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1. PANEL DISCUSSION

Author

Moss, Arthur J., primary, Assali, Nicholas S., additional, Braunwald, Eugene, additional, Downing, S. Evans, additional, Gessner, Ira H., additional, and Rudolph, Abraham M., additional

Published
2023
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3. Analysis of rare disruptive germline mutations in 2135 enriched BRCA-negative breast cancers excludes additional high-impact susceptibility genes

Author

Loveday, C., primary, Garrett, A., additional, Law, P., additional, Hanks, S., additional, Poyastro-Pearson, E., additional, Adlard, J.W., additional, Barwell, J., additional, Berg, J., additional, Brady, A.F., additional, Brewer, C., additional, Chapman, C., additional, Cook, J., additional, Davidson, R., additional, Donaldson, A., additional, Douglas, F., additional, Greenhalgh, L., additional, Henderson, A., additional, Izatt, L., additional, Kumar, A., additional, Lalloo, F., additional, Miedzybrodzka, Z., additional, Morrison, P.J., additional, Paterson, J., additional, Porteous, M., additional, Rogers, M.T., additional, Walker, L., additional, Eccles, D., additional, Evans, D.G., additional, Snape, K., additional, Hanson, H., additional, Houlston, R.S., additional, Turnbull, C., additional, Ardern-Jones, A., additional, Adlard, J., additional, Ahmed, M., additional, Attard, G., additional, Bailey, K., additional, Bancroft, E., additional, Bardsley, C., additional, Barton, D., additional, Bartlett, M., additional, Baxter, L., additional, Belk, R., additional, Bernhard, B., additional, Bishop, T., additional, Boyes, L., additional, Bradshaw, N., additional, Brant, S., additional, Brice, G., additional, Bromilow, G., additional, Brooks, C., additional, Bruce, A., additional, Bulman, B., additional, Burgess, L., additional, Campbell, J., additional, Canham, N., additional, Castle, B., additional, Cetnarskyj, R., additional, Claber, O., additional, Coates, N., additional, Cole, T., additional, Collins, A., additional, Coulson, S., additional, Crawford, G., additional, Cruger, D., additional, Cummings, C., additional, D’Mello, L., additional, Day, L., additional, Dell, B., additional, Dolling, C., additional, Dorkins, H., additional, Downing, S., additional, Drummond, S., additional, Dubras, C., additional, Dunlop, J., additional, Durrell, S., additional, Eddy, C., additional, Edwards, M., additional, Edwards, E., additional, Edwardson, J., additional, Eeles, R., additional, Ellis, I., additional, Elmslie, F., additional, Evans, G., additional, Gibbons, B., additional, Gardiner, C., additional, Ghali, N., additional, Giblin, C., additional, Gibson, S., additional, Goff, S., additional, Goodman, S., additional, Goudie, D., additional, Grier, J., additional, Gregory, H., additional, Halliday, S., additional, Hardy, R., additional, Hartigan, C., additional, Heaton, T., additional, Higgins, C., additional, Hodgson, S., additional, Homfray, T., additional, Horrigan, D., additional, Houghton, C., additional, Hughes, L., additional, Hunt, V., additional, Irvine, L., additional, Jacobs, C., additional, James, S., additional, James, M., additional, Jeffers, L., additional, Jobson, I., additional, Jones, W., additional, Kennedy, M.J., additional, Kenwrick, S., additional, Kightley, C., additional, Kirk, C., additional, Kirk, E., additional, Kivuva, E., additional, Kohut, K., additional, Kosicka-Slawinska, M., additional, Kulkarni, A., additional, Lambord, N., additional, Langman, C., additional, Leonard, P., additional, Levene, S., additional, Locker, S., additional, Logan, P., additional, Longmuir, M., additional, Lucassen, A., additional, Lyus, V., additional, Magee, A., additional, Male, A., additional, Mansour, S., additional, McBride, D., additional, McCann, E., additional, McConnell, V., additional, McEntagart, M., additional, McKeown, C., additional, McLeish, L., additional, McLeod, D., additional, Melville, A., additional, Mercer, L., additional, Mercer, C., additional, Mitra, A., additional, Murday, V., additional, Murray, A., additional, Myhill, K., additional, Myring, J., additional, O'Hara, E., additional, Pearson, P., additional, Pichert, G., additional, Platt, K., additional, Pottinger, C., additional, Price, S., additional, Protheroe, L., additional, Pugh, S., additional, Quarrell, O., additional, Randhawa, K., additional, Riddick, C., additional, Robertson, L., additional, Robinson, A., additional, Roffey-Johnson, V., additional, Rogers, M., additional, Rose, S., additional, Rowe, S., additional, Schofield, A., additional, Rahman, N., additional, Saya, S., additional, Scott, G., additional, Scott, J., additional, Searle, A., additional, Shanley, S., additional, Sharif, S., additional, Shaw, A., additional, Shaw, J., additional, Shea-Simonds, J., additional, Side, L., additional, Sillibourne, J., additional, Simon, K., additional, Simpson, S., additional, Slater, S., additional, Smalley, S., additional, Smith, K., additional, Snadden, L., additional, Soloway, J., additional, Stait, Y., additional, Stayner, B., additional, Steel, M., additional, Steel, C., additional, Stewart, H., additional, Stirling, D., additional, Thomas, M., additional, Thomas, S., additional, Tomkins, S., additional, Turner, H., additional, Vandersteen, A., additional, Wakeling, E., additional, Waldrup, F., additional, Watt, C., additional, Watts, S., additional, Webber, A., additional, Whyte, C., additional, Wiggins, J., additional, Williams, E., additional, and Winchester, L., additional

