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Publications
Neches V, Campbell K , Coll P, Moreno Guillen S, Martinez-Sesmero JM, Lopez Segui F, O'Brien P, Davis A , Anderson SJ, Schroeder M, Vallejo-Aparicio LA. Cost-effectiveness of cabotegravir long-acting for pre-exposure prophylaxis versus current use of daily oral tenofovir disoproxil fumarate/emtricitabine or no prep to prevent HIV-1 in individuals at high risk in Spain . Poster to be given at the ISPOR Europe 2024; November 17, 2024. Barcelona, Spain.
Yap C, Aiyegbusi OL, Alger E, Basch E, Bell J, Bhatnagar V, Cella D, Collis P, Dueck AC, Gilbert A, Gnanasakthy A , Greystoke A, Hansen AR, Kamudoni P, Kholmanskikh O, King-Kallimanis BL, Krumbolz H, Minchom A, O'Connor D, Petrie J, Piccinin C, Rantell KR, Rauz S, Retzer A, Rizk S, Wagner L, Sasseville M, Seymour LK, Weber HA, Wilson R, Calvert M, Peipert JD. Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable . EClinicalMedicine. 2024 Oct;76:102838. doi: 10.1016/j.eclinm.2024.102838
Haug U, Morales DR, Ehrenstein V, Esen BO, Didelez V, Schafer W, Reinbold J, Martinez D , Garcia de Albeniz X , Gini R, Ryan O, Young J. Target trial emulation with real world evidence: regulatory grade pharmacoepidemiology in the SIGMA consortium . Presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Girardi A, Limoncella G, Hyeraci G, Roberto G, Bartolini C, Paoletti O, Messina D, Villalobos F, Bissacco C, Van den Burg J, Houben E, Santaca k, Lentile V, Ingrasciotta Y, Trifiro G, Hoxhaj V, Duran C, Riera-Arnau J, Garcia P, Martin-Perez M, Huerta-Alvarez C, Llorente-Garcia A, Sanchez-Saez F, Rodriguez-Bernal C, Lassalle R, Jove J, Bernard M, Thurin N, Jordan S, Thayer D, Evans H, Coldea A, Manfrini M, Van Gelder M, Hayati S, Schink T, Tari M, Pajouheshnia R , Afonso A, Noan-Laine M, Molgaard-Nielsen D, Cunnington M, Dodd C, Sturkenboom M, Nordeng H, Gini R. Impact of data source diversity on the distribution of key variables in pregnancy cohorts based on the ConcePTION pregnancy algorithm leveraging a random forest imputation model . Presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Mayer SE, Kawai A , Fuller CC, Agan AA, Rao S , Koram N, Calingaert B , Marshall J, Connolly JG, Moyneur E, Jamal-allial A, Brown J, Burk J, Chomistek A, Daniels K, Dea K, DeFor TA, Diessner B, Djibo DA, Ezzy S, Hawrusik R, Johannes CB , Kendrick K, Layton JB , Ma Q, Mai X, Mack M, Pawloski PA, Reynolds JS, Selvan M, Sharma V, Vetter J, McMahill-Walraven CN, Platt R, Gilsenan A . Interim utilization results from a post-approval safety study of Pfizer-BioNTech monovalent COVID-19 vaccine in the United States . Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Danysh HE , Gilsenan A , Kaye JA, Garcia de Albeniz Martinez X , Schmid R, Bartsch J , Calingaert B , Rahman S, Layton JB , Gutierrez L . Validation of algorithms to identify breast cancer and bladder cancer among patients with type 2 diabetes mellitus in United States medicare administrative claims . Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Layton JB , Muthuri S, Lindaas A, Lloyd PC, Richey MM, Gruber JF, Clarke TC, Kowarski LS, McKillop M, Fisher S, Lyu H, Cheng A, Bui CL , Duenas PF, Chen Y, Forshee RA, Anderson SA, Beers JB, Burrell T, Chillarige Y, Anthony MS , Shoaibi A. Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States . Presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Layton JB , Lindaas A, Muthuri S, Lloyd PC, Richey MM, Gruber JF, Clarke TC, Kowarski L, McKillop M, Fisher S, Lyu H, Cheng A, Bui C , Duenas PF, Chen Y, Beers JB, Forshee RA, Anderson SA, Burrell T, Chillarige Y, Anthony MS , Shoaibi A. Risk of cardiovascular adverse events after COVID-19 diagnosis in the United States . Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Domenech E, Fortuny J , Martinez D , Tormos A , Huang Z, Hill D, Weinstein C, Esslinger S, Krumme A, Mines D, Gisbert J. A post-authorization safety study of golimumab in ulcerative colitis using the Spanish ENEIDA registry (MK8259-042) . Poster presented at the 2024 ISPE Annual Meeting; August 28, 2024. Berlin, Germany.
