CONFERENCE DAY TWO | Thursday, October 23

7:00 am Check-In & Coffee

7:50 am Chair’s Opening Remarks

  • Sushmita “Mimi” Roy Vice President - Technical Development, Chemistry, Manufacturing & Controls Operations, Rocket Pharmaceuticals

8:00 am Panel: Cracking the Code on Potency: Defining, Measuring, & Validating Functional Activity in Gene Therapy Products

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8:45 am Transforming AAV Analytics: Full-Length Transgene Quantification for Enhanced Process Development and Manufacturing

  • Qimin Quan Co-Founder & Chief Scientific Officer, NanoMosaic LLC

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Defining & Controlling Product Quality to Ensure Safety, Consistency, & Compliance

9:15 am Establishing Infectious Titer Assays with Accuracy & Confidence

  • Win Cheung Senior Director, Analytical Development, REGENXBIO

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9:40 am Technology Overview and Introduction of the Waters Charge Detection Mass Spectrometry (CDMS) instrument: Single-particle mass analysis enabling accurate characterization of large, heterogeneous biomolecules.

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9:50 am Aging Like Fine Champagne: Ensuring Consistent Quality with Reference Standards

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10:05 am Morning Break & Networking

Enhancing Analytical Methods for Gene Therapy Product Release & Compliance

11:05 am Characterizing Novel CRISPR Editors for Research & Therapeutics

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11:30 am Advancing Residual DNA Characterization with A Multiplexed Digital PCR-Based Approach to Size Profiling

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11:55 am Standardizing the Future: USP Standards for Advancing Analytical Quality for Gene Therapy

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12:20 pm Addressing the Challenge of ReplicationCompetent Virus Analytics in Gene Therapy

  • Susan Tam Senior Associate - Research & Analytical Development, Astellas Pharma

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Innovation, Risk, & Readiness in Physicochemical Analysis

12:45 pm Decoding LNPs: Advanced Analytical Strategies for Precise Characterization

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1:10 pm Lunch Break & Networking

2:10 pm Stability Science for Reliable Shelf Life & Commercial Success: The Mystery of AAV Instability – Bridging the Scientific Gaps in Vector Degradation

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2:35 pm Decoding AAV Degradation: Building a Framework for Stability-Indicating Assays

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3:10 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.

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4:25 pm Navigating RMAT Designation: Aligning Analytical Development with Accelerated Regulatory Pathways

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4:55 pm Chair’s Closing Remarks

5:00 pm End of the 7th Gene Therapy Analytical Development Summit

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