Deep learning image reconstruction to improve accuracy of iodine quantification and image quality in dual-energy CT of the abdomen: a phantom and clinical study.

OBJECTIVES: To investigate the effect of deep learning image reconstruction (DLIR) on the accuracy of iodine quantification and image quality of dual-energy CT (DECT) compared to that of other reconstruction algorithms in a phantom experiment and an abdominal clinical study. METHODS: An elliptical phantom with five different iodine concentrations (1-12 mgI/mL) was imaged five times with fast-kilovoltage-switching DECT for three target volume CT dose indexes. All images were reconstructed using filtered back-projection, iterative reconstruction (two levels), and DLIR algorithms. Measured and nominal iodine concentrations were compared among the algorithms. Contrast-enhanced CT of the abdomen with the same scanner was acquired in clinical patients. In arterial and portal venous phase images, iodine concentration, image noise, and coefficients of variation for four locations were retrospectively compared among the algorithms. One-way repeated-measures analyses of variance were used to evaluate differences in the iodine concentrations, standard deviations, coefficients of variation, and percentages of error among the algorithms. RESULTS: In the phantom study, the measured iodine concentrations were equivalent among the algorithms: within ± 8% of the nominal values, with root-mean-square deviations of 0.08-0.36 mgI/mL, regardless of radiation dose. In the clinical study (50 patients; 35 men; mean age, 68 ± 11 years), iodine concentrations were equivalent among the algorithms for each location (all p > .99). Image noise and coefficients of variation were lower with DLIR than with the other algorithms (all p < .01). CONCLUSIONS: The DLIR algorithm reduced image noise and variability of iodine concentration values compared with other reconstruction algorithms in the fast-kilovoltage-switching dual-energy CT. KEY POINTS: • In the phantom study, standard deviations and coefficients of variation in iodine quantification were lower on images with the deep learning image reconstruction algorithm than on those with other algorithms. • In the clinical study, iodine concentrations of measurement location in the upper abdomen were consistent across four reconstruction algorithms, while image noise and variability of iodine concentrations were lower on images with the deep learning image reconstruction algorithm.

Abbreviated Gadoxetic Acid-Enhanced MRI for the Detection of Liver Metastases in Patients With Potentially Resectable Pancreatic Ductal Adenocarcinoma.

BACKGROUND: Gadoxetic acid-enhanced magnetic resonance imaging (MRI) is useful in detecting liver metastases from pancreatic ductal adenocarcinoma (PDAC). However, the long examination time limits its utility in the initial workup of patients with PDAC. PURPOSE: To evaluate the incremental value of an abbreviated gadoxetic acid-enhanced MRI for the detection of liver metastases in patients with PDAC. STUDY TYPE: Retrospective. POPULATION: Patients (N = 130) with potentially resectable PDAC (women, 58 [44.6%]). FIELD STRENGTH/SEQUENCE: 1.5 T and 3 T; gradient dual-echo T1-weighted (in-phase and opposed-phase), fat-suppressed fast spin-echo T2-weighted, single-shot echo-planar diffusion-weighted, and three-dimensional fat-suppressed T1-weighted gradient-echo dynamic contrast-enhanced and hepatobiliary phase sequences, as well as contrast-enhanced computed tomography (CECT). ASSESSMENT: Three radiologists independently reviewed three different image sets to detect liver metastases: set 1, CECT alone; set 2, CECT and abbreviated MRI comprising fat-suppressed T2-weighted, diffusion-weighted, and hepatobiliary phase images; and set 3, CECT and standard gadoxetic acid-enhanced MRI. STATISTICAL TESTS: Figure of merit (FOM) was compared using the jackknife alternative free-response receiver operating characteristics, and other per-lesion and per-patient diagnostic parameters for each image set were compared using McNemar's and Fisher's test. P < 0.05 was considered statistically significant. RESULTS: A total of 43 liver metastases were identified in 13 patients. Reader-averaged FOM to detect liver metastases were significantly higher for sets 2 (0.884) and 3 (0.886) than for set 1 (0.609), while they were comparable between sets 2 and 3 (P = 0.96). The mean per-patient sensitivities, negative predictive values, and accuracies were significantly higher for sets 2 and 3 than for set 1, while those between sets 2 and 3 were not significantly different (not applicable, P > 0.99, and P > 0.99, respectively). DATA CONCLUSION: Gadoxetic acid-enhanced MRI combined with CECT had higher diagnostic performance than CECT alone for the detection of liver metastases in patients with PDAC. The incremental values were comparable for the abbreviated MRI and standard MRI. LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY: Stage 2.

