戻る Agenda
Opportunities and Challenges of Novel Clinical Endpoints and Approaches Enabling Personalised Healthcare
Session Chair(s)
Falk Ehmann, MD, PhD, MS
Head of Innovation and Development Accelerator
Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
Christine Mayer-Nicolai, PharmD
Vice President, Regulatory and Scientific Policy
Merck Healthcare Kgaa, Germany
Novel conduct of evidence generation and ways to provide optimised healthcare to patients will need to be embedded in regulatory processes to support the entry of precision treatment options into public healthcare systems. Regulatory evidence requirements and assessment will need to be developed further to enable patients’ access to these more complex health products/solutions. Through the examples of circulating tumour DNA (ctDNA) and Minimal Residual Disease (MRD), this session will outline opportunities and challenges for the development and employment of more personalised healthcare solutions. Both ctDNA and MRD offer innovative opportunities in regulatory science, though challenges will exist in their implementation and acceptance. Early involvement of relevant stakeholders throughout the development of these complex products/solutions is critical to success ensuring that there is appropriate consideration and value assessment during the regulatory process. We will consider and discuss these important topics in this session.
Speaker(s)
Sensitive ctDNA Detection and Monitoring in Breast Cancer: New Tools to Inform Treatment Development and Delivery?
Dave Cescon
Princess Margaret Cancer Centre, Canada
Medical Oncologist and Clinical Scientist, Conquer Cancer, the ASCO Foundation
Opportunities and Challenges of Novel Clinical Endpoints Enabling Personalised Healthcare
Paula Van Hennik, PhD
ProPharma Group, Netherlands
Director, Regulatory Sciences
Considerations of an Evolving Regulatory Paradigm: Challenges and Opportunities Using Novel Endpoints for Treatment
Lakshman Ramamurthy, PhD
GlaxoSmithKline, United States
Head of Global Regulatory, Precision Medicine and Digital Health