Regulatory Affairs: BLA submission support

Background

Alacrita`s client was nearing the completion of a pivotal Phase III 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 FDA under the SPA procedure and the client had gained fast-track status from FDA. In addition, the client had received EMA Scientific Advice and intended to file for Conditional MAA approval subject to satisfactory Phase III results.

Although Alacrita`s client was a fully integrated pharmaceutical 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 licence application and obtain high-level review and sign-off of the regulatory dossier.

Team

Alacrita’s Regulatory Practice has substantial experience of small molecule and biologics regulatory affairs. Whilst working in industry, Alacrita’s team took numerous pharma and biologic products from Phase I through to marketing approval in both EU and US. Alacrita’s US biologics consultant spent eight years at FDA/CBER acting as a BLA reviewer before moving into industry where she spent 20 years implementing innovative regulatory and quality strategies for timely product approvals.

Scope of Work

Alacrita prepared and presented an overview of the BLA process to the Client’s BLA Project Team. After the presentation Alacrita held a Q&A session on specific areas of the chemistry, manufacturing and controls, non-clinical, and clinical parts of the Common Technical Document

Alacrita performed a high-level review and sign-off of each section of the BLA, as it became available, to  ensure consistency of message and highlight any areas that could be improved to enhance the licensure process

Alacrita helped the client prepare for, and participate in, a pre-BLA meeting with the FDA. This included drafting of key questions to pose to the Agency, assistance with preparation of the meeting presentation materials, presentation rehearsal and participation in the meeting itself.

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