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#513: Advancing Chronic Disease Development: Insights from FDA, EMA, PMDA, and MHRA
Tuesday June 16, 2026 10:15am - 11:30am EDT
201AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-565-L04-P; CME 1.25; RN 1.25

Chronic Disease Town Hall spotlights emerging programs and global initiatives for chronic disease drug development, outlines the current landscape, explores opportunities and challenges, and assesses strategies to boost efficiency and accelerate therapeutic innovation.

Learning Objectives

Discuss the present landscape, opportunities, and challenges of chronic disease drug development; Describe emerging programs and global initiatives designed to facilitate development of chronic disease drugs; Assess various considerations and strategies to enhance the efficiency of chronic disease drug development.

Chair

Jingyu (Julia) Luan, PHD

Speaker

Panelist
Steffen Thirstrup, MD, PHD

Panelist
Alison Cave

Panelist
Maria Vassileva, PHD

Panelist
Ayaka Kubota, RPH


Speakers
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →
avatar for Ayaka Kubota

Ayaka Kubota

Office of Safty II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
She is a reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. She is involved in the scientific review of pharmaceuticals, primarily focusing on cardiovascular drugs and treatments for Alzheimer’s disease, with an emphasis on clinical evaluation and regulatory... Read More →
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States
Dr. Luan is currently the Executive Regulatory Science Director at AstraZeneca (AZ), where she oversees all regulatory aspects of obesity and diabetes drug development and supports the research, development, and commercialization efforts in these disease areas. She also leads the... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
avatar for Maria Vassileva

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

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