Webinar: Key Regulatory Considerations for Moving Your Cell Therapy Research to the Clinic by InsideScientific

Key Regulatory Considerations for Moving Your Cell Therapy Research to the Clinic

About

The cell and gene therapy market continues to advance with a significant impact on healthcare. As a cell therapy developer, qualifying raw materials used in your manufacturing process is critical to success in your translational journey. To help you reduce time and costs for translational projects, STEMCELL will walk you through key regulatory considerations that may determine the success of your clinical candidates.

Key learning objectives will include:

Learn about the latest developments in the regulatory landscape

Understand the key considerations for qualifying ancillary/raw materials for use in T cell therapy development

Learn how partnering with your supplier can help you avoid common obstacles in your translational projects

Presenters

Mike Jones, MSc

Director, Clinical Services and Alliances, STEMCELL Technologies

Mike Jones, Director of Clinical Services and Alliances at STEMCELL Technologies, has worked in the biotechnology industry for over 12 years, notably in Product Management and Regulatory Affairs. In the last 7 years, he has focused on supporting customers with the use of STEMCELL products as ancillary/raw materials for cell therapy manufacturing.

Lynn Csontos

Vice President, Regulatory Affairs,

Lynn Csontos, Vice President of Regulatory Affairs at STEMCELL Technologies, has worked in the biotechnology industry for over 25 years. Her background is primarily with small molecule API and drug products, and she uses that knowledge to navigate the regulatory landscape currently being defined for cellular, gene, and tissue engineered therapies.

Reserve Your Spot

First Name*

Last Name*

Email Address*

Organization / Company*

Job Title*

Country / Region*

At which stage of research are you currently?*

Fundamental research

Early preclinical

Late preclinical/process development

Clinical (Phase I–III)

Commercialization

I don't know

Not applicable

What part of your T cell workflow do you find the most challenging? *

Cell sourcing

Cell isolation

Cell expansion

Cell activation

Cell engineering

Other

I do not work with T cells

Please post any questions you might have for the speakers in the field below:

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