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7 Role of Research Funders in Multimodal Therapy Development
Pages 53-60

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From page 53...
... As demonstrated in the previous chapter and mentioned by FDA commissioner Robert Califf and others, governmental and charitable funding agencies play an important role in filling the gaps that may exist with respect to industry investment in developing novel multimodal interventions. For example, Karl Kieburtz suggested that third party investments might help mitigate the risk of partnerships among competitors, and Erich Mohr commented that peer-reviewed funding adds essential credibil 53
From page 54...
... Another area where funding agencies -- both public and private -- may facilitate progress is by bringing industry partners together to contribute compounds for repurposing, which have passed through safety endpoints in Phase II, but failed for the intended indication, said Stevin Zorn. ROLE OF RESEARCH AGENCIES IN DE-RISKING MULTIMODAL THERAPY DEVELOPMENT The NIH Blueprint for Neuroscience Research is a cooperative effort across 15 NIH centers and institutes to support discovery and development of therapeutics to combat nervous system disorders and conditions through grants, contract resources, and expert consultants.
From page 55...
... . Indeed, said Stuart Hoffman, senior scientific advisor for brain injury in the VHA Office of Research and Development, multimodal approaches are often necessary because a condition such as TBI has multiple consequences, including cognitive disability, psychological and behavioral disorders, sensory dysfunction, and pain; such a condition is typically accompanied by other visceral and orthopedic injuries.
From page 56...
... Sarah Lisanby com mmented that collaborationn across discciplines, incluuding neeuropsychiatry y, will be neeeded to studyy the full spectrum of mannifestatio ons of brain injury. Reco ognizing this,, in 2012 Prresident Obam ma issued an Executive Order callin ng for impro ved access too mental heallth servicees for veteranns, service meembers, and m military famiilies and the eestablish hment of a National N Reseearch Action Plan coordinnated by DoD, VA, an nd Departmen nts of Health and Human S Services and E Education.
From page 57...
... One of the multimodal intervention programs funded by the Alzheimer's Association -- the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) -- investigated whether a combination of lifestyle interventions, including exercise, diet, social engagement, and cognitive training, could slow cognitive decline among non-demented older individuals.
From page 58...
... , which will provide up to $2 million for a clinical trial testing repurposed drug combinations that target multiple biological mechanisms through Phase II proof of concept. Hendrix said another recent meeting of the Alzheimer's Association's Research Roundtable focused on neuropsychiatric symptoms associated with AD, in recognition that AD is more than a disease of cognition and that treatments are needed for these other disabling symptoms.
From page 59...
... The workgroup subsequently issued recommendations for monitoring ARIA in clinical trials (Sperling et al., 2011)


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