Clinical trial recommendations for potential Alport syndrome therapies

Autor: B. André Weinstock, David L. Feldman, Alessia Fornoni, Oliver Gross, Clifford E. Kashtan, Sharon Lagas, Rachel Lennon, Jeffrey H. Miner, Michelle N. Rheault, James F. Simon, Lisa Bonebrake, Marty Dunleavy, Phil Kumnick, Gina Parziale, Janine Reed, André Weinstock, Susie Gear, Kristen Binaso, Raymond Manuel, James Simon, Gerald Appel, Melanie Blank, Winson Tang, Aliza Thompson, Roser Torra, Kenneth Lieberman, Christoph Licht, Karin Dahan, Kandai Nozu, Hirofumi Kai, Sharon Ricardo, Anne Pariser, David Feldman, Heather Cook, Melanie Chin, Angela Goldsberry, Colin Meyer, Lisa Anne Melia, Radko Komers, Michael Markels, Alex Mercer, Marco Prunotto, Bruce Morgenstern, Ali Hariri, Vijay Modur, Neil Turner, Clifford Kashtan, Michelle Rheault, Colin Baigent, Stephano DeSacco, Laura Perin, Moumita Barua, Koichi Nakanishi, George Jarad, Jeffrey Miner

Publikováno v: Weinstock, B A, Feldman, D L, Fornoni, A, Gross, O, Kashtan, C E, Lagas, S, Lennon, R, Miner, J H, Rheault, M N, Simon, J F, Bonebrake, L, Dunleavy, M, Kumnick, P, Lagas, S, Parziale, G, Reed, J, Weinstock, A, Gear, S, Binaso, K, Manuel, R, Simon, J, Appel, G, Blank, M, Tang, W, Thompson, A, Torra, R, Lieberman, K, Licht, C, Dahan, K, Nozu, K, Kai, H, Ricardo, S, Pariser, A, Feldman, D, Cook, H, Chin, M, Goldsberry, A, Meyer, C, Melia, L A, Komers, R, Markels, M, Mercer, A, Prunotto, M, Morgenstern, B, Hariri, A, Modur, V, Turner, N, Gross, O, Fornoni, A, Kashtan, C, Rheault, M, Baigent, C, Desacco, S, Perin, L, Barua, M, Nakanishi, K, Jarad, G & Miner, J 2020, ' Clinical trial recommendations for potential Alport syndrome therapies ', Kidney International, vol. 97, no. 6, pp. 1109-1116 . https://doi.org/10.1016/j.kint.2020.02.029

Alport syndrome is experiencing a remarkable increase in preclinical investigations. To proactively address the needs of the Alport syndrome community, as well as offer clarity for future clinical research sponsors, the Alport Syndrome Foundation hos

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f7cd31a3ba1cfa1d09aa0e0800dd0db1
https://pubmed.ncbi.nlm.nih.gov/32386680

Food and Drug Administration Analysis of Ticagrelor

Autor: John Lawrence, Tzu-Yun McDowell, Norman Stockbridge, Melanie Blank

Publikováno v: Circulation. 134:1500-1502

Prognostic enrichment strategies are often used in cardiovascular outcome trials and enroll patients who are at higher risk for cardiovascular outcome events. By increasing the rate of outcome events, prognostic enrichment increases the absolute diff

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cac806bff72d8c54d3b8f1ac4a64626c
https://doi.org/10.1161/circulationaha.116.024691

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

Autor: Laura Suter, Aliza Thompson, Ernie Harpur, Gerard Maurer, Bruno Flamion, Douglas C. Throckmorton, Phil Rossi, Jackie Akunda, Nancy Xu, Stefan Sultana, Federico Goodsaid, Jonathan A. Phillips, Sven A. Beushausen, Valérie G. Barlow, Denise Bounous, Jacky Vonderscher, David Gerhold, Sean P. Troth, Elizabeth Hausner, Karol L. Thompson, Matthew J. Schipper, Spiros Vamvakas, David Jacobson-Kram, William Taylor, Jean Marc Vidal, Beatriz Silva Lima, Albert F. Defelice, Supriya Jayadev, Magalie Guffroy, Yi Zhong Gu, James Eric McDuffie, Daniela Ennulat, Jeff Waring, Patricia Harlow, Leslie A. Obert, Sandra Snook, Frank D. Sistare, Eric A.G. Blomme, William B. Mattes, Craig P. Webb, Mark Pinches, David Honor, Romaldas Mačiulaitis, Myrtle Davis, Jinhe Lee, Frank Dieterle, Marisa Papaluca, Melanie Blank, Nathaniel Collins, William Baer, Peter L. Goering, Shen Xiao, Anthony J. Senagore, Krishna Prasad, Denise Robinson-Gravatt, Josef S Ozer, Eric Abadie, Graham Betton, Kevin Carl, Peter Kasper, David Laurie, Manisha Sonee, Dina Andrews-Cleavenger, Elizabeth G. Walker, Dan Holder, Markku Pasanen

Publikováno v: Nature Biotechnology. 28:455-462

The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::153a6b13ac5e7fb2e36ce91685f63c53
https://doi.org/10.1038/nbt.1625

Novel Biomarkers of Acute Kidney Toxicity

Autor: Aliza Thompson, P. Harlow, Federico Goodsaid, Melanie Blank, Frank D. Sistare, Frank Dieterle, Elizabeth A. Hausner, Jacky Vonderscher

Publikováno v: Clinical Pharmacology & Therapeutics. 86:490-496

Novel biomarkers of kidney toxicity are powerful tools not only with respect to their clinical applications but also because of their impact on drug development. These biomarkers can influence the assessment of efficacy of new drugs for kidney diseas

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9522cf313769a1aaa8b4d0edc0462ac7
https://doi.org/10.1038/clpt.2009.149

Phase composition, mechanical performance and in vitro biocompatibility of hydraulic setting calcium magnesium phosphate cement

Autor: Isabelle Reske, Uwe Klammert, Alexander C. Kübler, Tobias Reuther, Uwe Gbureck, Jake E. Barralet, Liam M. Grover, Melanie Blank

Publikováno v: Acta biomaterialia. 6(4)

Brushite (CaHPO(4) x 2H(2)O)-forming calcium phosphate cements are of great interest as bone replacement materials because they are resorbable in physiological conditions. However, their short setting times and low mechanical strengths limit broad cl

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a9e62b200fb4cb4f974a048d49408a27
https://pubmed.ncbi.nlm.nih.gov/19837194