Estimation of pancreatic fibrosis and prediction of postoperative pancreatic fistula using extracellular volume fraction in multiphasic contrast-enhanced CT.

OBJECTIVE: To investigate the diagnostic performance of the extracellular volume (ECV) fraction in multiphasic contrast-enhanced computed tomography (CE-CT) for estimating histologic pancreatic fibrosis and predicting postoperative pancreatic fistula (POPF). METHODS: Eighty-five patients (49 men; mean age, 69 years) who underwent multiphasic CE-CT followed by pancreaticoduodenectomy with pancreaticojejunal anastomosis between January 2012 and December 2018 were retrospectively included. The ECV fraction was calculated from absolute enhancements of the pancreas and aorta between the precontrast and equilibrium-phase images, followed by comparisons among histologic pancreatic fibrosis grades (F0‒F3). The diagnostic performance of the ECV fraction in advanced fibrosis (F2‒F3) was evaluated using receiver operating characteristic curve analysis. Multivariate logistic regression analysis was used to evaluate the associations of the risk of POPF development with patient characteristics, histologic findings, and CT imaging parameters. RESULTS: The mean ECV fraction of the pancreas was 34.4% ± 9.5, with an excellent intrareader agreement of 0.811 and a moderate positive correlation with pancreatic fibrosis (r = 0.476; p < 0.001). The mean ECV fraction in advanced fibrosis was significantly higher than that in no/mild fibrosis (44.4% ± 10.8 vs. 31.7% ± 6.7; p < 0.001), and the area under the receiver operating characteristic curve for the diagnosis of advanced fibrosis was 0.837. Twenty-two patients (25.9%) developed clinically relevant POPF. Multivariate logistic regression analysis demonstrated that the ECV fraction was a significant predictor of POPF. CONCLUSIONS: The ECV fraction can offer quantitative information for assessing pancreatic fibrosis and POPF after pancreaticojejunal anastomosis. KEY POINTS: • There was a moderate positive correlation of the extracellular volume (ECV) fraction of the pancreas in contrast-enhanced CT with the histologic grade of pancreatic fibrosis (r = 0.476; p < 0.001). • The ECV fraction was higher in advanced fibrosis (F2‒F3) than in no/mild fibrosis (F0‒F1) (p < 0.001), with an AUC of 0.837 for detecting advanced fibrosis. • The ECV fraction was an independent risk factor for predicting subclinical (odds ratio, 0.81) and clinical (odds ratio, 0.80) postoperative pancreatic fistula.

Rim Enhancement on Contrast-Enhanced CT as a Predictor of Prognosis in Patients with Pancreatic Ductal Adenocarcinoma.

This study investigated the utility of imaging features, such as rim enhancement on contrast-enhanced CT (CECT), in predicting the prognosis of pancreatic ductal adenocarcinoma (PDAC). This retrospective study included 158 patients (84 men; mean age, 68 years) with pathologically confirmed PDAC. The following imaging features were evaluated on CECT by two radiologists: tumor size, tumor attenuation, and the presence of rim enhancement. Cox proportional hazards analysis was performed to identify the imaging and clinicopathological features for predicting disease-free survival (DFS) and overall survival (OS). Pathological features were compared with the presence of rim enhancement. Among the 158 patients, 106 (67%) underwent curative surgery (surgery group) and 52 (33%) received conservative treatment (non-surgery group). Rim enhancement was observed more frequently in the non-surgery group than in the surgery group (44% vs. 20%; p < 0.001). Rim enhancement showed significant associations with shorter DFS and OS in the surgery group (hazard ratios (HRs), 3.03 and 2.99; p < 0.001 and p = 0.003, respectively), whereas tumor size showed significant associations with shorter OS (HR per 1 mm increase, 1.08; p < 0.001). PDACs with rim enhancement showed significant associations with higher histological tumor grades (p < 0.001). PDAC with rim enhancement on CECT could predict poorer prognosis and more aggressive tumor grades.

Utility of Thin-slice Fat-suppressed Single-shot T2-weighted MR Imaging with Deep Learning Image Reconstruction as a Protocol for Evaluating the Pancreas.

