Literature DB >> 25359360

The Critical Path Institute: transforming competitors into collaborators.

Martha Brumfield1.   

Abstract

The Critical Path Institute brings scientists from regulatory agencies, industry and academia together to improve drug development and regulatory processes.

Mesh：

Year:  2014        PMID： 25359360     DOI： 10.1038/nrd4436

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


  4 in total

Review 1.  The FDA critical path initiative and its influence on new drug development.

Authors:  Janet Woodcock; Raymond Woosley
Journal:  Annu Rev Med       Date:  2008       Impact factor: 13.739

2.  Combining patient-level and summary-level data for Alzheimer's disease modeling and simulation: a β regression meta-analysis.

Authors:  James A Rogers; Daniel Polhamus; William R Gillespie; Kaori Ito; Klaus Romero; Ruolun Qiu; Diane Stephenson; Marc R Gastonguay; Brian Corrigan
Journal:  J Pharmacokinet Pharmacodyn       Date:  2012-07-21       Impact factor: 2.745

Review 3.  Multiple Sclerosis Outcome Assessments Consortium: Genesis and initial project plan.

Authors:  Richard A Rudick; Nicholas Larocca; Lynn D Hudson
Journal:  Mult Scler       Date:  2013-09-20       Impact factor: 6.312

4.  Operationalizing hippocampal volume as an enrichment biomarker for amnestic mild cognitive impairment trials: effect of algorithm, test-retest variability, and cut point on trial cost, duration, and sample size.

Authors:  Peng Yu; Jia Sun; Robin Wolz; Diane Stephenson; James Brewer; Nick C Fox; Patricia E Cole; Clifford R Jack; Derek L G Hill; Adam J Schwarz
Journal:  Neurobiol Aging       Date:  2013-10-03       Impact factor: 4.673
  4 in total
  6 in total

1.  The International Neonatal Consortium: collaborating to advance regulatory science for neonates.

Authors:  Mark A Turner; Jonathan M Davis; Susan McCune; Ralph Bax; Ronald J Portman; Lynn D Hudson
Journal:  Pediatr Res       Date:  2016-06-08       Impact factor: 3.756

Review 2.  New Frontiers in Parkinson's Disease: From Genetics to the Clinic.

Authors:  Lamya S Shihabuddin; Patrik Brundin; J Timothy Greenamyre; Diane Stephenson; S Pablo Sardi
Journal:  J Neurosci       Date:  2018-10-31       Impact factor: 6.167

Review 3.  Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science.

Authors:  Diane Stephenson; Robert Alexander; Varun Aggarwal; Reham Badawy; Lisa Bain; Roopal Bhatnagar; Bastiaan R Bloem; Babak Boroojerdi; Jackson Burton; Jesse M Cedarbaum; Josh Cosman; David T Dexter; Marissa Dockendorf; E Ray Dorsey; Ariel V Dowling; Luc J W Evers; Katherine Fisher; Mark Frasier; Luis Garcia-Gancedo; Jennifer C Goldsack; Derek Hill; Janice Hitchcock; Michele T Hu; Michael P Lawton; Susan J Lee; Michael Lindemann; Ken Marek; Nitin Mehrotra; Marjan J Meinders; Michael Minchik; Lauren Oliva; Klaus Romero; George Roussos; Robert Rubens; Sakshi Sadar; Joseph Scheeren; Eiichi Sengoku; Tanya Simuni; Glenn Stebbins; Kirsten I Taylor; Beatrice Yang; Neta Zach
Journal:  Digit Biomark       Date:  2020-11-26

4.  The 5th Annual One Mind Summit: Lessons Learned About "Science Informing Brain Health Policies and Practice".

Authors:  Ramona Hicks; Stephen Johnson; Amy C Porter; Douglas Zatzick
Journal:  J Neurotrauma       Date:  2017-05-17       Impact factor: 5.269

Review 5.  Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team.

Authors:  Stephen P Arnerić; Richard Batrla-Utermann; Laurel Beckett; Tobias Bittner; Kaj Blennow; Leslie Carter; Robert Dean; Sebastiaan Engelborghs; Just Genius; Mark Forrest Gordon; Janice Hitchcock; June Kaplow; Johan Luthman; Richard Meibach; David Raunig; Klaus Romero; Mahesh N Samtani; Mary Savage; Leslie Shaw; Diane Stephenson; Robert M Umek; Hugo Vanderstichele; Brian Willis; Susan Yule
Journal:  J Alzheimers Dis       Date:  2017       Impact factor: 4.472

6.  Accelerating drug development for Alzheimer's disease through the use of data standards.

Authors:  Jon Neville; Steve Kopko; Klaus Romero; Brian Corrigan; Bob Stafford; Elizabeth LeRoy; Steve Broadbent; Martin Cisneroz; Ethan Wilson; Eric Reiman; Hugo Vanderstichele; Stephen P Arnerić; Diane Stephenson
Journal:  Alzheimers Dement (N Y)       Date:  2017-04-15
  6 in total

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