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2. Observation of Gravitational Waves from the Coalescence of a $2.5\text{-}4.5~M_\odot$ Compact Object and a Neutron Star

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The LIGO Scientific Collaboration, the Virgo Collaboration, the KAGRA Collaboration, Abac, A. G., Abbott, R., Abouelfettouh, I., Acernese, F., Ackley, K., Adhicary, S., Adhikari, N., Adhikari, R. X., Adkins, V. K., Agarwal, D., Agathos, M., Abchouyeh, M. Aghaei, Aguiar, O. D., Aguilar, I., Aiello, L., Ain, A., Ajith, P., Akçay, S., Akutsu, T., Albanesi, S., Alfaidi, R. A., Al-Jodah, A., Alléné, C., Allocca, A., Al-Shammari, S., Altin, P. A., Alvarez-Lopez, S., Amato, A., Amez-Droz, L., Amorosi, A., Amra, C., Ananyeva, A., Anderson, S. B., Anderson, W. G., Andia, M., Ando, M., Andrade, T., Andres, N., Andrés-Carcasona, M., Andrić, T., Anglin, J., Ansoldi, S., Antelis, J. M., Antier, S., Aoumi, M., Appavuravther, E. Z., Appert, S., Apple, S. K., Arai, K., Araya, A., Araya, M. C., Areeda, J. S., Argianas, L., Aritomi, N., Armato, F., Arnaud, N., Arogeti, M., Aronson, S. M., Arun, K. G., Ashton, G., Aso, Y., Assiduo, M., Melo, S. Assis de Souza, Aston, S. M., Astone, P., Attadio, F., Aubin, F., AultONeal, K., Avallone, G., Azrad, D., Babak, S., Badaracco, F., Badger, C., Bae, S., Bagnasco, S., Bagui, E., Baier, J. G., Baiotti, L., Bajpai, R., Baka, T., Ball, M., Ballardin, G., Ballmer, S. W., Banagiri, S., Banerjee, B., Bankar, D., Baral, P., Barayoga, J. C., Barish, B. C., Barker, D., Barneo, P., Barone, F., Barr, B., Barsotti, L., Barsuglia, M., Barta, D., Bartoletti, A. M., Barton, M. A., Bartos, I., Basak, S., Basalaev, A., Bassiri, R., Basti, A., Bates, D. E., Bawaj, M., Baxi, P., Bayley, J. C., Baylor, A. C., Baynard II, P. A., Bazzan, M., Bedakihale, V. M., Beirnaert, F., Bejger, M., Belardinelli, D., Bell, A. S., Benedetto, V., Benoit, W., Bentara, I., Bentley, J. D., Yaala, M. Ben, Bera, S., Berbel, M., Bergamin, F., Berger, B. K., Bernuzzi, S., Beroiz, M., Berry, C. P. L., Bersanetti, D., Bertolini, A., Betzwieser, J., Beveridge, D., Bevins, N., Bhandare, R., Bhardwaj, U., Bhatt, R., Bhattacharjee, D., Bhaumik, S., Bhowmick, S., Bianchi, A., Bilenko, I. A., Billingsley, G., Binetti, A., Bini, S., Birnholtz, O., Biscoveanu, S., Bisht, A., Bitossi, M., Bizouard, M. -A., Blackburn, J. K., Blagg, L. A., Blair, C. D., Blair, D. G., Bobba, F., Bode, N., Boileau, G., Boldrini, M., Bolingbroke, G. N., Bolliand, A., Bonavena, L. D., Bondarescu, R., Bondu, F., Bonilla, E., Bonilla, M. S., Bonino, A., Bonnand, R., Booker, P., Borchers, A., Boschi, V., Bose, S., Bossilkov, V., Boudart, V., Boudon, A., Bozzi, A., Bradaschia, C., Brady, P. R., Braglia, M., Branch, A., Branchesi, M., Brandt, J., Braun, I., Breschi, M., Briant, T., Brillet, A., Brinkmann, M., Brockill, P., Brockmueller, E., Brooks, A. F., Brown, B. C., Brown, D. D., Brozzetti, M. L., Brunett, S., Bruno, G., Bruntz, R., Bryant, J., Bucci, F., Buchanan, J., Bulashenko, O., Bulik, T., Bulten, H. J., Buonanno, A., Burtnyk, K., Buscicchio, R., Buskulic, D., Buy, C., Byer, R. L., Davies, G. S. Cabourn, Cabras, G., Cabrita, R., Cáceres-Barbosa, V., Cadonati, L., Cagnoli, G., Cahillane, C., Bustillo, J. Calderón, Callister, T. A., Calloni, E., Camp, J. B., Canepa, M., Santoro, G. Caneva, Cannon, K. C., Cao, H., Capistran, L. A., Capocasa, E., Capote, E., Carapella, G., Carbognani, F., Carlassara, M., Carlin, J. B., Carpinelli, M., Carrillo, G., Carter, J. J., Carullo, G., Diaz, J. Casanueva, Casentini, C., Castro-Lucas, S. Y., Caudill, S., Cavaglià, M., Cavalieri, R., Cella, G., Cerdá-Durán, P., Cesarini, E., Chaibi, W., Chakraborty, P., Subrahmanya, S. Chalathadka, Chan, J. C. L., Chan, M., Chandra, K., Chang, R. -J., Chao, S., Char, P., Charlton, E. L., Charlton, P., Chassande-Mottin, E., Chatterjee, C., Chatterjee, Debarati, Chatterjee, Deep, Chattopadhyay, D., Chaturvedi, M., Chaty, S., Chatziioannou, K., Chen, A., Chen, A. H. -Y., Chen, D., Chen, H., Chen, H. Y., Chen, J., Chen, K. H., Chen, Y., Chen, Yanbei, Chen, Yitian, Cheng, H. P., Chessa, P., Cheung, H. T., Cheung, S. Y., Chiadini, F., Chiarini, G., Chierici, R., Chincarini, A., Chiofalo, M. L., Chiummo, A., Chou, C., Choudhary, S., Christensen, N., Chua, S. S. Y., Chugh, P., Ciani, G., Ciecielag, P., Cieślar, M., Cifaldi, M., Ciolfi, R., Clara, F., Clark, J. A., Clarke, J., Clarke, T. A., Clearwater, P., Clesse, S., Coccia, E., Codazzo, E., Cohadon, P. -F., Colace, S., Colleoni, M., Collette, C. G., Collins, J., Colloms, S., Colombo, A., Colpi, M., Compton, C. M., Connolly, G., Conti, L., Corbitt, T. R., Cordero-Carrión, I., Corezzi, S., Cornish, N. J., Corsi, A., Cortese, S., Costa, C. A., Cottingham, R., Coughlin, M. W., Couineaux, A., Coulon, J. -P., Countryman, S. T., Coupechoux, J. -F., Couvares, P., Coward, D. M., Cowart, M. J., Coyne, R., Craig, K., Creed, R., Creighton, J. D. E., Creighton, T. D., Cremonese, P., Criswell, A. W., Crockett-Gray, J. C. G., Crook, S., Crouch, R., Csizmazia, J., Cudell, J. R., Cullen, T. J., Cumming, A., Cuoco, E., Cusinato, M., Dabadie, P., Canton, T. Dal, Dall'Osso, S., Pra, S. Dal, Dálya, G., D'Angelo, B., Danilishin, S., D'Antonio, S., Danzmann, K., Darroch, K. E., Dartez, L. P., Dasgupta, A., Datta, S., Dattilo, V., Daumas, A., Davari, N., Dave, I., Davenport, A., Davier, M., Davies, T. F., Davis, D., Davis, L., Davis, M. C., Davis, P. J., Dax, M., De Bolle, J., Deenadayalan, M., Degallaix, J., De Laurentis, M., Deléglise, S., De Lillo, F., Dell'Aquila, D., Del Pozzo, W., De Marco, F., De Matteis, F., D'Emilio, V., Demos, N., Dent, T., Depasse, A., DePergola, N., De Pietri, R., De Rosa, R., De Rossi, C., DeSalvo, R., De Simone, R., Dhani, A., Diab, R., Díaz, M. C., Di Cesare, M., Dideron, G., Didio, N. A., Dietrich, T., Di Fiore, L., Di Fronzo, C., Di Giovanni, M., Di Girolamo, T., Diksha, D., Di Michele, A., Ding, J., Di Pace, S., Di Palma, I., Di Renzo, F., Divyajyoti, Dmitriev, A., Doctor, Z., Dohmen, E., Doleva, P. P., Dominguez, D., D'Onofrio, L., Donovan, F., Dooley, K. L., Dooney, T., Doravari, S., Dorosh, O., Drago, M., Driggers, J. C., Ducoin, J. -G., Dunn, L., Dupletsa, U., D'Urso, D., Duval, H., Duverne, P. -A., Dwyer, S. E., Eassa, C., Ebersold, M., Eckhardt, T., Eddolls, G., Edelman, B., Edo, T. B., Edy, O., Effler, A., Eichholz, J., Einsle, H., Eisenmann, M., Eisenstein, R. A., Ejlli, A., Eleveld, R. M., Emma, M., Endo, K., Engl, A. J., Enloe, E., Errico, L., Essick, R. C., Estellés, H., Estevez, D., Etzel, T., Evans, M., Evstafyeva, T., Ewing, B. E., Ezquiaga, J. M., Fabrizi, F., Faedi, F., Fafone, V., Fairhurst, S., Farah, A. M., Farr, B., Farr, W. M., Favaro, G., Favata, M., Fays, M., Fazio, M., Feicht, J., Fejer, M. M., Felicetti, R., Fenyvesi, E., Ferguson, D. L., Ferraiuolo, S., Ferrante, I., Ferreira, T. A., Fidecaro, F., Figura, P., Fiori, A., Fiori, I., Fishbach, M., Fisher, R. P., Fittipaldi, R., Fiumara, V., Flaminio, R., Fleischer, S. M., Fleming, L. S., Floden, E., Foley, E. M., Fong, H., Font, J. A., Fornal, B., Forsyth, P. W. F., Franceschetti, K., Franchini, N., Frasca, S., Frasconi, F., Mascioli, A. Frattale, Frei, Z., Freise, A., Freitas, O., Frey, R., Frischhertz, W., Fritschel, P., Frolov, V. V., Fronzé, G. G., Fuentes-Garcia, M., Fujii, S., Fujimori, T., Fulda, P., Fyffe, M., Gadre, B., Gair, J. R., Galaudage, S., Galdi, V., Gallagher, H., Gallardo, S., Gallego, B., Gamba, R., Gamboa, A., Ganapathy, D., Ganguly, A., Garaventa, B., García-Bellido, J., Núñez, C. García, García-Quirós, C., Gardner, J. W., Gardner, K. A., Gargiulo, J., Garron, A., Garufi, F., Gasbarra, C., Gateley, B., Gayathri, V., Gemme, G., Gennai, A., Gennari, V., George, J., George, R., Gerberding, O., Gergely, L., Ghonge, S., Ghosh, Archisman, Ghosh, Sayantan, Ghosh, Shaon, Ghosh, Shrobana, Ghosh, Suprovo, Ghosh, Tathagata, Giacoppo, L., Giaime, J. A., Giardina, K. D., Gibson, D. R., Gibson, D. T., Gier, C., Giri, P., Gissi, F., Gkaitatzis, S., Glanzer, J., Glotin, F., Godfrey, J., Godwin, P., Goebbels, N. L., Goetz, E., Golomb, J., Lopez, S. Gomez, Goncharov, B., Gong, Y., González, G., Goodarzi, P., Goode, S., Goodwin-Jones, A. W., Gosselin, M., Göttel, A. S., Gouaty, R., Gould, D. W., Govorkova, K., Goyal, S., Grace, B., Grado, A., Graham, V., Granados, A. E., Granata, M., Granata, V., Gras, S., Grassia, P., Gray, A., Gray, C., Gray, R., Greco, G., Green, A. C., Green, S. M., Green, S. R., Gretarsson, A. M., Gretarsson, E. M., Griffith, D., Griffiths, W. L., Griggs, H. L., Grignani, G., Grimaldi, A., Grimaud, C., Grote, H., Guerra, D., Guetta, D., Guidi, G. M., Guimaraes, A. R., Gulati, H. K., Gulminelli, F., Gunny, A. M., Guo, H., Guo, W., Guo, Y., Gupta, Anchal, Gupta, Anuradha, Gupta, Ish, Gupta, N. C., Gupta, P., Gupta, S. K., Gupta, T., Gupte, N., Gurs, J., Gutierrez, N., Guzman, F., H, H. -Y., Haba, D., Haberland, M., Haino, S., Hall, E. D., Hamilton, E. Z., Hammond, G., Han, W. -B., Haney, M., Hanks, J., Hanna, C., Hannam, M. D., Hannuksela, O. A., Hanselman, A. G., Hansen, H., Hanson, J., Harada, R., Hardison, A. R., Haris, K., Harmark, T., Harms, J., Harry, G. M., Harry, I. W., Hart, J., Haskell, B., Haster, C. -J., Hathaway, J. S., Haughian, K., Hayakawa, H., Hayama, K., Hayes, R., Heffernan, A., Heidmann, A., Heintze, M. C., Heinze, J., Heinzel, J., Heitmann, H., Hellman, F., Hello, P., Helmling-Cornell, A. F., Hemming, G., Henderson-Sapir, O., Hendry, M., Heng, I. S., Hennes, E., Henshaw, C., Hertog, T., Heurs, M., Hewitt, A. L., Heyns, J., Higginbotham, S., Hild, S., Hill, S., Himemoto, Y., Hirata, N., Hirose, C., Hoang, S., Hochheim, S., Hofman, D., Holland, N. A., Holley-Bockelmann, K., Holmes, Z. J., Holz, D. E., Honet, L., Hong, C., Hornung, J., Hoshino, S., Hough, J., Hourihane, S., Howell, E. J., Hoy, C. G., Hrishikesh, C. A., Hsieh, H. -F., Hsiung, C., Hsu, H. C., Hsu, W. -F., Hu, P., Hu, Q., Huang, H. Y., Huang, Y. -J., Huddart, A. D., Hughey, B., Hui, D. C. Y., Hui, V., Husa, S., Huxford, R., Huynh-Dinh, T., Iampieri, L., Iandolo, G. A., Ianni, M., Iess, A., Imafuku, H., Inayoshi, K., Inoue, Y., Iorio, G., Iqbal, M. H., Irwin, J., Ishikawa, R., Isi, M., Ismail, M. A., Itoh, Y., Iwanaga, H., Iwaya, M., Iyer, B. R., JaberianHamedan, V., Jacquet, C., Jacquet, P. -E., Jadhav, S. J., Jadhav, S. P., Jain, T., James, A. L., James, P. A., Jamshidi, R., Janquart, J., Janssens, K., Janthalur, N. N., Jaraba, S., Jaranowski, P., Jaume, R., Javed, W., Jennings, A., Jia, W., Jiang, J., Kubisz, J., Johanson, C., Johns, G. R., Johnson, N. A., Johnson-McDaniel, N. K., Johnston, M. C., Johnston, R., Johny, N., Jones, D. H., Jones, D. I., Jones, R., Jose, S., Joshi, P., Ju, L., Jung, K., Junker, J., Juste, V., Kajita, T., Kaku, I., Kalaghatgi, C., Kalogera, V., Kamiizumi, M., Kanda, N., Kandhasamy, S., Kang, G., Kanner, J. B., Kapadia, S. J., Kapasi, D. P., Karat, S., Karathanasis, C., Kashyap, R., Kasprzack, M., Kastaun, W., Kato, T., Katsavounidis, E., Katzman, W., Kaushik, R., Kawabe, K., Kawamoto, R., Kazemi, A., Kedia, A., Keitel, D., Kelley-Derzon, J., Kennington, J., Kesharwani, R., Key, J. S., Khadela, R., Khadka, S., Khalili, F. Y., Khan, F., Khan, I., Khanam, T., Khursheed, M., Khusid, N. M., Kiendrebeogo, W., Kijbunchoo, N., Kim, C., Kim, J. C., Kim, K., Kim, M. H., Kim, S., Kim, Y. -M., Kimball, C., Kinley-Hanlon, M., Kinnear, M., Kissel, J. S., Klimenko, S., Knee, A. M., Knust, N., Kobayashi, K., Koch, P., Koehlenbeck, S. M., Koekoek, G., Kohri, K., Kokeyama, K., Koley, S., Kolitsidou, P., Kolstein, M., Komori, K., Kong, A. K. H., Kontos, A., Korobko, M., Kossak, R. V., Kou, X., Koushik, A., Kouvatsos, N., Kovalam, M., Kozak, D. B., Kranzhoff, S. L., Kringel, V., Krishnendu, N. V., Królak, A., Kruska, K., Kuehn, G., Kuijer, P., Kulkarni, S., Ramamohan, A. Kulur, Kumar, A., Kumar, Praveen, Kumar, Prayush, Kumar, Rahul, Kumar, Rakesh, Kume, J., Kuns, K., Kuntimaddi, N., Kuroyanagi, S., Kurth, N. J., Kuwahara, S., Kwak, K., Kwan, K., Kwok, J., Lacaille, G., Lagabbe, P., Laghi, D., Lai, S., Laity, A. H., Lakkis, M. H., Lalande, E., Lalleman, M., Lalremruati, P. C., Landry, M., Landry, P., Lane, B. B., Lang, R. N., Lange, J., Lantz, B., La Rana, A., La Rosa, I., Lartaux-Vollard, A., Lasky, P. D., Lawrence, J., Lawrence, M. N., Laxen, M., Lazzarini, A., Lazzaro, C., Leaci, P., Lecoeuche, Y. K., Lee, H. M., Lee, H. W., Lee, K., Lee, R. -K., Lee, R., Lee, S., Lee, Y., Legred, I. N., Lehmann, J., Lehner, L., Jean, M. Le, Lemaître, A., Lenti, M., Leonardi, M., Lequime, M., Leroy, N., Lesovsky, M., Letendre, N., Lethuillier, M., Levin, S. E., Levin, Y., Leyde, K., Li, A. K. Y., Li, K. L., Li, T. G. F., Li, X., Li, Z., Lihos, A., Lin, C-Y., Lin, C. -Y., Lin, E. T., Lin, F., Lin, H., Lin, L. C. -C., Lin, Y. -C., Linde, F., Linker, S. D., Littenberg, T. B., Liu, A., Liu, G. C., Liu, Jian, Villarreal, F. Llamas, Llobera-Querol, J., Lo, R. K. L., Locquet, J. -P., London, L. T., Longo, A., Lopez, D., Portilla, M. Lopez, Lorenzini, M., Lorenzo-Medina, A., Loriette, V., Lormand, M., Losurdo, G., Lott IV, T. P., Lough, J. D., Loughlin, H. A., Lousto, C. O., Lowry, M. J., Lu, N., Lück, H., Lumaca, D., Lundgren, A. P., Lussier, A. W., Ma, L. -T., Ma, S., Ma'arif, M., Macas, R., Macedo, A., MacInnis, M., Maciy, R. R., Macleod, D. M., MacMillan, I. A. O., Macquet, A., Macri, D., Maeda, K., Maenaut, S., Hernandez, I. Magaña, Magare, S. S., Magazzù, C., Magee, R. M., Maggio, E., Maggiore, R., Magnozzi, M., Mahesh, M., Mahesh, S., Maini, M., Majhi, S., Majorana, E., Makarem, C. N., Makelele, E., Malaquias-Reis, J. A., Mali, U., Maliakal, S., Malik, A., Man, N., Mandic, V., Mangano, V., Mannix, B., Mansell, G. L., Mansingh, G., Manske, M., Mantovani, M., Mapelli, M., Marchesoni, F., Pina, D. Marín, Marion, F., Márka, S., Márka, Z., Markosyan, A. S., Markowitz, A., Maros, E., Marsat, S., Martelli, F., Martin, I. W., Martin, R. M., Martinez, B. B., Martinez, M., Martinez, V., Martini, A., Martinovic, K., Martins, J. C., Martynov, D. V., Marx, E. J., Massaro, L., Masserot, A., Masso-Reid, M., Mastrodicasa, M., Mastrogiovanni, S., Matcovich, T., Matiushechkina, M., Matsuyama, M., Mavalvala, N., Maxwell, N., McCarrol, G., McCarthy, R., McClelland, D. E., McCormick, S., McCuller, L., McEachin, S., McElhenny, C., McGhee, G. I., McGinn, J., McGowan, K. B. M., McIver, J., McLeod, A., McRae, T., Meacher, D., Meijer, Q., Melatos, A., Mellaerts, S., Menendez-Vazquez, A., Menoni, C. S., Mera, F., Mercer, R. A., Mereni, L., Merfeld, K., Merilh, E. L., Mérou, J. R., Merritt, J. D., Merzougui, M., Messenger, C., Messick, C., Meyer-Conde, M., Meylahn, F., Mhaske, A., Miani, A., Miao, H., Michaloliakos, I., Michel, C., Michimura, Y., Middleton, H., Miller, A. L., Miller, S., Millhouse, M., Milotti, E., Milotti, V., Minenkov, Y., Mio, N., Mir, Ll. M., Mirasola, L., Miravet-Tenés, M., Miritescu, C. -A., Mishra, A. K., Mishra, A., Mishra, C., Mishra, T., Mitchell, A. L., Mitchell, J. G., Mitra, S., Mitrofanov, V. P., Mittleman, R., Miyakawa, O., Miyamoto, S., Miyoki, S., Mo, G., Mobilia, L., Mohapatra, S. R. P., Mohite, S. R., Molina-Ruiz, M., Mondal, C., Mondin, M., Montani, M., Moore, C. J., Moraru, D., More, A., More, S., Moreno, G., Morgan, C., Morisaki, S., Moriwaki, Y., Morras, G., Moscatello, A., Mourier, P., Mours, B., Mow-Lowry, C. M., Muciaccia, F., Mukherjee, Arunava, Mukherjee, D., Mukherjee, Samanwaya, Mukherjee, Soma, Mukherjee, Subroto, Mukherjee, Suvodip, Mukund, N., Mullavey, A., Munch, J., Mundi, J., Mungioli, C. L., Oberg, W. R. Munn, Murakami, Y., Murakoshi, M., Murray, P. G., Muusse, S., Nabari, D., Nadji, S. L., Nagar, A., Nagarajan, N., Nagler, K. N., Nakagaki, K., Nakamura, K., Nakano, H., Nakano, M., Nandi, D., Napolano, V., Narayan, P., Nardecchia, I., Narikawa, T., Narola, H., Naticchioni, L., Nayak, R. K., Neilson, J., Nelson, A., Nelson, T. J. N., Nery, M., Neunzert, A., Ng, S., Quynh, L. Nguyen, Nichols, S. A., Nielsen, A. B., Nieradka, G., Niko, A., Nishino, Y., Nishizawa, A., Nissanke, S., Nitoglia, E., Niu, W., Nocera, F., Norman, M., North, C., Novak, J., Siles, J. F. Nuño, Nuttall, L. K., Obayashi, K., Oberling, J., O'Dell, J., Oertel, M., Offermans, A., Oganesyan, G., Oh, J. J., Oh, K., O'Hanlon, T., Ohashi, M., Ohkawa, M., Ohme, F., Oliveira, A. S., Oliveri, R., O'Neal, B., Oohara, K., O'Reilly, B., Ormsby, N. D., Orselli, M., O'Shaughnessy, R., O'Shea, S., Oshima, Y., Oshino, S., Ossokine, S., Osthelder, C., Ota, I., Ottaway, D. J., Ouzriat, A., Overmier, H., Owen, B. J., Pace, A. E., Pagano, R., Page, M. A., Pai, A., Pal, A., Pal, S., Palaia, M. A., Pálfi, M., Palma, P. P., Palomba, C., Palud, P., Pan, H., Pan, J., Pan, K. C., Panai, R., Panda, P. K., Pandey, S., Panebianco, L., Pang, P. T. H., Pannarale, F., Pannone, K. A., Pant, B. C., Panther, F. H., Paoletti, F., Paolone, A., Papalexakis, E. E., Papalini, L., Papigkiotis, G., Paquis, A., Parisi, A., Park, B. -J., Park, J., Parker, W., Pascale, G., Pascucci, D., Pasqualetti, A., Passaquieti, R., Passenger, L., Passuello, D., Patane, O., Pathak, D., Pathak, M., Patra, A., Patricelli, B., Patron, A. S., Paul, K., Paul, S., Payne, E., Pearce, T., Pedraza, M., Pegna, R., Pele, A., Arellano, F. E. Peña, Penn, S., Penuliar, M. D., Perego, A., Pereira, Z., Perez, J. J., Périgois, C., Perna, G., Perreca, A., Perret, J., Perriès, S., Perry, J. W., Pesios, D., Petracca, S., Petrillo, C., Pfeiffer, H. P., Pham, H., Pham, K. A., Phukon, K. S., Phurailatpam, H., Piarulli, M., Piccari, L., Piccinni, O. J., Pichot, M., Piendibene, M., Piergiovanni, F., Pierini, L., Pierra, G., Pierro, V., Pietrzak, M., Pillas, M., Pilo, F., Pinard, L., Pinto, I. M., Pinto, M., Piotrzkowski, B. J., Pirello, M., Pitkin, M. D., Placidi, A., Placidi, E., Planas, M. L., Plastino, W., Poggiani, R., Polini, E., Pompili, L., Poon, J., Porcelli, E., Porter, E. K., Posnansky, C., Poulton, R., Powell, J., Pracchia, M., Pradhan, B. K., Pradier, T., Prajapati, A. K., Prasai, K., Prasanna, R., Prasia, P., Pratten, G., Principe, G., Principe, M., Prodi, G. A., Prokhorov, L., Prosposito, P., Puecher, A., Pullin, J., Punturo, M., Puppo, P., Pürrer, M., Qi, H., Qin, J., Quéméner, G., Quetschke, V., Quigley, C., Quinonez, P. J., Raab, F. J., Raabith, S. S., Raaijmakers, G., Raja, S., Rajan, C., Rajbhandari, B., Ramirez, K. E., Vidal, F. A. Ramis, Ramos-Buades, A., Rana, D., Ranjan, S., Ransom, K., Rapagnani, P., Ratto, B., Rawat, S., Ray, A., Raymond, V., Razzano, M., Read, J., Payo, M. Recaman, Regimbau, T., Rei, L., Reid, S., Reitze, D. H., Relton, P., Renzini, A. I., Rettegno, P., Revenu, B., Reyes, R., Rezaei, A. S., Ricci, F., Ricci, M., Ricciardone, A., Richardson, J. W., Richardson, M., Rijal, A., Riles, K., Riley, H. K., Rinaldi, S., Rittmeyer, J., Robertson, C., Robinet, F., Robinson, M., Rocchi, A., Rolland, L., Rollins, J. G., Romano, A. E., Romano, R., Romero, A., Romero-Shaw, I. M., Romie, J. H., Ronchini, S., Roocke, T. J., Rosa, L., Rosauer, T. J., Rose, C. A., Rosińska, D., Ross, M. P., Rossello, M., Rowan, S., Roy, S. K., Roy, S., Rozza, D., Ruggi, P., Ruhama, N., Morales, E. Ruiz, Ruiz-Rocha, K., Sachdev, S., Sadecki, T., Sadiq, J., Saffarieh, P., Sah, M. R., Saha, S. S., Saha, S., Sainrat, T., Menon, S. Sajith, Sakai, K., Sakellariadou, M., Sakon, S., Salafia, O. S., Salces-Carcoba, F., Salconi, L., Saleem, M., Salemi, F., Sallé, M., Salvador, S., Sanchez, A., Sanchez, E. J., Sanchez, J. H., Sanchez, L. E., Sanchis-Gual, N., Sanders, J. R., Sänger, E. M., Santoliquido, F., Saravanan, T. R., Sarin, N., Sasaoka, S., Sasli, A., Sassi, P., Sassolas, B., Satari, H., Sathyaprakash, B. S., Sato, R., Sato, Y., Sauter, O., Savage, R. L., Sawada, T., Sawant, H. L., Sayah, S., Scacco, V., Schaetzl, D., Scheel, M., Schiebelbein, A., Schiworski, M. G., Schmidt, P., Schmidt, S., Schnabel, R., Schneewind, M., Schofield, R. M. S., Schouteden, K., Schulte, B. W., Schutz, B. F., Schwartz, E., Scialpi, M., Scott, J., Scott, S. M., Seetharamu, T. C., Seglar-Arroyo, M., Sekiguchi, Y., Sellers, D., Sengupta, A. S., Sentenac, D., Seo, E. G., Seo, J. W., Sequino, V., Serra, M., Servignat, G., Sevrin, A., Shaffer, T., Shah, U. S., Shaikh, M. A., Shao, L., Sharma, A. K., Sharma, P., Sharma-Chaudhary, S., Shaw, M. R., Shawhan, P., Shcheblanov, N. S., Sheridan, E., Shikano, Y., Shikauchi, M., Shimode, K., Shinkai, H., Shiota, J., Shoemaker, D. H., Shoemaker, D. M., Short, R. W., ShyamSundar, S., Sider, A., Siegel, H., Sieniawska, M., Sigg, D., Silenzi, L., Simmonds, M., Singer, L. P., Singh, A., Singh, D., Singh, M. K., Singh, S., Singha, A., Sintes, A. M., Sipala, V., Skliris, V., Slagmolen, B. J. J., Slaven-Blair, T. J., Smetana, J., Smith, J. R., Smith, L., Smith, R. J. E., Smith, W. J., Soldateschi, J., Somiya, K., Song, I., Soni, K., Soni, S., Sordini, V., Sorrentino, F., Sorrentino, N., Sotani, H., Soulard, R., Southgate, A., Spagnuolo, V., Spencer, A. P., Spera, M., Spinicelli, P., Spoon, J. B., Sprague, C. A., Srivastava, A. K., Stachurski, F., Steer, D. A., Steinlechner, J., Steinlechner, S., Stergioulas, N., Stevens, P., Stevenson, S., StPierre, M., Stratta, G., Strong, M. D., Strunk, A., Sturani, R., Stuver, A. L., Suchenek, M., Sudhagar, S., Sueltmann, N., Suleiman, L., Sullivan, K. D., Sun, L., Sunil, S., Suresh, J., Sutton, P. J., Suzuki, T., Suzuki, Y., Swinkels, B. L., Syx, A., Szczepańczyk, M. J., Szewczyk, P., Tacca, M., Tagoshi, H., Tait, S. C., Takahashi, H., Takahashi, R., Takamori, A., Takase, T., Takatani, K., Takeda, H., Takeshita, K., Talbot, C., Tamaki, M., Tamanini, N., Tanabe, D., Tanaka, K., Tanaka, S. J., Tanaka, T., Tang, D., Tanioka, S., Tanner, D. B., Tao, L., Tapia, R. D., Martín, E. N. Tapia San, Tarafder, R., Taranto, C., Taruya, A., Tasson, J. D., Teloi, M., Tenorio, R., Themann, H., Theodoropoulos, A., Thirugnanasambandam, M. P., Thomas, L. M., Thomas, M., Thomas, P., Thompson, J. E., Thondapu, S. R., Thorne, K. A., Thrane, E., Tissino, J., Tiwari, A., Tiwari, P., Tiwari, S., Tiwari, V., Todd, M. R., Toivonen, A. M., Toland, K., Tolley, A. E., Tomaru, T., Tomita, K., Tomura, T., Tong, H., Tong-Yu, C., Toriyama, A., Toropov, N., Torres-Forné, A., Torrie, C. I., Toscani, M., Melo, I. Tosta e, Tournefier, E., Trapananti, A., Travasso, F., Traylor, G., Trevor, M., Tringali, M. C., Tripathee, A., Troian, G., Troiano, L., Trovato, A., Trozzo, L., Trudeau, R. J., Tsang, T. T. L., Tsuchida, S., Tsukada, L., Tsutsui, T., Turbang, K., Turconi, M., Turski, C., Ubach, H., Uchikata, N., Uchiyama, T., Udall, R. P., Uehara, T., Uematsu, M., Ueno, K., Ueno, S., Undheim, V., Ushiba, T., Vacatello, M., Vahlbruch, H., Vaidya, N., Vajente, G., Vajpeyi, A., Valdes, G., Valencia, J., Valentini, M., Vallejo-Peña, S. A., Vallero, S., Valsan, V., van Bakel, N., van Beuzekom, M., van Dael, M., Brand, J. F. J. van den, Broeck, C. Van Den, Vander-Hyde, D. C., van der Sluys, M., Van de Walle, A., van Dongen, J., Vandra, K., van Haevermaet, H., van Heijningen, J. V., Van Hove, P., VanKeuren, M., Vanosky, J., van Putten, M. H. P. M., van Ranst, Z., van Remortel, N., Vardaro, M., Vargas, A. F., Varghese, J. J., Varma, V., Vecchio, A., Vedovato, G., Veitch, J., Veitch, P. J., Venikoudis, S., Venneberg, J., Verdier, P., Verkindt, D., Verma, B., Verma, P., Verma, Y., Vermeulen, S. M., Vetrano, F., Veutro, A., Vibhute, A. M., Viceré, A., Vidyant, S., Viets, A. D., Vijaykumar, A., Vilkha, A., Villa-Ortega, V., Vincent, E. T., Vinet, J. -Y., Viret, S., Virtuoso, A., Vitale, S., Vives, A., Vocca, H., Voigt, D., von Reis, E. R. G., von Wrangel, J. S. A., Vyatchanin, S. P., Wade, L. E., Wade, M., Wagner, K. J., Wajid, A., Walker, M., Wallace, G. S., Wallace, L., Wang, H., Wang, J. Z., Wang, W. H., Wang, Z., Waratkar, G., Warner, J., Was, M., Washimi, T., Washington, N. Y., Watarai, D., Wayt, K. E., Weaver, B. R., Weaver, B., Weaving, C. R., Webster, S. A., Weinert, M., Weinstein, A. J., Weiss, R., Wellmann, F., Wen, L., Weßels, P., Wette, K., Whelan, J. T., Whiting, B. F., Whittle, C., Wildberger, J. B., Wilk, O. S., Wilken, D., Wilkin, A. T., Willadsen, D. J., Willetts, K., Williams, D., Williams, M. J., Williams, N. S., Willis, J. L., Willke, B., Wils, M., Winterflood, J., Wipf, C. C., Woan, G., Woehler, J., Wofford, J. K., Wolfe, N. E., Wong, H. T., Wong, H. W. Y., Wong, I. C. F., Wright, J. L., Wright, M., Wu, C., Wu, D. S., Wu, H., Wuchner, E., Wysocki, D. M., Xu, V. A., Xu, Y., Yadav, N., Yamamoto, H., Yamamoto, K., Yamamoto, T. S., Yamamoto, T., Yamamura, S., Yamazaki, R., Yan, S., Yan, T., Yang, F. W., Yang, F., Yang, K. Z., Yang, Y., Yarbrough, Z., Yasui, H., Yeh, S. -W., Yelikar, A. B., Yin, X., Yokoyama, J., Yokozawa, T., Yoo, J., Yu, H., Yuan, S., Yuzurihara, H., Zadrożny, A., Zanolin, M., Zeeshan, M., Zelenova, T., Zendri, J. -P., Zeoli, M., Zerrad, M., Zevin, M., Zhang, A. C., Zhang, L., Zhang, R., Zhang, T., Zhang, Y., Zhao, C., Zhao, Yue, Zhao, Yuhang, Zheng, Y., Zhong, H., Zhou, R., Zhu, X. -J., Zhu, Z. -H., Zimmerman, A. B., Zucker, M. E., and Zweizig, J.

