Manufacturing a clinically compatible human embryonic stem cell-derivedmidbrain dopamine progenitor and neuron cell product, MSK-DA01
Mark J. Tomishima is the Head of the SKI Stem Cell Research Facility, part of theCenter for Stem Cell Biology and the Developmental Biology Program at Sloan KetteringInstitute in New York City. Dr. Tomishima earned his Ph.D. at Princeton University where he studied the movement of alpha-herpes viruses through neurons. At the time, this work required primary neuron culture that limited throughput. After earning his Ph.D., he performed postdoctoral work with Lorenz Studer at Sloan Kettering where he learned to convert pluripotent stem cells to unlimited amounts of neurons, bypassing the need for the primary culture. In the Studer Lab, Dr. Tomishima pioneered the use of bacterial artificial chromosomes that were used to purify populations of neural cells. Such purified populations are useful in understanding the transcriptome of different neural cell populations, and allowed for transplantation of different stages of ESC-derived neural cells into animal models of Parkinson’s disease. He was also part of an international team that used nuclear cloning technology to create a pluripotent, autologous model ofParkinson’s cell therapy. For the past decade, Dr. Tomishima has run the SKI Stem CellResearch Facility, a human pluripotent stem cell shared facility that provides a number of services to the stem cell community. One focus of his group was to perform the process, assay and SOP/BR development around MSK DA01, a human embryonic stem cell-derived midbrain floor plate and dopamine neuron product intended to treatParkinson’s disease patients. Dr. Tomishima and his group manufactured MSK DA01 in a cGMP cleanroom and the product is currently undergoing the final IND-enabling studies. The Lorenz Studer-led consortium hopes to file the IND application with the FDA in the summer of 2018.