“County Executive PJ Wendel and chairman of the legislature Pierre Chagnon have been tireless advocates for this Lake, and I'm glad to see so much willingness to collaborate.” "This Congressional Roundtable was important to me because it allowed me to hear directly from the officials and community leaders who are so dedicated to the health and future of Chautauqua Lake,” said Congressman Nick Langworthy. Specifically, $282 million dollars is spent annually by tourists in the county, with associated state and local taxes generating $36 million dollars for our communities.įrom an ecological standpoint, the lake is classified by the New York State Department of Environmental Conservation as a “Class A Waterbody” and suitable for drinking water however the lake also is listed as an “Impaired Lake” because its usability is impacted negatively by nuisance vegetation, including weeds and harmful algal blooms (HABs). In addition to its environmental significance, the lake is a major economic driver for our county with over 66 percent of visitors to Chautauqua County utilizing a lake or waterway and 47 percent of sales tax generated is credited to municipalities immediately surrounding Chautauqua Lake itself. The Collaboratory, led by Critical Path Institute (C-Path), works in a transparent, open forum, with a diverse set of global stakeholders including, but not limited to, clinicians, scientists, U.S.(Image by Justin Gould / Media Information Officer)īEMUS POINT, NY – Congressman Nick Langworthy and Chautauqua County Executive PJ Wendel have partnered to encourage collaboratory efforts on Chautauqua Lake, bringing together stakeholders during a roundtable discussion on Wednesday.Ĭhautauqua Lake is considered by many as one our area’s greatest natural gems. As regulators globally pilot programs, an ability to provide lessons learned and potentially share information to harmonize processes will enable pharma and manufacturers to better align by reducing complexity, lowering costs and ensuring safe and effective treatments for all patients. Although many of the challenges of drug repurposing are global, regulators need to address these locally and within the existing regulatory systems. The path chosen will depend on the drug(s) in question (patented vs generic), the disease epidemiology and natural history (availability and procurement of sufficient data), and the existing legislative mechanisms (sponsor, payer, and/or patient support). The data gathered through the CURE ID app can be used to inform the design of clinical trials, to evaluate the effectiveness and safety of a marketed therapy intended for repurposing, or to support treatment guideline development. This includes creating a path of potential scenarios, depending upon the context of the specific indication, unmet patient needs, the engagement of the drug sponsor or the first NDA holder and the status of current legislation. CDRC is strongly interested in capturing data from diverse populations, including pediatric patients and pregnant women, as well as under-served populations.Īs part of this process, a roadmap will be developed for the efficient generation of evidence, in order for FDA to update labeling. In response to these challenges, the CURE Drug Repurposing Collaboratory (CDRC) was founded to explore whether already marketed drugs can be repurposed for diseases that are not commercially attractive. Many existing drugs might work to treat these diseases, but often there are no commercial or regulatory incentives – or there are actual disincentives - to do the extensive clinical testing required to show they are effective. That leaves around 7,500 diseases without FDA approved treatment, many of which are rare diseases, diseases in pregnant women, children and neonates, as well as neglected tropical diseases and emerging/reemerging infectious diseases. There are approximately 10,000 known diseases, but only 2,500 of them are addressed by FDA-approved drugs.
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