What is the Academic Urology Research Investigators Consortium?
The Academic Urology Research Investigators Consortium (AURIC) is an innovative and focused full service research model created to enhance the state of care for GU cancer patients, with a goal of expediting the process of identifying and efficiently testing active new compounds for the treatment of GU cancers. Our ability to rapidly design and execute focused clinical trials in GU cancers will enhance our partner sponsors ability to make informed decisions on the development of their compounds. Ultimately, the Academic Urology Research Investigators Consortium’s goal is to serve as an important model for speeding time-to-market for drugs targeting all GU cancers. AURIC officially launched with a kick-off meeting in July 2022.
The Consortium initiative, first proposed by Lawrence Leichman, M.D., originated from frustration over the lack of compounds currently on the market for cancers that could prove effective over the long term, and with the potential for targeting actual cancer-causing molecular events. The use of targeted agents presents opportunities that may reduce the problems associated with cytotoxic drugs that not only kill large numbers of cancer cells, but kill normal tissue as well, typically leading to severe side effects for cancer patients. The challenge was to create a new process for clinical trials that would be faster and more efficient, in order to expedite the identification and testing of targeted agents that are in development but still require evaluation for usefulness. To that end, AURIC has assembled the best possible team of institutions and investigators to assist in the design and rapid completion of Phase I and II clinical trials in GU malignancies.
A Request For Application was sent to leading U.S. institutions announcing the formation of AURIC, and seeking applications from interested institutions and investigators for membership in the Consortium. The institutions were selected based upon criteria that included institutional commitment to a GU cancer program, the Principal Investigator’s experience and expertise, and clinical research operations.
This innovative model is the merger of full-service operations with a select group of the best and brightest investigators from prestigious cancer centers around the country. Each member demonstrates clinical and translational research capabilities in GU cancers and shares a common commitment to exploring and creating new frontiers in GU cancer research.
The Academic Urology Research Investigators Consortium builds upon the complementary strengths of the member institutions selected for the Consortium, each of which is funded via a competitive support grant to be used for expanding and supplementing their ongoing clinical and translational genito-urinary cancer programs.
Translational Science
The Consortia Model improves and advances research outcomes
The most important conceptual difference between the classical clinical trial and the consortia approach is that the Consortia Model, with its highly experienced clinical scientists, is involved on an intellectual advisory level with every step of clinical investigation in a GU cancer study. Classical clinical trials groups “just run the study” with their only substantive role being patient accrual.
Translational science is motivated by the need to provide effective treatments to the right patients at the right doses for a specific disease indication. The term, as used in the health sciences, refers to real-time translation of bench science conducted only in a lab, to bedside clinical practice with eventual dissemination to population-based community interventions. (Source: NIH)
The discipline of clinical and translational science encompasses a broad spectrum of research, extending from basic discoveries with implications for human health to community-based epidemiologic and health services studies. The unifying theme is a commitment to apply scientific methodologies to address a health need. SCTS (The Society for Clinical and Translational Science) defines it as:
“…a multi-dimensional, cross-cutting discipline that encompasses multidisciplinary investigative teams from many different subspecialty areas. Moreover, success in clinical and translational science commonly requires constructive partnerships with industry, granting agencies, public health agencies, and regulatory agencies. “
For more information on how the Consortia Model applies translational science to successful research outcomes, please contact Henry G. Kaplan, MD at: hkaplan@criteriuminc.com
| Activity | Clinical Trials Group | Consortia Model |
| Concept | Developed by Sponsor | Developed by Sponsor in consultation with Consortia “Brain Trust/Virtual Advisory Board” |
| Protocol | Written by Sponsor | Written by Consortia with Sponsor |
| FDA/Regulatory Agency Contact | Done by Sponsor | Consortia functions as “Virtual Advisory Board” to help Sponsor with FDA/Regulatory issues |
| Translational science with clinical outcomes | Little or NONE | Consortia interfaces translational science with clinical outcomes and can show the value of translational science to a positive outcome of regulatory approval process*; consortia institutions have capability to collect tissue and access to labs to analyze and interpret data; consortia sites were selected for their access to patients with specific diseases and for their ability to enroll such patients on clinical trials. |
| Role of Investigators | Accrue patients to established protocol | The consortium investigators are the “Brain Trust clinical scientists who are not only involved in the conceptual design of trial, but also are actively enrolling patients to a trial. ** |
| Role of investigators in result analysis/ interpretation | NONE | Consortia puts the whole package (clinical & translational science) together into a coherent whole which clarifies the value of this package to the regulatory approval process along with providing comprehensive information to the sponsor to facilitate go-no go decisions. |
*Interfacing clinical & translational science is critical to the Consortia’s contribution to research projects.
**Throughout the clinical trial the Consortia contributes ideas and experience.
AURIC brings together the best minds in GU cancer research to expedite the discovery and efficient testing of active new compounds for the treatment of GU cancers, enabling sponsors to bring efficacious new drugs to the market to advance the state of care for GU cancer patients.
