Overcoming knowledge gaps to gain FDA IND study approval

A Europe-based biotech company with limited knowledge of FDA regulatory requirements sought support from ICON during the initial Investigational New Drug (IND) review clock. During this 30-day period the FDA may request further information which requires a rapid response. The biotech Sponsor was preparing to enter phase 1/2a study for an oncology treatment. Due to their lack of direct prior experience with filing an initial IND the Sponsor engaged with ICON Regulatory Affairs.

The Sponsor had limited understanding of the FDA 30-day review clock process. The company had scaled rapidly and new and junior team members had not been part of the initial IND submission. The time zone difference between the EU and US meant that there was a risk that requests for information might not trigger responses as quickly as necessary. A missed response could result in the study being halted.

In advance of the 30-day window ICON arranged meetings to give team members an in depth understanding of the review cycle process, expectations and timelines. The training outlined individual roles and responsibilities and emphasised the need for urgency in responding to FDA queries. A tailored strategy was developed to ensure that all requests were answered promptly. This training was put to the test on the last day of the review when the FDA asked for a protocol amendment with just a few hours turnaround. The time difference became a major challenge. ICON secured an extension from the FDA until the following morning so that the European Sponsor could implement the amendment in the tight timeframe.

The initial IND was cleared by FDA allowing the clinical study to proceed in the US on the planned timeline. Delays were avoided and the new team members strengthened their understanding of FDA regulations for future trials. The Sponsor has continued to engage ICON for regulatory maintenance support for four other ongoing INDs.