A US venture-funded biotech was planning a pivotal trial with a highly efficacious infectious disease therapy. It asked Alacrita’s pharma market access consultants to conduct a high-level ‘gap analysis’ to identify shortcomings in the proposed trial protocol from a European market access perspective.
We identified a number of issues that, if addressed, would put the company in a better position for approaching European Health Technology Assessment bodies. We ranked each issue by severity and set out recommendations for the biotech company in order to address them. Some issues were easily overcome by modifying the protocol through, for example, adding certain secondary endpoints. Others required more in-depth research to implement. They all had a significant impact on the value of the asset in Europe and enhanced our client’s ex-US partnering prospects.