PURPOSE: To compare the utility of thin-slice fat-suppressed single-shot T2-weighted imaging (T2WI) with deep learning image reconstruction (DLIR) and conventional fast spin-echo T2WI with DLIR for evaluating pancreatic protocol. METHODS: This retrospective study included 42 patients (mean age, 70.2 years) with pancreatic cancer who underwent gadoxetic acid-enhanced MRI. Three fat-suppressed T2WI, including conventional fast-spin echo with 6 mm thickness (FSE 6 mm), single-shot fast-spin echo with 6 mm and 3 mm thickness (SSFSE 6 mm and SSFSE 3 mm), were acquired for each patient. For quantitative analysis, the SNRs of the upper abdominal organs were calculated between images with and without DLIR. The pancreas-to-lesion contrast on DLIR images was also calculated. For qualitative analysis, two abdominal radiologists independently scored the image quality on a 5-point scale in the FSE 6 mm, SSFSE 6 mm, and SSFSE 3 mm with DLIR. RESULTS: The SNRs significantly improved among the three T2-weighted images with DLIR compared to those without DLIR in all patients (P < 0.001). The pancreas-to-lesion contrast of SSFSE 3 mm was higher than those of the FSE 6 mm (P < 0.001) and tended to be higher than SSFSE 6 mm (P = 0.07). SSFSE 3 mm had the highest image qualities regarding pancreas edge sharpness, pancreatic duct clarity, and overall image quality, followed by SSFSE 6 mm and FSE 6 mm (P < 0.0001). CONCLUSION: SSFSE 3 mm with DLIR demonstrated significant improvements in SNRs of the pancreas, pancreas-to-lesion contrast, and image quality more efficiently than did SSFSE 6 mm and FSE 6 mm. Thin-slice fat-suppressed single-shot T2WI with DLIR can be easily implemented for pancreatic MR protocol.

Evaluation and Prediction of Post-Hepatectomy Liver Failure Using Imaging Techniques: Value of Gadoxetic Acid-Enhanced Magnetic Resonance Imaging.

Despite improvements in operative techniques and perioperative care, post-hepatectomy liver failure (PHLF) remains the most serious cause of morbidity and mortality after surgery, and several risk factors have been identified to predict PHLF. Although volumetric assessment using imaging contributes to surgical simulation by estimating the function of future liver remnants in predicting PHLF, liver function is assumed to be homogeneous throughout the liver. The combination of volumetric and functional analyses may be more useful for an accurate evaluation of liver function and prediction of PHLF than only volumetric analysis. Gadoxetic acid is a hepatocyte-specific magnetic resonance (MR) contrast agent that is taken up by hepatocytes via the OATP1 transporter after intravenous administration. Gadoxetic acid-enhanced MR imaging (MRI) offers information regarding both global and regional functions, leading to a more precise evaluation even in cases with heterogeneous liver function. Various indices, including signal intensity-based methods and MR relaxometry, have been proposed for the estimation of liver function and prediction of PHLF using gadoxetic acid-enhanced MRI. Recent developments in MR techniques, including high-resolution hepatobiliary phase images using deep learning image reconstruction and whole-liver T1 map acquisition, have enabled a more detailed and accurate estimation of liver function in gadoxetic acid-enhanced MRI.

Added value of contrast enhancement boost images in routine multiphasic contrast-enhanced CT for the diagnosis of small (<20 mm) hypervascular hepatocellular carcinoma.

PURPOSE: To investigate the added value of contrast enhancement boost (CE-boost) images in multiphasic contrast-enhanced CT (CE-CT) for diagnosing small (<20 mm) hypervascular hepatocellular carcinoma (HCC). MATERIALS AND METHODS: This retrospective study included 69 patients (age, 74 ± 8 years; 52 men) with 70 hypervascular HCCs (<20 mm) who underwent multiphasic CE-CT (pre-contrast, late arterial phase [LAP], portal venous phase [PVP], and equilibrium phase). Two types of CE-boost images were generated by subtracting PVP from LAP (LA-PV) images and LAP from PVP (PV-LA) images to enhance the contrast effect of hepatic arterial and portal venous perfusion more selectively. Tumor-to-liver contrast-to-noise ratios (CNRs) in CE-boost images were compared with those in CE-CT images using the Wilcoxon signed-rank test. Two independent readers reviewed the imaging datasets: CE-CT alone and CE-CT with CE-boost images. The diagnostic performance of each dataset was compared using jackknife alternative free-response receiver operating characteristics (JAFROC-1). RESULTS: The tumor-to-liver CNRs in the LA-PV (6.4 ± 3.0) and PV-LA (-3.3 ± 2.1) images were greater than those in the LAP (3.2 ± 1.7) and PVP images (-1.1 ± 1.4) (p <.001 for both). The reader-averaged figures of merit were 0.751 for CE-CT alone and 0.807 for CE-CT with CE-boost images (p <.001). Sensitivities increased by adding CE-boost images for both readers (p <.001 and = 0.03), while positive predictive values were equivalent (p >.99). CONCLUSION: Adding CE-boost images to multiphasic CE-CT can improve the diagnostic accuracy and sensitivity for small hypervascular HCC by increasing the tumor-to-liver CNR.

