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1.
Alzheimers Dement ; 20(3): 2298-2308, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38265159

RESUMO

Despite its high prevalence among dementias, Lewy body dementia (LBD) remains poorly understood with a limited, albeit growing, evidence base. The public-health burden that LBD imposes is worsened by overlapping pathologies, which contribute to misdiagnosis, and lack of treatments. For this report, we gathered and analyzed public-domain information on advocacy, funding, research outputs, and the therapeutic pipeline to identify gaps in each of these key elements. To further understand the current gaps, we also conducted interviews with leading experts in regulatory/governmental agencies, LBD advocacy, academic research, and biopharmaceutical research, as well as with funding sources. We identified wide gaps across the entire landscape, the most critical being in research. Many of the experts participated in a workshop to discuss the prioritization of research areas with a view to accelerating therapeutic development and improving patient care. This white paper outlines the opportunities for bridging the major LBD gaps and creates the framework for collaboration in that endeavor. HIGHLIGHTS: A group representing academia, government, industry, and consulting expertise was convened to discuss current progress in Dementia with Lewy Body care and research. Consideration of expert opinion,natural language processing of the literature as well as publicly available data bases, and Delphi inspired discussion led to a proposed consensus document of priorities for the field.


Assuntos
Doença por Corpos de Lewy , Humanos , Doença por Corpos de Lewy/diagnóstico , Doença por Corpos de Lewy/terapia
6.
Clin Pharmacol Ther ; 105(4): 886-898, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30636288

RESUMO

At the turn of the century, the pharmaceutical industry began a transition toward a focus on oncology, rare diseases, and other areas of high unmet need that required a new, more complex approach to drug development. For many of these disease states and novel approaches to therapy, traditional approaches to clinical trial design fall short, and a number of innovative trial designs have emerged. In light of these changes, regulators across the globe are implementing new programs to provide regular development program support, facilitate accelerated access, use real-world data, and use digital tools to improve patients' lives. Emerging market regulators are also focusing on simplifying their regulatory pathways via regional harmonization schemes with varying levels of ambition. These changes in the external environment imply that biopharma regulatory teams need to adapt and evolve, leveraging digital tools, data, and analytics, and positioning themselves as strategic advisors during development.


Assuntos
Desenvolvimento de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Oncologia/legislação & jurisprudência , Ensaios Clínicos como Assunto/legislação & jurisprudência , Humanos , Doenças Raras , Projetos de Pesquisa/legislação & jurisprudência
9.
Drug Discov Today ; 22(12): 1749-1753, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-28646641

RESUMO

There is current uncertainty regarding the effects of mergers on pharmaceutical R&D productivity, with various mechanisms reported by which mergers could either help or harm R&D, and mixed empirical findings in prior analyses. Here, we present an analysis that is novel in several ways: we use downstream measures of R&D productivity, account for both inputs and outputs in our calculations, and use a self-controlled design. We find that recent large pharmaceutical mergers are associated with statistically significant increases in R&D productivity. These results are perhaps not surprising in light of the broader literature on R&D productivity that points to two factors as instrumental in driving higher R&D productivity (depth of scientific information, and objectivity of decision-making based on that information), both of which could be expected to increase because of a merger.


Assuntos
Descoberta de Drogas , Indústria Farmacêutica/organização & administração , Eficiência Organizacional , Pesquisa Biomédica
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