TUCSON, Ariz., March 19, 2020 — The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has funded a cooperative agreement to establish a Rare Disease Clinical Outcome Assessment (COA) Consortium. The grant (U01FD006882)* was awarded to the Critical Path Institute (C-Path) with the National Organization for Rare Disorders (NORD) as a sub-awardee. The first step taken toward the establishment of the new consortium has been the creation of the Rare Disease Subcommittee within C-Path’s Patient-Reported Outcome (PRO) Consortium. The PRO Consortium will serve as an incubator for the maturation of a pre-competitive, multi-stakeholder consortium within C-Path’s COA Program.Continue reading
Author Archive: Roxan Olivas
C-Path and Lundbeck Announce a Data Sharing Collaboration to Enable Development of Advanced Drug Development Tools in Alzheimer’s Disease
TUCSON, Ariz., March 18, 2020 — The Critical Path Institute (C-Path) and H. Lundbeck A/S (Lundbeck) are proud to announce that they will work together to significantly improve the scientific community’s insight in Alzheimer’s disease (AD) through Lundbeck’s contribution of a unique set of clinical trial data from more than 2,500 AD patients to the Critical Path for Alzheimer’s Disease (CPAD) consortium’s integrated database for qualified researchers across the globe to access.Continue reading
C-Path to Lead Multi-Stakeholder Engagement on FDA’s Proposed Novel Framework to Enhance the Pediatric Medical Device Ecosystem
TUCSON, Ariz., March 17, 2020 — The Critical Path Institute (C-Path) today announced it has been awarded a grant to conduct stakeholder engagement to garner insights, feedback and refinement of the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health’s (CDRH) proposed framework to enhance the pediatric medical device ecosystem and to develop a strategic plan for implementation. Funded by a cooperative agreement through the FDA, C-Path will work in collaboration with CDRH and other stakeholders to organize a workshop to brainstorm on the framework and strategic plan for building a viable ecosystem.Continue reading
C-Path Appoints Dr. Klaus Romero as Chief Science Officer
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
C-Path Selects Experienced Neuroscientist to Lead Alzheimer’s Consortium
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
Innovative Data and Analytics Platform to Accelerate Drug Development for Rare Diseases
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.
Funded by FDA, C-Path and NORD to Launch Rare Disease Data Analytics Platform
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.
Graduate Certificate Program in Regulatory Science Offered by UA Colleges of Law and Pharmacy and the Critical Path Institute Now Accepting Applications
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).
C-Path Taps Medical Science Operations Executive Kristen Swingle as Chief Operating Officer
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.
C-Path Receives Qualification from FDA for the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD)
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.