TUCSON, Ariz., March 16, 2020 — The Critical Path Institute (C-Path) today announced the appointment of Klaus Romero, M.D., M.S., F.C.P., as its new Chief Science Officer (CSO) effective April 1, 2020. Dr. Romero, a clinical pharmacologist and epidemiologist with more than 17 years combined experience in academic and pharmaceutical clinical research, translational sciences, pharmacometrics, modeling and simulation and pharmacoepidemiology, has been with C-Path since December 2007. His most recent role has been as Executive Director of Clinical Pharmacology and Quantitative Medicine. He will continue in dual roles as CSO and head of the Quantitative Medicine Program.Continue reading
TUCSON, Ariz., March 13, 2020 — The Critical Path Institute (C-Path) today announced it has named Sudhir Sivakumaran, Ph.D., as Executive Director of its Critical Path for Alzheimer’s Disease (CPAD) consortium effective immediately. Dr. Sivakumaran, a neuroscientist and research and development professional, has nearly 20 years combined experience in academic, pre-clinical and early clinical research and development, phase 1 and phase 2 clinical study design, data analysis and diligence and business development. He has been with C-Path since July 2019 as Associate Director for CPAD.Continue reading
Launched by C-Path and NORD through an FDA grant, the goal of the new platform is to accelerate the development of cures by addressing the need to better characterize rare diseases.
TUCSON, Ariz. and WASHINGTON, September 19, 2019 — The Critical Path Institute (C-Path) and the National Organization for Rare Disorders® (NORD) launched the Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) in Rockville, MD on Tuesday, Sept. 17. The platform, funded by a cooperative agreement through the Food and Drug Administration, [Critical Path Public-Private Partnerships Grant Number U18 FD005320], will provide data and analytics to aid in the understanding of rare diseases and to inform long-term drug development and support innovative trial designs.
The collaborative project between the organizations will kick off at a launch meeting in September and will aim to reduce barriers for the development of new treatments and cures for rare diseases
TUCSON, Ariz. and WASHINGTON, August 7, 2019 — The Critical Path Institute (C-Path) and the National Organization for Rare Disorders® (NORD) will host a meeting on Tuesday, September 17 in Bethesda, MD to formally launch development of a new rare disease data and analytics platform. Funded by a cooperative agreement through the Food and Drug Administration, [Critical Path Public-Private Partnerships Grant Number U18 FD005320 from the US Food and Drug Administration] the goal of the platform is to accelerate the movement of therapies from bench to bedside for rare diseases. The platform will provide the infrastructure for a sustainable, cooperative scientific approach to clinical trial readiness in rare diseases by addressing vast knowledge gaps about the natural course of disease, the clinical evaluation of new treatments, and patients’ perspective on disease and treatment.
Designed for graduate students and working professionals, the certificate program provides specialized training in navigating the path from research to bringing medical products to market.
TUCSON, Ariz., July 16, 2019 — The University of Arizona and the Critical Path Institute are urging students and working professionals to apply now for acceptance into their new online graduate certificate program designed to equip participants across multiple disciplines with core competencies in regulatory science. Regulatory science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all products regulated by the U.S. Food and Drug Administration (FDA).
TUCSON, Ariz., July 2, 2019 — The Critical Path Institute (C-Path) is pleased to announce that after an extensive search, it has appointed Kristen Swingle as its new Chief Operating Officer, effective July 1, 2019.
Swingle, who previously served as Vice President of Stem Cell Operations for Cord Blood Registry (CBR), a part of California Cryobank Life Sciences, specialized in newborn stem cell collection, processing and cryopreservation, brings nearly two decades’ worth of experience in the medical and molecular sciences industry to bear in her new role as she leads the daily operations of the organization and development and implementation of C-Path’s global strategy and goals.
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.
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.
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.
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