Our client was nearing the completion of a pivotal Phase III trial with a novel antibody-based therapeutic. The product was designed to delay recurrence in cancer patients with minimum residual disease following debulking surgery and standard chemotherapy.

The Phase III trial design had been agreed with the FDA under the SPA procedure and the client had gained fast-track status. In addition, the client had received EMA scientific advice and intended to file for conditional MAA approval, subject to satisfactory Phase III results.

Although our client was a fully integrated pharma company, and had significant regulatory experience with small molecules, this was the company’s first biological product candidate to reach the registration stage. The company was therefore seeking to supplement its existing in-house capabilities with the appropriate external biologics regulatory expertise.

Specifically, the company needed to gain a better understanding of the BLA process, clarify the level of detail needed for the various sections of the license application and obtain high-level review and sign-off of the regulatory dossier.


We prepared and presented an overview of the BLA process to our client’s BLA project team. After the presentation we held a Q&A session on specific areas of the chemistry, manufacturing and controls, non-clinical, and clinical parts of the Common Technical Document.

We performed a high-level review and sign-off of each section of the BLA to ensure consistency of message and highlight any areas that could be improved to enhance the licensure process.

We then helped our client prepare for, and participate in, a pre-BLA meeting with the FDA. This included drafting key questions for the agency, helping prepare the presentation materials, a presentation rehearsal and participation in the meeting itself.


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