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. As part of the continued clinical development of the drug, the client asked Alacrita to prepare and submit an EU Paediatric Investigators Plan (PIP) for the product.
Solution:
Alacrita supported the client throughout the process of preparing for and submitting a PIP for their drug by managing the following items:
- Input into submission strategy.
- Preparation and submission of the Letter of Intent.
- Preparation of the Key Elements form.
- Preparation of Parts A, B, C, D and E of the application form, including:
- Overall development and information on conditions.
- Product specific waivers.
- Quality.
- Nonclinical and clinical plans.
- Timings.
- Compilation of the bibliography and obtaining references as required.
- Preparation and attendance at pre-submission meetings.
- Publishing and submitting the original application.
- Validating responses/modifications to the submission and submitting the revised application.
Alacrita's 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.
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