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[F4–08–04]: BIG PHARMA IN VCID: WHAT WILL IT TAKE?
Author(s) -
Sims John R.
Publication year - 2017
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2017.07.405
Subject(s) - drug development , population , process management , disease , drug discovery , clinical trial , risk analysis (engineering) , proof of concept , business , data science , medicine , psychology , computer science , pharmacology , drug , bioinformatics , pathology , biology , environmental health , operating system
Background:Drug development by large pharmaceutical companies for vascular cognitive disorders has largely been absent. A potential framework of scientific development is needed to enhance investment in this area.Methods:Adiscussion of a progressive evidentiary development program designed to provide increasing support for successful trials will be presented. Results:Well validated targets of interest are the initial step. Scientific tools for discovery development are essential. Moving to the clinic, proof of compound present in the compartment of interest, target engagement and evidence of pharmacodynamics in the tissue of interest are the next steps. Downstream biomarkers of disease processes are desirable. Means to identify the target population are required. Well validated outcome measures are necessary that show both disease progression and can detect treatment differences.Conclusions:Awell-established scientific framework is needed to increase confidence of successful trials. If you build it they will come. Author is an employee of Eli Lilly and Company.