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Replies to post #184443 on Anavex Life Sciences Corp (AVXL)
Public Health Relevance
Alzheimer's disease (AD) remains one of greatest unmet medical needs in our country with estimates of over 5 million Americans suffering from the disease in 2016 with no new symptomatic therapies having been approved over the past 12 years, and currently no approved disease-modifying agents. The timeframe, complexity, and expense of the recruitment process and site activation for AD trials are extremely challenging, and indeed trial enrollment and site network development represent a bottleneck for drug development for the AD field; there is a growing consensus that we must fundamentally overhaul the current clinical trial recruitment and assessment structure. This proposal aims aim to create an optimized infrastructure to optimally design, efficiently launch, rapidly recruit with improved diversity, and successfully complete NIH supported clinical trials in AD and related dementias.
This ACTC will provide expertise and infrastructure to design and conduct trials across the full continuum of AD, from primary prevention initiatives to combination trials for advanced symptomatic stages. We also stand ready to collaborate on trials in other age- related dementias, leveraging the experience of the NeuroNext team at Harvard and other expert investigators in vascular and non-AD neurodegenerative diseases. We will build on our successes with public/private partnerships and continue to strengthen our strategic alliances to conduct large scale trials, but will also focus on supporting novel approaches to smaller investigator-initiated POC studies that will better inform Phase 3 decision-making. Finally, we will provide training and leadership opportunities to young clinical investigators to facilitate continued innovation in trial design, and catalyze the next generation of AD clinical trials.
Public Health Relevance
Alzheimer's disease (AD) remains one of greatest unmet medical needs in our country with estimates of over 5 million Americans suffering from the disease in 2016 with no new symptomatic therapies having been approved over the past 12 years, and currently no approved disease-modifying agents. The timeframe, complexity, and expense of the recruitment process and site activation for AD trials are extremely challenging, and indeed trial enrollment and site network development represent a bottleneck for drug development for the AD field; there is a growing consensus that we must fundamentally overhaul the current clinical trial recruitment and assessment structure. This proposal aims aim to create an optimized infrastructure to optimally design, efficiently launch, rapidly recruit with improved diversity, and successfully complete NIH supported clinical trials in AD and related dementias.
Why do they continue to ignore obvious benefit and utility of technology like ERP? For example? They are their own worst enemy. IMO, these people represent the (ESTBALISHMENT-RESPONSIBLE FOR THE HOLE ARE IN).
