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.

The remaining list of author names, affiliations and Regulatory Agencies Disclaimer can be found at the end of the articleThe 2018 12 th Workshop on Recent Issues in Bioanalysis took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day full immersion in bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small-and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS and LBA/cell-based assays approaches. This 2018 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. Due to its length, the 2018 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for large molecule bioanalysis, biomarkers and immunogenicity using LBA and cell-based assays. Part 1 (LCMS for small molecules, peptides, oligonucleotides and small molecule biomarkers) and Part 2 (hybrid LBA/LCMS for biotherapeutics and regulatory agencies' inputs) are published in volume 10 of Bioanalysis, issues 22 and 23 (2018), respectively.

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Pancreatic cancer (PC) is the fourth leading cause of cancer death worldwide, and predicted to be the second within a decade. Five-year survival of PC is less than 5% with a median survival just a couple of months. Therefore, a better understanding of the molecular pathology of PC is an urgent need to achieve advances in clinical treatment for patients. Genomic analyses previously have revealed heterogeneous landscapes of mutation, copy number variation, structural variation and gene expression in pancreatic cancer. While clinical evidence for this proposition is limited and the signaling and biological effects of genomic variations are not routinely determined in human tumors even though they are rationally considered to be drug targets. Luckily, with recent advances in mass spectrometry (MS), comprehensive proteomic and lipidomics analyses provide a potentially valuable approach to validate genomic findings and discover targeted treatments for pancreatic cancer patients. We generated high-throughput proteomic and lipidomic data for pancreatic cancer patients aged from 40 to 80 years old with matched normal samples using TMT-labeling quantitative proteomic method and target lipidomic method. We found promising protein and lipid biomarkers closely related with the clinical outcome of pancreatic cancer patients. Taking signaling and biologically pathways into consideration, we used an edge-based method to distinguish prognostics, where edge features were constructed based on the correlation between each pair of molecules. We then performed feature selection and prognostic classification for both the original expression dataset and the transformed edge dataset and found the edge-based features can give a more accuracy for prognostic prediction, suggesting the promising role of protein and lipid edge biomarkers for clinical utility in pancreatic cancer. Our preliminary results highlight the usefulness of edge-based integration of proteomics and lipidomics data. To explain the mechanisms in the development of pancreatic cancer, we are going to integrate genomic variations from whole genome sequencing (WGS) into our current progress for further analysis. In conclusion, this initial work demonstrated a strategy that may enable more accurate prediction of the survival of pancreatic cancer by integrating multi-omics data from genomics, proteomics and lipidomics. In principle, we anticipate the declaration of possible mechanisms enabling the treatment of pancreatic cancer patients in the near future. Citation Format: Yidi Sun, Chen Li, Rong Zeng. Edge-based integration of multi-omics data gives more accurate prognostic prediction in pancreatic cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 1319.