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.

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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 WASHINGTONAugust 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 Administrationthe 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

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

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)

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

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

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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