Coast IRB halts operations amid concerns of subjects’ safety in clinical trials
ROCKVILLE, Md. A company in Colorado that offers oversight services for clinical trials of drugs has agreed to voluntarily halt operations due to concerns that it has not adequately protected the safety of patient subjects in the trials.
The Food and Drug Administration announced Tuesday that it imposed restrictions on Colorado Springs, Colo.-based Coast IRB after an undercover investigation by the Government Accountability Office. The GAO submitted a fictitious research study to Coast IRB for review about a medical device that had purportedly received clearance from the FDA. The FDA said it evaluated information that the GAO provided and determined that Coast IRB committed several violations of laws and regulations intended to protect rights and welfare of human research subjects and failed to conduct an adequate review.
Under federal law, clinical research involving human subjects and FDA-regulated products must have the review and approval of an institutional review board, comprising doctors, scientists and non-scientists who review the research to protect the rights and welfare of human study subjects.
Petrou tapped to become HHS chief of staff
WASHINGTON A former aide of former Sen. Tom Daschle will become the new chief of staff for the Department of Health and Human Services, according to published reports.
Politico reported that Laura Petrou, who worked for the South Dakota Democrat for 20 years, will start the position this week.
Mark Childress has served in the position since January. Childress also previously worked for Daschle.
Mylan announces new VP global business development
PITTSBURGH Generic drug maker Mylan announced Tuesday that it made an appointment to its executive leadership team.
Mylan appointed former Merrill Lynch investment banker Andrew Cuneo as VP global business development. The company said Cuneo is responsible for coordinating its global business development and strategic efforts.
“Drew brings a wealth of experience in the pharmaceutical, biotechnology and healthcare sectors,” Mylan vice chairman and CEO Robert Coury said in a statement. “His familiarity with our industry – and in particular with Mylan, given his and Merrill Lynch’s active role with the company during the past five years – makes him ideally suited to support the company’s continued growth.”
Most recently, Cuneo served as Merrill Lynch’s director in its global healthcare investment banking group. He earned his bachelor’s degree in economics and psychology from Vanderbilt University.