With this information, we review currently approved and investigational therapies designed to restore lost or damaged myelin and protect against neuronal degeneration. The development of therapies to restore lost myelin and protect neurons is a promising avenue of investigation for the benefit of patients with MS.
Ongoing research into the function of oligodendrocytes and myelin has revealed the importance of their relationship with neuronal health. Demyelination in MS leads to a number of pathophysiologic changes contributing to axonal generation. Among these are mitochondrial dysfunction, persistent neuroinflammation, and the effects of reactive oxygen and nitrogen species. With this information, we review currently approved and investigational therapies designed to restore lost or damaged myelin and protect against neuronal degeneration. The development of therapies to restore lost myelin and protect neurons is a promising avenue of investigation for the benefit of patients with MS.Honeybee venom (Apitoxin, BV), a secretion substance expelled from the venom gland of bees, has being reported as antimicrobial against various bacterial species; however, the mechanism of action remains uncharacterized. In this study, the antibacterial activity of BV was investigated on hygiene indicator Escherichia coli and the environmental pathogen and spoilage bacterial species, Pseudomonas putida and Pseudomonas fluorescens. An array of methods was combined to elucidate the mode of action of BV. https://www.selleckchem.com/products/chloroquine-phosphate.html Viability by culture on media was combined with assessing cell injury with flow cytometry analysis. ATP depletion was monitored as an indicator to metabolic activity of cells, by varying BV concentration (75, 225and 500 µg/mL), temperature (25 [Formula see text] and 37 [Formula see text]), and time of exposure (0 to 24 h). Venom presented moderate inhibitory effect on E. coli by viability assay, caused high membrane permeability and significant ATP loss where the effect was increased by increased concentration. The viability of P. putida was reduced to a greater extent than other tested bacteria at comparable venom concentrations and was dictated by exposure time. On the contrary, P. fluorescens appeared less affected by venom based on viability; however, flow cytometry and ATP analysis highlighted concentration- and time-dependent effect of venom. According to Transmission Electron Microscopy results, the deformation of the cell wall was evident for all species. This implies a common mechanism of action of the BV which is as follows the cell wall destruction, change of membrane permeability, leakage of cell contents, inactivation of metabolic activity and finally cell death.
The role of lung ultrasound (LUS) in evaluating the mid- and long-term prognoses of patients with COVID-19 pneumonia is not yet known. The objectives of this study were to evaluate associations between LUS signs at the time of screening and clinical outcomes 1month after LUS and to assess LUS signs at the time of presentation with known risk factors for COVID-19 pneumonia.

This was a retrospective study of data prospectively collected 1month after LUS screening of 447 adult patients diagnosed with COVID-19 pneumonia. Sonographic examination was performed in screening tents with the participants seated. The LUS signs (B-lines > 2, coalescent B-lines, and subpleural consolidations) were captured in six areas of each hemithorax and a LUS aeration score was calculated; in addition, the categories of disease probability based on patterns of LUS findings (high-probability, intermediate-probability, alternate, and low-probability patterns) were evaluated. The LUS signs at patients' initial evaluation were rel admission (p = 0.031).

In patients with COVID-19 pneumonia, LUS signs were related to respiratory symptoms 1month after LUS screening. Strong relationships were identified between LUS signs and the need for hospitalization and death.
In patients with COVID-19 pneumonia, LUS signs were related to respiratory symptoms 1 month after LUS screening. Strong relationships were identified between LUS signs and the need for hospitalization and death.
There is considerable controversy on the role of genetics, mechanical and environmental factors, and, recently, on subclinical infection in triggering inflammaging leading to disk degeneration. The present study investigated sequential molecular events in the host, analyzing proteome level changes that will reveal triggering factors of inflammaging and degeneration.

Ten MRI normal disks (ND) from braindead organ donors and 17 degenerated disks (DD) from surgery were subjected to in-gel-based label-free ESI-LC-MS/MS analysis. Bacterial-responsive host-defense response proteins/pathways leading to Inflammaging were identified and compared between ND and DD.