Highlights of the 14th Japan Bioanalysis Forum Symposium.

The 14th Japan Bioanalysis Forum Symposium was held at Tower Hall Funabori, Japan from 1-3 March 2023. The conference theme, 'Bringing Together - the Expertise of Bioanalysis', aimed to enable people from various fields to gather, learn and collaborate together for the common goal of delivering medicines to patients faster. Approximately 360 participants from various fields, including pharmaceutical industries, contractors, academia and regulatory authorities, gathered at an in-person symposium which had an online participation option, for the first time in 4 years. The symposium offered a wide range of topics including ICH M10, new modalities, biomarkers, immunogenicity, electronization and patient-centric sampling. The latest research results were provided from domestic and overseas scientists. This report summarizes the major topics.

Transarterial Chemoebolization in Hepatocellular Carcinoma: A Binational Japanese-German Study.

Objective: The purpose of this study was to investigate outcomes of transarterial chemoembolization (TACE) in treating hepatocellular carcinoma (HCC) comparing the different approaches used in Germany and Japan. Methods: This binational IRB-approved retrospective dual-center study included a total of 94 HCC patients subdivided in a German and a Japanese cohort. For each patient, liver and tumor volumetry was performed using computed tomography (CT) and magnetic resonance imaging (MRI). Furthermore, a comprehensive risk profile, including body constitution and liver and kidney function was established. Primary endpoints were progression-free and overall survival (PFS/OS). Results: PFS in the German cohort was 168 vs 224d in the Japanese cohort (p=0.640). When subdivided by BCLC stage, no significant differences were reported (p=0.160-0.429). OS was significantly longer in the Japanese cohort with 856 vs. 303d (p<0.001). OS for BCLC A was significantly longer in the Japanese cohort (1960 vs. 428d; p<0.001), while survival rates did not differ significantly in BCLC B (785 vs 330d; p=0.067) and C-stages (208 vs 302d; p=0.186). Older age (p=0.034), poorer liver/kidney function (p=0.025-0-035), and a higher liver/tumor ratio (p<0.001) were found to correlate with shorter survival. ECOG scores were significantly higher in the German cohort (p=0.002). Conclusion: While OS is longer in TACE-treated patients in the Japanese cohort compared to the German cohort, the two approaches seem to be equally effective as PFS does not differ significantly. The different survival rates may be caused by the different clinical performance status of the selected collectives. In very early and early stage HCC, TACE in Japan seems to be an effective treatment option while in Germany for patients in those stages TACE remains a second-line option for patients not available for surgery or ablation.

Highlights of the 13th Japan Bioanalysis Forum Symposium.

Approximately 280 people from pharmaceutical industries, contractors, academic institutions and regulatory authorities attended the 13th Japan Bioanalysis Forum Symposium. The symposium was held via web to prevent the spread of COVID-19 from the 28 February to 2 March 2022. The theme of the symposium was 'All for One Goal', and the event has provided an opportunity for open discussion among researchers with different backgrounds but who share a common goal: "to deliver more effective and safe pharmaceuticals to patients as quickly as possible". The speakers focused on hot topics in bioanalysis, including chromatography, biomarker analysis, cell and gene therapy, COVID-19 and antidrug antibody. This symposium provided a great opportunity for the participants to have meaningful discussions, even though 'on the web' was a limited space.

Development and multicenter validation of an LC-MS-based bioanalytical method for antisense therapeutics.

Background: Many bioanalytical methods for antisense oligonucleotides (ASOs) using LC-MS have been reported. However, no data have been available on the reproducibility and robustness of a single bioanalytical method for ASOs. As such, in the current study, we evaluated the reproducibility and robustness of LC-MS-based bioanalytical methods for ASOs in multiple laboratories. Methods/Results: Seven independent laboratories were included in this study. Mipomersen was measured by ion-pairing LC-MS (IP-LC-MS) as a model ASO using different LC-MS. The validation results of calibration curve, accuracy, precision and selectivity met the criteria of conventional bioanalytical method validation guidelines using LC/GC-MS for drugs in all laboratories. Meanwhile, carryover (>20%) was detected in three laboratories. Conclusion: We first demonstrated the multicenter-validated IP-LC-MS bioanalytical method for ASOs. Our data showed that the method was sensitive, robust and reproducible. However, the occurrence of carryover should be carefully monitored in its future application.

