Publications

• September 20, 2019
  

  The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson’s Disease

  Diane Stephensona,∗, Derek Hillb, Jesse M. Cedarbaumc, Maria Tomed, Spiros Vamvakasd, Klaus Romeroa, Daniela J. Conradoa, David T. Dextere, John Seibylf, Danna Jenningsg, Timothy Nicholash, Dawn Matthewsi, Zhiyong Xieh, Syed Imamp, Paul Maguirej, David Russellf, Mark Forrest Gordonk, Glenn T. Stebbinso, Ed Somerl, Jill Gallaghere, Arthur Roache, Peter Bassechesm, Donald Grossetn and Kenneth Marekf on behalf of the Critical Path for Parkinson’s Consortium

• September 13, 2019
  

  Symptoms of Major Depressive Disorder Scale: Performance of a Novel Patient-Reported Symptom Measure

• August 14, 2019
  

  Conrado et al. 2019 Towards Regulatory Endorsement

  Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in Duchenne muscular dystrophy.
• June 24, 2019
  

  The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson’s Disease

• June 11, 2019
  

  Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices

  Brad Ackermann, Eli Lilly; John Allinson, Immunologix Laboratories; Mark Arnold, Covance;Shashi Amur, U.S. FDA; Jiri Aubrecht, Takeda; Amanda Baker, Ventana Medical Systems, Inc.; Robert Becker, U.S. FDA; ShaAvrée Buckman-Garner, U.S. FDA; Jennifer Burkey, Critical Path Institute; Martha Donoghue, U.S. FDA; Carmen Fernandez-Metzler, PharmaCadence; Fabio Garofolo, Angelini; Russ Grant, LabCorp; Huidong Gu, Bristol-Myers Squibb; Vinita Gupta, Exelixis; Steve Gutman, Kylie Haskins, U.S. FDA; Illumina; John Kadavil, U.S. FDA; Yan Mao, Boehringer Ingelheim; Nicholas King, Critical Path Institute; Omar Laterza, Merck; Jean Lee, BioQualQuan; Steve Lowes, Q2 Solutions; Vasum Peiris, U.S. FDA; Steven P. Piccoli, GlaxoSmithKline; Mark Rose, CHDI; Afshin Safavi, BioAgilytix; John Michael Sauer, Critical Path Institute; Shelli Schomaker, (retired); Rick Steenwyk, Pfizer (retired); Lauren Stevenson, Immunologix Laboratories; Meena Subramanyam, Takeda; Matt Szapacs, GlaxoSmithKline; Faye Vazvei, Merck; Sue Jane Wang, U.S. FDA; Jianing Zeng, Bristol-Myers Squibb;