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Biological activity is a critical quality attribute for biopharmaceuticals, which is accurately measured using an appropriate relative potency bioassay. Developing a bioassay is a complex, rigorous undertaking that needs to address several challenges including modelling all of the mechanisms of action associated with the biotherapeutic. Bioassay development is also an exciting and fast evolving field, not only from a scientific, medical and technological point of view, but also in terms of statistical approaches and regulatory expectations. This has led to an industry-wide discussion on the most appropriate ways to develop, validate and control the bioassays throughout the drug lifecycle.

Abstract:One explanation for the modest pace of efforts to mitigate climate change, both federally and internationally, is that constituents do not ascribe much beneficial value to new laws that change the way we produce and consume energy. We surveyed estimates of consumer willingness to pay (WTP) for climate policy to: (1) assess the validity of this explanation, (2) compare elicitation techniques, and (3) explore factors that might explain variation in WTP estimates. We recalculated WTP estimates on an equivalent basis across 27 studies and found a range for WTP of $22-$437/household annually, with a median of $135. We also discuss outliers not included in this range. Discrepancies among estimates drawn from American, Asian, and European samples enable some preliminary inferences about the effects of nationality on WTP for climate stability. Environmental attitudes and beliefs are common explanatory elements in WTP surveys. Others include income, education, and political views. While valuation methods and survey types vary, the great majority of existing work in this area has relied on contingent valuation.