Monday, November 29, 2010
Nearly 3,000 small biotechnology companies have been awarded a total of $1 billion in government tax credits and grants to help speed the development of promising new therapies, create jobs and maintain U.S. leadership in biotechnology innovation.
At the investigator meeting prior to the start of a clinical trial, principal investigators and their staffs sit together to hear the sponsor explain the protocol and to ask questions. Everyone socializes over snacks or a meal, connecting faces to names and discussing the ins and outs of the trial.
A patch that delivers medicine transdermally may act very differently on a resident of Fargo, N.D., than on someone in South Florida. Thus, the amount of medicine that enters their bloodstreams may be different. That’s the assertion of the FDA’s Office of Generic Drugs, and that’s why the regulatory body now asks that drug developers working on transdermal patches—at least in the generics realm—test their patches in multiple divergent climates.
Some private-practice physicians who decide to conduct clinical trials can have trouble meeting enrollment goals because they forget to speak with their patients about study participation. Others inadvertently miss a patient visit and have to fill out numerous forms explaining why they deviated from the clinical trial protocol.
Sixty percent of investigative sites have less than three months of operating cash on hand in the bank, according to the 2010 Site Solutions Summit survey.
As drug development grows ever more global, India continues to stand out as one of the key places to be. And with President Barack Obama having just wrapped up a high-profile, economic-focused trip to India last week, it’s clear that doing business with and in this country is a top priority across many sectors.
Researchers at the University of Michigan have received a $1.5 million grant to demonstrate how adaptive clinical trial design can improve the speed, efficiency and safety of clinical research. As part of the three-year project, the researchers also will identify barriers to widespread adoption of these innovative trial designs in academic research.
Several doctors paid to speak on behalf of big pharmaceutical companies aren’t, in fact, the thought leaders consumers often consider them to be, but instead have been sanctioned for various forms of misconduct. And psychiatrists collect more in speaking and consulting fees from pharma companies than doctors in any other specialty.
After spiking to 6,069 job cuts in September, layoffs in the pharmaceutical industry dropped to 1,900 in October, according to a report in FiercePharma from consultancy Challenger, Gray and Christmas. The industry ranks 7th in total job cuts this month; for most of the year, it’s been one of the top five job-cutting industries. But with 45,263 cuts reported so far in 2010, pharma remains the second-highest job-cutting sector. Overall, the pace of job cutting is down 62 percent from a year ago, with employers announcing 449,258 job cuts year to date, compared to 1,192,587 over the same period in 2009.