Evolving immunogenicity assay performance expectations and a lack of harmonized anti-drug antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving filing queries. Following debate at the American Association of Pharmaceutical Sciences National Biotechnology Conference, a group was formed to address these gaps. Over the last 3 years, 44 members from...

Developing countries face risks from coastal hazards that are being amplified by climate change. The selection of effective adaptation interventions to manage these risks requires a sufficiently accurate assessment of the coastal hazard at a given location. Yet challenges remain in terms of understanding local coastal risks given the coarseness of global wave models and the paucity of locally scaled data in most developing cou...

Climate change impacts, sea level rise, and changes to the frequency and intensity of storms, in particular, are projected to increase the coastal land and assets exposed to coastal erosion. The selection of appropriate adaptation strategies requires an understanding of the costs and how such costs will vary by the magnitude and timing of climate change impacts. By drawing comparisons between past events and climate change pro...