PHARMACY

FDA names board of CTTI

BY Drew Buono

WASHINGTON The Clinical Trials Transformation Initiative, which was founded by the Food and Drug Administration and Duke University in an effort to improve the quality and efficiency of clinical trials, has named a 12-member executive board that will oversee its activities.

“We hope that by simplifying the way we conduct trials, we can capitalize more quickly on the wealth of recent biomedical advances and develop much better evidence about the balance of benefits and risk of medical technologies,” said Robert Califf, vice chancellor for clinical research at Duke and co-chair of the executive board.

Rachel Behrman, director of the office of Critical Path Programs in the Office of the Commissioner at FDA, will serve as co-chair of the executive board. Judith Kramer, associate professor of medicine at Duke, will serve as the executive director of CTTI.

Other members include:

  • Susan Alpert, senior vice president and chief quality and regulatory officer, Medtronic
  • David DeMets, professor of biostatistics and medical informatics, University of Wisconsin, Madison
  • Kenneth Getz, senior research fellow, Tufts Center for the Study of Drug Development
  • Glenn Gormley, senior vice president, global clinical development and medical affairs, Novartis Pharmaceuticals
  • Alberto Grignolo, corporate vice president and general manager, drug development consulting, PAREXEL consulting, representing the Association of Contract Research Organizations
  • Nancy Roach, C3: Colorectal Cancer Coalition
  • Jay Siegel, group president, research and development, biotechnology, immunology and oncology, Johnson & Johnson
  • Lana Skirboll, associate director, science policy, National Institutes of Health
  • Robert Temple, Office of Medical Policy and Office of Drug Evaluation I in the Office of New Drugs, Center for Drug Evaluation and Research, FDA
  • Bram Zuckerman, director, Division of Cardiovascular Devices, Center for Devices and Radiological Health, FDA

One of the first tasks of the executive board will be to define the group’s strategy and prioritize areas for projects that do “research on research.”

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Hormone deemed effective in male birth-control pill

BY Drew Buono

TORRANCE, Calif. According to published reports, one of the two government-funded research centers in the U.S. for male contraceptives has discovered hormone pills that block sperm production in men and has found them to be safe and reversible.

The hormone combination that proved most successful halts testosterone production in the testicles, but fakes the body into believing that testosterone levels are the same, according to the study. The progestin, typically a female hormone, speeds the process and improves the effectiveness of the drug, research shows. The hormones can be taken in a pill or injection form.

As with female birth control, the male contraceptives don’t prevent sexually transmitted disease. But they have proven as effective as female pills in preventing pregnancy, according to the study.

The next goal is to find pharmaceutical companies that want to conduct final development of the drug, but so far companies have been unwillingly to take part because of the regulatory requirement involved in manufacturing a contraceptive.

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Federal appeals court lets Washington state Plan B ruling stand

BY Drew Buono

LOS ANGELES A federal appeals court on Thursday left in place a lower court’s ruling that allowed Washington state pharmacists to refuse to sell Duramed’s emergency contraceptive pill Plan B on religious grounds, according to Reuters.

A federal judge in Seattle suspended state rules that required pharmacies to dispense the drug and other emergency contraceptives that prevent fertilized eggs from implanting, which some people believe is the same as abortion.

U.S. District Judge Ronald Leighton found that the state rules force pharmacists into an unconstitutional choice between their religious beliefs and their work.

State officials and several women had asked the Ninth U.S. Circuit Court of Appeals to suspend the judge’s preliminary injunction, which bars them from enforcing the law, while they appeal his ruling.

In a split decision, the appeals court denied that request, finding that the state and the women did not show that they would suffer irreparable harm if the injunction stayed in place pending the appeal.

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