Out of the 263 well-established host-defense response proteins (HDRPs), 243 proteins were identified, and 64 abundantly expressed HDRPs were analyzed further. Among the 21 HDRPs common to both ND and DD, complement factor 3 (C3) and heparan sulfate proteoglycan 2 (HSPG2) were significantly upregulated, and lysozyme (LYZ), superoxide dismutase 3 (SOD3), degranulation, and oxidative-stress regulation indicated an ongoing infection mediated inflammatory process in DD. Our study has documented increasing evidence for bacteria's role in triggering the innate immune system leading to chronic inflammation and degenerative disk disease.Human operators often experience large fluctuations in cognitive workload over seconds timescales that can lead to sub-optimal performance, ranging from overload to neglect. Adaptive automation could potentially address this issue, but to do so it needs to be aware of real-time changes in operators' spare cognitive capacity, so it can provide help in times of peak demand and take advantage of troughs to elicit operator engagement. However, it is unclear whether rapid changes in task demands are reflected in similarly rapid fluctuations in spare capacity, and if so what aspects of responses to those demands are predictive of the current level of spare capacity. We used the ISO standard detection response task (DRT) to measure cognitive workload approximately every 4 s in a demanding task requiring monitoring and refueling of a fleet of simulated unmanned aerial vehicles (UAVs). We showed that the DRT provided a valid measure that can detect differences in workload due to changes in the number of UAVs. We used cross-validation to assess whether measures related to task performance immediately preceding the DRT could predict detection performance as a proxy for cognitive workload.

With this information, we review currently approved and investigational therapies designed to restore lost or damaged myelin and protect against neuronal degeneration. The development of therapies to restore lost myelin and protect neurons is a promising avenue of investigation for the benefit of patients with MS.
Ongoing research into the function of oligodendrocytes and myelin has revealed the importance of their relationship with neuronal health. Demyelination in MS leads to a number of pathophysiologic changes contributing to axonal generation. Among these are mitochondrial dysfunction, persistent neuroinflammation, and the effects of reactive oxygen and nitrogen species. With this information, we review currently approved and investigational therapies designed to restore lost or damaged myelin and protect against neuronal degeneration. The development of therapies to restore lost myelin and protect neurons is a promising avenue of investigation for the benefit of patients with MS.Honeybee venom (Apitoxin, BV), a secretion substance expelled from the venom gland of bees, has being reported as antimicrobial against various bacterial species; however, the mechanism of action remains uncharacterized. In this study, the antibacterial activity of BV was investigated on hygiene indicator Escherichia coli and the environmental pathogen and spoilage bacterial species, Pseudomonas putida and Pseudomonas fluorescens. An array of methods was combined to elucidate the mode of action of BV. Viability by culture on media was combined with assessing cell injury with flow cytometry analysis. ATP depletion was monitored as an indicator to metabolic activity of cells, by varying BV concentration (75, 225and 500 µg/mL), temperature (25 [Formula see text] and 37 [Formula see text]), and time of exposure (0 to 24 h). Venom presented moderate inhibitory effect on E. coli by viability assay, caused high membrane permeability and significant ATP loss where the effect was increased by increased concentration. The viability of P. https://www.selleckchem.com/products/ver155008.html putida was reduced to a greater extent than other tested bacteria at comparable venom concentrations and was dictated by exposure time. On the contrary, P. fluorescens appeared less affected by venom based on viability; however, flow cytometry and ATP analysis highlighted concentration- and time-dependent effect of venom. According to Transmission Electron Microscopy results, the deformation of the cell wall was evident for all species. This implies a common mechanism of action of the BV which is as follows the cell wall destruction, change of membrane permeability, leakage of cell contents, inactivation of metabolic activity and finally cell death.
The role of lung ultrasound (LUS) in evaluating the mid- and long-term prognoses of patients with COVID-19 pneumonia is not yet known. The objectives of this study were to evaluate associations between LUS signs at the time of screening and clinical outcomes 1month after LUS and to assess LUS signs at the time of presentation with known risk factors for COVID-19 pneumonia.

This was a retrospective study of data prospectively collected 1month after LUS screening of 447 adult patients diagnosed with COVID-19 pneumonia. Sonographic examination was performed in screening tents with the participants seated. The LUS signs (B-lines > 2, coalescent B-lines, and subpleural consolidations) were captured in six areas of each hemithorax and a LUS aeration score was calculated; in addition, the categories of disease probability based on patterns of LUS findings (high-probability, intermediate-probability, alternate, and low-probability patterns) were evaluated. The LUS signs at patients' initial evaluation were rel admission (p = 0.031).

