Sector Working Groups

SCB’s projects and initiatives are organized and advanced within a set of working groups focused on four regenerative medicine fields:

  • Gene Therapy

  • Cell Therapy

  • Tissue Engineering

  • Cell-Based Drug Discovery

Each working group is made up of expert representatives from industry, academia, clinical practice, and other relevant stakeholder groups, who identify and assess needs for standards or best practices that can support the advancement of the regenerative medicine field.

Once the sector working group has identified a standards need, SCB may then form a project working group to further assess the potential standard’s priority and feasibility and ultimately coordinate its advancement through a relevant standards developing organization (SDO).

If you are interested in joining a sector working group or providing feedback about standards needs in your sector, contact SCB.

GENE THERAPY

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

CELL THERAPY

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

TISSUE ENGINEERING

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

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

CELL-BASED DRUG DISCOVERY

Cell-based drug discovery uses live cells in pharmaceutical research to study diseases and suboptimal cell function and to test potential treatment compounds in the laboratory for safety and efficacy.

  • Working Group Charter: Identify potential standards that will enable more accurate, efficient, and comparable cell-based assay results and continually assess other needs in the sector

  • Chair: Gary Gintant, PhD — Senior Research Fellow in the Department of Integrative Pharmacology, Integrated Science and Technology, at AbbVie