Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium
Frank Dieterle(Novartis (Switzerland)), J. Eric McDuffie(Janssen (United States)), Melanie Blank(United States Food and Drug Administration), Éric Abadie(Ifremer), Manisha Sonee(Johnson & Johnson (United States)), Craig P. Webb(Van Andel Institute), Patricia Harlow(United States Food and Drug Administration), Frank D. Sistare(United States Military Academy), Jonathan A. Phillips(Boehringer Ingelheim (United States)), David Laurie(Novartis (Switzerland)), Albert DeFelice(United States Food and Drug Administration), Sean P. Troth(Merck & Co., Inc., Rahway, NJ, USA (United States)), David Gerhold(National Center for Advancing Translational Sciences), Stefan Sultana, Beatriz Silva Lima(University of Lisbon), Graham R. Betton(AstraZeneca (United Kingdom)), Kevin Carl(Novartis (Switzerland)), Marisa Papaluca, Nancy Xu(United States Food and Drug Administration), Romaldas Mačiulaitis(Hospital of Lithuanian University of Health Sciences Kaunas Clinics), Matthew J. Schipper(EP Analytics (United States)), Gerald Maurer(European Society of Radiology), Peter L. Goering(United States Food and Drug Administration), William Baer(Retina Specialists of Michigan), Anthony J. Senagore(Legacy Emanuel Medical Center), Bruno Flamion, Jackie Akunda(Eli Lilly (United States)), David Jacobson‐Kram(United States Food and Drug Administration), Jacky Vonderscher(Roche (Switzerland)), Federico Goodsaid, Spiros Vamvakas, Daniela Ennulat(GlaxoSmithKline (United States)), Denise Robinson-Gravatt(Pfizer (United States)), Markku Pasanen(University of Eastern Finland), Elizabeth A. Hausner(United States Food and Drug Administration), Shen Xiao(Research Triangle Park Foundation), Myrtle A. Davis(National Institutes of Health), Kushal Prasad, Aliza Thompson(United States Food and Drug Administration), Peter Kasper(Federal Institute for Drugs and Medical Devices), William Taylor(United States Food and Drug Administration), Jean-Marc Vidal, Josef Ozer(United States Military Academy), Dan Holder(United States Military Academy), Ernie Harpur(Sanofi (United States)), Karol L. Thompson(United States Food and Drug Administration), Yi-Zhong Gu, Denise I. Bounous(Bristol-Myers Squibb (United States)), Douglas C. Throckmorton(United States Food and Drug Administration), Dina Andrews-Cleavenger(Amgen (United States))
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