LEXINGTON, Mass.--(BUSINESS WIRE)--Global Coalition for Adaptive Research (GCAR), a 501(c)(3) nonprofit charitable organization, comprised of some of the world’s foremost clinical, translational and basic science investigators working collectively to help speed the discovery and development of cures for rare and deadly diseases, announced its official launch today. As its first priority, GCAR will serve as the official sponsor of GBM AGILE, an adaptive platform trial for patients with glioblastoma (GBM) – the most common and deadliest of malignant primary brain tumors.
“We believe our dedication to the advancement of science through innovative trial design will ultimately result in better treatments and drive rapid progress in order to make a real difference in patients’ lives,” said Dr. Brian M. Alexander, GCAR president and chief executive officer. “Our first effort seeks to improve treatment options for patients with glioblastoma – of which there is no known prevention or early detection methods, few available treatment options, and no cure.”
Initial Goals
GCAR will first aim to
operationalize GBM AGILE, a platform trial to identify new and effective
therapies for glioblastoma. In addition, it will work to create a
repository of clinical, safety and biomarker data from GBM patients to
serve as an important tool for further understanding of this deadly
disease. Finally, GCAR, using GBM AGILE as a model for the efficient
evaluation and development of therapies and biomarkers, will build
additional platform trial collaborations to support the evaluation of
drugs for rare and deadly diseases.
GBM AGILE Overview
GBM AGILE is an
international, seamless Phase II (efficacy and safety)/Phase III
(confirmatory) trial designed to evaluate multiple regimens in newly
diagnosed and recurrent glioblastoma. The goal is to identify effective
therapies and the most promising biomarker-defined populations for those
therapies in patients with glioblastoma. GBM AGILE is a flexible and
adaptable approach that allows researchers to study the effects of
multiple treatment options simultaneously. Furthermore, new treatments
and biomarkers can be added after the trial has started, creating a
learning system in perpetuity.
GBM AGILE is changing the IDEA of clinical trials:
- Innovative – Next-generation trial that will lower cost of development and speed progress.
- Dynamic – Perpetual learning system to quickly add potentially promising new drugs and drop those that appear to be ineffective.
- Efficient – Design and trial structure that will require fewer patients and a shorter time frame to get important answers about a drug’s effectiveness.
- Accessible – Global effort open to a broad patient population newly diagnosed and recurrent GBM patients.
“Building on previous biomedical research discoveries, including traditional randomized controlled trials, a committed group of over 130 oncologists, statisticians, pathologists, neurosurgeons, imagers, advocates, and researchers from academia, industry and government have been working collectively since 2015 to develop an innovative trial approach for GBM – one that we hope will accelerate the way therapies are identified for this deadly disease,” said Dr. Tim Cloughesy, chief medical officer and board member. “The leadership team at GCAR is pleased that its first project will be to act as the official sponsor of GBM AGILE – a revolutionary and patient-centric trial.”
GCAR Leadership
The Global Coalition
for Adaptive Research will be headquartered in Lexington, Mass. and led
by an accomplished team of individuals.
Executive Team:
- Brian M. Alexander, M.D., M.P.H., President and Chief Executive Officer; Associate Professor, Radiation Oncology, Harvard Medical School; Disease Center Leader for Radiation Oncology, Center for Neuro-Oncology, Dana-Farber/Brigham and Women’s Cancer Center; Deputy Director for Regulatory Science, Harvard/MIT Center for Regulatory Science
- Tim Cloughesy, M.D., Chief Medical Officer and Board Member; Director, Neuro-Oncology Program, Professor, Neurology, David Geffen School of Medicine University of California, Los Angeles
- Webster Cavenee, Ph.D., Chief Scientific Officer; Director, Ludwig Institute for Cancer Research; Distinguished Professor, University of California, San Diego
- W.K. Alfred Yung, M.D., Executive Vice President of International Collaborations; Chairman, Department of Neuro-Oncology, Margaret and Ben Love Chair in Clinical Cancer Care, University of Texas, MD Anderson Cancer Center
Board of Directors:
- Faramarz Yousefzadeh, J.D., LL.M., Chairman of the Board; Chairman, Windmill Capital
- Tim Cloughesy, M.D., Board Member and Chief Medical Officer; Director, Neuro-Oncology Program, Professor, Neurology, David Geffen School of Medicine University of California, Los Angeles
- Sujuan Ba, Ph.D., Board Member; President and Chief Operating Officer, National Foundation for Cancer Research
- John Frishkopf, M.M.S., Board Member; Founder and President, Drumlin Field Ventures; Director, Trinitas Capital Management
Strategic Partners
The Global
Coalition for Adaptive Research appreciates the generosity, dedication
and collaboration of its strategic partners who play an important role
in furthering GCAR’s mission of speeding the discovery and development
of cures for patients with rare and deadly diseases. GCAR’s initial
strategic partners include the following organizations:
- Berry Consultants
- Novella Clinical
- National Foundation for Cancer Research
- Cure Brain Cancer Foundation
- Eliminate Cancer Initiative
- Minderoo Foundation
- Wilson Sonsini Goodrich & Rosati
To learn more about GCAR, visit our website: www.gcaresearch.org. Additionally, “like” us on Facebook at www.facebook.com/GCAResearch, follow us on Twitter and add us on Instagram at @GCAResearch.
About Global Coalition for Adaptive Research
The Global
Coalition for Adaptive Research (GCAR) is a 501(c)(3) nonprofit
charitable organization, comprised of some of the world’s foremost
physicians, clinical researchers and investigators united in expediting
the discovery and development of cures for patients with rare and deadly
diseases. As its first priority, GCAR is the official sponsor of GBM
AGILE, an adaptive platform trial for patients with glioblastoma (GBM) –
the most common and deadliest of malignant primary brain tumors. To
learn more, visit: www.gcaresearch.org
