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Is uncertainty concerning the regulation of antimicrobial drug trials stifling investment in infectious disease treatments? Here, experts from a large pharma company and a biotech firm provide their perspectives.
Although whole phage continue to generate interest as an alternative to antibiotics, focus is shifting to the use of purified phage components as antibacterial agents.
A combination of approaches and compounds—many of which failed to yield immediate results in the past—will ultimately prove invaluable to the drug industry in the ongoing battle against infectious disease.
To avoid duplication of effort, slow adoption and inefficiency in development, those developing biological standards need to communicate more with each other, attract help from experts in the ontology/standards communities and keep focused on needs of users.
Contrary to conventional thinking, there are compelling reasons for investors to consider early-stage life science ventures, especially in the context of a maturing biotech business 'ecosystem'.
Implementation of the Minimal Information About a Microarray Experiment document provides several lessons for similar ongoing initiatives in other fields.
Objective quality control indices are needed to facilitate clinical implementation of DNA microarrays used in transcriptional profiling as well as other types of genomic analysis.
The US Environmental Protection Agency is developing a new guidance that outlines best practice in the submission, quality assurance, analysis and management of genomics data for environmental applications.
By rejecting gene-spliced ingredients in their products, some major food companies may be making foods that are less safe and wholesome for consumers—and that expose them to litigation.
Although technology adoption and remuneration are significant barriers to the development and implementation of innovative diagnostics, health imperialism may be just as important.
Tests for identifying the world's most important microbial pathogens are antiquated, inaccurate and inadequate. Innovative public-private partnership is needed to develop and produce new infectious disease diagnostics that are more rapid and of greater accuracy and sensitivity.
A major outreach effort is under way that recruits scientific and technological expertise in industry and academia to optimize regulatory decision-making for next-generation diagnostic tests.