Exact(1)
Barry Dowell, Abbott Laboratories, pointed out key challenges in biomarker commercialization: the selection of biomarkers to address unmet needs, pre-analytical and analytical issues, clinical performance assessment, regulatory approval, physician education, launch of new products, post-launch studies, and marketing issues.
Similar(7)
Phenotypic variability which affects sporulation in the laboratory could also affect the multiplication of blastospores in the host haemocoel, isolate pathogenicity, as well as commercial conidial production, which has important implications for maintenance, preservation and the selection of isolates for commercialization [ 11, 14].
The MRC and FDC were worried about the 'marketing of inferior preparations', so they attempted to control the selection of companies for commercialization.
With the commercialization of transgenic crops expressing B. thuringiensis toxins (Bt-crops) the selection pressure has increased, with the consequent increased risk of resistance development.
Haslberger (2003) presents a number of transgenic plant examples claimed to illustrate such unintended effects; however, none of the cited examples are truly representative, as they had not gone through the selection processes associated with the transformation, lead event selection and commercialization of GM crops.
The selection?
The recent commercialization of Zr and the availability of an easy-to-use radiolabeling strategy using Df-Bz-NCS allow further exploration of Zr-immuno-PET as an imaging tool for the selection of high potential candidate mAbs for therapy as well as for the selection of patients with the highest chance of benefit from mAb-based therapy [ 2].
The launch phase involves the commercialization of the product.
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