Subjects
Astrophysics - High Energy Astrophysical Phenomena, General Relativity and Quantum Cosmology
Abstract

We report the observation of a coalescing compact binary with component masses $2.5\text{-}4.5~M_\odot$ and $1.2\text{-}2.0~M_\odot$ (all measurements quoted at the 90% credible level). The gravitational-wave signal GW230529_181500 was observed during the fourth observing run of the LIGO-Virgo-KAGRA detector network on 2023 May 29 by the LIGO Livingston Observatory. The primary component of the source has a mass less than $5~M_\odot$ at 99% credibility. We cannot definitively determine from gravitational-wave data alone whether either component of the source is a neutron star or a black hole. However, given existing estimates of the maximum neutron star mass, we find the most probable interpretation of the source to be the coalescence of a neutron star with a black hole that has a mass between the most massive neutron stars and the least massive black holes observed in the Galaxy. We provisionally estimate a merger rate density of $55^{+127}_{-47}~\text{Gpc}^{-3}\,\text{yr}^{-1}$ for compact binary coalescences with properties similar to the source of GW230529_181500; assuming that the source is a neutron star-black hole merger, GW230529_181500-like sources constitute about 60% of the total merger rate inferred for neutron star-black hole coalescences. The discovery of this system implies an increase in the expected rate of neutron star-black hole mergers with electromagnetic counterparts and provides further evidence for compact objects existing within the purported lower mass gap., Comment: 45 pages (10 pages author list, 13 pages main text, 1 page acknowledgements, 13 pages appendices, 8 pages bibliography), 17 figures, 16 tables. Update to match version published in The Astrophysical Journal Letters. Data products available from https://zenodo.org/records/10845779

