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Session 1 Track A: Modernizations Initiatives: Advanced Therapeutic Products (ATPs)
Session Chair(s)
Samar Darwish, MBA, MSc
Director, Drug Regulatory Affairs, Boehringer Ingelheim, Canada
Products are becoming increasingly complex (e.g. AI, machine learning, advanced cell therapy, 3-d printed products), and many of these products are challenging the current regulatory system and need innovative and agile solutions to enable access to these products. These Advanced Therapeutic products (ATPs) are becoming a reality and several of these transformative therapies have been approved by major and midsized authorities.
In this session, you will hear from Health Canada on the progress of the implementation of the Advanced Therapeutic Products (ATP) pathway, the identification of ATP candidates and the timelines of implementation of the first pilot ATP pathway. In addition, you will learn from an industry perspective on what is different about cell and Gene therapies, their science, their benefits and challenges, as well as the regulatory landscape impacting the future of these promising therapies. The session will conclude with a panel discussion and a Q&A session.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize what makes cell and Gene therapies different from traditional therapies
- Discuss the opportunities and challenges of ATPs
- Describe the Health Canada proposed ATP pathway
Speaker(s)
Kenneth Joly, MS
Senior Policy Analyst, Office of Advanced Therapeutic Products, Health Canada, Canada
Advanced Therapeutic Products
Chin Koerner, MS
Executive Director, Development and Regulatory Policy, Novartis , United States
Cell and Gene Therapies/ATMPs: Where are We?
Nicole Mahoney, PhD
Executive Director US Regulatory Policy & Intelligence , Novartis, United States
Panelist