CONFERENCE DAY TWO | Thursday, October 23 8:30 am Check-In & Coffee 9:25 am Chair’s Opening Remarks Sushmita “Mimi” Roy Vice President of Technical Development and CMC Operations, Rocket Pharmaceuticals 9:30 am Panel: Cracking the Code on Potency: Defining, Measuring, & Validating Functional Activity in Gene Therapy Products Debojit Bose Principal Scientist, Regeneron Pharmaceuticals Marina Feschenko Head of Drug Product Sciences, Analytical & Formulation, Voyager Therapeutics, Inc Crystal Bryan Associate Director - Quality Control & Analytical Technologies, Editas Medicine Synopsis Download The Brochure For More Information About This Session 10:30 am Session Reserved for NanoMosaic 11:00 am Morning Break & Networking Bioassays & Molecular Biology Enhancing Analytical Methods for Gene Therapy Product Release & Compliance 12:00 pm Characterizing Novel CRISPR Editors for Research & Therapeutics T.J. Craddick Head of Genome Editing, CRISPR Therapeutics Synopsis Download The Brochure For More Information About This Session 12:30 pm Advancing Residual DNA Characterization with A Multiplexed Digital PCR-Based Approach to Size Profiling Chynna Broxton Analytical Development Scientist, Spark Therapeutics, Inc. Synopsis Download The Brochure For More Information About This Session 1:00 pm Lunch Break & Networking 2:00 pm Standardizing the Future: USP Standards for Advancing Analytical Quality for Gene Therapy Anthony Blaszczyk Senior Scientist, U.S. Pharmacopeia Synopsis Download The Brochure For More Information About This Session 2:30 pm Addressing the Challenge of ReplicationCompetent Virus Analytics in Gene Therapy Susan Tam Quality Control Analyst, Astellas Pharma Synopsis Download The Brochure For More Information About This Session Physicochemical Properties Innovation, Risk, & Readiness in Physicochemical Analysis 12:00 pm Round-table: From R&D to QC: Validating Novel Physicochemical Methods Synopsis Download The Brochure For More Information About This Session 12:30 pm Decoding LNPs: Advanced Analytical Strategies for Precise Characterization Kan Zhu Director, CSL Seqirus Synopsis Download The Brochure For More Information About This Session 2:00 pm Stability Science for Reliable Shelf Life & Commercial Success: The Mystery of AAV Instability – Bridging the Scientific Gaps in Vector Degradation Susumu Uchiyama Scientific Advisor, Osaka University Synopsis Download The Brochure For More Information About This Session 2:30 pm Decoding AAV Degradation: Building a Framework for Stability-Indicating Assays Damon Barbacci Director, Genentech Synopsis Download The Brochure For More Information About This Session 3:00 pm Afternoon Break & Networking 4:00 pm Harmonizing Global Regulatory Expectations for CMC in Gene Therapy: Challenges & Solutions Suman Jangid Director - Global Regulatory Chemistry, Manufacturing, & Controls Gene Therapy, BridgeBio Pharma, Inc. Synopsis Download The Brochure For More Information About This Session 4:30 pm Navigating RMAT Designation: Aligning Analytical Development with Accelerated Regulatory Pathways Sarah Tuller CRO, Opus Genetics Synopsis Download The Brochure For More Information About This Session 5:00 pm Chair’s Closing Remarks 5:15 pm End of the 7th Gene Therapy Analytical Development Summit REGISTER NOW VIEW EVENT GUIDE PARTNER WITH US