In patients with COVID-19 pneumonia, LUS signs were related to respiratory symptoms 1month after LUS screening. Strong relationships were identified between LUS signs and the need for hospitalization and death.
In patients with COVID-19 pneumonia, LUS signs were related to respiratory symptoms 1 month after LUS screening. Strong relationships were identified between LUS signs and the need for hospitalization and death.
There is considerable controversy on the role of genetics, mechanical and environmental factors, and, recently, on subclinical infection in triggering inflammaging leading to disk degeneration. The present study investigated sequential molecular events in the host, analyzing proteome level changes that will reveal triggering factors of inflammaging and degeneration.

Ten MRI normal disks (ND) from braindead organ donors and 17 degenerated disks (DD) from surgery were subjected to in-gel-based label-free ESI-LC-MS/MS analysis. Bacterial-responsive host-defense response proteins/pathways leading to Inflammaging were identified and compared between ND and DD.

Out of the 263 well-established host-defense response proteins (HDRPs), 243 proteins were identified, and 64 abundantly expressed HDRPs were analyzed further. Among the 21 HDRPs common to both ND and DD, complement factor 3 (C3) and heparan sulfate proteoglycan 2 (HSPG2) were significantly upregulated, and lysozyme (LYZ), superoxide dismutase 3 (SOD3), degranulation, and oxidative-stress regulation indicated an ongoing infection mediated inflammatory process in DD. Our study has documented increasing evidence for bacteria's role in triggering the innate immune system leading to chronic inflammation and degenerative disk disease.Human operators often experience large fluctuations in cognitive workload over seconds timescales that can lead to sub-optimal performance, ranging from overload to neglect. Adaptive automation could potentially address this issue, but to do so it needs to be aware of real-time changes in operators' spare cognitive capacity, so it can provide help in times of peak demand and take advantage of troughs to elicit operator engagement. However, it is unclear whether rapid changes in task demands are reflected in similarly rapid fluctuations in spare capacity, and if so what aspects of responses to those demands are predictive of the current level of spare capacity. We used the ISO standard detection response task (DRT) to measure cognitive workload approximately every 4 s in a demanding task requiring monitoring and refueling of a fleet of simulated unmanned aerial vehicles (UAVs). We showed that the DRT provided a valid measure that can detect differences in workload due to changes in the number of UAVs. We used cross-validation to assess whether measures related to task performance immediately preceding the DRT could predict detection performance as a proxy for cognitive workload.

