Supporting a CTA submission for the oral form of an approved biologic drug

Challenge:

Our client was developing an oral form of an approved biologic drug which appeared to have excellent properties in terms of a rapid time to maximum concentration in the blood. A Phase II trial in an orphan indication was underway in the client's home country and the company intended to open a UK trial site as soon as practicable.

Solution:

We worked with the client to assemble a CTA application for a UK trial. Based on our review of the clients materials to date, our suggested approach was to:

• Integrate all available information into an IMPD format, highlighting gaps that needed to be filled and discussing the best approach to move forward (e.g. commission an external report or a technical study)
• Iterate with the client team until a suitable IMPD and CTA submission was ready

We published and submitted the CTA to the MHRA and acted as point of contact for all communications there after. Following this, we have been retained to provide ongoing CMC and regulatory support by the company.

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