National Institutes of Health (NIH) Launches $140M Project to Predict Drug Toxicity

via Science Magazine, by Jocelyn Kaiser

National Institutes of Health (NIH) Director Francis Collins's controversial plan to launch a new center for translational biomedical research got a boost today in a White House announcement on science initiatives. NIH also rolled out an early project for the planned center, promising up to $140 million over 5 years to develop a chip for predicting drug toxicity.

The drug chip will be developed in a partnership to include NIH, the Food and Drug Administration (FDA), and DARPA--the Defense Advanced Research Projects Agency--which is known for funding risky research. Collins says the first-ever collaboration of this kind will try to combine human cell types, such as liver and kidney cells, that can represent physiological systems and "talk to each other" on a chip that will be used to predict whether a drug will be safe. Researchers will try to grow cells in three dimensions rather than as a flat layer because that's a better way to model how a drug will act in human tissues. The project "is really ambitious," Collins says.

DARPA this week began soliciting proposals for its piece, which will focus on engineering. NIH's half of the funding, which may involve both intramural and extramural researchers, will come from the director's Common Fund.

The drug chip will be a project of the National Center for Advancing Translational Sciences (NCATS), which got a mention when President Barack Obama signed a new patent bill. The White house also touted a new low-cost licensing agreement to help startup companies license inventions from NIH and FDA intramural research.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Obama Pushes More Competition on Biologic Drugs

via The New York Times, by Andrew Pollack

President Obama is not giving up when it comes to trying to introduce competition to expensive drugs made by biotechnology.

Tucked into the president’s deficit reduction plan released on Monday was a proposal to reduce the market exclusivity offered to brand-name biologic drugs to seven years, down from the 12 incorporated in the 2010 federal health care legislation.

That would allow so-called generic versions of such drugs to reach the market sooner, saving an estimated $3.5 billion in federal health spending over 10 years, or a little over one-tenth of 1 percent of the $3 trillion the president’s deficit reduction plan is supposed to save in a decade.

Biologic drugs are proteins made in living cells, like Avastin and Herceptin for cancer and Enbrel and Humira for rheumatoid arthritis. Such drugs can cost tens of thousands of dollars a year and are not subject to the same rapid onset of generic competition as drugs made in chemical factories, like Lipitor and Prozac.
The issue was a thorny one during the debate in Congress over the health care legislation.

The biotechnology industry argued it needed 12 years of freedom from lower priced competition to recoup research and development costs. Any less, it argued, would retard innovation. The generic industry, as well as many insurers and employers who pay health care bills, said a much shorter period would suffice.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Using HIV medication to treat other ailments

via The Bay Citizen, by Scott James

Thirty years into the AIDS epidemic, the antiretroviral drugs that have provided lifesaving treatment for many of those infected with H.I.V. — 1.1 million in the United States today — are now being used or considered for treating other ailments.

When medications have proved safe and effective for most patients, it is standard practice for pharmaceutical companies to see if the drugs have other applications. But with H.I.V. drugs, the practice has been unusually contentious, fostering debates about questionable science, safety and profiteering, and concerns that thousands of Americans infected with H.I.V. cannot get the medications.

At the center of this controversy is Gilead Sciences, a pharmaceutical company based in Foster City. Gilead is the nation’s largest producer of H.I.V. medications (including Viread, Truvada, and Atripla), accounting for nearly half the United States market for them. The drugs produce $3.5 billion in annual revenues, with profit margins reportedly twice the industry average.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

2012 International Microbicides Conference (M2012) in Sydney, Australia

The next International Microbicides Conference will be held in Sydney, Australia from April 15-18th, 2012!

Registration
Registration is not yet open, but to submit an expression of interest, please click here. By submitting this, you will be contacted as soon as official registration opens!

Abstract Submission
The 2012 International Microbicides Conference (M2012) invites papers of high quality in the areas of HIV prevention, with a particular focus on microbicides, oral chemoprophylaxis, and their interface with other prevention strategies. The conference is interdisciplinary, and encourages the full involvement of communities and individuals affected by HIV. Abstract submissions will be reviewed by the Scientific Program Committee for content, presentation, timeliness, and current interest of the topic to M2012 participants. Abstracts are welcomed from researchers, program implementers, policy makers, advocates, and community members, and will be considered for inclusion provided they meet the guidelines below.

Please click here to view the abstract submission guidelines.  Authors should submit abstracts no later than 5pm AEST time on Thursday 17 November 2011. Click here for more information and details about uploading your abstract.

Scholarships
Scholarships are available to attend the 2012 International Microbicides Conference (M2012) in Sydney, Australia.

Scholarships will be offered in four categories that have distinct criteria:
1. Research
2. Community
3. Government Official/Public Health Policy
4. Media (Further details to come - Media scholarships will open 23 September)

Scholarship applications are due 5:00 pm AEST on Thursday 17 November 2011.  Click here for more details about scholarships and to apply.

For any other information about M2012 please go to microbicides2012.org.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

'Less education' associated with PrEP and PEP use

via aidsmap, by Gus Cairns

A survey (Mansergh) of 454 HIV-negative gay men in four US cities (New York, Los Angeles, Chicago and San Francisco) has found that men with lower educational attainment (high school only) were more likely to use antiretrovirals informally for HIV prevention, either as pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), than men who had had further education.

In a parallel survey of 557 HIV-positive gay men, men with lower educational attainment were, similarly, more likely to share their antiretroviral pills with HIV-negative partners to use as PrEP or PEP.

Taken together, 22% of the men in the two surveys were under 30, 35% in their 30s and 43% 40 or over. A third were black, 38% white and the rest Hispanic or of other ethnicity.

Roughly a third each of the sample had education only to high school level, to some college qualification, or to a university degree.

The survey asked both groups if they had used PrEP or PEP or, in the case of the HIV-positive men, provided it to others, in the last six months.

Informal use of PrEP or PEP was still comparatively uncommon; only a few per cent of those surveyed overall had used ARVs as prevention or provided them in the previous six mnoths.

However men with high-school-only education were two to six times more likely to report using one of these strategies.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]