Researchers have launched a search for people who are the human equivalent of a cancer-immune "supermouse" discovered in 1999 that could resist even aggressive cancers. The goal is to recruit about 20 people whose white blood cells possess that same ability, in the hopes it can lead to a pancreatic cancer cure in five years.
Many of the behaviors slowing faster progress in the discovery and development of new medical products are things that organizations everywhere have been confronting for decades. What can the biomedical R&D ecosystem learn from outside the space about how to change organizational culture and behavior to build a more effective, efficient enterprise? Join us Wednesday, March 29, from 2 p.m. to 3 p.m. for a free webinar exploring this topic.
The US Food and Drug Administration (FDA) has faced persistent challenges in hiring and retaining top talent in the centers that review medical products. FasterCures has been following this issue closely, and much of the problem can be traced to industry having a competitive advantage in vying for a very small pool of highly trained experts. We have identified opportunities to address this disadvantage.
Researchers may have to turn to rats, instead of mice, for studies of drug candidates to treat autism, as most clinical trials based on promising mouse models have failed, scientists said. Rats can be more difficult and expensive to work with but have bigger brains than mice, and scientists said they may offer new insights into autism.
The Ohio State University's Drug Development Institute has targeted six projects this year aimed at moving cancer therapies from the laboratory to patients. Director Jeffrey Patrick said the route from discovery to drug development is complex and researchers may not know all of the steps, so the institute helps them with all aspects of the process, from efficacy and toxicity to testing, patents and regulatory hurdles.
For more:FasterCures' report "Crossing Over the Valley of Death" explores the importance of translational research in the therapeutic development process, identifies some of the major challenges to its conduct and points the way toward some possible solutions.
A round of Series C financing has pulled in approximately $74 million for Cell Medica. The proceeds will fund further study of the firm's cell-based immunotherapy platforms and pipeline, which include baltaleucel-T, an FDA fast-tracked candidate that is being assessed in a midstage trial as a treatment for patients with advanced lymphomas related to the Epstein-Barr virus.
Bristol-Myers Squibb and CytomX Therapeutics expanded their 2014 immuno-oncology agreement to add up to eight immune-system checkpoints to the four targets originally agreed upon. CytomX will pay BMS research funding and an upfront payment of $200 million, while BMS gets the exclusive rights to use CytomX's technology to develop and market two noncancer targets and as many as six oncology targets.
Researchers say President Donald Trump's proposed budget, which would cut almost 20% from the NIH, would diminish biomedical research and is a signal their work is not valued by the administration. Keith Yamamoto at the University of California at San Francisco called the plan "tremendously shocking."
The FDA is seeking feedback on the idea of creating an office for patient affairs to support efforts to engage patients in the drug development process. The office would work to increase understanding of patient experiences and make patients and advocates more familiar with the regulatory process.
The total fees charged by the FDA to review and approve new drugs and medical devices would more than double to more than $2 billion under the fiscal 2018 budget proposed by the Trump administration. In exchange, the document says, the approval process would be streamlined.
The FDA approval process can be improved to get orphan drugs to patients with rare diseases faster but it does not need the sweeping deregulation called for by President Donald Trump, says Frazer Gieselmann, the Tennessee father of two daughters with Batten disease. He said developing drugs for rare diseases that affect a small number of patients is different than developing therapies for common ailments, and in cases where death at a young age is likely, small clinical trials should be enough and an expedited review period for treatments should be assured.
FasterCures is an action tank that works across sectors and diseases to improve the effectiveness and efficiency of the medical research enterprise. FasterCures, a center of the Milken Institute, is nonpartisan and independent of interest groups.
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