The Future of Cell-Based Therapies: Challenges and Opportunities in Making Gene Therapies More Widely Available
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The Future of Cell-Based Therapies: Challenges and Opportunities in Making Gene Therapies More Widely Available

December 13, 2017

8:00 a.m. PST / 11:00 a.m. EST / 16:00 GMT / 17:00 CET

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Overview

 

On August 30, 2017, Novartis made history when the company received approval from the U.S. Food & Drug Administration for tisagenlecleucel, a gene therapy for treatment of childhood leukemia. Seven weeks later, Kite Pharma followed, receiving FDA approval for axicabtagene ciloleucel, for non-Hodgkin lymphoma. It took three decades of research and clinical testing for the FDA to give its first-ever approvals for gene-therapy products.

Both tisagenlecleucel and axicabtagene ciloleucel are dramatically different from any drugs previously approved by FDA. Most notably, they are patient-specific drugs: T-cells from the leukemia patients' immune systems are harvested and genetically reprogrammed to express a chimeric antigen receptor (CAR) protein. The modified CAR T-cells are reinfused into patients to hunt their cancerous prey.

Radically different biologic drugs like tisagenlecleucel and axicabtagene ciloleucel require a radically different style of manufacture. This webinar will look at challenges facing researchers and product development teams, as this technology becomes more widely adopted as a treatment.

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Key Topics:

 

• Treatment areas where cell-based gene therapies will play a role

• Developing manufacturing programs with automated or semi-automated processing

• Managing manufacturing process changes and demonstrating comparability

• Selecting, qualifying, and managing contract service providers for cell and gene therapy

• Handling the challenges of variable raw materials

• The regulatory pathway for gene therapy products

• The future of off-the-shelf gene therapy treatments and barriers to overcome

Who Should Attend:

 

• Researchers

• Laboratory managers/directors/operators

• Heads of core facilities

• Managers at CMOs and CDMOs

 

Speakers

 
Don Healey, Ph.D.,
Senior VP of Operations,
KBI Biopharma
Scott R. Burger, M.D.,
Principal of Advanced Cell and Gene Therapy
 

Moderator

 
Jeffrey Lee,
Senior Editor
C&EN BrandLab
 

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