The results provide new insight into the mechanisms of how miRNAs act as TLR ligands. Eventually, BrainDead implements a generic machine learning methodology for learning and predicting the functions of short RNAs in any context.Purpose This study investigated the efficacy of Treatment for Establishing Motor Program Organization (TEMPOSM) in childhood apraxia of speech (CAS).Method A mixed between- and within-participant design with multiple baselines across participants and behaviors was used to examine acquisition, generalization, and maintenance of skills. TEMPOSM was administered in four one-hour sessions a week over a four-week period for eleven participants (ages 5 to 8), allocated to either an immediate treatment group or a wait-list control group. Acoustic and perceptual variables were measured at baseline, immediate post-treatment, and one-month post-treatment.Results Children demonstrated significant improvements in specific acoustic measures of segmentation and lexical stress, as well as perceptual measures of fluency, lexical stress, and speech-sound accuracy. Treatment and generalization effects were maintained one-month post-treatment with generalization to untreated stimuli.Conclusion TEMPOSM was efficacious in improving segmental and suprasegmental impairments in the speech of children with CAS.The major problems with cancer therapy are drug-induced side effects. There is an urgent need for safe anti-tumor drugs. Artemisinin is a Chinese herbal remedy for malaria with efficacy and safety. However, several studies reported that artemisinin causes neurotoxicity and cardiotoxicity in animal models. Recently, nanostructured drug delivery systems have been designed to improve therapeutic efficacy and reduce toxicity. Artemisinin has been reported to show anticancer properties. The anticancer effects of artemisinin appear to be mediated by inducing cell cycle arrest, promoting ferroptosis and autophagy, inhibiting cell metastasis. Therefore, the review is to concentrate on mechanisms and molecular targets of artemisinin as anti-tumor agents. We believe these will be important topics in realizing the potential of artemisinin and its derivatives as potent anticancer agents.Objective We evaluated the cost-effectiveness of olaparib and niraparib as maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer.Methods A decision analysis model compared the costs and effectiveness of olaparib and niraparib versus placebo for patients with or without germline BRCA mutations. Resource use and associated costs were estimated from the 2020 National Health Insurance Administration reimbursement price list. Clinical effectiveness was measured in progression-free survival per life-years (PFS-LY) based on the results of clinical trials SOLO2/ENHOT-Ov21 and ENGOT-OV16/NOVA. The incremental cost-effectiveness ratio (ICER) was estimated from a single-payer perspective.Results In the base case, olaparib was the more cost-effective treatment regimen. The ICERs for olaparib and niraparib compared to placebo were NT$1,804,785 and NT$2,340,265 per PFS-LY, respectively. Tornado analysis showed that PFS and the total resource use cost of niraparib regimen for patients without gBRCA were the most sensitive parameters impacting the ICER. https://www.selleckchem.com/products/ck-586.html The ICERs for both drugs in patients with a gBRCA mutation were lower than in patients without a gBRCA mutation. Probabilistic sensitivity analysis indicated that olaparib was more cost-effective than niraparib at the willingness-to-pay threshold of NT$2,602,404 per PFS life-year gained.Conclusion Olaparib was estimated to be less cost and more effective compared to niraparib as maintenance therapy for patients with recurrent platinum-sensitive ovarian cancer.New challenges and other topics in non-clinical safety testing of biotherapeutics were presented and discussed at the nineth European BioSafe Annual General Membership meeting in November 2019. The session topics were selected by European BioSafe organization committee members based on recent company achievements, agency interactions and new data obtained in the non-clinical safety testing of biotherapeutics, for which data sharing would be of interest and considered as valuable information. The presented session topics ranged from strategies of in vitro testing, immunogenicity prediction, bioimaging, and developmental and reproductive toxicology (DART) assessments to first-in-human (FIH) dose prediction and bioanalytical challenges, reflecting the entire space of different areas of expertise and different molecular modalities. During the 9th meeting of the European BioSafe members, the following topics were presented and discussed in 6 main sessions (with 3 or 4 presentations per session) and in three small group breakout sessions 1) DART assessment with biotherapeutics what did we learn and where to go?; 2) Non-animal testing strategies; 3) Seeing is believing new frontiers in imaging; 4) Predicting immunogenicity during early drug development hope or despair?; 5) Challenges in FIH dose projections; and 6) Non-canonical biologics formats challenges in bioanalytics, PKPD and biotransformation for complex biologics formats. Small group breakout sessions were organized for team discussion about 3 specific topics 1) Testing of cellular immune function in vitro and in vivo; 2) MABEL approach (toxicology and pharmacokinetic perspective); and 3) mRNA treatments. This workshop report presents the sessions and discussions at the meeting.
Snapping scapula syndrome (SSS) is commonly misdiagnosed and underreported due to lack of awareness.

This scoping review aims to summarize the current evidence related to SSS diagnosis and treatment to aid clinicians in managing the condition more effectively.

PubMed, Medline, and Embase databases were searched for studies related to the etiology, diagnosis, or treatment of SSS (database inception to March 2020).

Databases were searched for available studies related to the etiology, diagnosis, or treatment of SSS.

A scoping review study design was selected to explore the breadth of knowledge in the literature regarding SSS diagnosis and treatment.

Level 4.

Primary outcomes abstraction included accuracy of diagnostic tests, functional outcomes, and pain relief associated with various nonoperative and operative treatment options for SSS.

A total of 1442 references were screened and 40 met the inclusion criteria. Studies commonly reported SSS as a clinical diagnosis and relied heavily on a focused history and physical examination.

5) and a coefficient of variation less then 10%. Candidate reference genes were validated by quantitative real-time PCR in independent samples.We identified a total of 264 genes stably expressed in EndoC-βH1 cells and human islets following cytokines - or palmitate-induced stress, displaying a low coefficient of variation. Validation by quantitative real-time PCR of the top five genes ARF1, CWC15, RAB7A, SIAH1 and VAPA corroborated their expression stability under most of the tested conditions. Further validation in independent samples indicated that the geometric mean of ACTB and VAPA expression can be used as a reliable normalizing factor in human beta cells.
Transsphenoidal endoscopic surgery is the first-line treatment for growth hormone-secreting adenomas.

To analyse the results of the transsphenoidal endoscopic approach for acromegaly and to determine the predictive factors of remission.

A single-centre retrospective review was performed in patients who underwent endoscopic transsphenoidal surgery for acromegaly between January 2009 and January 2019. Demographic features, clinical presentation, histopathology records, complications and pre- and postoperative radiologic and endocrinological assessments were evaluated. The factors that influenced the remission rates were investigated.