The Academic GU Cancer Consortium’s primary objectives include:
- Advance clinical and translational research in genito-urinary malignancies through a Consortium of institutions and investigators with expertise in the natural history and molecular biology of GU cancers.
- Create an effective model for privately funded clinical and translational research in GU cancers.
- Rapidly and efficiently test the efficacy of compounds in development as anti-cancer agents through innovative Phase I and II trials, with the goal of increasing the number of useful compounds available to treat patients with advanced genito-urinary malignancies.
Overview
The Academic GU Cancer Consortium is a full-service organization positioned to design, perform, and analyze clinical trials focused on GU cancers. Consortium Investigators have demonstrated expertise in the natural history and molecular basis of genito-urinary malignancies.
Central Coordination
The Academic GU Cancer Consortium possesses an experienced centralized research department that integrates coordinated project management, finance, contract, and grant management capabilities. This highly effective infrastructure allows for rapid study development, start-up, and enrollment, as well as the capabilities to perform all phases of clinical trials.
Sponsor Advantages
The Academic GU Cancer Consortium offers an innovative and focused research model that speeds decision making by the sponsor on development of drugs targeted to GU Cancer.
Site Expertise
World class investigators and institutions were selected through a highly competitive process that focused specifically on an exemplary combination of qualifications. Each member institution possesses the following attributes:
- An established and vigorous GU cancer treatment program.
- A demonstrated commitment to GU cancer treatment, especially through community access, professional support, and multi-organizational communication.
- A mature clinical research program with a substantial support infrastructure.
- Outstanding and nationally recognized laboratory, treatment, and research facilities.
- Clinicians who are leaders in GU cancer research and treatment.
- Ability to contribute to translational research endpoints.
- A Principal Investigator who is a renowned clinical research leader.
The Leadership Team
Thomas W. Flaig, M.D.
Director of AURIC
Thomas Flaig, MD, was appointed vice chancellor for research for the CU Denver and CU Anschutz Medical Campus in March of 2020. A medical oncologist, Dr. Flaig has been part of CU since 2003, when he arrived as an oncology fellow. In 2016, he became the inaugural chief clinical research officer of UCHealth and associate dean for clinical research at the CU School of Medicine. In this role, he led numerous efforts to create the infrastructure and streamline the processes to provide an efficient and attractive environment for conducting research on our campuses, and to coordinate research activities with the university’s clinical partners.
Dr. Flaig has provided leadership for the expansion of systemwide clinical trial activity at UCHealth and the ongoing implementation of OnCore campuswide. A comprehensive clinical trial management system, OnCore has greatly improved and modernized the management approach to the more than 1,000 clinical research projects on the CU Anschutz Medical Campus.
In addition to his clinical and administrative work, Dr. Flaig has significant clinical and translational research experience, having led both local and national multi-center clinical trials and served as the local principal investigator on a large number of Phase I, II and III studies. He previously served as medical director of the clinical trials office and associate director of clinical research at the CU Cancer Center.
Known nationally for his work on bladder cancer, Dr. Flaig has been a member of the National Cancer Institute’s Investigational Drug Steering Committee and the bladder cancer task force. He also serves as chair of the bladder cancer committee for the National Comprehensive Care Network, which publishes internationally recognized treatment guidelines, updated regularly with new research findings. He has personal experience with the translation of lab discoveries to the clinic, having founded a small business to advance work done in his lab and associated patents.
Henry G. Kaplan, M.D.
Senior Medical Advisor & Medical Monitor for the Oncology Consortia of Criterium
For more than 40 years, Hank Kaplan, M.D., has cared for the community with an unparalleled level of expertise and compassion. He pioneered a revolutionary approach to breast cancer research at the Swedish Cancer Institute developing one of the most detailed breast cancer research databases in the country. While the primary focus of Dr. Kaplan’s research continues to be on breast cancer, he has also worked extensively in hematological malignancies – cancers affecting blood, bone marrow and lymph nodes – and, more recently, in the area of targeted therapy for genomic mutation.
Dr. Kaplan attended Medical School at the University of Rochester, NY. He did his Residency at the University of Washington, WA and a Fellowship with the National Cancer Institute/National Institutes of Health. Previously he was Chief Resident, Dept of Medicine at University of Washington, WA; Assistant Professor of Medicine at Brown University; Adjunct Professor of Pharmacy at University of Rhode Island; and Assistant Professor of Medicine at University of Washington. His Board Certifications include Internal Medicine and Oncology. He is currently Senior Medical and Research Director for Breast Cancer & Translational Genomics Research at the Swedish Cancer Institute and Clinical Associate Professor of Medicine at the University of Washington
He has received multiple faculty teaching awards, AOA and a Swedish Physician Recognition Award. Dr. Kaplan was named the Distinguished Alumnus of the Year by the University of Washington School of Medicine in 2016 and has been recognized in Seattle Metropolitan magazine’s annual Top Doctors and Nurse Practitioners feature.
Please see a selection of his recent papers and publications.
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