Case Study: a global biotechnology company improves gene therapy trial design with Certara Evidence and Access

Early Value Assessment in Gene Therapy Clinical Trial Design

The customer, a global biotechnology company developing precision genetic medicines for rare diseases, faced a challenge in assessing how its proposed clinical trial design for a gene therapy would impact potential payer coverage and revenue. They engaged Certara’s Evidence and Access service within its Cell & Gene Therapy practice for expertise in early commercialization support.

Certara’s team analyzed several clinical trial designs and fixed prices, providing a key finding that the original design would have resulted in payer policies narrowing the patient population so much that revenue objectives could not be met. This evidence was used by the company's commercial team to successfully argue for a change in the clinical trial design. A company director stated the team was blown away by the speed and quality of the insights provided by Certara.