Published
2022
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4. Combining sterile insect releases with refuge areas to delay the evolution of resistance to Bt sugarcane: an agent-based modeling approach.

Author

Potgieter L, Human DJ, and Downing S

Abstract

The strategic use of refuge areas is a well-known method for delaying the development of pest resistance to Bacillus thuringiensis (Bt) crop. A lesser-known method to control against resistance development is sterile insect releases. In this article, an agent-based simulation model is used to test the effectiveness of combining the use of Bt sugarcane, refuge areas, and sterile insect releases as an integrated strategy against Eldana saccharina Walker (Lepidoptera: Pyralidae) infestation and resistance development. Individual insects are modeled with their own genetic traits on a simulated sugarcane field that represents either Bt or refuge area. The model is applied to 2 hypothetical case studies. In the first experiment, resistance development and infestation dynamics in Bt sugarcane without refuge areas are considered using various sterile:wild sterile release ratios, and different release distributions. In the second experiment, the inclusion of a refuge area in Bt sugarcane is considered, using various sterile:wild releases ratios and different release distributions. A trade-off between sterile insect releases and the use of the refuge area was observed, and could, in some cases, work against each other., (© The Author(s) 2024. Published by Oxford University Press on behalf of Entomological Society of America.)

Published
2024
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5. Animal-assisted interventions in adult hospital rehabilitation settings: A scoping review.

Author

O'Louglin M, Edwards R, Bould E, Devine S, and Downing S

Subjects
Humans, Animals, Dogs, Adult, Animal Assisted Therapy methods, Animal Assisted Therapy standards, Animal Assisted Therapy trends
Abstract

Animal-assisted interventions (AAIs) have the potential to enhance people's well-being and function and are increasingly being implemented across a range of settings. This scoping review explored how AAIs have been used in adult hospital rehabilitative care. Using JBI and PRISMA-ScR guidelines, a systematic search of four databases was undertaken. Inclusion criteria involved adults, aged >18 years, who had received AAIs in the hospital rehabilitation setting. Twenty-two articles met the inclusion criteria. Results identified two intervention types: visitation activities (n = 8 studies) and structured therapeutic interventions (n = 14 studies). Dogs were the most common animal species. Improvements in social and emotional well-being were reported across both types of interventions, with improvements in ambulation, motor skills, and verbal communication reported by those engaged in structured therapeutic interventions. Implementation challenges included a dependency on volunteer dog-handlers; the need for better recording of interventions in medical records to enable evaluation; and cost, safety, infection control, and animal welfare considerations. Strengthening the planning of AAIs is fundamental for the realization of potential outcomes from human-animal interactions in hospital rehabilitative care., (© 2024 The Author(s). Nursing & Health Sciences published by John Wiley & Sons Australia, Ltd.)

