With 2023 welcoming newly FDA-approved gene therapies from BioMarin, Krystal Biotech and Sarepta Therapeutics, many more treatments are hot on their heels for approval, investment is pouring into developing gene therapies and the role of regulatory affairs has never been more important.

As the first ever regulatory affairs forum wholly dedicated to gene therapy, this meeting uniquely unites regulatory bodies and the leading regulatory personnel across big pharma and innovative biotech to discuss the hottest topics, identify industry bottlenecks and offer actionable insights.

Join 80+ industry leaders from 4D Molecular Therapeutics, Advanced Cell & Gene Therapy, Adverum Biotechnologies, Astrazeneca, Bridge Bio, Health Canada, Omega Therapeutics, Opus Genetics, Regeneron Pharmaceuticals, Sangamo Therapeutics, Solid Biosciences, Spark Therapeutics, Ultragenyx Pharmaceutical, and more…

By attending this summit, you will get a chance to:

• Understand the nuanced differences and the route to harmonization in global regulation across the EMA, MHRA, FDA & Health Canada
• Hone your regulatory intelligence, understand how to use biomarkers as surrogate endpoints and perfect clinical trial strategy for regulatory success
• Explore the next steps for specific technologies beyond AAV and novel regulatory route
• Hear from the regulators in the Health Canada and the FDA to have your queries clarified

Overcome your CMC hurdles to prove the efficacy, purity & comparability of your compound to avoid later setbacks in poor manufacturing preparation

Don’t miss out on this unrivalled opportunity to inform your trial design, perfect your CMC approach and supercharge your global submission strategy for regulatory success.

Download the full agenda here to see our full speaker faculty, 3-day agenda and audience breakdown: https://ter.li/sgkcr9