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ISCT Webinar 2019: Best Practices for Designing CGT Clinical Trials

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ISCT Webinar

Planning for Commercial Success – Best Practices for Designing Cell & Gene Therapy Clinical Trials

Sponsored by IQVIA

An ISCT Market Access & Patient Advocacy Subcommittee Webinar

Event Date
Thursday, November 21, 2019
08:00 PDT, 11:00 EDT, 16:00 GMT


About the Webinar
Cell and gene therapy applications have, in the last three years, made the jump from pure research products to commercialized products with high clinical efficacy, particularly for hematologic malignancies. In order to facilitate further development of cell and gene therapies for other diseases, such as solid cancers and inherited diseases, it will be important to define a framework for such undertakings, and choose the right path for eventual commercialization of successful products. This webinar will discuss how such programs can be designed, how clinical trials can be appropriately structured and how the product candidates can be successfully commercialized in the target markets. Case examples will be presented, and an overview of the current international developments in the cell and gene therapy field will be given.

Gerhard Bauer, PhD

GMP Facility, UC Davis Institute for Regenerative Cures
Chair, ISCT Market Access & Patient Advocacy Subcommittee
United States


Siofradh McMahon
Senior Manager
Clinical translation regulatory affairs

Early development considerations for commercial success

How to design early development programmes and clinical trials for CGTs to ensure that the product can be commercialized successfully in all target markets i.e. can be reimbursed and adopted successfully despite small patient numbers, rare diseases, complex administration etc.

Jacqueline Barry, PhD
Chief Clinical Officer
Cell & Gene Therapy Catapult
United Kingdom

Challenges with implementation of clinical trials across multiple geographies

The webinar will discuss the considerations for developers in the registration with Competent Authorities and Ethics Committees through to the execution of clinical trials of Cell and Gene Therapies.

Benjamin Smith
United States

Using Real-world Data to Support Innovative Clinical Research in CGT

Approaches and case examples for using RWD in CGT clinical development (e.g., external comparator / synthetic control), including acquisition, integration, analytics and insight sharing.


Registration for this Webinar has been sponsored by IQVIA.


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