Barcelona, Catalonia, Spain
My responsibilities as senior director include the role of Clinical Lead for a large pivotal Ph3 in metastatic Castration-Sensitive Prostate Cancer, responsible for: - All clinical/scientific aspects and strategy related to study design (towards Ph3ID) and now during study execution and delivery of the study - Driving all governance interactions - Delivery of health authority interactions representing the clinical/science function (FDA, EMA, PMDA) - Engaging with KEEs, forming and overseeing the steering committee & IDMC I further support the broader clinical development programme in the context of health authority interactions, efficacy & safety data reviews & stakeholder interactions.
As member of EMA's Oncology Working Party I contributed to updating of the main EMA guideline for anticancer drug development, "Evaluation of anticancer medicinal products in man".
Member of The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) joint task force, which aimed to describe from a regulatory perspective the big data landscape and identify practical steps for the European medicines regulatory network to make best use of big data in support of innovation and public health in the European Union (EU). The reports that we generated from this task force can be found here: https://www.ema.europa.eu/en/about-us/how-we-work/big-data
The research I performed at the Netherlands Cancer Institute focused on identifying biomarkers to determine patients' risk of treatment-related toxicity during chemotherapy with fluoropyrimidines: https://pubmed.ncbi.nlm.nih.gov/?term=meulendijks+D The research we performed made a significant impact on the decision to clinically implement DPYD genotype testing in clinical practice across many regions, as well as regulatory action in relation to testing of patients for these biomarkers. The European Medicines Agency now recommends that patients should be tested for the lack of the enzyme dihydropyrimidine dehydrogenase (DPD) before starting cancer treatment with fluoropyrimidines: https://www.ema.europa.eu/en/documents/referral/fluorouracil-fluorouracil-related-substances-article-31-referral-assessment-report_en.pdf https://www.ema.europa.eu/en/news/ema-recommendations-dpd-testing-prior-treatment-fluorouracil-capecitabine-tegafur-flucytosine