Skip links

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

 

Discover how Camargo applied these principles in this in-depth case study for an immuno-oncology development program. Find the answers to several important questions for your program, such as

  1. What disciplines should be canvassed during the evaluation of a program?
  2. What are some of the critical components of due diligence for a development program?
  3. How can a product be evaluated for expedited approval eligibility?
  4. What CMC parameters are likely to impact product development?
  5. What are the advantages of multi-disciplinary planning and review?

Camargo has the breadth and depth of interdisciplinary expertise to partner with product sponsors and achieve success, while de-risking patient and program failures. Contact us today to find out how we can help you map the patient and product development journey for your product.