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The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a weeklong event - A Full Immersion Week of Bioanalysis for PK, Biomarkers and Immunogenicity. As usual, it is specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecules involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on PK, biomarkers and immunogenicity. This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This White Paper is published in 3 parts due to length. This part (Part 3) discusses the recommendations for large molecule bioanalysis using LBA, biomarkers and immunogenicity. Parts 1 (small molecule bioanalysis using LCMS) and Part 2 (Hybrid LBA/LCMS and regulatory inputs from major global health authorities) have been published in the Bioanalysis journal, issues 22 and 23, respectively.

SummaryBiopharmaceuticals (BPs) represent a rapidly growing class of approved and investigational drug therapies that is contributing significantly to advancing treatment in multiple disease areas, including inflammatory and autoimmune diseases, genetic deficiencies and cancer. Unfortunately, unwanted immunogenic responses to BPs, in particular those affecting clinical safety or efficacy, remain among the most common negative effects associated with this important class of drugs. To manage and reduce risk of unwanted immunogenicity, diverse communities of clinicians, pharmaceutical industry and academic scientists are involved in: interpretation and management of clinical and biological outcomes of BP immunogenicity, improvement of methods for describing, predicting and mitigating immunogenicity risk and elucidation of underlying causes. Collaboration and alignment of efforts across these communities is made difficult due to lack of agreement on concepts, practices and standardized terms and definitions related to immunogenicity. The Innovative Medicines Initiative (IMI; www.imi-europe.org), ABIRISK consortium [Anti‐Biopharmaceutical (BP) Immunization Prediction and Clinical Relevance to Reduce the Risk; www.abirisk.eu] was formed by leading clinicians, academic scientists and EFPIA (European Federation of Pharmaceutical Industries and Associations) members to elucidate underlying causes, improve methods for immunogenicity prediction and mitigation and establish common definitions around terms and concepts related to immunogenicity. These efforts are expected to facilitate broader collaborations and lead to new guidelines for managing immunogenicity. To support alignment, an overview of concepts behind the set of key terms and definitions adopted to date by ABIRISK is provided herein along with a link to access and download the ABIRISK terms and definitions and provide comments (http://www.abirisk.eu/index_t_and_d.asp).

Understanding and managing coupled human and natural systems (CHANS) is a central challenge of the 21st century, but more focus is needed to pursue the most important questions within this vast field given limited research capacity and funding. We present 40 important questions for CHANS research, identified through a two-part crowdsourcing exercise within the CHANS community. We solicited members of the International Network of Research on Coupled Human and Natural Systems (CHANS-Net) to submit up to three questions that they considered transformative, receiving 540 questions from 207 respondents. After editing for clarity and consistency, we asked the network's members to each evaluate a random subset of 20 questions in importance on a scale from 1 (least important) to 7 (extremely important). Questions on land use and agriculture topped the list, with a median importance ranking of 5.7, followed by questions of scale, climate change and energy, sustainability and development, adaptation and resilience, in addition to seven other categories. We identified 40 questions with a median importance of 6.0 or above, which we highlight as the current view of researchers active in the field as research questions to pursue in order to maximize impact on understanding and managing coupled human and natural systems for achieving sustainable development goals and addressing emerging global challenges.

Understanding the linkages between ecosystem services (ES) and human well-being (HWB) is crucial to sustain the flow of ES for HWB. The Millennium Ecosystem Assessment (MA) provided a state-of-the-art synthesis of such knowledge. However, due to the complexity of the linkages between ES and HWB, there are still many knowledge gaps, and in particular a lack of quantitative indicators and integrated models based on the MA framework. To fill some of these research needs, we developed a quantitative index system to measure HWB, and assessed the impacts of an external driver – the 2008 Wenchuan Earthquake – on HWB. Our results suggest that our proposed index system of HWB is well-designed, valid and could be useful for better understanding the linkages between ES and HWB. The earthquake significantly affected households' well-being in our demonstration sites. Such impacts differed across space and across the five dimensions of the sub-index (i.e., the basic material for good life, security, health, good social relations, and freedom of choice and action). Since the conceptual framework is based on the generalizable MA framework, our methods should also be applicable to other study areas.