Biotechnology

Technology developed through the study and application of living systems, important for medical advances in areas such as prosthetics.

The FDA, 23andMe, And What We Really Want From Genetic Testing

Nov. 27, 2013

In a harshly worded letter released Monday, the Food and Drug Administration (FDA) ordered the company 23andMe to “immediately discontinue marketing” its saliva spit test (from which a consumer’s DNA is isolated) and personalized genome service until it provides the FDA with requested information on safety and effectiveness. I asked Reed Pyeritz, MD, PhD, a medical geneticist at Penn and former president of the American College of Medical Genetics, to comment on this development. He wrote:

When Genetic Screening is Useful, but Not Used

Issue Brief
Aug. 3, 2011

This Issue Brief describes the case of a genetic condition for which genetic screening of family members is clearly useful, and just as clearly underused. It explores the barriers to the use of genetic screening and has implications for the future as genetic technologies become more complex and produce more uncertainty.

Determinants of R&D Success in Biotech and Pharmaceuticals

Principal Investigator:
Patricia M. Danzon, PhD

Abstract: The purpose of the proposed research is to develop empirical estimates of how characteristics of biotech and pharma firms affect the likelihood and timing of success in developing new drugs. Previous studies of pharmaceutical R&D have reported overall industry-wide average estimates of success rates of drug candidates, based on data from a subset of large pharma firms in the 1980s. Our research will use more recent, time series data (1990-1999) for the universe of biotech and pharma companies.

Pages