Published
2024
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3. Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

Author

Gaur, Aditya H, Capparelli, Edmund V, Calabrese, Katherine, Baltrusaitis, Kristin, Marzinke, Mark A, McCoig, Cynthia, Van Solingen-Ristea, Rodica M, Mathiba, Sisinyana Ruth, Adeyeye, Adeola, Moye, John H, Heckman, Barbara, Lowenthal, Elizabeth D, Ward, Shawn, Milligan, Ryan, Samson, Pearl, Best, Brookie M, Harrington, Conn M, Ford, Susan L, Huang, Jenny, Crauwels, Herta, Vandermeulen, Kati, Agwu, Allison L, Smith-Anderson, Christiana, Camacho-Gonzalez, Andres, Ounchanum, Pradthana, Kneebone, Jared L, Townley, Ellen, Bolton Moore, Carolyn, Buisson, Sarah, Cheung, S. Y. Amy, Chounta, Vasiliki, Deprez, Isabelle, Desmond, Alicia Catherine, Han, Kelong, Hanley, Sherika, Lin, Yu-Wei, Patel, Faeezah, Paul, Mary E., Roberts, Gilly, Whitson, Kyle, and Zabih, Sara

Abstract

Combined intramuscular long-acting cabotegravir and long-acting rilpivirine constitute the first long-acting combination antiretroviral therapy (ART) regimen approved for adults with HIV. The goal of the IMPAACT 2017 study (MOCHA [More Options for Children and Adolescents]) was to assess the safety and pharmacokinetics of these drugs in adolescents.

Published
2024
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4. Pediatric oncology drug development and dosage optimization.

Author

Cheung, S. Y. Amy, Hay, Justin L., Yu-Wei Lin, de Greef, Rik, and Bullock, Julie

Subjects
PEDIATRIC oncology, DRUG development, ANTINEOPLASTIC agents, CHILD patients, DRUG discovery
Abstract

Oncology drug discovery and development has always been an area facing many challenges. Phase 1 oncology studies are typically small, open-label, sequential studies enrolling a small sample of adult patients (i.e., 3-6 patients/cohort) in dose escalation. Pediatric evaluations typically lag behind the adult development program. The pediatric starting dose is traditionally referenced on the recommended phase 2 dose in adults with the incorporation of body size scaling. The size of the study is also small and dependent upon the prevalence of the disease in the pediatric population. Similar to adult development, the dose is escalated or de-escalated until reaching the maximum tolerated dose (MTD) that also provides desired biological activities or efficacy. The escalation steps and identification of MTD are often rule-based and do not incorporate all the available information, such as pharmacokinetic (PK), pharmacodynamic (PD), tolerability and efficacy data. Therefore, it is doubtful if the MTD approach is optimal to determine the dosage. Hence, it is important to evaluate whether there is an optimal dosage below the MTD, especially considering the emerging complexity of combination therapies and the long-term tolerability and safety of the treatments. Identification of an optimal dosage is also vital not only for adult patients but for pediatric populations as well. Dosage-finding is much more challenging for pediatric populations due to the limited patient population and differences among the pediatric age range in terms of maturation and ontogeny that could impact PK. Many sponsors defer the pediatric strategy as they are often perplexed by the challenges presented by pediatric oncology drug development (model of action relevancy to pediatric population, budget, timeline and regulatory requirements). This leads to a limited number of approved drugs for pediatric oncology patients. This review article provides the current regulatory landscape, incentives and how they impact pediatric drug discovery and development. We also consider different pediatric cancers and potential clinical trial challenges/opportunities when designing pediatric clinical trials. An outline of how quantitative methods such as pharmacometrics/modelling & simulation can support the dosage-finding and justification is also included. Finally, we provide some reflections that we consider helpful to accelerate pediatric drug discovery and development. [ABSTRACT FROM AUTHOR]

Published
2024
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5. How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement

Author

Severin, Thomas, Corriol-Rohou, Solange, Bucci-Rechtweg, Christina, an Haack, Kristina, Fuerst-Recktenwald, Sabine, Lepola, Pirkko, Norjavaara, Ensio, Dehlinger-Kremer, Martine, Haertter, Sebastian, and Cheung, S. Y. Amy

Abstract

Background: Pediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investing in building appropriate structures and capabilities as part of their business strategy to better tackle the challenges and opportunities of pediatric drug development. Methods: The EFGCP Children’s Medicines Working Party and the IQ Pediatric working group have joined their efforts to survey their member company representatives to understand how pharmaceutical companies are organized to fulfill their regulatory obligations and optimize their pediatric drug development programs. Results: Key success factors and recommendations for a fit-for-purpose Pediatric Expert Group (PEG) were identified. Conclusion: Pediatric structures and expert groups were shown to be important to support optimization of the development of pediatric medicines.

Published
2024
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6. Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials.