Highlights of the 12th Japan Bioanalysis Forum Symposium.

Approximately 300 people associated with pharmaceutical industries, contractors, academic institutions and regulatory authorities attended the 12th Japan Bioanalysis Forum Symposium. The webinar was conducted from 9 to 11 March 2021. The theme of the symposium was 'for the next generation', and the event provided 'an opportunity for young researchers in bioanalysis (including students)' and 'an opportunity to discuss new frontiers of bioanalysis'. The speakers focused on hot topics of bioanalysis, including biomarker analysis, patient centric sampling, virtual clinical trials, gene therapy, cancer genome medicine and therapeutic middle molecules. The symposium presented a platform for the discussion of the prospects and challenges facing bioanalysts working in the field of pharmacokinetics. This report presents the key issues discussed.

Bioanalysis of therapeutic monoclonal antibody by peptide adsorption-controlled LC-MS.

Aim: We aimed to develop an easy, low-cost and versatile mass spectrometric method for the bioanalysis of a therapeutic monoclonal antibody (mAb) in human serum that employs peptide adsorption-controlled (PAC)-LC/MS using selected reaction monitoring mode (LC-MS/MS-SRM). Materials & methods: Rituximab was used as a model mAb. To apply the method to human serum samples, a peptide of the complementarity-determining region was selected as the surrogate peptide. The usefulness of PAC-LC-MS/MS-SRM was evaluated by a collaborative study. Results: The calibration curve ranged from 0.5 (or 1.0) to 1000.0 µg/ml. The selectivity, linearity, accuracy and precision met the predefined acceptance criteria. Conclusion: Our method could be a useful bioanalytical method for the quantification of mAbs in clinical samples.

CT Body Composition of Sarcopenia and Sarcopenic Obesity: Predictors of Postoperative Complications and Survival in Patients with Locally Advanced Esophageal Adenocarcinoma.

BACKGROUND: To assess the impact of body composition imaging biomarkers in computed tomography (CT) on the perioperative morbidity and survival after surgery of patients with esophageal cancer (EC). METHODS: Eighty-five patients who underwent esophagectomy for locally advanced EC after neoadjuvant therapy between 2014 and 2019 were retrospectively enrolled. Pre- and postoperative CT scans were used to assess the body composition imaging biomarkers (visceral (VAT) and subcutaneous adipose tissue (SAT) areas, psoas muscle area (PMA) and volume (PMV), total abdominal muscle area (TAMA)). Sarcopenia was defined as lumbar skeletal muscle index (LSMI) ≤38.5 cm2/m2 in women and ≤52.4 cm2/m2 in men. Patients with a body mass index (BMI) of ≥30 were considered obese. These imaging biomarkers were correlated with major complications, anastomotic leakage, postoperative pneumonia, duration of postoperative hospitalization, disease-free survival (DFS), and overall survival (OS). RESULTS: Preoperatively, sarcopenia was identified in 58 patients (68.2%), and sarcopenic obesity was present in 7 patients (8.2%). Sarcopenic patients were found to have an elevated risk for the occurrence of major complications (OR: 2.587, p = 0.048) and prolonged hospitalization (32 d vs. 19 d, p = 0.040). Patients with sarcopenic obesity had a significantly higher risk for postoperative pneumonia (OR: 6.364 p = 0.018) and a longer postoperative hospital stay (71 d vs. 24 d, p = 0.021). Neither sarcopenia nor sarcopenic obesity was an independent risk factor for the occurrence of anastomotic leakage (p > 0.05). Low preoperative muscle biomarkers (PMA and PMV) and their decrease (ΔPMV and ΔTAMA) during the follow-up period significantly correlated with shorter DFS and OS (p = 0.005 to 0.048). CONCLUSION: CT body composition imaging biomarkers can identify high-risk patients with locally advanced esophageal cancer undergoing surgery. Sarcopenic patients have a higher risk of major complications, and patients with sarcopenic obesity are more prone to postoperative pneumonia. Sarcopenia and sarcopenic obesity are both subsequently associated with a prolonged hospitalization. Low preoperative muscle mass and its decrease during the postoperative follow-up are associated with lower DFS and OS.

