Literature DB >> 25359364

The predictive safety testing consortium and the coalition against major diseases.

Diane Stephenson1, John-Michael Sauer1.   

Abstract

The Predictive Safety Testing Consortium and the Coalition Against Major Diseases, both launched by the Critical Path Institute, provide valuable examples of the outcomes and lessons learned by different types of consortia working on new drug development tools.

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Year:  2014        PMID： 25359364     DOI： 10.1038/nrd4440

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


  4 in total

1.  Towards consensus practices to qualify safety biomarkers for use in early drug development.

Authors:  Frank D Sistare; Frank Dieterle; Sean Troth; Daniel J Holder; David Gerhold; Dina Andrews-Cleavenger; William Baer; Graham Betton; Denise Bounous; Kevin Carl; Nathaniel Collins; Peter Goering; Federico Goodsaid; Yi-Zhong Gu; Valerie Guilpin; Ernie Harpur; Alita Hassan; David Jacobson-Kram; Peter Kasper; David Laurie; Beatriz Silva Lima; Romaldas Maciulaitis; William Mattes; Gérard Maurer; Leslie Ann Obert; Josef Ozer; Marisa Papaluca-Amati; Jonathan A Phillips; Mark Pinches; Matthew J Schipper; Karol L Thompson; Spiros Vamvakas; Jean-Marc Vidal; Jacky Vonderscher; Elizabeth Walker; Craig Webb; Yan Yu
Journal:  Nat Biotechnol       Date:  2010-05-10       Impact factor: 54.908

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

Authors:  Frank Dieterle; Frank Sistare; Federico Goodsaid; Marisa Papaluca; Josef S Ozer; Craig P Webb; William Baer; Anthony Senagore; Matthew J Schipper; Jacky Vonderscher; Stefan Sultana; David L Gerhold; Jonathan A Phillips; Gérard Maurer; Kevin Carl; David Laurie; Ernie Harpur; Manisha Sonee; Daniela Ennulat; Dan Holder; Dina Andrews-Cleavenger; Yi-Zhong Gu; Karol L Thompson; Peter L Goering; Jean-Marc Vidal; Eric Abadie; Romaldas Maciulaitis; David Jacobson-Kram; Albert F Defelice; Elizabeth A Hausner; Melanie Blank; Aliza Thompson; Patricia Harlow; Douglas Throckmorton; Shen Xiao; Nancy Xu; William Taylor; Spiros Vamvakas; Bruno Flamion; Beatriz Silva Lima; Peter Kasper; Markku Pasanen; Krishna Prasad; Sean Troth; Denise Bounous; Denise Robinson-Gravatt; Graham Betton; Myrtle A Davis; Jackie Akunda; James Eric McDuffie; Laura Suter; Leslie Obert; Magalie Guffroy; Mark Pinches; Supriya Jayadev; Eric A Blomme; Sven A Beushausen; Valérie G Barlow; Nathaniel Collins; Jeff Waring; David Honor; Sandra Snook; Jinhe Lee; Phil Rossi; Elizabeth Walker; William Mattes
Journal:  Nat Biotechnol       Date:  2010-05-10       Impact factor: 54.908

3.  Understanding placebo responses in Alzheimer's disease clinical trials from the literature meta-data and CAMD database.

Authors:  Kaori Ito; Brian Corrigan; Klaus Romero; Richard Anziano; Jon Neville; Diane Stephenson; Richard Lalonde
Journal:  J Alzheimers Dis       Date:  2013       Impact factor: 4.472

4.  Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease.

Authors:  Derek L G Hill; Adam J Schwarz; Maria Isaac; Luca Pani; Spiros Vamvakas; Robert Hemmings; Maria C Carrillo; Peng Yu; Jia Sun; Laurel Beckett; Marina Boccardi; James Brewer; Martha Brumfield; Marc Cantillon; Patricia E Cole; Nick Fox; Giovanni B Frisoni; Clifford Jack; Thomas Kelleher; Feng Luo; Gerald Novak; Paul Maguire; Richard Meibach; Patricia Patterson; Lisa Bain; Cristina Sampaio; David Raunig; Holly Soares; Joyce Suhy; Huanli Wang; Robin Wolz; Diane Stephenson
Journal:  Alzheimers Dement       Date:  2014-07       Impact factor: 21.566
  4 in total
  3 in total

1.  Industry-academia collaborations for biomarkers.

Authors:  Khusru Asadullah; Andreas Busch; Matthias Gottwald; Petra Reinke; Lilla Landeck
Journal:  Nat Rev Drug Discov       Date:  2015-10-30       Impact factor: 84.694

Review 2.  Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies.

Authors:  Stephen R Karpen; Jessica L Dunne; Brigitte I Frohnert; Marjana Marinac; Claudia Richard; Sarah E David; Inish M O'Doherty
Journal:  Diabetologia       Date:  2022-07-22       Impact factor: 10.460

3.  Methodological considerations for measuring biofluid-based microRNA biomarkers.

Authors:  Brian N Chorley; Elnaz Atabakhsh; Graeme Doran; Jean-Charles Gautier; Heidrun Ellinger-Ziegelbauer; David Jackson; Tatiana Sharapova; Peter S T Yuen; Rachel J Church; Philippe Couttet; Roland Froetschl; James McDuffie; Victor Martinez; Parimal Pande; Lauren Peel; Conor Rafferty; Frank J Simutis; Alison H Harrill
Journal:  Crit Rev Toxicol       Date:  2021-05-26       Impact factor: 6.184
  3 in total

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