Author

Sebastien, Bernard, Cheung, S. Y. Amy, Corriol-Rohou, Solange, Gamalo-Siebers, Margaret, Jreich, Rana, Krishna, Rajesh, and Liu, Jing

Subjects
*CLINICAL trials, *SAMPLE size (Statistics)
Abstract

The use of Bayesian methodology to design and analyze pediatric efficacy trials is one of the possible options to reduce their sample size. This reduction of the sample size results from the use of an informative prior for the parameters of interest. In most of the applications, the principle of 'information borrowing' from adults' trials is applied, which means that the informative prior is constructed using efficacy results in adult of the drug under investigation. This implicitly assumes similarity in efficacy between the selected pediatric dose and the efficacious dose in adults. The goal of this article is to propose a method to construct prior distribution for the parameter of interest, not directly constructed from the efficacy results of the efficacious dose in adult patients but using pharmacodynamic modeling of a bridging biomarker using early phase pediatric data. When combined with a model bridging the biomarker with the clinical endpoints, the prior is constructed using a variational method after simulation of the parameters of interest. A use case application illustrates how the method can be used to construct a realistic informative prior. [ABSTRACT FROM AUTHOR]

Published
2023
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11. Cost effectiveness analyses of pharmacological treatments in heart failure

Author

Lim, Audrey Huili, Abdul Rahim, Nusaibah, Zhao, Jinxin, Cheung, S. Y. Amy, and Lin, Yu-Wei

Subjects
Pharmacology, Pharmacology (medical)
Abstract

In a rapidly growing and aging population, heart failure (HF) has become recognised as a public health concern that imposes high economic and societal costs worldwide. HF management stems from the use of highly cost-effective angiotensin converting enzyme inhibitors (ACEi) and β-blockers to the use of newer drugs such as sodium-glucose cotransporter-2 inhibitors (SGLT2i), ivabradine, and vericiguat. Modelling studies of pharmacological treatments that report on cost effectiveness in HF is important in order to guide clinical decision making. Multiple cost-effectiveness analysis of dapagliflozin for heart failure with reduced ejection fraction (HFrEF) suggests that it is not only cost-effective and has the potential to improve long-term clinical outcomes, but is also likely to meet conventional cost-effectiveness thresholds in many countries. Similar promising results have also been shown for vericiguat while a cost effectiveness analysis (CEA) of empagliflozin has shown cost effectiveness in HF patients with Type 2 diabetes. Despite the recent FDA approval of dapagliflozin and empagliflozin in HF, it might take time for these SGLT2i to be widely used in real-world practice. A recent economic evaluation of vericiguat found it to be cost effective at a higher cost per QALY threshold than SGLT2i. However, there is a lack of clinical or real-world data regarding whether vericiguat would be prescribed on top of newer treatments or in lieu of them. Sacubitril/valsartan has been commonly compared to enalapril in cost effectiveness analysis and has been found to be similar to that of SGLT2i but was not considered a cost-effective treatment for heart failure with reduced ejection fraction in Thailand and Singapore with the current economic evaluation evidences. In order for more precise analysis on cost effectiveness analysis, it is necessary to take into account the income level of various countries as it is certainly easier to allocate more financial resources for the intervention, with greater effectiveness, in high- and middle-income countries than in low-income countries. This review aims to evaluate evidence and cost effectiveness studies in more recent HF drugs i.e., SGLT2i, ARNi, ivabradine, vericiguat and omecamtiv, and gaps in current literature on pharmacoeconomic studies in HF.

Published
2022

12. Epstein-Barr Virus Reactivation After Paediatric Haematopoietic Stem Cell Transplantation: Risk Factors and Sensitivity Analysis of Mathematical Model

Author

Kania, Soumya P., primary, Silva, Juliana M. F., additional, Charles, Oscar J., additional, Booth, John, additional, Cheung, S. Y. Amy, additional, Yates, James W. T., additional, Worth, Austen, additional, Breuer, Judith, additional, Klein, Nigel, additional, Amrolia, Persis J., additional, Veys, Paul, additional, and Standing, Joseph F., additional

Published
2022
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14. Supporting Prospective Pregnancy Trials via Modeling and Simulation: Lessons From the Past and Recommendations for the Future.

Author

Cheung, S. Y. Amy and Barrett, Jeffrey S.

Subjects
*CLINICAL trials, *PREGNANCY, *SIMULATION methods in education
Abstract

Despite the increasing awareness and guidance to support drug research and development in the pregnant population, there is still a high unmet medical need and off‐label use in the pregnant population for mainstream, acute, chronic, rare disease, and vaccination/prophylactic use. There are many obstacles to enrolling the pregnant population in a study, ranging from ethical considerations, the complexity of the pregnancy stages, postpartum, fetus–mother interaction, and drug transfer to breast milk during lactation and impacts on neonates. This review will outline the common challenges of incorporating physiological differences in the pregnant population and historical but noninformative practice in a past clinical trial in pregnant women that led to labeling difficulties. The recommendations of different modeling approaches, such as a population pharmacokinetic model, physiologically based pharmacokinetic modeling, model‐based meta‐analysis, and quantitative system pharmacology modeling, are presented with some examples. Finally, we outline the gaps in the medical need for the pregnant population by classifying various types of diseases and some considerations that exist to support the use of medicines in this area. Ideas on the potential framework to support clinical trials and collaboration examples are also presented that could also accelerate understanding of drug research and medicine/prophylactics/vaccines in the pregnant population. [ABSTRACT FROM AUTHOR]

Published
2023
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17. Reproductive Realities in Modern China: Birth Control and Abortion, 1911–2021.

Author

Cheung, S. Y.

Subjects
*BIRTH control, *ABORTION, *ABORTION laws, *ADULTERY, *PREMARITAL sex, *FAMILY planning
Abstract

"Reproductive Realities in Modern China: Birth Control and Abortion, 1911–2021" by Sarah Mellors Rodriguez explores the history of birth control and abortion in China through archival work and oral histories. The book focuses on the grassroots perspective, departing from previous literature that centered on the one-child policy and elite actors. It reveals the uneven implementation of birth control policies and challenges the notion of the Chinese government's control over reproduction. The book also highlights the gendered nature of fertility control and the practical motivations behind individuals' decisions. [Extracted from the article]

Published
2024
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18. 1013. Predicting RSV Efficacy for MK-1654 in Temperate and Tropical Climates using MBMA and Clinical Trial Simulation to Account for Seasonal Differences in RSV Force-of-Infection

Author

Plock, Nele, primary, Lommerse, Jos, additional, Maas, Brian M, additional, Chen, Jingxian, additional, Bellanti, Francesco, additional, Qin, Li, additional, Witjes, Han, additional, Pierrillas, Philippe, additional, Railkar, Radha, additional, Aliprantis, Antonios O, additional, Vora, Kalpit A, additional, Gao, Wei, additional, Caro, Luzelena, additional, Amy Cheung, S Y, additional, and Sachs, Jeffrey R, additional

Published
2021
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20. 998. Forward and Reverse Translational Approaches to Predict Efficacy of the Neutralizing Respiratory Syncytial Virus (RSV) Antibody MK-1654

Author

Maas, Brian M, primary, Lommerse, Jos, additional, Plock, Nele, additional, Railkar, Radha, additional, Amy Cheung, S Y, additional, Caro, Luzelena, additional, Chen, Jingxian, additional, Liu, Wen, additional, Zhang, Ying, additional, Huang, Qinlei, additional, Gao, Wei, additional, Qin, Li, additional, Meng, Jie, additional, Witjes, Han, additional, Schindler, Emilie, additional, Guiastrennec, Benjamin, additional, Bellanti, Francesco, additional, Spellman, Daniel, additional, Roadcap, Brad, additional, Kalinova, Mariya, additional, Fok-Seang, Juin, additional, Catchpole, Andrew P, additional, Espeseth, Amy, additional, Aubrey Stoch, S, additional, Lai, Eseng, additional, Vora, Kalpit A, additional, Aliprantis, Antonios O, additional, and Sachs, Jeffrey R, additional

Published
2021
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24. Danya Glabau, Food Allergy Advocacy: Parenting and the Politics of Care.

Author

Cheung, S Y

Subjects
*FOOD allergy, *RACE relations, *SOCIAL status, *ACTIVISM, *FEMINISM, *NUCLEAR families, *HOME schooling
Abstract

"Danya Glabau, Food Allergy Advocacy: Parenting and the Politics of Care" is an ethnography that explores the role of food allergy activism in the United States. The book argues that food allergy advocacy perpetuates White affluence and heteronormative family relations as conditions for health and well-being. It also examines how mainstream biomedical interventions hold mothers responsible for managing allergies in the home. The book highlights the gendered work of allergy management and the capitalist interests that shape the treatment of allergies. It concludes by calling for social changes that prioritize the safety of all individuals rather than relying on narrow biomedical fixes. [Extracted from the article]

Published
2024
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25. Concentration‐QT modelling shows no evidence of clinically significant QT interval prolongation with capivasertib at expected therapeutic concentrations.