Prediction of post-hepatectomy liver failure using gadoxetic acid-enhanced magnetic resonance imaging for hepatocellular carcinoma with portal vein invasion.

PURPOSE: Accurate prediction of post-hepatectomy liver failure (PHLF) is important in advanced hepatocellular carcinoma (HCC). We aimed to retrospectively evaluate the utility of gadoxetic acid-enhanced MRI for predicting PHLF in patients who underwent anatomic hepatectomy for HCC with portal vein invasion. METHODS: Forty-one patients (32 men, 9 women) were included. Hepatobiliary-phase MR images were acquired 20 min after injection of gadoxetic acid using a 3D fat-suppressed T1-weighted spoiled gradient-echo sequence. Liver-spleen ratio (LSR), remnant hepatocellular uptake index (rHUI), and HUI were calculated. The severity of PHLF was defined according to the International Study Group of Liver Surgery. Differences in LSR between the resected liver and the remnant liver, and HUI and rHUI/HUI between no/mild and severe PHLF were compared using the Wilcoxon signed-rank test and Wilcoxon rank-sum test, respectively. Univariate and multivariate logistic regression analyses were performed to identify predictors of severe PHLF. Areas under the receiver operating characteristic curves (AUCs) of rHUI and rHUI/HUI were calculated for predicting severe PHLF. RESULTS: Nine patients developed severe PHLF. LSR of the remnant liver was significantly higher than that of the resected liver (P < 0.001). Severe PHLF demonstrated significantly lower rHUI (P < 0.001) and rHUI/HUI (P < 0.001) compared with no/mild PHLF. Multivariate logistic regression analysis showed that decreased rHUI (P = 0.012, AUC=0.885) and rHUI/HUI (P = 0.002, AUC=0.852) were independent predictors of severe PHLF. CONCLUSION: Gadoxetic acid-enhanced MRI can be a promising noninvasive examination for assessing global and regional liver function, allowing estimation of the functional liver remnant and accurate prediction of severe PHLF before hepatic resection.

Development of a bioanalytical method for an antisense therapeutic using high-resolution mass spectrometry.

Background: Ion-pairing reverse-phase LC coupled with high-resolution mass spectrometry (IP-LC/HRMS) has gained attention in oligonucleotide therapeutic bioanalyses owing to its high sensitivity and selectivity. However, optimization and validation of IP-LC/HRMS-based methods are rare. The objective of this study is the development of a sensitive and reproducible IP-LC/HRMS-based bioanalytical method using clinically approved mipomersen as a model for antisense oligonucleotides. Materials & methods/results: Mipomersen was extracted from rat plasma using Clarity OTX SPE and quantified by IP-LC/HRMS. The calibration range was 0.5-250.0 ng/ml. The developed method met the general regulatory criteria for accuracy, precision, carry-over, selectivity, matrix effect and dilution integrity. Conclusion: A highly sensitive and reliable method for mipomersen measurement with potential antisense oligonucleotide bioanalysis applications has been developed.

The 10th Japan Bioanalysis Forum Symposium conference: a report.

The Japan Bioanalysis Forum Symposium was held on 12-14 February 2019 (Yokohama, Japan), in celebration of its 10th anniversary, and over 370 participants from pharmaceutical industries, contractors, academia and regulatory authorities from home and abroad came together in Yokohama. The 3-day symposium particularly aimed to foster collaboration with the scientists surrounding bioanalysts, according to the theme 'Open to the Public.' The symposium also included a broad range of pioneering programs, such as lectures by speakers from DMPK/metabolomics fields, discussions of future bioanalysis and poster presentations by publicly offered presenters as well as the regular ones we had organized. This report summarizes the major topics as a conference report.

The ninth Japan Bioanalysis Forum symposium.

The ninth Japan Bioanalysis Forum symposium took place at tower hall Funabori, Tokyo, Japan, between 6 and 8 February, 2018. Bioanalytical scientists from the pharmaceutical industry, CROs, academia and regulatory bodies had many meaningful and relevant discussions on current topics of interest in bioanalysis. The 3-day symposium featured updated perspectives and experiences on regulated bioanalysis of small and large molecules, biomarker measurement and assessment of immunogenicity, as well as new areas of bioanalytical validation such as quantitative polymerase chain reaction(qPCR) and flow cytometry. There were over 260 participants from six countries, with 23 oral and 11 poster presentations, including the outcomes of Japan Bioanalysis Forum discussion groups. This report summarizes the major discussion topics from the conference.