Ensure Therapeutic Efficacy, Meet Regulatory Standards & Elucidate Mechanism of Action of Complex Gene Therapies with Robust, Validated Potency Assays

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

uditha

Uditha deAlwis

Vice President - Analytical Development & Quality Control

Sarepta Therapeutics

Accelerate Commercialization with Robust Potency Assays from Preclinical Development Through to Approval

Returning by huge demand, the hotly anticipated 2nd Gene Therapy Potency Summit will help you to navigate matrix approaches for potency, elucidate the mechanism of action for complex gene therapies, and consistently measure biological activity to demonstrate product efficacy to regulators.

Overcome the unique and diverse challenges that potency poses for gene therapies with novel case studies and unpublished data on developing phase-appropriate assays, cutting-edge HPLC and mass spectrometry approaches, and parallel line analysis.

Engage with industry leaders from clinically successful companies to develop your own potency strategy, with collaborative sessions addressing the latest FDA guidance, partnering and resource management with CROs, and balancing risk in upfront strategy.

With industry-leading experts uniting 70+ potency assay developers and solution providers from the likes of Sarepta Therapeutics, Ultragenyx, Sanofi, Spark Therapeutics, Vertex, Sangamo Therapeutics, and many others, this meeting offers the most comprehensive agenda yet.

Join us in July to collaborate with critical decision makers, perfect your potency strategy, and ultimately demonstrate to regulators that your product is efficacious.

In the Room for 2024

What's New for 2024?

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

Our Partners:

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Other Events in the Series: