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A decade back, extreme examples of class IV compounds were an exception rather than the rule, yet today many drug candidates under development pipeline fall into this category.
Discussion topics included: (1) pathophysiology of disease; (2) current gaps in the knowledge of global disease burden and serotype distribution; (3) vaccine candidates under development; (4) design considerations for phase III trials; and (5) pathways to licensure, policy recommendations and use.
Genome-wide gene expression profiling has become standard for assessing potential liabilities as well as for elucidating mechanisms of toxicity of drug candidates under development.
Other companies with H7N9 vaccine candidates under development include Greffex, Protein Sciences Corporation and Medicago (see Human Vaccines and Immunotherapeutics News 9 6 ).
In addition, site-specific conjugation approaches have been demonstrated to achieve a superior therapeutic index compared with conventional conjugation approaches, and therapeutic anti-SAIL ADC candidates under development may harness similar site-specific ADC technology.
A crucial point to emphasise is the fact that we do not have available clinical data to support the idea that one of the vaccine candidates under development could prove to be more effective than the vaccine currently in use, which is the Bacillus Calmette-Guérin (BCG) vaccine.
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Crystallization of a potent oncology drug candidate under development at GlaxoSmithKline proved to be challenging in terms of obtaining acceptable yield, consistent and desirable Active Pharmaceutical Ingredient APII) powder properties, with satisfactory process robustness and scalability.
Although several vaccine candidates are under development, comparisons between laboratories will be difficult without relatively standardized laboratory materials and methods [ 12] or algorithms to control for variations in protocol.
But the utility, availability and cost of the most promising candidate vaccine under development is also a question mark.
Current candidate microbicides under development encompass chemical and physical agents as well as biologicals, including virion-inactivating agents, entry/fusion inhibitors, reverse transcriptase inhibitors, and others (www.microbicide.org).org
Table 3 summarizes the current cell culture produced influenza candidate vaccines under development.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com