Pre-Conference Workshops

Workshop A: Deep Dive: Exploring the ‘What, Why & How’ of
Re-Dosing for Gene Therapy

Tuesday, August 4 - 8.00 - 11.00

Attend this workshop to learn about:
• The main concerns regarding immunogenicity and re-dosing
• How likely re-dosing is by analyzing factors of current gene therapy efficacy and safety
• What are the implications for the safety and efficacy of gene therapies if re-dosing is to occur?
• What effect repeat exposure has on the immune response to gene therapies

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Takashi Kishimoto
Chief Scientific Officer
Selecta Biosciences Inc.

David Favre
Vice President Translational Medicine
Asklepios BioPharmaceutical

Workshop B: Standardization of Assay Design, Validation & Application

Tuesday, August 4 - 11.30 - 2.30

Attend this workshop to learn about:
• Nonclinical studies of pre-existing immunity to AAV vectors
• How studies of vector immunogenicity can be translated to the selection of patients for clinical trials
• How assays can be utilized alongside a companion diagnostic to better inform decision making regarding immunogenicity

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Brian Long
Associate Director
BioMarin

Andrew Melton
Senior Scientist II
BioMarin

Klaudia Kuranda
Immunology Leader
Spark Therapeutics

Workshop C: Outsourcing Immunogenicity Assays to CROs for Gene Therapy

Tuesday, August 4 - 3.00 - 6.00

Attend this workshop to learn about:

•What challenges sponsors and CRO’s face with immunogenicity bioanalytical assays
• What factors are important to consider when selecting a CRO and how to vet them
• Do and should CROs vet sponsor relationships?
• How to establish quality and long-standing relationships between sponsors and CROs
• Regulatory aspects of immunogenicity assay for cell and gene therapy: Is the current guidance sufficient? What else is needed?

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Liching Cao
Director Bioanalytical Operations
Sangamo