Author

Voronova, Veronika, Cullberg, Marie, Delff, Philip, Parkinson, Joanna, Dota, Corina, Schiavon, Gaia, Maroj, Brijesh, Rekić, Dinko, and Cheung, S. Y. Amy

Subjects
BRUGADA syndrome, ELECTROCARDIOGRAPHY, PROSTATE cancer
Abstract

Pharmacokinetics‐matched digital electrocardiogram data (n = 503 measurements from 180 patients) collected in a first‐in‐human, multi‐part, dose‐escalation (from 80 to 800 mg) and dose expansion (at 480 mg) phase 1 study in patients with advanced solid malignancies, were used to assess potential risk of QT prolongation associated with the AKT inhibitor capivasertib. The relationship between plasma drug concentrations and baseline‐adjusted Fridericia‐corrected QT (ΔQTcF) values was estimated using a prespecified linear mixed‐effects model. The model provided an unbiased reproduction of the experimental data set, estimating a small but positive correlation between capivasertib concentration and ΔQTcF. At the expected therapeutic dose (400 mg twice daily) the predicted mean ΔQTcF at the steady state maximum concentration was 3.97 ms with an upper limit of the 90% CI of 5.07 ms; below the 10 ms limit proposed by ICH E14 guidance. This analysis suggests that capivasertib is not expected to present a clinically significant risk for QT prolongation that is associated with pro‐arrhythmic effects. [ABSTRACT FROM AUTHOR]

Published
2022
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27. Artificial Intelligence and Machine Learning Applied at the Point of Care

Author

Angehrn, Zuzanna, primary, Haldna, Liina, additional, Zandvliet, Anthe S., additional, Gil Berglund, Eva, additional, Zeeuw, Joost, additional, Amzal, Billy, additional, Cheung, S. Y. Amy, additional, Polasek, Thomas M., additional, Pfister, Marc, additional, Kerbusch, Thomas, additional, and Heckman, Niedre M., additional

Published
2020
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28. Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop

Author

Barrett, Jeffrey S., primary, Bucci‐Rechtweg, Christina, additional, Amy Cheung, S. Y., additional, Gamalo‐Siebers, Margaret, additional, Haertter, Sebastian, additional, Karres, Janina, additional, Marquard, Jan, additional, Mulugeta, Yeruk, additional, Ollivier, Cecile, additional, Strougo, Ashley, additional, Yanoff, Lisa, additional, Yao, Lynne, additional, and Zeitler, Philip, additional

Published
2020
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29. V2ACHER: Visualization of complex trial data in pharmacometric analyses with covariates.

Author

Lommerse, Jos, Plock, Nele, Cheung, S. Y. Amy, and Sachs, Jeffrey R.

Subjects
DATA analysis, VISUALIZATION, CROSS-functional teams, DECISION making, COMMUNICATION models
Abstract

Pharmacometric models can enhance clinical decision making, with covariates exposing potential contributions to variability of subpopulation characteristics, for example, demographics or disease status. Intuitive visualization of models with multiple covariates is needed because sparsity of data in visualizations trellised by covariate values can raise concerns about the credibility of the underlying model. V2ACHER, introduced here, is a stepwise transformation of data that can be applied to a variety of static (non‐ordinary‐differential‐equation‐based) pharmacometric analyses. This work uses four examples of increasing complexity to show how the transformation elucidates the relationship between observations and model results and how it can also be used in visual predictive checks to confirm the quality of a model. V2ACHER facilitates consistent, intuitive, single‐plot visualization of a multicovariate model with a complex data set, thereby enabling easier model communication for modelers and for cross‐functional development teams and facilitating confident use in support of decisions. [ABSTRACT FROM AUTHOR]

Published
2021
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30. A phase i open-label study to identify a dosing regimen of the pan-akt inhibitor azd5363 for evaluation in solid tumors and in pik3ca-mutated breast and gynecologic cancers

Author

Banerji, Udai, Dean, Emma J, Pérez-Fidalgo, J Alejandro, Batist, Gerald, Bedard, Philippe L, You, Benoit, Westin, Shannon N, Kabos, Peter, Garrett, Michelle D, Tall, Mathew, Ambrose, Helen, Barrett, J Carl, Carr, T Hedley, Cheung, S Y Amy, Corcoran, Claire, Cullberg, Marie, Davies, Barry R, de Bruin, Elza C, Elvin, Paul, Foxley, Andrew, Lawrence, Peter, Lindemann, Justin P O, Maudsley, Rhiannon, Pass, Martin, Rowlands, Vicky, Rugman, Paul, Schiavon, Gaia, Yates, James, Schellens, Jan H M, Afd Pharmacoepi & Clinical Pharmacology, and Pharmacoepidemiology and Clinical Pharmacology

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Performance status, Manchester Cancer Research Centre, business.industry, Nausea, ResearchInstitutes_Networks_Beacons/mcrc, Common Terminology Criteria for Adverse Events, Rash, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Tolerability, 030220 oncology & carcinogenesis, Internal medicine, Pharmacodynamics, Medicine, Dosing, medicine.symptom, business, Adverse effect
Abstract

Purpose: This phase I, open-label study (Study 1, D3610C00001; NCT01226316) was the first-in-human evaluation of oral AZD5363, a selective pan-AKT inhibitor, in patients with advanced solid malignancies. The objectives were to investigate the safety, tolerability, and pharmacokinetics of AZD5363, define a recommended dosing schedule, and evaluate preliminary clinical activity. Experimental Design: Patients were aged ≥18 years with World Health Organization (WHO) performance status of 0 to 1. Dose escalation was conducted within separate continuous and intermittent [4 days/week (4/7) or 2 days/week (2/7)] schedules with safety, pharmacokinetic, and pharmacodynamic analyses. Expansion cohorts of approximately 20 patients each explored AZD5363 activity in PIK3CA-mutant breast and gynecologic cancers. Results: MTDs were 320, 480, and 640 mg for continuous (n = 47), 4/7 (n = 21), and 2/7 (n = 22) schedules, respectively. Dose-limiting toxicities were rash and diarrhea for continuous, hyperglycemia for 2/7, and none for 4/7. Common adverse events were diarrhea (78%) and nausea (49%) and, for Common Terminology Criteria for Adverse Events grade ≥3 events, hyperglycemia (20%). The recommended phase II dose (480 mg bid, 4/7 intermittent) was assessed in PIK3CA-mutant breast and gynecologic expansion cohorts: 46% and 56% of patients, respectively, showed a reduction in tumor size, with RECIST responses of 4% and 8%. These responses were less than the prespecified 20% response rate; therefore, the criteria to stop further recruitment to the PIK3CA-mutant cohort were met. Conclusions: At the recommended phase II dose, AZD5363 was well tolerated and achieved plasma levels and robust target modulation in tumors. Proof-of-concept responses were observed in patients with PIK3CA-mutant cancers treated with AZD5363. Clin Cancer Res; 24(9); 2050–9. ©2017 AACR. See related commentary by Costa and Bosch, p. 2029

Published
2018

32. Best Practices to Maximize the Use and Reuse of Quantitative and Systems Pharmacology Models: Recommendations From the United Kingdom Quantitative and Systems Pharmacology Network

Author

Cucurull‐Sanchez, Lourdes, primary, Chappell, Michael J., additional, Chelliah, Vijayalakshmi, additional, Amy Cheung, S. Y., additional, Derks, Gianne, additional, Penney, Mark, additional, Phipps, Alex, additional, Malik‐Sheriff, Rahuman S., additional, Timmis, Jon, additional, Tindall, Marcus J., additional, Graaf, Piet H., additional, Vicini, Paolo, additional, and Yates, James W. T., additional

Published
2019
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33. Advanced methods for dose and regimen finding during drug development:Summary of the EMA /EFPIA workshop on dose finding (London 4-5 December 2014)

Author

Musuamba, F. T., Manolis, E., Holford, N., Cheung, S. Y. A., Friberg, Lena E, Ogungbenro, K., Posch, M., Yates, J. W. T., Berry, S., Thomas, N., Corriol-Rohou, S., Bornkamp, B., Bretz, F., Hooker, Andrew, Van der Graaf, P. H., Standing, J. F., Hay, J., Cole, S., Gigante, V., Karlsson, K., Dumortier, T., Benda, N., Serone, F., Das, S., Brochot, A., Ehmann, F., Hemmings, R., and Rusten, I. Skottheim

Subjects
Clinical Trials as Topic, Dose-Response Relationship, Drug, Pharmaceutical Preparations, Research Design, Drug Discovery, White Paper, Animals, Humans, Pharmacology and Toxicology, Models, Theoretical, Farmakologi och toxikologi
Abstract

Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late-stage attritions in clinical development and postmarketing commitments required by regulatory institutions. In an effort to shift the current paradigm in dose and regimen selection and highlight the availability and usefulness of well-established and regulatory-acceptable methods, the European Medicines Agency (EMA) in collaboration with the European Federation of Pharmaceutical Industries Association (EFPIA) hosted a multistakeholder workshop on dose finding (London 4-5 December 2014). Some methodologies that could constitute a toolkit for drug developers and regulators were presented. These methods are described in the present report: they include five advanced methods for data analysis (empirical regression models, pharmacometrics models, quantitative systems pharmacology models, MCP-Mod, and model averaging) and three methods for study design optimization (Fisher information matrix (FIM)-based methods, clinical trial simulations, and adaptive studies). Pairwise comparisons were also discussed during the workshop; however, mostly for historical reasons. This paper discusses the added value and limitations of these methods as well as challenges for their implementation. Some applications in different therapeutic areas are also summarized, in line with the discussions at the workshop. There was agreement at the workshop on the fact that selection of dose for phase III is an estimation problem and should not be addressed via hypothesis testing. Dose selection for phase III trials should be informed by well-designed dose-finding studies; however, the specific choice of method(s) will depend on several aspects and it is not possible to recommend a generalized decision tree. There are many valuable methods available, the methods are not mutually exclusive, and they should be used in conjunction to ensure a scientifically rigorous understanding of the dosing rationale.

