Industry > ITCC advice on paediatric oncology drug development
Developing oncology treatments for adults is complex enough, but transitioning to paediatric applications requires a unique set of considerations. At ITCC, we assist pharmaceutical and biotech companies in navigating the regulatory and scientific challenges associated with pediatric oncology drug development within the EU and US frameworks. Here's how we help:
Key Questions
When considering whether an oncology drug designed for adults should also be developed for paediatric use, two critical questions arise:
Is the drug relevant for paediatric malignancies?
- Does the drug's target or mechanism of action apply to paediatric cancers?
- Are there preclinical studies involving paediatric tumor models that support further development, or would a scientifically sound waiver be more appropriate?
What should a paediatric development plan look like?
- If paediatric development is warranted, what is the best design for a comprehensive development plan that meets both the needs of paediatric patients and regulatory standards?
How ITCC Supports You
ITCC offers a range of services to guide you through these questions, providing expert advice and generating the necessary biological and preclinical data to support your development process.
- Advisory Meetings: We arrange meetings with a panel of 6 to 12 experts to discuss your drug's biological and preclinical data, evaluate the unmet needs of paediatric patients, and propose either a development plan or a justified waiver. The meetings are confidential, ensuring that your data and discussions remain secure.
- Comprehensive Advisory Reports: Following the meeting, we provide a detailed report outlining our recommendations. This report can be used to guide regulatory interactions and further development efforts.
- Fast Turnaround: From the initial contact to the delivery of our advisory report, we aim for a maximum turnaround time of three months.
- Additional Support: We offer facilitated access to the ITCC Pediatric Cancer Data Portal and ITCC P4 Preclinical Testing resources. Moreover, we assist with interactions with regulatory authorities to ensure your development plan aligns with official requirements.
With ITCC's expertise, you can confidently navigate the complexities of paediatric oncology drug development, ensuring your treatment has the best chance of success while meeting the needs of young patients and satisfying regulatory demands. Contact us today to start your journey towards effective paediatric oncology therapies.
How to contact us
For any queries, please contact Carole Lecinse, ITCC Director of Operations: carole.lecinse@gustaveroussy.fr