Variations in internal standard: an inspector's perspective by Vinter, Stephen

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Conduct of remote inspections: challenges and progress by Wakelin-Smith, Jason, Vinter, Stephen

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Crucial importance of evaluating internal standards (IS) response and troubleshooting in effective LCMS method development, validation and sample analysis by Cho, Seongeun Julia, Vinter, Stephen, Garofolo, Fabio

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Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK by Khin, Ni A., Grandinetti, Cheryl, Dixey, Hayley, Yu, Bei, Skeete, Rachel, Ayalew, Kassa, Budwal‐Jagait, Mandy, Cho, Seongeun‐Julia, Dasgupta, Arindam, Fisher, Andrew, Kleppinger, Cynthia, Kronstein, Phillip D., Martin, Jennifer, McGuinness, Michael, Mulinde, Jean, Vinter, Stephen, Wakelin‐Smith, Jason, Walker, Paula, Francis, Gail

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Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice W... by Khin, Ni A., Francis, Gail, Mulinde, Jean, Grandinetti, Cheryl, Skeete, Rachel, Yu, Bei, Ayalew, Kassa, Cho, Seongeun‐Julia, Fisher, Andrew, Kleppinger, Cynthia, Ayala, Ruben, Bonapace, Charles, Dasgupta, Arindam, Kronstein, Phillip D., Vinter, Stephen

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2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-... by Kaur, Surinder, Alley, Stephen C, Szapacs, Matt, Wilson, Amanda, Ciccimaro, Eugene, Su, Dian, Henderson, Neil, Chen, Linzhi, Garofolo, Fabio, Hengel, Shawna, Jian, Wenying, Kellie, John F, Lee, Anita, Mehl, John, Palandra, Joe, Qiu, Haibo, Savoie, Natasha, Shakleya, Diaa, Staelens, Ludovicus, Sugimoto, Hiroshi, Sumner, Giane, Welink, Jan, Wheller, Robert, Xue, Y J, Zeng, Jianing, Zhang, Jinhui, Zhou, Huiyu, Wang, Jian, Summerfield, Scott, Kavetska, Olga, Dillen, Lieve, Ramanathan, Ragu, Baratta, Mike, Dasgupta, Arindam, Edmison, Anna, Ferrari, Luca, Fischer, Sally, Fraier, Daniela, Haidar, Sam, Heermeier, Kathrin, James, Christopher, Ji, Allena, Luo, Lina, Lima Santos, Gustavo Mendes, Post, Noah, Rosenbaum, Anton I, Sporring, Sune, Surapaneni, Sekhar, Vinter, Stephen, Wan, Katty, Woolf, Eric, Cho, Seongeun (Julia), Kossary, Elham, Prior, Sandra, Abhari, Mohsen Rajabi, Soo, Catherine, Wang, Yow-Ming, Bandukwala, Abbas, Cherry, Elana, Cludts, Isabelle, Ghosh, Soma, Hopper, Shirley, Ishii-Watabe, Akiko, Kirshner, Susan, Maher, Kevin, Maxfield, Kimberly, Pedras-Vasconcelos, Joao, Saito, Yoshiro, Smith, Dean, Solstad, Therese, Verthelyi, Daniela, Wadhwa, Meenu, Wagner, Leslie, Waxenecker, Günter, Yan, Haoheng, Zhang, Lucia

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2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome by Neubert, Hendrik, Alley, Stephen C, Lee, Anita, Jian, Wenying, Buonarati, Michael, Edmison, Anna, Garofolo, Fabio, Gorovits, Boris, Haidar, Sam, Mylott, Bill, Nouri, Parya, Qian, Mark, Vinter, Stephen, Voelker, Troy, Welink, Jan, Wu, Jiang, Yang, Eric, Yu, Hongbin, Evans, Chris, Summerfield, Scott, Wang, Jian, Bateman, Kevin, Boer, Jason, Dean, Brian, Dillen, Lieve, Faustino, Patrick, Ferrari, Luca, Hughes, Nicola, Luo, Lina, Olah, Timothy, Post, Noah, Spellman, Daniel S., Sydor, Jens, Zhang, Hui, Zhang, Jenny, Zhang, Jinhui, Fandozzi, Christine, Wilson, Amanda, Fraier, Daniela, Beaver, Christopher J., Dandamudi, Suman, Dasgupta, Arindam, Elliott, Rebecca, Ji, Allena, Li, Wenkui, McGuinness, Michael, Lima Santos, Gustavo Mendes, Mirza, Tahseen, Savoie, Natasha, Shakleya, Diaa, Sporring, Sune, Stojdl, Susan, Sundman, Phillip, Tampal, Nilufer, Woolf, Eric

