News & Events
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June 19, 2019
The Critical Path for Parkinson’s consortium announces C-Path’s Data Sharing Pioneer Award recipients
The Critical Path for Parkinson’s consortium (CPP) is pleased to announce the following recipients as the first to receive C-Path’s Data Sharing Pioneer Award. This award is bestowed to member organizations and advisors who have demonstrated dedicated commitment to sharing patient-level data for inclusion in our integrated Parkinson’s database. The database is fundamental to CPP’s... -
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;
- June 3, 2019
- May 24, 2019
