Our Offer
We offer a unique combination of services to help pharmaceutical companies and academic researchers to preclinically assess the efficacy of their assets against paediatric tumours.
Which Services does ITCC-P4 offer?
Why testing your Oncology assets on paediatric tumour models is important?
Which Services does ITCC-P4 offer?
We offer a 4-step approach to design, execute, evaluate and consolidate the most suitable testing experiments for your assets:
1. Experimental Design
Our Experts provide their inputs for you to define the most suitable design of experiments and select the right entities and PDX models, based on the tumour molecular profile review. Depending on your timing needs, we can fine-tune the PDX selection based on “ready-to-use” models available at each CRO.
2. Data generation
We provide a full assessment of the efficacy of your compound(s) or combination therapies. Dosing, scheduling and toxicity studies can be added as needed. Our CROs deliver short timelines and fast turnaround times, both for study initiation and results’ delivery.
3. Evaluation of results
Thanks to our ITCC-P4 Database, your experimental data is analysed and evaluated based on up-to-date scientific, treatment-oriented expertise and in accordance with the already available molecular data at ITCC-P4s database. Our Experts also provide a final recommendation on the relevance -or not- of the compound in the tested setting.
4. Final Report
The report as a deliverable consolidates the data and its evaluation . It also provides a final recommendation on the relevance of the compound in the tested setting and can be used during interaction with regulatory authorities.
Why testing your oncology assets on paediatric tumour models is important?
Through ITCC-P4, we aim to address the critical challenges in paediatric oncology regarding unmet medical needs and a changing regulatory environment.
Unfortunately, ~25% of children suffering from cancer experience relapses of their malignant tumours and then typically do not have remaining curative treatment options. Thus, it is crucial to identify innovative treatment approaches, develop new anti-cancer drugs and make them available through market registration for these indications.
In addition, the regulatory environment is evolving and poses new challenges for drug sponsors. With the FDA Research to Accelerate Cures and Equity (RACE) for Children Act, paediatric assessments are now required when the mechanism-of-action of drugs under review are substantially relevant to paediatric cancer. The European regulations are being revised along similar lines.
From a regulatory and scientific perspectives, comprehensive biological and preclinical data on relevant models are required to decide whether or not an asset should be developed as single agent and in combination for the treatment of children and adolescent with cancer.
Why ITCC-P4 is the right solution for you?
Your organization will find fit for purpose conditions.
ITCC-P4 is the only entity worldwide offering a package including design, execution and evaluation of the experiments ideally suited for systematic preclinical testing of your assets.
We provide access to a large repertoire of more than 400 newly established well-characterized patient-derived paediatric tumour in vivo models, supported by a comprehensive dataset of corresponding molecular phenotyping and pharmacological characterization enhanced with advice & reviews from internationally recognized paediatric oncology experts.
The experimental data are owned by the customer.
Collaborating contract research organizations (CROs) contribute their long-standing experience with a state-of-the-art methodological spectrum covering all aspects of preclinical drug testing experiments.
Moreover, we can contribute data matching requests from regulatory authorities.
Your organization will be a benefactor.
ITCC-P4 is a non-profit organization. Our revenues are pooled and re-invested into our R&D program through which we aim to continuously expand technologies and our model repertoire to optimally address preclinical testing needs for children with cancer.
Together, we will be pushing frontiers.
By choosing ITCC-P4, we will be joining forces to accelerate paediatric anti-cancer drug development. Together, we will catalyse the development of new cancer therapies for children and adolescents for pharmaceutical companies and academic research institutions. We will contribute to the prioritization of potentially effective treatments, identification of rational combinations, and validation of predictive biomarkers. With this, we will help overcoming the unmet medical needs in paediatric oncology by prioritizing and deprioritizing assets in a rational, transparent, and scalable fashion.