Early Phase Cell Therapy Product Development: Potency Assays · 1/16/2018 · therapy products is...

Web Seminar Series: Early Phase Cell Therapy

Product Development

Please Join Us!

Tuesday, 16 January 2018

12:00-1:00 pm ETIntended Audience:

Scientists, Researchers, Lab Directors, QA/QC Managers and Technologists

specializing in cell therapy

Fee: No Charge

PACT will be conducting a short web seminar series covering topics critical to early phase of celltherapy product development. Potency assays for cell therapy products are intended to reflect thespecific ability of the product to effect a given result. However, the biological function of celltherapy products is not always fully elucidated, especially in early phase clinical trials. The webinarwill offer practical guidance, replete with specific examples, on approaches to development ofpotency assays that emerge by way of product characterization during preclinical and earlyclinical investigations. The presentation will incorporate recommendations from FDA guidancedocuments and will focus on test methods employed through validation including demonstration ofaccuracy, precision, sensitivity and specificity. It is anticipated that participants will emerge with asolid working knowledge of how to design, execute and analyze studies for potency assaydevelopment that is consistent with their clinical trial phase.

Registration is open!Register online at www.pactgroup.net.

Attendees will receive an email detailing audio and web access requirements.

CE INFORMATION: AMA and ASCLS P.A.C.E.

credit available see website for details

-PACT Mission-

Provide assistance for cellular therapy translational research and the manufacture of cellular therapy products

This project has been funded in whole or in part with Federal funds from the NHLBI, NIH

under Contract No. HHSN268201600020C.

-Speakers-

Emily Hopewell, PhD – Assistant Technical Director, Cell Therapy Facility, Moffitt Cancer Center

Cheryl Cox, MT ASCP – Manager, Experimental Therapies, Moffitt Cancer Center

Early Phase Cell Therapy Product Development: Potency Assays

Visit www.pactgroup.net for information on the PACT program

Objectives-

• Acquire knowledge of the regulatory expectations for potency assay rigor in early or late phase clinical trials

• Observe relevant examples of potency assay application for a variety of traditional and emerging cell therapy products

• Determine when and what test methods to apply during cell therapy product characterization and validation

Early Phase Cell Therapy Product Development: Potency Assays · 1/16/2018 · therapy products is...

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