News & Events

• June 11, 2019
  

  C-Path’s PSTC Releases Points to Consider Outlining Recommendations for Analytical Validation of Assays Used in Qualifying Biomarkers

  The document serves as a guide to the analysis of biomarkers in drug development   TUCSON, Ariz., June 11, 2019 — The Critical Path Institute’s (C-Path) Predictive Safety Testing Consortium (PSTC) has released a new consensus paper titled, “Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the...
• 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;

• May 22, 2019
  Measurement Comparability of Electronic and Paper Administered Visual Analogue Scales: A Review of Published Studies

• May 16, 2019
  

  Poster presentation at the 2019 Arizona Alzheimer’s Consortium Annual Scientific Conference, May 16, 2019, Tempe, AZ

• May 16, 2019
  

  Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials (May 16, 2019)

  This webinar provides an overview of the issues related to the use of paper backups in studies for which PRO data is collected electronically. Viable strategies to eliminate the necessity of a paper-backup system are provided. Presenters: Cindy Howry, MS (.assisTek) and Paul O’Donohoe, MSc (Medidata Solutions) PDF version