Bridging EU and US: IND preparation and submission

This business case is about IND preparation and submission.

A small European biotech company focused on drug discovery and development, investigating the clinical potential of a novel compound (newchemical entity) in various autoimmune diseases, interested in engaging with the FDA and submitting an IND.

The product had: a complete set of nonclinical studies, completed phase I and phase II clinical studies, as well as available IMPD and IB.

The project presented the following challenges:

• Client without prior regulatory experience in the US
• Critical deadlines for timely approval of an additional Phase II clinical trial in the US

The activities performed by Asphalion included:

• A screening, cleaning and mapping exercise to identify the non-clinical studies to be considered in the preparation of the IND sections
• Writing of the non-clinical, drug substance and drug product IND sections based on an existing IMPD
• Provision of IND word templates: up-to-date, ICH compliant CTD templates, including headers and footers according to client´s preference, active elements for creating Tables of Contents, List of Tables and List of Figures
• Complete IND eCTD publishing
• Submission to FDA through FDA electronic submissions gateway
• Asphalion appointed a project manager to coordinate the different teams and activities to ensure a timely delivery

Successful results regarding:

• IND templates can be used for future submissions
• Streamlining nonclinical studies package to ensure an effective submission and a more focused evaluation
• Preparation of a robust CMC package: received no questions from FDA
• All tasks delivered within defined timeframe and high quality of deliverables that ensured a successful IND approval and led to a currently ongoing phase II study