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2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs by Szapacs, Matt, Jian, Wenying, Spellman, Daniel, Cunliffe, Jennifer, Verburg, Elizabeth, Kaur, Surinder, Kellie, John, Li, Wenkui, Mehl, John, Qian, Mark, Qiu, Xiazi, Sirtori, Federico Riccardi, Rosenbaum, Anton I., Sikorski, Tim, Surapaneni, Sekhar, Wang, Jian, Wilson, Amanda, Zhang, Jinhui, Xue, Yongjun, Post, Noah, Huang, Yue, Goykhman, Dina, Yuan, Long, Fang, Kasie, Casavant, Ellen, Chen, Linzhi, Fu, Yunlin, Huang, Ming, Ji, Allena, Johnson, Jay, Lassman, Michael, Li, Jing, Saad, Ola, Sarvaiya, Hetal, Tao, Lin, Wang, Yuting, Zheng, Naiyu, Dasgupta, Arindam, Abhari, Mohsen Rajabi, Ishii-Watabe, Akiko, Saito, Yoshiro, Mendes Fernandes, Dulcyane Neiva, Bower, Joseph, Burns, Chris, Carleton, Kevin, Cho, Seongeun (Julia), Du, Xiulian, Fjording, Marianne, Garofolo, Fabio, Kar, Sumit, Kavetska, Olga, Kossary, Elham, Lu, Yang, Mayer, Andrew, Palackal, Nisha, Salha, Danielle, Thomas, Eric, Verhaeghe, Tom, Vinter, Stephen, Wan, Katty, Wang, Yow-Ming, Williams, Kathi, Woolf, Eric, Yang, Li, Yang, Eric, Bandukwala, Abbas, Hopper, Shirley, Maher, Kevin, Xu, Joshua, Brodsky, Eric, Cludts, Isabelle, Irwin, Chad, Joseph, Julie, Kirshner, Susan, Manangeeswaran, Mohanraj, Maxfield, Kimberly, Pedras-Vasconcelos, Joao, Solstad, Therese, Thacker, Seth, Tounekti, Omar, Verthelyi, Daniela, Wadhwa, Meenu, Wagner, Leslie, Yamamoto, Takenori, Zhang, Lucia, Zhou, Lin

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2017 White Paper on Recent Issues in Bioanalysis: Aren’t Bmv Guidance/Guidelines ‘ Scientific ’? (Part 1 – LCMS: Small Molecules, Peptides and Small Molecule Biomarkers) by Welink, Jan, Yang, Eric, Hughes, Nicola, Rago, Brian, Woolf, Eric, Sydor, Jens, Coppola, Laura, Ackermann, Brad, Li, Wenkui, Alley, Stephen C, Arnold, Mark, Berger, Isabella, Briscoe, Chad, Buonarati, Michael, Bustard, Mark, Cancilla, Mark, Cho, Seongeun (Julia), Duggan, Jeff, Fraier, Daniela, Garofolo, Fabio, Green, Rachel, Haidar, Sam, Hittle, Lucinda, Ishii-Watabe, Akiko, Islam, Rafiq, Jenkins, Rand, Jones, Barry, Kadavil, John, Kassim, Sean, Kavetska, Olga, Blaye, Olivier Le, Lee, Anita, Liu, Hanlan, Mehl, John, Lima Santos, Gustavo Mendes, Musuku, Adrien, Ramanathan, Ragu, Saito, Yoshiro, Savoie, Natasha, Summerfield, Scott, Surapaneni, Sekhar, Szapacs, Matthew, Tampal, Nilufer, Verhaeghe, Tom, Vinter, Stephen, Whale, Emma

