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Session 2: Panel Discussion on the Challenges of Global Development for Cell and Gene Therapies
Session Chair(s)
Raju Kucherlapati
Paul C. Cabot Professor of Genetics and Professor of Medicine
Harvard Medical School, United States
Global regulatory frameworks have evolved in tandem with the rapid advancements in cell and gene therapies. This session will review the latest regulatory guidance documents from global regulatory agencies and identify strategies that have been used to address key challenges in the field, such as protecting patient safety and product efficacy. Given the need for efficiency in a fast-moving landscape yet a balance of regulatory rigor, panelists will draw attention to how existing regulatory frameworks have adapted to the increase of cell and gene therapies and recent opportunities for global harmonization of regulatory processes. The session will highlight examples of international collaboration, how approval pathways have been streamlined, and regulatory trends that are molding the future of cell and gene therapy.
Learning Objective : - Differentiate global harmonization efforts and understand the role of international collaboration in approval pathways
- Evaluate the impact of recent global regulatory guidance on cell and gene therapy development
- Identify key regulatory challenges in balancing safety, efficacy, and efficiency
Speaker(s)
Speaker
Renata Miranda Parca, AHIP
ANVISA, Brazil
Health regulatory specialist
Speaker
Yasuhiro Kishioka, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of Cellular and Tissue-based Products
Speaker
Nicole Verdun, MD
FDA, United States
Director, Office of Therapeutic Products, CBER
Speaker
Christine Ho, RPh
Health Sciences Authority, Singapore, Singapore
Director, Advanced Therapy Products Branch
Speaker
Julian Beach
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Interim Executive Director, Healthcare Quality and Access
Speaker
Evdokia Korakianiti, PhD, MSc
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
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