Pre-Conference Workshop Day - Monday | October 28, 2024

Discover practical solutions for current industry challenges at our pre-conference workshops! This is an opportunity for you to tackle global regulatory challenges and streamline the IND process from pre-clinical to clinical phases!

8:00 am Check-In & Coffee

9:00 – 12:00
Workshop A

Cultivating a Global Perspective on Regulation to Unveil the Similarities & Differences in Regulation Across the World to Simplify Application Processes in Regions Outside the USA

  • Chris Sharpe Vice President, Regulatory Affairs, Quell Therapeutics

Synopsis

With many companies preparing for global expansion of their cell and gene therapies, clarity in regulation across the USA, Europe, UK, Australia, Canada, Japan, and South America is paramount to this journey. Whilst there is much similarity between regulatory body requirements, this session aims to highlight key differences to foster understanding and provide solutions to challenges.

Join this session to:

  • Explore Europe’s CTR processes to address challenges specific to cell and gene therapies in comparison to general biologics
  • Unpack the intricacies of genetically modified organism (GMO) classification in this region to streamline documentation processes
  • Compare regulations from a global perspective and review convergence among different regions

12:00 pm Lunch Break & Networking

1:00 – 4:00
Workshop B

Unraveling Regulatory Challenges in Transitioning from Pre-Clinical to Clinical Phases, Focusing on the IND Process

  • Omer Butt Vice President, Regulatory Affairs, CytoImmune Therapeutics
  • Melody Dai Vice President, Head of Regulatory Affairs & CMC, Novasenta
  • Shirley Bartido Director, Global Regulatory Affairs & Cell Therapy Oncology, Takeda Pharmaceuticals

Synopsis

Cell and gene therapies span pipelines across every phase of development, from preclinical stages through to approval. This presents an opportunity to learn from various phases and make regulatory processes more efficient.

Join this session to:

  • Hear case studies from companies overcoming challenges in transitioning between development stages to review and apply learnings to your own work
  • Map out the regulatory landmarks from pre-clinical to clinical phases to gain a highlevel viewpoint of potential bottlenecks
  • Focus on IND submissions to map out the key stages of the submission process
  • Reflect on future collaboration opportunities to brainstorm possible solutions

4:00 pm End of Pre-Conference Workshop Day

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Conference Day One