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Session 7: Roundtable Discussions
Session Chair(s)
Maria Vassileva, PHD
Chief Science and Regulatory Officer, DIA, United States
In Session 6, some of the most pressing challenges in advancing cell and gene therapies will be on the table, as global experts engage in three focused roundtables covering regulatory, access, and chemistry, manufacturing, and controls (CMC) issues that are shaping the CGT landscape.
The first roundtable will explore how regulatory frameworks can evolve to keep pace with rapid scientific advancements in cell and gene therapies, support innovation, and enable global regulatory convergence. The second roundtable will focus on addressing access barriers in developing countries, highlighting strategies to ensure that patients with urgent and unmet medical needs can benefit from newly approved cell and gene therapies. The third roundtable will center on CMC challenges in cell and gene therapy production, with a focus on scalability, quality control, and evolving regulatory standards across global markets.
Attendees will have the opportunity to engage directly with thought leaders, exchange perspectives, and contribute to identifying collaborative solutions that can accelerate the development and global delivery of safe, effective, and accessible cell and gene therapies.
Learning Objective : - Examine regulatory, access, and manufacturing challenges in advancing CGTs
- Evaluate global strategies to improve patient access and regulatory alignment
- Understand key CMC considerations impacting CGT scalability and quality
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Consider collaborative approaches to support global delivery of CGTs
Speaker(s)
Lesbeth Caridad Rodriguez, MS
Director, Regulatory Affairs Policy and Science, Bayer, United States
Topic 1: CMC Hurdles with Cell and Gene Therapy Manufacturing
Tamei Elliott, MS
Director, Global Scientific Content, DIA, United States
Topic 1: CMC Hurdles with Cell and Gene Therapy Manufacturing - Moderators
Sandra Blumenrath, PHD, MS
Executive Editor, Scientific Publications & Senior Scientific Program Manager, DIA, United States
Topic 1: CMC Hurdles with Cell and Gene Therapy Manufacturing - Moderators
Monica Veldman
Director, Global Regulatory Policy, Alliance for Regenerative Medicine, United States
Topic 2: Regulatory Challenges: Ideas of how to best harmonize regulations globally and adapt existing regulatory processes in the context of application to cell and gene therapies
Radha Goolabsingh
Global Regulatory Strategist, DIA, United States
Topic 2: Regulatory Challenges - Moderators
Sara Torgal, MPHARM
Global Regulatory Policy Lead, DIA, Switzerland
Topic 2: Regulatory Challenges - Moderators
Ralf Herold, DrMed, MD
Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands
Topic 2: Regulatory Challenges - Moderators
James Wabby, MHS
VP, Head of Regulatory Strategy, Emerging Technologies and Combination Products, AbbVie, United States
Topic 3: Ensuring Timely Access to Approved Therapies in Developing Countries: Addressing Patient Needs and Unmet Public Health Challenges
Maria Paula Bautista Acelas, MSC
Scientific Program Manager, Research Partnerships, DIA, United States
Topic 3: Ensuring Timely Access to Approved Therapies in Developing Countries: Addressing Patient Needs and Unmet Public Health Challenges - Moderators
Luiz Correa
Associate Director, Scientific Programs - EMEAI, DIA, Switzerland
Topic 3: Ensuring Timely Access to Approved Therapies in Developing Countries: Addressing Patient Needs and Unmet Public Health Challenges - Moderators