Author Archive: Roxan Olivas

Funded by FDA, C-Path and NORD to Launch Rare Disease Data Analytics Platform

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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. 

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Graduate Certificate Program in Regulatory Science Offered by UA Colleges of Law and Pharmacy and the Critical Path Institute Now Accepting Applications

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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).

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C-Path Taps Medical Science Operations Executive Kristen Swingle as Chief Operating Officer

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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.

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C-Path Receives Qualification from FDA for the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD)

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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.

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C-Path President and CEO, Board Director Selected to Serve on Esteemed National Academies of Sciences, Engineering and Medicine Committee

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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.

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C-Path Selects Global Regulatory Affairs Leader as New President and CEO

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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.

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