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Monday, June 17 • 3:30pm - 4:30pm
#154: Impact of Accelerated Pathways on Patients in Five Countries/Regions

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-553-L04-P; CME 1.00; RN 1.00

Several global regulatory authorities have similar expedited pathways in which a regulatory approval can be granted that would fulfill an unmet medical need based on preliminary/early data from clinical studies. This session will use a recent Oncology case study comparing the different outcomes resulting from using these five different systems aiming to accelerate development and speed up availability of new treatments to patients. This will be followed by a panel with senior regulators and a patient representative to discuss the regulatory perspective and experience with accelerated approvals. The objective is to identify potential opportunities that could help to achieve more collaboration and equity of access for patients across multiple countries/regions.

Learning Objectives

Recognize the differences of accelerated pathways in US, EU, Canada, Japan and Australia; Discuss the impact of these pathways on patient access and treatment outcomes; Identify opportunities to increase global collaboration and international patient equity.

Chair

Sunita Zalani, PhD

Speaker

EMA Update
Francesco Pignatti, MD

Health Canada Update
Isabelle Rousse, MSc

PMDA Update
Yoko Aoi, PhD

FDA Update
R. Angelo De Claro, MD


Speakers
avatar for Yoko Aoi

Yoko Aoi

Deputy Review Director, Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yoko Aoi is a deputy review director of Office of New Drug V responsible for review and scientific advice on oncology drugs. After joining PMDA, Dr. Aoi was involved in review and scientific advice on new drugs for rheumatoid arthritis, asthma, COPD etc. (2011-2016) and planning... Read More →
avatar for R. Angelo De Claro

R. Angelo De Claro

Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States
Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
IR

Isabelle Rousse

Associate Director, Bureau of Metabolism, Oncology, Reproductive Sciences, PDD, Health Canada, Canada
Isabelle Rousse joined Health Canada in 2006. She holds a Bachelor of Science in Biomedical Sciences and a Master of Science in Physiology from University of Montreal. At Health Canada, she has been a Scientific Evaluator in the Marketed Pharmaceuticals Bureau (MPB) within the Marketed... Read More →
avatar for Sunita Zalani

Sunita Zalani

Vice President, Regulatory Affairs, Oncology, Merck & Co., Inc., United States
Sunita Zalani, PhD is the Vice President and Therapeutic Area Head for Oncology and In-vitro diagnostics in Global Regulatory Affairs and Clinical Safety at Merck. In her current role, she has responsibilities for formulation and execution of global regulatory strategy for the oncology... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session