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2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback by Spitz, Susan, Zhang, Yan, Fischer, Sally, McGuire, Kristina, Sommer, Ulrike, Amaravadi, Lakshmi, Bandukwala, Abbas, Eck, Steven, Garofolo, Fabio, Islam, Rafiqul, Jordan, Gregor, King, Lindsay, Saito, Yoshiro, Sumner, Giane, Terry, Linda, Vitaliti, Alessandra, Wang, Yow-Ming, Grimaldi, Christine, Joyce, Alison, Palmer, Rachel, Andisik, Matthew, Araya, Marcela, Azadeh, Mitra, Baltrukonis, Daniel, Elliott, Rebecca, Haidar, Sam, Kumar, Seema, Mayer, Andrew, Neff, Florian, Palackal, Nisha, Peng, Kun, Abhari, Mohsen Rajabi, Satterwhite, Christina, Savoie, Natasha, Soo, Catherine, Vinter, Stephen, Welink, Jan, Yan, Weili, Maher, Kevin, Lanham, David, Bertholet, Sylvie, Dakappagari, Naveen, Gonneau, Christèle, Green, Cherie, Junker, Fabian, Kar, Sumit, Patti-Diaz, Lisa, Sarikonda, Shyam, McCausland, Megan, Teixeira, Priscila Camillo, Decman, Vilma, Estevam, Jose, Hedrick, Michael, Robert, Alberto Hidalgo, Hopkins, Gregory, Nuti, Sandra, Tangri, Shabnam, Wnek, Richard, Dandamudi, Suman, Dasgupta, Arindam, Edmison, Anna, Faustino, Patrick, McGuinness, Michael, Lima Santos, Gustavo Mendes, Mirza, Tahseen, Shakleya, Diaa, Stojdl, Susan, Tampal, Nilufer, Zhang, Jinhui, Cherry, Elana, Cludts, Isabelle, Exley, Andrew, Ishii-Watabe, Akiko, Kirshner, Susan, Pedras-Vasconcelos, Joao, Shen, Meiyu, Siggers, Richard, Solstad, Therese, Verthelyi, Daniela, Yan, Haoheng, Zhang, Lucia

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2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regul... by Neubert, Hendrik, Olah, Timothy, Lee, Anita, Fraser, Stephanie, Dodge, Robert, Laterza, Omar, Szapacs, Matthew, Alley, Stephen C, Saad, Ola M, Amur, Shashi, Chen, Linzhi, Cherry, Elana, Cho, Seongeun (Julia), Cludts, Isabelle, Donato, Lorella Di, Edmison, Anna, Ferrari, Luca, Garofolo, Fabio, Haidar, Sam, Hopper, Shirley, Hottenstein, Scott, Ishii-Watabe, Akiko, Kassim, Sean, Kurki, Pekka, Lima Santos, Gustavo Mendes, Miscoria, Gilles, Palandra, Joe, Pedras-Vasconcelos, João, Piccoli, Steven, Rogstad, Sarah, Saito, Yoshiro, Savoie, Natasha, Sikorski, Timothy, Spitz, Susan, Staelens, Ludovicus, Verthelyi, Daniela, Vinter, Stephen, Wadhwa, Meenu, Wang, Yow-Ming, Welink, Jan, Weng, Naidong, Whale, Emma, Woolf, Eric, Wu, Jiang, Yan, Haoheng, Yu, Hongbin, Zhou, Shaolian

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2018 White Paper on Recent Issues in Bioanalysis: ‘A Global Bioanalytical Community Perspective on Last Decade of Incurred Samples Reanalysis (ISR)’ (Part 1 – Small Molecule Regula... by Welink, Jan, Xu, Yuanxin, Yang, Eric, Wilson, Amanda, Henderson, Neil, Luo, Lina, Fraser, Stephanie, Kavita, Uma, Musuku, Adrien, James, Christopher, Fraier, Daniela, Zhang, Yan, Goykhman, Dina, Summerfield, Scott, Woolf, Eric, Verhaeghe, Tom, Hughes, Nicola, Behling, Alexander, Brown, Kirk, Bulychev, Alex, Buonarati, Michael, Cherry, Elana, Cho, Seongeun (Julia), Cludts, Isabelle, Dillen, Lieve, Dodge, Robert, Edmison, Anna, Garofolo, Fabio, Green, Rachel, Haidar, Sam, Hottenstein, Charles, Ishii-Watabe, Akiko, Jang, Hyun Gyung, Ji, Allena, Jones, Barry, Kassim, Sean, Ma, Mark, Meena, Lima Santos, Gustavo Mendes, Norris, Daniel A, Owen, Tate, Piccoli, Steven, Ramanathan, Ragu, Röhl, Ingo, Rosenbaum, Anton I, Saito, Yoshiro, Sangster, Timothy, Savoie, Natasha, Stebbins, Christopher, Sydor, Jens, de Merbel, Nico van, Verthelyi, Daniela, Vinter, Stephen, Whale, Emma

