Gene Therapy Regulatory Affairs Boston Park Plaza, Boston

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.

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.

Join 80+ industry leaders from 4D Molecular Therapeutics, Advanced Cell and 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…

Speakers: Anastasia Yemelyanova, Regulatory Affairs CMC Lead, Spark Therapeutics, Brian Baker, Senior Director of IVD Regulatory Affairs, Regeneron Pharmaceuticals, Catherine Campbell, Vice President of Regulatory Affairs and Quality Assurance, Deirdre Harwood, Senior Director of Regulatory Affairs, Ultragenyx Pharmaceutical, Dunni Odumosu, Vice President of Global Regulatory Affairs, Bridge Bioscience Corp, Jim Wang, Chief Regulatory Officer, Adverum, Maria Lobikin, Director, Regulatory CMC, Solid Biosciences, Natalia Shunmugan, Senior Director of Global Regulatory Intelligence and Policy, Ultragenyx, Omar Tounekti, Manager, Health Canada, Q. Melody Dai, Senior Director of Regulatory Affairs, Adverum Biotechnologies, Sarah Tuller, Vice President and Chief Regulatory Officer, Opus Genetics, Inc, Saumyaa Saumyaa, Associate Director, AstraZeneca, Scott Burger, Principal, Advanced Cell and Gene Therapy, Sianna Castillo, Senior Director, Sangamo Therapeutics, Suman Jangid, Associate Director – Global Regulatory CMC – Novel Gene Therapy, Omega Therapeutics, Inc., Thomas Powers, Senior Principal Scientist and Group Leader, Pfizer, Yao-Yao Zhu, Director of Global Regulatory Affairs, AstraZeneca