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Situation

A US start-up business, specialising in the field of gastroenterology, was looking to repurpose an old molecule for a new indication encompassing a different route of administration.

Challenge

An overall product development plan was not available and the business lacked the understanding and required knowledge of steps that were necessary and had to be taken to see the product approved for use in a Phase 1 trial.

Solution

Assion developed a comprehensive project plan to encompass all the necessary undertakings including; timelines, milestones and budgets. We then created a dedicated team with the required clinical, preclinical and CMC expertise to manage all interactions including; contact with the preclinical CRO. The strategy for the clinical assessment was developed along with the CTA submission, which included the preparation of the IMPD and regulatory documentation.

Benefits

The new product was approved for use in a Phase 1 Clinical Trial.