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2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs by Booth, Brian, Stevenson, Lauren, Pillutla, Renuka, Buonarati, Michael, Beaver, Chris, Fraier, Daniela, Garofolo, Fabio, Haidar, Sam, Islam, Rafiq, James, Christopher, Kadavil, John, Kavetska, Olga, Li, Fumin, Satterwhite, Christina, Savoie, Natasha, Subramaniam, Sriram, Tampal, Nilufer, Thway, Theingi, Woolf, Eric, Blaye, Olivier Le, Andisik, Matthew, Briscoe, Chad, Cape, Stephanie, Dasgupta, Arindam, Fischer, Sally, Hayes, Roger, Kamerud, John, Lima Santos, Gustavo Mendes, Nehls, Corey, Soo, Catherine, Vinter, Stephen, Whale, Emma, Xu, Keyang, Cho, Seongeun (Julia), Edmison, Anna, Kassim, Sean, Rocha, Thais Correa, Welink, Jan, Amur, Shashi, Bandukwala, Abbas, Cherry, Elana, Hopper, Shirley, Ishii-Watabe, Akiko, Kirshner, Susan, Maher, Kevin, Pedras-Vasconcelos, Joao, Saito, Yoshiro, Saunders, Therese Solstad, Skibeli, Venke, Verthelyi, Daniela, Wang, Yow-Ming, Yan, Haoheng

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2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 2 – Hybrid LBA/LCMS and Input from Regulatory Agencies) by Ackermann, Brad, Neubert, Hendrik, Hughes, Nicola, Garofolo, Fabio, Abberley, Lee, Alley, Stephen C, Brown-Augsburger, Patricia, Bustard, Mark, Chen, Lin-zhi, Heinrich, Julia, Katori, Noriko, Kaur, Surinder, Kirkovsky, Leo, Laterza, Omar F, Le Blaye, Olivier, Lévesque, Ann, Santos, Gustavo Mendes Lima, Olah, Timothy, Savoie, Natasha, Skelly, Michael, Spitz, Susan, Szapacs, Matthew, Tampal, Nilufer, Wang, Jian, Welink, Jan, Wieling, Jaap, Haidar, Sam, Vinter, Stephen, Whale, Emma, Witte, Bärbel

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2017 White Paper on Recent Issues in Bioanalysis: Rise of Hybrid LBA/LCMS Immunogenicity Assays (Part 2: Hybrid LBA/LCMS Biotherapeutics, Biomarkers & Immunogenicity Assays and Reg... by Neubert, Hendrik, Song, An, Lee, Anita, Wei, Cong, Duggan, Jeff, Xu, Keyang, Woolf, Eric, Evans, Chris, Palandra, Joe, Laterza, Omar, Amur, Shashi, Berger, Isabella, Bustard, Mark, Cancilla, Mark, Chen, Shang-Chiung, Cho, Seongeun (Julia), Ciccimaro, Eugene, Cludts, Isabelle, Cocea, Laurent, D’Arienzo, Celia, Danan-Leon, Lieza, Donato, Lorella Di, Garofolo, Fabio, Haidar, Sam, Ishii-Watabe, Akiko, Jiang, Hao, Kadavil, John, Kassim, Sean, Kurki, Pekka, Blaye, Olivier Le, Liu, Kai, Mathews, Rod, Lima Santos, Gustavo Mendes, Niwa, Makoto, Pedras-Vasconcelos, João, Qian, Mark, Rago, Brian, Saad, Ola, Saito, Yoshiro, Savoie, Natasha, Su, Dian, Szapacs, Matthew, Tampal, Nilufer, Vinter, Stephen, Wang, Jian, Welink, Jan, Whale, Emma, Wilson, Amanda, Xue, Y-J

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2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies) by Song, An, Lee, Anita, Garofolo, Fabio, Kaur, Surinder, Duggan, Jeff, Evans, Christopher, Palandra, Joe, Donato, Lorella Di, Xu, Keyang, Bauer, Ronald, Bustard, Mark, Chen, Linzhi, Cocea, Laurent, Croft, Stephanie, Galliccia, Fabrizio, Haidar, Sam, Hughes, Nicola, Ishii-Watabe, Akiko, Islam, Rafiqul, Jones, Barry, Kadavil, John, Krantz, Carsten, Lima Santos, Gustavo Mendes, Olah, Timothy, Pedras-Vasconcelos, João, Staelens, Ludovicus, Saito, Yoshiro, Savoie, Natasha, Scheibner, Kara, Spitz, Susan, Tampal, Nilufer, Thomas, Eric, Vinter, Stephen, Wakelin-Smith, Jason, Welink, Jan, Zeng, Jianing, Zhou, Shaolian

