26 years in scientific research focused on translational medicine. Diverse scientific experience and a clinical perspective attained as a critical care nurse. 15 years experience in R&D. Recognized as a leader in biomarker/ patient phenotyping initiatives including ECLIPSE, ERICA, COPD MAP & CBQC.
26 years in scientific research focused on translational medicine. Diverse scientific experience and a clinical perspective attained as a critical care nurse. 15 years experience in R&D. Recognized as a leader in biomarker/ patient phenotyping initiatives including ECLIPSE, ERICA, COPD MAP & CBQC.
Coordinator of the service 'Drugs Monitoring Registers'. Master Degree in HTA, Degree in arts. At present, he’s also the technical director of the international project 'Electronic Bibliography of Troubadours'( Un. of Rome La Sapienza).
Dr. Leidy has over 25 years of experience in clinical and health outcomes research, specializing in instrument development and clinical trial design and analysis. She has more than 100 scientific publications and for the past several years has served as PI of the EXACT-PRO Initiative.
Description
This session will focus on an emerging approach to R&D using specific examples for public-private partnerships in chronic obstructive pulmonary disease and oncology. The role of biomarkers and patient-reported outcomes in research and development of new medicines, the current regulatory environment for biomarker and endpoint qualification, and key success factors for public-private partnerships will be discussed.
Learning Objectives: Describe the role of biomarkers in R&D of new medicines Discuss the current regulatory environment for biomarkers and PRO qualifications Discuss the use of health care web-based registers for clinical research Identify key success factors for public-private partnerships using an example of COPD and oncology.