Consultant with 33 years of scientific experience driving assay development and translational research in regenerative medicine and tissue engineering.
Deep expertise in cell viability and potency assays, cell-based therapies, biomaterials and tissue-engineering scaffolds.
Proven leader of high-impact, cross-disciplinary projects integrating artificial intelligence, advanced image analysis & bioassays.
Expertise in traceability, reference materials, and assay comparability to improve measurement quality and enable robust product characterization from discovery through clinical translation.
Extensive hands-on experience with bone marrow stromal cells, retinal pigment epithelium and complex biological systems; as well as electrospun fiber scaffolds, hydrogels and calcium phosphate cement.
Figure Caption: Potency and efficacy process charts. Comparison of potency and efficacy definitions for an example CAR T cell therapy demonstrates the parallelism between the two processes. (a) Definitions of the components of a potency and efficacy process chart. (b) Potency chart for treating leukemia with a CAR T-cell therapy (based on Kymriah). The figure graphically represents the relationships among the three inherent components of any analytical assessment: effect; attribute (measurands); and measurement; for both potency and efficacy.
Abbreviations: CT = computed tomography scan; ELISA = enzyme linked immunosorbent assay; IL5 = interleukin 5; MHC major histocompatibility; PCR = polymerase chain reaction.
Note: Examples are meant to illustrate concepts and are not intended as recommendations for potency tests or efficacy endpoint tests. Charts are not comprehensive and there may be other MOAs, attributes or tests.
Reference: Simon Jr CG, Bozenhardt EH, Celluzzi CM, Dobnik D, Grant ML, Lakshmipathy U, Nebel T, Peltier L, Ratcliffe A, Sherley JL, Stacey GN, Taghizadeh RR, Tan EHP, Vessillier S (2024) Mechanism of action, potency and efficacy: considerations for cell therapies. J Trans Med 22:416. https://doi.org/10.1186/s12967-024-05179-7
Contact:
Cornerstone Biomedical Consulting LLC
Carl G. Simon, Jr., Ph.D.
Olney, MD, USA
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