Before testing new drugs in human beings, drug developers must first perform a series of safety tests in animals. Unfortunately, these preclinical toxicology studies are typically protected as trade secrets. In fact, many countries have laws that specifically bar drug regulators from releasing preclinical toxicology data submitted by drug developers. Unless you take the extreme… Continue reading Toxic Waste?
Tag: gene transfer
Centralized Revue
In the most recent issue of Molecular Therapy, U Penn researcher Hildegrund Ertl provides a strong and eloquent defense of the Recombinant DNA Advisory Committee (RAC). RAC was initially formed to evaluate the safety of studies involving recombinant DNA. In the last decade, however, its most visible function has been to provide advise to researchers… Continue reading Centralized Revue
Departing Milano Stazione? ADA-SCID and Gene Transfer
Greetings after a hiatus for teaching, grants, committees, book deadlines, wiping runny noses, and more. Much has happened since my last posting, and in the next two or three weeks, I hope to catch up. First item on the agenda is a Jan 29 report in New England Journal of Medicine (NEJM) describing successful reconstitution of… Continue reading Departing Milano Stazione? ADA-SCID and Gene Transfer
GenetEx Cathedra
On December 12, the Catholic Church issued what the New York Times called “the most sweeping document on bioethical issues,” its Dignitas Personae. The document– the summary of which is available on the web– is dominated by discussion of in vitro fertilization, embyro research, and stem cells. But there is a section on gene transfer–… Continue reading GenetEx Cathedra