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Or maybe they have a vision for stitching together a set of technologies. Either way, they are venturing into a great unknown to see if they can make a big step ahead in medicine. They often have insights, big ideas, that put them years ahead of the lumbering drug giants. The odds are stacked against the creators. But even in failure, startups can sometimes offer clues on where medicine is heading. Sometimes outside groups will see what’s wrong and fix it. And yes, sometimes the startups will succeed, going public or getting acquired. Here were a few trends I observed from covering startups which raised issues that will remain relevant in the year ahead. New ideas for the treatment of Alzheimers Alzheimers disease is a demographic iceberg. As the baby boomers get older, the national healthcare bills for dealing with it are astronomicalwith one analysis estimating Alzheimers will gobble up one-fourth of Medicare spending in 2040 . The pharmaceutical industry has had no effective response yet.
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The Vanderbilt researchers believe that the current standard of care for Alzheimer’s disease, cholinesterase inhibitors, has a different mechanism of action. They are hoping to establish through future clinical testing that the molecule is broadly effective across a number of cognitive and neuropsychiatric disorders, including schizophrenia. “This is the first instance I am aware of where an academic drug discovery group moved a molecule designed to hopefully treat a chronic brain disorder all the way from early discovery to human trials without there being, at some point along the way, a pharmaceutical partner,” said P. Jeffrey Conn, Ph.D., Lee E. Limbird Professor of Pharmacology in the Vanderbilt University School of Medicine and director of the Vanderbilt Center for Neuroscience Drug Discovery (VCNDD). “And that really Thanking You is crossing what people refer to all of the time as the ‘Valley of Death,’ where good research discoveries have a hard time moving into the clinical testing phase due to lack of funding,” he said. “Importantly, at this early stage, the FDA has only granted permission to assess potential safety of this investigational new drug in healthy volunteers” said Conn. “We cannot predict the outcome, but if these studies are successful in demonstrating that the investigational drug can be safely administered to humans, this would pave the way to allow filing of additional applications with the FDA to seek permission to advance to testing for efficacy in improving cognitive function in patients suffering from Alzheimer’s disease, and possibly schizophrenia or other brain disorders. While we cannot predict the outcome of any future safety or efficacy studies, this decision by FDA allowing clinical research to begin represents a major milestone in allowing us to hopefully provide answers to those critical questions in the future.” VCNDD Co-Director Craig W. Lindsley, Ph.D., director of Medicinal Chemistry and William K. Warren, Jr.
For the original version including any supplementary images or video, visit https://www.eurekalert.org/pub_releases/2016-12/vumc-ind122716.php