One of the biggest recent advances in cancer therapy has been the arrival of novel immunotherapies, such as anti-PD1 antibodies, which have demonstrated remarkable efficacy in multiple tumor types. In many instances supported by the ‘Breakthrough’ status granted by the FDA, many pharmaceutical companies are making huge efforts to bring these promising treatments to cancer patients in a timely fashion.
In this webinar, Rik de Greef discussed how modeling and simulation can support a focused and efficient development program for immunotherapies in cancer. Key challenges around dose selection, clinical pharmacology profiling and drug labeling were addressed through a variety of M&S techniques. Apart from discussing a conceptual framework for M&S in immuno-oncology, several practical applications were discussed, demonstrating the utility of M&S in this exciting area of drug development.
About Our Speaker
Rik de Greef, Executive Director, Quantitative Solutions, a Certara company. Rik de Greef joined Quantitative Solutions in July 2014 as Executive Director and lead of the group in Oss, The Netherlands. Rik has been trained as a PK-PD scientist at Leiden University, The Netherlands. In 1998, he joined Organon, where he has been the key driver for the successful implementation of model based drug development approaches, supporting the development and registration of e.g. asenapine (schizophrenia & bipolar disorder) and corifollitropin alfa (fertility).
多年来，Rik 在 Organon 及其后继公司 Schering-Plough 和 Merck/MSD 担任了重要职务。最近，他担任临床 PK-PD 的负责人。在担任该职务期间，他领导小组从 15 名同事扩展到 34 名同事。此外，他还领导了 Merck 公司肿瘤学关键项目 — pembrolizumab 的 BLA 申请早期临床部分的准备工作。
Rik’s key interests are in the integration of model based components with overall clinical pharmacology and clinical development deliverables throughout the development trajectory. 他喜欢结合自己的分析能力和创造力来设计有效的药物开发策略，以在适当的时间解决适当的问题。In his spare time, Rik enjoys spending time with his family, and fostering his broad range of other interests: music, nature, design, food and combinations thereof.
One of the biggest recent advances in cancer therapy has been the arrival of novel immunotherapies, such as anti-PD1 antibodies, which have demonstrated remarkable efficacy in multiple tumor types. In many instances supported by the ‘Breakthrough’ status granted by the FDA, many pharmaceutical companies are making huge efforts to bring these promising treatments to cancer patients in a timely fashion.
In this webinar, Rik de Greef discussed how modeling and simulation can support a focused and efficient development program for immunotherapies in cancer. Key challenges around dose selection, clinical pharmacology profiling and drug labeling were addressed through a variety of M&S techniques. Apart from discussing a conceptual framework for M&S in immuno-oncology, several practical applications were discussed, demonstrating the utility of M&S in this exciting area of drug development.