Weibel D, De Luise C, Cid Royo A, Ryan O, Vaz T, Aguado J , Marsal J , Garcia de Albeniz Martinez X , Weinrib R , Yefimenko N, Pala E, Poblador-Plou B, Gimeno-Miguel A, Santos-Mejias A, Marconi E, Barbieri E, Stona L, Lysen T, Roy D, Hyeraci G, Girardi A, Lupattelli A, Desalegn AA, Villalobos F, Bissacco CA, Kendrick K, Garg R, Rubino H, Sturkenboom MCJM, Arana A . Interim results from the VAC4EU Post-Authorization Safety Study (PASS) among recipients of the Pfizer-BioNTech COVID-19 (Comirnaty®) vaccine in Europe . Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Ahmadizar F, Fortuny J , Royo AC, Plana E , Weinrib R , Garcia Esteban R , Boric K , Yefimenko N, Haugh M, Carreras JJ, Urchueguia-Fornes A, Correcher E, van den Berg JM, Lysen T, Villalobos F, Bissacco CA, Newbern EC, Willame C, Praet N, Sturkenboom MCJM. Safety of the Janssen COVID-19 vaccine (JCOVDEN) using VAC4EU European healthcare data sources: methods and results of the second study feasibility assessment . Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Jacobson MH, Sabido M, Afonso AS, Ajao A, Alghamdi EA, Andrade S, Bennett D, Kharat V, Kurzinger ML, Le Noan-Laine M, Molgaard-Nielsen D, Murray G, Rivero-Ferrer E , Lopez-Leon S. Algorithms to identify major congenital malformations in routinely collected healthcare databases: a systematic literature review . Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Peetluk LS, Djibo DA, Layton JB , Deng J, Deshazo J, Richey MM, Ogilvie RP, Parambi RJ, Miller M, Song J, Tarazi W, Weatherby LB, Bell EJ, Anthony MS , McMahill-Walraven CN, Yang GW, Seeger JD, Amend KL. Considerations for negative control outcome analyses in vaccine effectiveness studies: post-hoc analyses from an adult vaccine effectiveness study conducted within the FDA BEST initiative . Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Broe A, Willis SK, Dareng E, Haviland M, van Gelder MMHJ, Nordeng HME, Wood ME, Sahin L, Margulis AV , Rivero-Ferrer E . Building global consensus on definitions for drug safety studies in pregnancy to improve harmonized evaluation of real-world data . Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Layton JB , Peetluk LS, Lloyd PC, Jiao Y, Djibo DA, Deng J, Gruber JF, Ogilvie RP, Parambi R, Miller M, Song J, Weatherby LB, Bell EJ, Lo AC, Hervol JR, Wernecke M, Cho S, Wong H-L, Clarke TC, Bui CL , Stone A, Tarazi W, Deshazo J, Forshee RA, Anderson SA, Seeger JD, Amend KL, MaMahill-Walraven CN, Chillarige Y, Yang GW, Anthony MS , Shoaibi A. Effectiveness over time of a complete primary series of the original, monovalent COVID-19 vaccines among adults aged 18-64 years in the United States . Poster presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Layton JB , Richey M, Lindaas A, Muthuri S, Lloyd PC, Gruber JF, Bui C , McKillop M, Kowarski L, Lyu H, Cheng A, Wan Z, Clarke TC, Kawai AT , Beers J, Forshee RA, Anderson SA, Burrell T, Chillarige Y, Anthony MS , Shoaibi A. Events on day zero of follow-up: considerations for cohort studies of adverse events after COVID-19 diagnosis . Presented at the 2024 ISPE Annual Meeting; August 27, 2024. Berlin, Germany.
Johannes CB , Ziemiecki R , Pladevall-Vila M , Kosvesdy CP, Ebert N, Thomsen RWW, Christiansen CF, Baak B, Cabaninas CR, Kashihara N, Yano Y, Kanegae H, Coleman CI, Okami S, Li u F, Layton JB , Vizcaya D, Oberprieler NG. Use of SGLT2 inhibitors in patients with type 2 diabetes and chronic kidney disease: a multicountry report from the FOUNTAIN platform . Poster presented at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.
Pajouheshnia R , Gini R, Gardarsdottir H, Bennett D, Li L, Gulea C, Wientzek-Fleischmann A, Bazelier M, Burcu M, Dodd C, Duran C, Kaplan S, Lanes S, Marinier K, Roberto G, Soman KV, Platt R, Setoguchi S, Hall G, Zhou X. Describing diversity of real-world data sources: a new framework adapted from the DIVERSE initiative scoping review . Poster presented at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.
Weinrib R , Fortuny J , Martinez D , Kollhorst B, Haug U, Kousholt A, Ehrenstein V, Iversen P, Mortensen J, Bosch D, Kuppen M, Pisa F, Vassiley Z. Drug utilisation of radium-223 under routine clinical practice (DIRECT) in Europe: a post-authorisation safety study . Poster presented at the 2024 ISPE Annual Meeting; August 26, 2024. Berlin, Germany.