A total of 73 patients underwent surgery via the transsphenoidal endoscopic approach. Cavernous sinus invasion was detected in 32 patients (43.8%); and macroadenoma, in 57 (78%). The pathology specimens of the 27 patients (36.9%) showed dual-staining adenomas with prolactin. A total of 51 patients (69.8%) attained biochemical remission 1 year after surgery. A second operation was performed in 10 patients (13.6%) with residual tumours without biochemical remission in the first year. Six (60%) of the patients attained remission at the last follow-up. Transient diabetes insipidus was observed in 18 patients (24.6%); and rhinorrhoea, which was resolved with conservative treatment, in 4 (5.4%). None of the patients developed panhypopituitarism. The presence of cavernous sinus invasion and preoperative IGF-1, immediate postoperative GH and third-month IGF-1 levels were predictive of remission.

Transsphenoidal endoscopic surgery is a safe and effective treatment for acromegaly. https://www.selleckchem.com/products/SB-203580.html Reoperation should be considered in patients with residual tumours without remission.
Transsphenoidal endoscopic surgery is a safe and effective treatment for acromegaly. Reoperation should be considered in patients with residual tumours without remission.The etiology of Crohn's disease (CD) is multifactorial. Bacterial and fungal microbiota are involved in the onset and/or progression of the disease. A bacterial dysbiosis in CD patients is accepted; however, less is known about the mycobiome and the relationships between the two communities. We investigated the interkingdom relationships, their metabolic consequences, and the changes in the fungal community during relapse and remission in CD.Two cohorts were evaluated a British cohort (n = 63) comprising CD and ulcerative colitis patients, and controls. The fungal and bacterial communities of biopsy and fecal samples were analyzed, with the fecal volatiles; datasets were also integrated; and a Dutch cohort (n = 41) comprising CD patients and healthy controls was analyzed for stability of the gut mycobiome.A dysbiosis of the bacterial community was observed in biopsies and stool. Results suggest Bacteroides is likely key in CD and may modulate Candida colonization. A dysbiosis of the fungal community was observed only in the Dutch cohort; Malassezia and Candida were increased in patients taking immunosuppressants. Longitudinal analysis showed an increase in Cyberlindnera in relapse. Saccharomyces was dominant in all fecal samples, but not in biopsies, some of which did not yield fungal reads; amino acid degradation was the main metabolic change associated with CD and both bacteria and fungi might be implicated.We have shown that Bacteroides and yeasts may play a role in CD; understanding their role and relationship in the disease would shed new light on the development and treatment of CD.
The hypoxic tumor microenvironment represents a persistent obstacle in the treatment of most solid tumors. In the past years, significant efforts have been made to improve the efficacy of anti-cancer drugs. Therefore, hypoxia-activated prodrugs (HAPs) of chemotherapeutic compounds have attracted widespread interest as a therapeutic means to treat hypoxic tumors.

This updated review paper covers key patents published between 2006 and 2021 on the developments of HAP derivatives of anti-cancer compounds.

