The Academic Breast Cancer Consortium is an innovative research model that has brought together an expert team of institutions and investigators to design and rapidly complete clinical trials in breast cancer with the ultimate goal of identifying new drugs to treat this disease.
What is ABRCC?
ABRCC stands for the Academic Breast Cancer Consortium, an innovative and focused full service research model created to enhance the state of care for breast cancer patients, with a goal of expediting the process of identifying and efficiently testing active new compounds for the treatment of breast cancer. Our ability to rapidly design and execute focused clinical trials in these cancers will enhance our partner sponsors ability to make informed decisions on the development of their compounds. Ultimately, the Academic Breast Cancer Consortium’s goal is to serve as an important model for speeding time-to-market for drugs targeting all breast cancers.
The Consortium initiative 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 we assembled the best possible team of institutions and investigators to assist in the design and rapid completion of Phase I and II clinical trials. These institutions were selected based upon criteria that included institutional commitment to a targeted cancer drug program, the Principal Investigator’s experience and expertise, and clinical research operations.
ABRCC officially launched its kick-off meeting in August 2014. The Academic Breast Cancer Consortium builds upon the complementary strengths of the member institutions selected for the Consortium.
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 GI 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.
ABRCC is a full service organization positioned to design, perform and analyze clinical trials with a focus on Phase I, IB and Phase II clinical trials. Our trial program is a collaborative effort with the scientific support of our consortium investigators, who have demonstrated expertise in treating the disease and are translational research experts.
The Academic Breast Cancer Consortium centralized research team integrates coordinated project management, monitoring and data management, review and analysis. Master clinical trial agreements with each institution minimize time to contract execution and simplify finance, grant, and contract management for both the institutions and the sponsors. This highly effective infrastructure allows for rapid study development and start-up.
Our world class investigators and institutions were selected through a highly competitive process that focused on an exemplary combination of qualifications.
Each member institution was selected based on these attributes:
- An established breast cancer treatment program with infrastructure support
- A demonstrated commitment to cancer treatment, especially through community access and professional support
- Outstanding and nationally recognized laboratory, treatment and research facilities
- Clinicians with expertise in breast cancer research and treatment
- Ability to contribute to translational research endpoints
- Principal Investigators who are renowned clinical research leaders
The Academic Breast Cancer Consortium offers an innovative and focused research model that facilitates sponsor decision making for the development of new cancer drugs.
Overview
The Academic Breast Cancer Consortium is a full service organization positioned to design, perform and analyze clinical trials focused on thoracic and lung cancers. Consortium Investigators have demonstrated expertise in the natural history and molecular basis of thoracic and lung malignancies.
Central Coordination
The Academic Breast 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 Breast Cancer Consortium offers an innovative and focused research model that speeds decision making by the sponsor on development of drugs targeted to thoracic and lung cancers.
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 cancer treatment program.
- A demonstrated commitment to 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 cancer research and treatment.
- Ability to contribute to translational research endpoints.
- A Principal Investigator who is a renowned clinical research leader.
The Leadership Team
Peter Kabos M.D.
Director of ABRCC
Dr. Peter Kabos is Assistant Professor, Division of Medical Oncology at University of Colorado Cancer Center. Dr. Kabos joined the UCD faculty in July 2009 and was a member of the breast oncology program there. He spent four years as a post-doctoral research fellow at Cedars-Sinai Medical Center studying the biology of normal and cancer stem cells in gliomas. He completed his Internal Medicine residency training at USC Keck School of Medicine in Los Angeles and a fellowship in Hematology/Oncology at the University of Colorado Denver. He received his MD from Comenius University, Slovakia.
His research focus is in translating preclinical findings into novel treatments for patients with breast cancer. The Kabos Lab at the university focuses on the role of breast cancer stem cells and tumor microenvironment in treatment resistance.
His specialties and certifications include: Internal Medicine, Board Certification (2006); Internal Medicine – Medical Oncology, Board Certification (2009). His awards and honors include the ASCO Young Investigator Award and a Spore Seed Grant for Breast Cancer.
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.
John S. Macdonald, M.D.
Advisor Emeritus for the Oncology Consortia of Criterium
John S. Macdonald, MD, is the Advisor Emeritus for Criterium Inc. He served as Medical Director and Chief of Gastrointestinal Oncology at St. Vincent’s Comprehensive Cancer Center in New York City from 1998-2007. Dr Macdonald is Board certified in internal medicine and oncology. In addition to his responsibilities at the Saint Vincent’s Cancer Center from 1998 to 2007, Dr. Macdonald served as Chief of Medical Oncology at St. Vincent’s Hospital and Medical Center, and Professor of Medicine at the New York Medical College.
Dr. Macdonald was named as the first recipient of an endowed professorship, the Lynn Wood Neag Distinguished Professor of Gastrointestinal Oncology, in 1999. He is recognized as a leading educator in Medical Oncology and has received numerous forms of recognition for his skills in medical education including being honored as Outstanding Clinical Attending Physician by the Department of Medicine at Georgetown University in 1977 and serving as a member of the Medical Oncology Section of the American Board of Internal Medicine from 1987 to 1993. Dr Macdonald served as Chair of the Gastrointestinal Cancer Committee of the Southwest Oncology Group between 1985 and 2000.
A leader in his field and a specialist in gastrointestinal cancer, Dr. Macdonald has authored more than 400 articles, abstracts and book chapters and has been published in many medical journals, including The New England Journal of Medicine, Cancer; Recent Results in Cancer Research; Advances in Medical Oncology, Research, and Education; and Medscape Hematology-Oncology. In addition to his writing he has served as editor of multiple journals including Cancer Treatment Reports, Journal of Clinical Oncology, and the Manual of Oncologic Therapeutics. In 2007 he served as editor of Advances in the Management of gastric Cancer.
Dr. Macdonald is a member of numerous professional organizations including the American College of Physicians, American Association for Cancer Research and American Society of Clinical Oncology. He has made over 400 presentations both nationally and internationally.
Dr. Macdonald received his medical degree from Harvard Medical School. He then went on to complete an internship and residency in internal medicine at the Beth Israel Hospital in Boston, and was awarded a fellowship in oncology at the National Cancer Institute. He was awarded an American Cancer Society Junior Faculty Fellowship. Dr. Macdonald was named a Fellow of the American Collage of Physicians in 1979.
Dr. Macdonald has received numerous awards and distinctions including being named in the Best Doctors in America listing in Good Housekeeping’s “Best 300 Doctors in America.” He has been named one of New York Magazine’s “Best Doctors in New York” over a seven year period.
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