Perspective on the debate over regulating stem cell clinics, the launch of CRL’s CRISPR services, a way to end cholera in Haiti.
(GEN, 12/5/2016, Shawna Jackman)
The influx of clinics using a patient’s own fat stem cells to treat all kinds of health problems—from inflammation and multiple sclerosis and cancer and Parkinson’s—has sparked a debate in cellular therapeutics culminating with a two-day hearing in September by the US Food and Drug Administration. Charles River Principal Research Scientist Shawna Jackman captures the debate over whether and how these procedures should be regulated in an exclusive this week in the publication GEN, and efforts by the FDA to regulate them. “The finalization of these [FDA] guidance documents is encouraged by the cell therapy community so that the requirements for autologous therapies are established and stem cell interventions can be safely available to patients,” wrote Jackman.
(Outsourced Pharma, 12/6/2016, Melissa Fassbender)
Charles River Laboratories has launched CRISPR-Cas9 genome-engineering technology through an arrangement with the Broad Institute, and developed partnerships with three companies for in vivo model creation services. The customized in vivo and in vitro genome editing now being offered by Charles River will help to improve the efficiency and effectiveness of the drug discovery. “Working with us, clients can generate custom cell lines for early, exploratory discovery research, as well as generate in vivo pharmacology models, produce those models, and then use our Discovery Services offering to place those models in in vivo studies,” said Dr. Iva Morse, Corporate Vice President, Chief Scientific Officer, Global Research Models and Services for CRL. Fierce Biotech also covered this story.
NEJM, 12/7/2016, Louise Ivers)
Mass cholera vaccination in Haiti would save lives, and modeling suggests that such an intervention, coupled with targeted, effective water, sanitation, and hygiene interventions, could substantially control, if not eliminate, the disease within a few years of the program’s introduction, at an affordable cost, says . Louise Ivers, the Senior Health and Policy Advisor for Boston-based Partners In Health in a commentary this week in NEJM.