Cell therapy products use living cells as a means of replacing or repairing damaged cells to treat disease.

Working Group Charter: Assess potential standards that could improve the safety, quality, and efficacy of cell therapy products and enable more efficient product development processes, such as by establishing common methods to measure cells’ functional response to their environment

Chairs:

Naynesh Kamani, MD — practicing physician and former Division Director of the American Association of Blood Banks (AABB) Center for Cellular Therapies

Rodney Rietze, PhD — CEO and co-founder of iVexSol, a vector manufacturing company

Gene therapy involves the use of a vector, such as an inactivated virus, to insert a new copy of a gene or relevant nucleotide sequence into a patient’s cells to treat a genetic health condition.

Working Group Charter: Evaluate the potential for standards that can help improve the safety and efficacy of gene therapy treatments, such as by improving screening for pre-existing immunity to common viral vectors

Chairs:

Mike Kelly, PhD — Vice President of Process Development at Avrobio

Maritza McIntyre, PhD — President of Advanced Therapies Partners, LLC

Tissue engineering uses scaffolds, cells, and biologically active molecules to create new, functional tissue or whole organs to restore, maintain, or improve tissues or organs that have been physically damaged or affected by disease.

Working Group Charter: Assess potential standards that can improve the precision and consistency of complex tissue engineering processes—including scaffold development and 3D bioprinting specifications—to allow safer and more efficient product development

Jason Wertheim, MD, PhD — Vice Chair for Research of the Department of Surgery at Northwestern University