News & Events
News & Events
December 19, 2018
In Recognition of 10th Anniversary, Raymond Woosley and Janet Woodcock Address CPAD Consortium’s 2018 Annual Meeting and Regulatory Science WorkshopAt its 10th Annual Meeting and Regulatory Science Workshop, November 13, 2018, in Bethesda, MD, C-Path’s Critical Path for Alzheimer’s Disease (CPAD) consortium hosted key stakeholders who gathered to review the progress made made over the past year and identify and prioritize regulatory science needs for Alzheimer disease (AD) and related dementias. At the meeting,...
December 18, 2018
Critical Path Institute Encouraged by FDA to Move Forward on Type 1 Diabetes Biomarker InitiativeBiomarker potentially could identify individuals at risk of developing T1D TUCSON, Ariz., December 18, 2018 — Critical Path Institute (C-Path) announced today that its Type 1 Diabetes (T1D) Consortium has received a positive response to its Letter of Intent (LOI) from the U.S. Food and Drug Administration (FDA) detailing the FDA’s decision to accept the...
December 17, 2018
CPTR Newsletter – December 2018CPTR Newsletter – December 2018 In this issue: In the Spotlight: TB-ReFLECT Manuscript Published Updates to the TB-PACTS Clinical Trial Data Repository Project Highlights: Application of the HFS-TB to Inform Regimen Development Programs Collaboration to Expand ReSeqTB Clinical Data Sets Supporting Global Surveillance of TB Resistance Progress with Regulatory Authorities LAM Biomarker Notes...
December 12, 2018
U.S. Food and Drug Administration Awards Contract to Critical Path Institute for Kidney Transplant DatabasePatient-level data will inform the creation of drug development tools and speed development of new immunosuppressive treatments TUCSON, Ariz., December 12, 2018 — The U.S. Food and Drug Administration (FDA) has awarded a contract to Critical Path Institute (C-Path) in support of a new project to create a database of patient-level clinical trial data that...
November 28, 2018
Sharing Data to Accelerate Medicines Development and Improve Neonatal Care: Data Standards and Harmonized Definitions
Kate Costeloe, MD, Mark A. Turner, MBChB, PhD, Michael A. Padula, MD, MBI, Prakesh S. Shah, MD, Neena Modi, MD, Roger Soll, MD, Dominique Haumont, MD, Satoshi Kusuda, MD, Wolfgang Göpel, MD, Yun Sil Chang, MD, PhD, P. Brian Smith, MD, Kei Lui, MD, Jonathan M. Davis, MD, and Lynn D. Hudson, PhD, and the International Neonatal Consortium