TUCSON, Ariz., April 9, 2019 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces U.S. Food and Drug Administration (FDA) qualification of two new clinical outcome assessment tools: the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD). The qualification of the ADSD and the ANSD represents a major milestone for the PRO Consortium and specifically for the Asthma Working Group. It is the culmination of a multi-year collaboration between FDA’s Center for Drug Evaluation and Research (CDER) and the PRO Consortium.
Author Archive: Roxan Olivas
C-Path President and CEO, Board Director Selected to Serve on Esteemed National Academies of Sciences, Engineering and Medicine Committee
C-Path President and CEO Martha Brumfield, PhD, and C-Path Board Director Alastair J. Wood, MD, FRCP, have both been selected to the serve on the National Academy Consensus Committee examining Mutual Recognition Agreements in the Regulation of Medicines under The National Academies of Sciences, Engineering and Medicine. Dr. Wood will serve as chair.
C-Path Selects Global Regulatory Affairs Leader as New President and CEO
TUCSON, Ariz., March 21, 2019 — After a worldwide search, the Critical Path Institute (C-Path) today announced it has appointed Joseph Scheeren, Pharm. D., as its new President and Chief Executive Officer. Scheeren previously served as Senior Advisor Research and Development for Bayer AG and has had a distinguished 36-year career in the pharmaceutical industry having held positions domestically and internationally in drug development and regulatory approval on three continents.
C-Path, FNIH Announce Clinical Development User’s Guide for Kidney Safety Biomarkers
TUCSON, Ariz., March 14, 2019 — The Critical Path Institute’s (C-Path) Predictive Safety Testing Consortium (PSTC) today announced availability of the User’s Guide: Kidney Safety Composite Measure Biomarker for Use in Clinical Development.Continue reading