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2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs) by Neubert, Hendrik, Song, An, Lee, Anita, Wei, Cong, Duggan, Jeff, Xu, Keyang, Woolf, Eric, Evans, Chris, Palandra, Joe, Laterza, Omar, Amur, Shashi, Berger, Isabella, Bustard, Mark, Cancilla, Mark, Chen, Shang-Chiung, Cho, Seongeun (Julia), Ciccimaro, Eugene, Cludts, Isabelle, Cocea, Laurent, D'Arienzo, Celia, Danan-Leon, Lieza, Donato, Lorella Di, Garofolo, Fabio, Haidar, Sam, Ishii-Watabe, Akiko, Jiang, Hao, Kadavil, John, Kassim, Sean, Kurki, Pekka, Blaye, Olivier Le, Liu, Kai, Mathews, Rod, Lima Santos, Gustavo Mendes, Niwa, Makoto, Pedras-Vasconcelos, João, Qian, Mark, Rago, Brian, Saad, Ola, Saito, Yoshiro, Savoie, Natasha, Su, Dian, Szapacs, Matthew, Tampal, Nilufer, Vinter, Stephen, Wang, Jian, Welink, Jan, Whale, Emma, Wilson, Amanda, Xue, Y-J

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2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 1 – Small Molecules by LCMS) by Welink, Jan, Fluhler, Eric, Hughes, Nicola, Arnold, Mark, Garofolo, Fabio, Bustard, Mark, Coppola, Laura, Dhodda, Raj, Evans, Christopher, Gleason, Carol, Haidar, Sam, Hayes, Roger, Heinig, Katja, Katori, Noriko, Blaye, Olivier Le, Li, Wenkui, Liu, Guowen, Lima Santos, Gustavo Mendes, Meng, Min, Nicholson, Bob, Savoie, Natasha, Skelly, Michael, Sojo, Luis, Tampal, Nilufer, de Merbel, Nico van, Verhaeghe, Tom, Vinter, Stephen, Wickremsinhe, Enaksha, Whale, Emma, Wilson, Amanda, Witte, Bärbel, Woolf, Eric

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2018 White Paper on Recent Issues in Bioanalysis by Welink, Jan, Xu, Yuanxin, Yang, Eric, Wilson, Amanda, Henderson, Neil, Luo, Lina, Fraser, Stephanie, Kavita, Uma, Musuku, Adrien, James, Christopher, Fraier, Daniela, Zhang, Yan, Goykhman, Dina, Summerfield, Scott, Woolf, Eric, Verhaeghe, Tom, Hughes, Nicola, Behling, Alexander, Brown, Kirk, Bulychev, Alex, Buonarati, Michael, Cherry, Elana, Cho, Seongeun (Julia), Cludts, Isabelle, Dillen, Lieve, Dodge, Robert, Edmison, Anna, Garofolo, Fabio, Green, Rachel, Haidar, Sam, Hottenstein, Charles, Ishii-Watabe, Akiko, Jang, Hyun Gyung, Ji, Allena, Jones, Barry, Kassim, Sean, Ma, Mark, Lima Santos, Gustavo Mendes, Norris, Daniel A, Owen, Tate, Piccoli, Steven, Ramanathan, Ragu, Röhl, Ingo, Rosenbaum, Anton I, Saito, Yoshiro, Sangster, Timothy, Savoie, Natasha, Stebbins, Christopher, Sydor, Jens, de Merbel, Nico van, Verthelyi, Daniela, Vinter, Stephen, Whale, Emma

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2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines ' by Welink, Jan, Yang, Eric, Hughes, Nicola, Rago, Brian, Woolf, Eric, Sydor, Jens, Coppola, Laura, Ackermann, Brad, Li, Wenkui, Alley, Stephen C, Arnold, Mark, Berger, Isabella, Briscoe, Chad, Buonarati, Michael, Bustard, Mark, Cancilla, Mark, Cho, Seongeun (Julia), Duggan, Jeff, Fraier, Daniela, Garofolo, Fabio, Green, Rachel, Haidar, Sam, Hittle, Lucinda, Ishii-Watabe, Akiko, Islam, Rafiq, Jenkins, Rand, Jones, Barry, Kadavil, John, Kassim, Sean, Kavetska, Olga, Blaye, Olivier Le, Lee, Anita, Liu, Hanlan, Mehl, John, Lima Santos, Gustavo Mendes, Musuku, Adrien, Ramanathan, Ragu, Saito, Yoshiro, Savoie, Natasha, Summerfield, Scott, Surapaneni, Sekhar, Szapacs, Matthew, Tampal, Nilufer, Verhaeghe, Tom, Vinter, Stephen, Whale, Emma

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