Published
2017

34. How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement.

Author

Severin, Thomas, Corriol-Rohou, Solange, Bucci-Rechtweg, Christina, an Haack, Kristina, Fuerst-Recktenwald, Sabine, Lepola, Pirkko, Norjavaara, Ensio, Dehlinger-Kremer, Martine, Haertter, Sebastian, and Cheung, S. Y. Amy

Subjects
DRUG laws, PEDIATRICS, PHARMACEUTICAL industry, DRUG development
Abstract

Background: Pediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investing in building appropriate structures and capabilities as part of their business strategy to better tackle the challenges and opportunities of pediatric drug development. Methods: The EFGCP Children's Medicines Working Party and the IQ Pediatric working group have joined their efforts to survey their member company representatives to understand how pharmaceutical companies are organized to fulfill their regulatory obligations and optimize their pediatric drug development programs. Results: Key success factors and recommendations for a fit-for-purpose Pediatric Expert Group (PEG) were identified. Conclusion: Pediatric structures and expert groups were shown to be important to support optimization of the development of pediatric medicines. [ABSTRACT FROM AUTHOR]

Published
2020
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36. Abstract CT118: PK-Biomarker-Safety modelling aids choice of recommended Phase II dose and schedule for AZD6738 (ATR inhibitor)

Author

Berges, Alienor, primary, Cheung, S. Y. Amy, additional, Pierce, Andrew J., additional, Dean, Emma, additional, Felicetti, Brunella, additional, Standifer, Nathan, additional, Smith, Simon, additional, Yates, James, additional, Lau, Alan, additional, Stephens, Christine, additional, Krebs, Matthew, additional, Harrington, Kevin, additional, and Hollingsworth, Simon J., additional

Published
2018
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37. Abstract CT135: A pre-surgical window of opportunity study to investigate the biomarker effects of DNA damage response (DDR) agents in patients (pts) with head and neck squamous cell carcinoma (HNSCC)

Author

Duvvuri, Umamaheswar, primary, Dean, Emma, additional, Frewer, Paul, additional, Berges, Alienor, additional, Cheung, S. Y., additional, Stephens, Christine, additional, Khan, Musaddiq, additional, Hollingsworth, Simon J., additional, and Pierce, Andrew J., additional

Published
2018
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39. Dose-exposure-response relationship between AZD6738 and peripheral monocytes.

Author

Pierce, Andrew, primary, Berges, Alienor, additional, Cheung, S Y Amy, additional, Standifer, Nathan, additional, Ross, Graham, additional, Smith, Simon, additional, Hollingsworth, Simon J, additional, Krebs, Matthew, additional, Postel-Vinay, Sophie, additional, Bang, Yung-Jue, additional, El-Khoueiry, Anthony B., additional, Abida, Wassim, additional, Sundar, Raghav, additional, Carter, Louise, additional, Castanon-Alvarez, Eduardo, additional, Im, Seock-Ah, additional, Lopez, Juanita Suzanne, additional, Yap, Timothy Anthony, additional, Harrington, Kevin, additional, and Soria, Jean-Charles, additional

Published
2017
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40. Understanding Hematological Toxicities Using Mathematical Modeling.

Author

Fornari, Chiara, Collins, Teresa A., O'Connor, Lenka Oplustil, Yates, James W. T., Cheung, S. Y. Amy, Jodrell, Duncan I., and Mettetal, Jerome T.

Subjects
ANTINEOPLASTIC agents, TOXICITY testing, MYELOSUPPRESSION, CANCER treatment, BONE marrow
Abstract

Balancing antitumor efficacy with toxicity is a significant challenge, and drug‐induced myelosuppression is a common dose‐limiting toxicity of cancer treatments. Mathematical modeling has proven to be a powerful ally in this field, scaling results from animal models to humans, and designing optimized treatment regimens. Here we outline existing mathematical approaches for studying bone marrow toxicity, identify gaps in current understanding, and make future recommendations to advance this vital field of safety research further. [ABSTRACT FROM AUTHOR]

Published
2018
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42. Predictive Performance of Physiologically Based Pharmacokinetic (PBPK) Modeling of Drugs Extensively Metabolized by Major Cytochrome P450s in Children.

Author

Bui, Khanh H., Li, Jianguo, Xu, Hongmei, Al‐Huniti, Nidal, Zhou, Diansong, Zhou, Wangda, Johnson, Trevor N., and Cheung, S. Y. Amy

Subjects
PHARMACOKINETICS, PREDICTION models, EFFECT of drugs on enzymes, CYTOCHROME P-450, DRUG development, PEDIATRICS, PHYSIOLOGY
Abstract

The accuracy of physiologically based pharmacokinetic (PBPK) model prediction in children, especially those younger than 2 years old, has not been systematically evaluated. The aim of this study was to characterize the pediatric predictive performance of the PBPK approach for 10 drugs extensively metabolized by CYP1A2 (theophylline), CYP2C8 (desloratidine, montelukast), CYP2C9 (diclofenac), CYP2C19 (esomeprazole, lansoprazole), CYP2D6 (tramadol), and CYP3A4 (itraconazole, ondansetron, sufentanil). Model performance in children was evaluated by comparing simulated plasma concentration–time profiles with observed clinical results for each drug and age group. PBPK models reasonably predicted the pharmacokinetics of desloratadine, diclofenac, itraconazole, lansoprazole, montelukast, ondansetron, sufentanil, theophylline, and tramadol across all age groups. Collectively, 58 out of 67 predictions were within 2‐fold and 43 out of 67 predictions within 1.5‐fold of observed values. Developed PBPK models can reasonably predict exposure in children age 1 month and older for an array of predominantly CYP metabolized drugs. [ABSTRACT FROM AUTHOR]

Published
2018
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43. Concerns and developmental needs of highly confident and less confident elementary coaches in Hong Kong

Author

Cheung, S-Y and Fung, L

Abstract

The development of this study was based on three assumptions, namely 1) that coaching efficacy (confidence specific to the task of coaching) impacts the performance of coaches, 2) that coaching efficacy is influenced by the individual's procedural and declarative knowledge on coaching, and 3) that coaches do their work best when they are confident in carrying out their tasks and when their concerns and developmental needs are adequately addressed. With these assumptions in mind, this study aimed to explore the concerns and developmental needs of highly confident and less confident elementary coaches in Hong Kong. Data was collected by means of the Coaching Efficacy Scale developed by Feltz et al. (1999), the Coaches Concern Scale developed by Fung (2004), and a self-developed Coach Education Needs Survey. Descriptive statistics and t-tests were used to analyze the data. Results indicated that coaches who are less confident did not see the need for development as much as those coaches who have more confident. Furthermore, the latter are also more concerned about themselves as coaches. The importance of this finding is discussed and directions for future research are provided. African Journal for Physical, Health Education, Recreation & Dance Vol. 13 (2) 2007: pp. 119-126

Published
2007

44. Pharmacodynamic activity of the AKT inhibitor AZD5363 in patients with advanced solid tumors.

Author

Elvin, Paul, primary, Palmer, Amy, additional, Womack, Chris, additional, Tall, Matthew, additional, Swales, Karen E, additional, Garrett, Michelle D, additional, Banerji, Udai, additional, Tamura, Kenji, additional, Cheung, S Y Amy, additional, Lawrence, Peter, additional, Lindemann, Justin, additional, Ambrose, Helen, additional, Stephens, Christine, additional, Davies, Barry, additional, Foxley, Andrew, additional, Pass, Martin, additional, Harrington, Elizabeth A., additional, and Barrett, J. Carl, additional

Published
2014
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45. CCF: A Framework for Collaborative Computing

Author

Sunderam, V., Cheung, S. Y., Chodrow, S., Gray, P., Grigni, M., Hirsch, M., Hutto, P., Krantz, A., Olesen, S., Rhee, I., Goddard, T., Sult, J., Migliardi, Mauro, Marzilli, L., Ano, S., Williams, K., and Sullivan, S.

Published
2000

49. CCF.

Author

Sunderam, V., Cheung, S. Y., Hirsch, M., Chodrow, S., Grigni, M., Krantz, A., Rhee, I., Gray, P., Olesen, S., Hutto, P., and Sult, J.

Published
1998

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