DIA Biosimilars 2013

NIH

Hutchinson Center to lead $20 million HIV research grant

Tuesday, July 12, 2011 12:25 PM

Whether a stem cell transplant using an HIV-infected person’s own genetically modified immune cells can become a cure for the disease is the focus of a new $20 million, five-year research grant award announced by the National Institutes of Health to the Fred Hutchinson Cancer Research Center.

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Cenduit: Now with Patient Reminders

Cleveland State University wins $1.8 million grant

Monday, April 18, 2011 12:05 PM

Cleveland State University was granted $1.78 million by the National Institutes of Health to study African sleeping sickness, a sometimes fatal parasitic disease similar to malaria that has become an endemic in certain regions of sub-Saharan Africa.  

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CRF Health – eCOA Forum

Amylin’s metreleptin shows improvement in patients with lipodystrophy

Friday, April 15, 2011 12:38 PM

Amylin Pharmaceuticals reports results from an analysis of an ongoing, long-term research study of the investigational drug metreleptin, an analog of the human hormone leptin, for the treatment of lipodystrophy.  The study is being conducted by investigators from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH).

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New $1b NIH center will tackle early-stage drug development to ease industry risk of failure

Monday, February 7, 2011 07:00 AM

A billion-dollar U.S. government drug development center, which will focus on moving potential new discoveries out of the lab and into early-phase trials, could help biopharmaceutical companies improve their success rate in developing new treatments by reducing the risk of failure in early-stage research.

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Grants awarded to research benefits of adaptive clinical trial design, identify barriers

Monday, November 8, 2010 11:16 AM

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.

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NIH official sees need to evaluate effectiveness of IRBs in protecting study volunteers

Monday, October 18, 2010 07:40 AM

Institutional Review Boards (IRBs) are central to the system of protecting human subjects who participate in clinical research, yet concerns have been raised that there is no way to measure whether IRBs actually do their job of protecting study volunteers from unnecessary risk of harm.

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Conflict of Interest Case Could Change Disclosure Rules

Tuesday, October 14, 2008 06:37 AM

The congressional investigation into an influential psychiatrist’s failure to disclose more than a million dollars in drugmaker payments is the latest in a spate of conflict-of-interest investigations that may force changes in the way financial disclosures are handled.

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NIH Pushes Academic Collaboration vs. Competition

Thursday, October 12, 2006 05:46 PM

The National Institutes of Health (NIH) has begun the development of a unique translational research consortium composed of some of the most well renowned top academic health centers (AHC) in the U.S. This is somewhat unique in a research community that has become extremely competitive for NIH grant money.

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A New Era Begins for India’s Clinical Research Market

Friday, July 7, 2006 11:16 AM

India’s participation in global clinical trials has nearly quintupled between 2001 and 2005, as investment in the country by large international and domestic pharmaceutical companies, small and medium-sized Western biotechs and the National Institutes of Health (NIH) has grown as well. The clinical research outsourcing market in India grew to $70.5 million last year and will continue to climb.

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Who Owns the Rights to Human Tissue?

Thursday, June 15, 2006 10:09 AM

A recent Boston Globe article reported on a National Institute of Health (NIH) senior scientist selling human tissue to drug giant Pfizer, for Alzheimer’s disease research.

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CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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