Navigate Matrix Approaches for Potency, Elucidate Mechanism of Action for Complex Gene Therapies & Consistently Measure Biological Activity to Demonstrate Product Efficacy to Regulators

Welcome to the 2nd Gene Therapy Potency Assay Summit

According to the FDA, 2024 will be the ’breakout year’ for gene therapies. For these therapies to gain regulatory approval, it’s crucial to have robust potency assays in place, making it paramount that an effective potency design is incorporated into every drug developer’s analytical strategy.

With that in mind, the 2nd Gene Therapy Potency Summit is returning to Boston in July to support you in designing and validating robust potency assays to accelerate commercialization across a range of vector types and delivery modalities.

From case studies on phase-appropriate assay development to novel data presentations on cutting-edge HPLC and mass-spectrometry-based approaches, join us this year to meet 100+ industry-leading potency assay experts from the likes of Sarepta Therapeutics, Ultragenyx, Sanofi, Spark Therapeutics, Vertex, Sangamo Therapeutics, and many others.

If you’re working on a gene therapy potency strategy, this is the leading forum to uncover relevant CQAs, evolve your potency matrix, and meet the recent changes to regulatory demands in order to ultimately prove that your product is efficacious and to accelerate commercial approval.

World-Class Speaker Faculty Includes:

Hesham Nawar

Analytical Development Lead

Spark Therapeutics

Jie Li

Director

Vertex Pharmaceuticals

Ping Carlson

Director of Bioassay

Passage Bio

Sangeet Lal

Senior Manager - Cell-Based Potency Assays Development & Quality Control

4D Molecular Therapeutics

Susan Rutberg

Director - Bioassays & Molecular Biology

Sanofi

Susan Sleep

Director - Assay Development

Beacon Therapeutics

Ting He

Senior Scientist, AAV Pharmaceutical Development

Ultragenyx Pharmaceutical

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Uditha deAlwis

Vice President - Analytical Development & Quality Control

Sarepta Therapeutics

Expanding on the inaugural summit’s content, join us in 2024 to also:

Attend Tracked Workshops: Suitable for both technical scientists and senior decision makers, choose the most relevant workshop for you, such as relative potency assessment or discussing the importance of the TCID-50 assay

Determine the impact of relevant CQAs: PTMs, Impurities & Empty/Full Ratios – how do they impact potency?

Develop protocols for effective resource management and documentation handling to facilitate communication with CROs

Series Attendee Companies Include:

48789 - previously attending companies

Our Partners:

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