Published
2024
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7. 2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( PART 2 - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).

Author

Kholmanskikh O, Wang YM, Hersey S, Wadhwa M, Block K, Bandukwala A, Szapacs M, Weiner R, Awwad K, Dessy F, Downing S, Du X, Garofolo F, Harris S, Hou V, Jones J, Kar S, Kinhikar A, Li M, Mathews J, Meissen J, Sumner GO, Pan L, Sanderink G, Scully I, Stanta J, Tanaka Y, Vauleon S, Wagner L, Wang K, Zhu L, Eck S, Lin YD, Azadeh M, Decman V, Diebold S, Du X, Goihberg P, Alcaide EG, Gonneau C, Hedrick MN, Hopkins G, Kar S, Loschko J, McCausland M, Mendez L, Sehra S, Stevens E, Sun YS, Tangri S, Trampont PC, Cludts I, Dysinger M, Kavita U, Sugimoto H, Chilewski S, Grimaldi C, Jiang Y, Kamerud J, Liu S, Owen C, Palackal N, Petit-Frere C, Pine S, Abhari MR, Scheibner K, Williams L, Xu T, and Zhang G

Subjects
Humans, Biological Assay methods, European Union, Flow Cytometry, Biomarkers analysis, Cell- and Tissue-Based Therapy, Vaccines immunology
Abstract

The 17 th Workshop on Recent Issues in Bioanalysis (17 th WRIB) took place in Orlando, FL, USA on 19-23 June 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17 th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.Moreover, in-depth workshops on "EU IVDR 2017/746 Implementation and impact for the Global Biomarker Community: How to Comply with these NEW Regulations" and on "US FDA/OSIS Remote Regulatory Assessments (RRAs)" were the special features of the 17 th edition.As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues.This 2023 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 2023 edition of this comprehensive White Paper has been divided into three parts for editorial reasons.This publication (Part 2) covers the recommendations on Biomarkers, IVD/CDx, LBA and Cell-Based Assays. Part 1A (Mass Spectrometry Assays and Regulated Bioanalysis/BMV), P1B (Regulatory Inputs) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 16 of Bioanalysis, issues 9 and 7 (2024), respectively.

Published
2024
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8. 2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays ( Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).

Author

Pan L, Mora J, Walravens K, Wagner L, Hopper S, Loo L, Bettoun D, Bond S, Dessy F, Downing S, Garofolo F, Gupta S, Henderson N, Irwin C, Ishii-Watabe A, Kar S, Jawa V, Joseph J, Malvaux L, Marshall JC, McDevitt J, Mohapatra S, Seitzer J, Smith J, Solstad T, Sugimoto H, Tounekti O, Wu B, Wu Y, Xu Y, Xu J, Yamamoto T, Yang L, Torri A, Kirshner S, Maxfield K, Vasconcelos JP, Abhari MR, Verthelyi D, Brodsky E, Carrasco-Triguero M, Kamerud J, Andisik M, Baltrukonis D, Bivi N, Cludts I, Coble K, Gorovits B, Gunn GR, Gupta S, Millner AH, Joyce A, Kubiak RJ, Kumar S, Liao K, Manangeeswaran M, Partridge M, Pine S, Poetzl J, Rajadhyaksha M, Rasamoelisolo M, Richards S, Song Y, Swanson S, Thacker S, Wadhwa M, Wolf A, Zhang L, and Zhou L

Subjects
Technology, Biological Assay methods, Biomarkers analysis, Cell- and Tissue-Based Therapy, Prescription Drugs
Abstract

The 2022 16th Workshop on Recent Issues in Bioanalysis (WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on ICH M10 BMV final guideline (focused on this guideline training, interpretation, adoption and transition); mass spectrometry innovation (focused on novel technologies, novel modalities, and novel challenges); and flow cytometry bioanalysis (rising of the 3rd most common/important technology in bioanalytical labs) were the special features of the 16th edition. As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2022 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 2022 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations on Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity. Part 1 (Mass Spectrometry and ICH M10) and Part 2 (LBA, Biomarkers/CDx and Cytometry) are published in volume 15 of Bioanalysis, issues 16 and 15 (2023), respectively.

Published
2023
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