Challenge:
Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation study. Direct injection of the therapeutic into human tumors also led to extensive tumor reduction with no harm to normal brain cells, with extended patient survival appearing to correlate with radiological complete responses. The client now wished to obtain Early Access to Medicines (EAMS) status in the UK.
The EAMS program involves a two-step application process:
Step 1: Application for Promising Innovative Medicine (PIM) designation.
Step 2: Application for an EAMS Scientific Opinion after sufficient data have been gathered in the clinic. The opinion will support the prescriber and patient to make a decision on whether to use the medicine before its licence is approved. An EAMS Scientific Opinion can only be provided for products with a PIM designation.
Solution:
Alacrita provided regulatory affairs support to the client throughout the EAMS application process, including the below items:
- Preparing the application forms.
- Documenting the condition and unmet need.
- Justifying that the medicinal product was likely to offer major advantage over methods currently used in the UK.
- Justifying that the potential adverse effects of the medicinal product are likely to be outweighed by the benefits.
- Compiling the bibliography and obtaining references as required.
- Handling the submissions.
- Attending the designation meeting at MHRA and preparing minutes/action items
Our Regulatory Affairs Expertise
Our regulatory affairs consultants can help you devise effective regulatory strategies to place you on the best path torward regulatory approval, helping you avoid regulatory delays and overcome critical regulatory hurdles. We also provide hands-on support, including assistance with regulatory applications and eCTD publishing. Our experts can work alongside and supplement your internal regulatory teams to solve bandwidth challenges. We can also provide interim regulatory affairs leadership during periods of transition. Additionally, our team conducts regulatory due diligence both for internal purposes as well as for external parties engaged in licensing, investment, and M&A activities.