-faceted and risky process. Particularly for complex programs, development plans must be customized based on real-world patient experience and optimized for a product’s post-approval success.

A cross-disciplinary team is essential for crafting and assessing complex development programs. These experts should review individually and as a whole the various aspects of the program. Further, experienced advocates with an understanding of patient-centered drug development should identify opportunities to gain the patient perspective at every step of the development process.

In this way, a sponsor can anticipate and reduce development and regulatory risk, control expenses, and optimize speed to market while accounting for the many variables in a development plan:

  • Patient population
  • Study design
  • Enrollment criteria
  • Standard of care
  • Appropriate endpoints
  • Benefit/risk
  • Manufacturing timelines
  • Patient burden
  • Provider agreement
  • Expedited approval options
  • Relevant guidances

In the end, this early planning allows the sponsor to achieve the Five Rs: Getting the right dose of the right product in the right indication to the right patient at the right time.

Case Study: Immuno-Oncology Regulatory & Strategic Development