Despite significant achievements in the development of HAP derivatives of anti-cancer compounds and although many clinical trials have been performed or are ongoing both as monotherapies and as part of combination therapies, there has currently no HAP anti-cancer agent been commercialized into the market. Unsuccessful clinical translation is partly due to the lack of patient stratification based on reliable biomarkers that are predictive of a positive response to hypoxia-targeted therapy.
Despite significant achievements in the development of HAP derivatives of anti-cancer compounds and although many clinical trials have been performed or are ongoing both as monotherapies and as part of combination therapies, there has currently no HAP anti-cancer agent been commercialized into the market. Unsuccessful clinical translation is partly due to the lack of patient stratification based on reliable biomarkers that are predictive of a positive response to hypoxia-targeted therapy.MicroRNAs (miRNAs) can serve as activation signals for membrane receptors, a recently discovered function that is independent of the miRNAs' conventional role in post-transcriptional gene regulation. Here, we introduce a machine learning approach, BrainDead, to identify oligonucleotides that act as ligands for single-stranded RNA-detecting Toll-like receptors (TLR)7/8, thereby triggering an immune response. link2 BrainDead was trained on activation data obtained from in vitro experiments on murine microglia, incorporating sequence and intra-molecular structure, as well as inter-molecular homo-dimerization potential of candidate RNAs. The method was applied to analyse all known human miRNAs regarding their potential to induce TLR7/8 signalling and microglia activation. We validated the predicted functional activity of subsets of high- and low-scoring miRNAs experimentally, of which a selection has been linked to Alzheimer's disease. High agreement between predictions and experiments confirms the robustness and power of BrainDead. The results provide new insight into the mechanisms of how miRNAs act as TLR ligands. Eventually, BrainDead implements a generic machine learning methodology for learning and predicting the functions of short RNAs in any context.Purpose This study investigated the efficacy of Treatment for Establishing Motor Program Organization (TEMPOSM) in childhood apraxia of speech (CAS).Method A mixed between- and within-participant design with multiple baselines across participants and behaviors was used to examine acquisition, generalization, and maintenance of skills. TEMPOSM was administered in four one-hour sessions a week over a four-week period for eleven participants (ages 5 to 8), allocated to either an immediate treatment group or a wait-list control group. Acoustic and perceptual variables were measured at baseline, immediate post-treatment, and one-month post-treatment.Results Children demonstrated significant improvements in specific acoustic measures of segmentation and lexical stress, as well as perceptual measures of fluency, lexical stress, and speech-sound accuracy. Treatment and generalization effects were maintained one-month post-treatment with generalization to untreated stimuli.Conclusion TEMPOSM was efficacious in improving segmental and suprasegmental impairments in the speech of children with CAS.The major problems with cancer therapy are drug-induced side effects. There is an urgent need for safe anti-tumor drugs. Artemisinin is a Chinese herbal remedy for malaria with efficacy and safety. However, several studies reported that artemisinin causes neurotoxicity and cardiotoxicity in animal models. Recently, nanostructured drug delivery systems have been designed to improve therapeutic efficacy and reduce toxicity. Artemisinin has been reported to show anticancer properties. link3 The anticancer effects of artemisinin appear to be mediated by inducing cell cycle arrest, promoting ferroptosis and autophagy, inhibiting cell metastasis. Therefore, the review is to concentrate on mechanisms and molecular targets of artemisinin as anti-tumor agents. We believe these will be important topics in realizing the potential of artemisinin and its derivatives as potent anticancer agents.Objective We evaluated the cost-effectiveness of olaparib and niraparib as maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer.Methods A decision analysis model compared the costs and effectiveness of olaparib and niraparib versus placebo for patients with or without germline BRCA mutations. Resource use and associated costs were estimated from the 2020 National Health Insurance Administration reimbursement price list. Clinical effectiveness was measured in progression-free survival per life-years (PFS-LY) based on the results of clinical trials SOLO2/ENHOT-Ov21 and ENGOT-OV16/NOVA. The incremental cost-effectiveness ratio (ICER) was estimated from a single-payer perspective.Results In the base case, olaparib was the more cost-effective treatment regimen. The ICERs for olaparib and niraparib compared to placebo were NT$1,804,785 and NT$2,340,265 per PFS-LY, respectively. Tornado analysis showed that PFS and the total resource use cost of niraparib regimen for patients without gBRCA were the most sensitive parameters impacting the ICER. The ICERs for both drugs in patients with a gBRCA mutation were lower than in patients without a gBRCA mutation. Probabilistic sensitivity analysis indicated that olaparib was more cost-effective than niraparib at the willingness-to-pay threshold of NT$2,602,404 per PFS life-year gained.Conclusion Olaparib was estimated to be less cost and more effective compared to niraparib as maintenance therapy for patients with recurrent platinum-sensitive ovarian cancer.New challenges and other topics in non-clinical safety testing of biotherapeutics were presented and discussed at the nineth European BioSafe Annual General Membership meeting in November 2019. The session topics were selected by European BioSafe organization committee members based on recent company achievements, agency interactions and new data obtained in the non-clinical safety testing of biotherapeutics, for which data sharing would be of interest and considered as valuable information. The presented session topics ranged from strategies of in vitro testing, immunogenicity prediction, bioimaging, and developmental and reproductive toxicology (DART) assessments to first-in-human (FIH) dose prediction and bioanalytical challenges, reflecting the entire space of different areas of expertise and different molecular modalities. During the 9th meeting of the European BioSafe members, the following topics were presented and discussed in 6 main sessions (with 3 or 4 presentations per session) and in three small group breakout sessions 1) DART assessment with biotherapeutics what did we learn and where to go?; 2) Non-animal testing strategies; 3) Seeing is believing new frontiers in imaging; 4) Predicting immunogenicity during early drug development hope or despair?; 5) Challenges in FIH dose projections; and 6) Non-canonical biologics formats challenges in bioanalytics, PKPD and biotransformation for complex biologics formats.

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