What is the Academic GI Cancer Consortium?
The Academic GI Cancer Consortium is an innovative and focused full service research model created to enhance the state of care for GI cancer patients, with a goal of expediting the process of identifying and efficiently testing active new compounds for the treatment of GI cancers. Our ability to rapidly design and execute focused clinical trials in GI cancers will enhance our partner sponsors ability to make informed decisions on the development of their compounds. Ultimately, the Academic GI Cancer Consortium’s goal is to serve as an important model for speeding time-to-market for drugs targeting all GI cancers.
The Consortium initiative, first proposed by Lawrence Leichman, M.D., originated from frustration over the lack of compounds currently on the market for GI 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 GI 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, AGICC 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 GI malignancies.
A Request For Application was sent to leading U.S. institutions announcing the formation of AGICC, 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 GI cancer program, the Principal Investigator’s experience and expertise, and clinical research operations.
AGICC officially launched with a kick-off meeting in September 2008 at Christiana Care Healthcare Systems in Newark, Delaware. There, protocols for the first trials in colorectal cancer were discussed, along with plans to enroll the Consortium’s first research participants in 2009.
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 GI cancers and shares a common commitment to exploring and creating new frontiers in GI cancer research.
The Academic GI Cancer 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 gastrointestinal 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 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.
AGICC brings together the best minds in GI cancer research to expedite the discovery and efficient testing of active new compounds for the treatment of GI cancers, enabling sponsors to bring efficacious new drugs to the market to advance the state of care for GI cancer patients.
The Academic GI Cancer Consortium’s primary objectives include:
- Advance clinical and translational research in gastrointestinal malignancies through a Consortium of institutions and investigators with expertise in the natural history and molecular biology of GI cancers.
- Create an effective model for privately funded clinical and translational research in GI 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 gastrointestinal malignancies.
Overview
The Academic GI Cancer Consortium is a full service organization positioned to design, perform and analyze clinical trials focused on GI cancers. Consortium Investigators have demonstrated expertise in the natural history and molecular basis of gastro-intestinal malignancies.
Central Coordination
The Academic GI 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 GI Cancer Consortium offers an innovative and focused research model that speeds decision making by the sponsor on development of drugs targeted to GI 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 GI cancer treatment program.
- A demonstrated commitment to GI 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 GI cancer research and treatment.
- Ability to contribute to translational research endpoints.
- A Principal Investigator who is a renowned clinical research leader.
The Leadership Team
Wells A. Messersmith, M.D.
Director of AGICC
Dr. Messersmith trained in internal medicine at Massachusetts General Hospital / Harvard Medical School and did his Medical Oncology / Drug Development Fellowship at Johns Hopkins, where he was on the faculty from 2004-2007 as Assistant Professor in the GI Oncology and Drug Development programs. He joined the University of Colorado Cancer Center in August 2007 as the Director of Gastrointestinal Medical Oncology. He was appointed co-Leader of Developmental Therapeutics in 2010, and in 2014 became Division Head of Medical Oncology, which has >50 faculty.
His focus is on clinical and translational cancer research in gastrointestinal cancers. The comprehensive GI cancer program at Colorado includes multi-disciplinary GI cancer clinics, tumor boards, and research endeavors. He has held NIH and DOD grants, and has served as the principal investigator on >60 national and local therapeutic trials. As an active investigator in the developmental therapeutics laboratory, he is working on novel targeted agents and immunotherapies as well as correlative studies for use on human tissue samples.
Dr. Messersmith is a member of multiple national committees, including the NCI Colon Cancer Task Force, National Comprehensive Cancer Network (NCCN) Committee on Colon/Rectal/Anal Cancers (which sets treatment guidelines used internationally), NCCN Investigator Steering Committee, Medical Oncology Committee of the American Board of Internal Medicine (ABIM), and others.
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.
Lawrence Leichman, M.D.
Medical Advisor for the Oncology Consortia of Criterium & Founding Member, AGICC
Dr. Leichman, Medical Oncologist & Professor of Medicine, most recently posted at UC San Diego Health is now Consultant and Advisor to AGICC.
Lawrence Leichman, MD, is a board-certified medical oncologist who specializes in treating gastrointestinal (GI) cancers. These include cancers of the esophagus, pancreas, stomach, liver, rectum and colon. He uses numerous forms of therapy such as chemotherapy, immunotherapy, biologic therapy, and targeted therapy to offer the best possible treatment options for patients. Dr. Leichman also has expertise in using neoadjuvant therapies to treat gastrointestinal malignancies. Neoadjuvant therapies, which include chemotherapy, radiation therapy and hormone therapy, are delivered to a person before the main treatment (surgery), with the intent lower to lower the risk that the cancer will return.
Over his career, Dr. Leichman has served as a leader in developing GI programs at several cancer centers. He has also led key initiatives to advance the research needed for making new treatments available to patients. He often works with surgical oncologists, radiation oncologists, pathologists and science co-investigators in an ongoing commitment to advance translational medicine for GI cancers. Dr. Leichman has co-authored many articles, and his work has been published in journals such as Journal of Clinical Oncology and Journal of the National Cancer Institute, among others.
Dr. Leichman has served as director of GI Malignancies in the Division of Hematology and Medical Oncology at NYU Langone Medical Center and was a professor in the Department of Medicine at NYU School of Medicine. While there, he was awarded faculty of the year in the Division of Hematology and Medical Oncology in 2013. In 2006, Dr. Leichman founded the Aptium Oncology GI Cancer Consortium (now AGICC), a group that includes membership of some of the leading university cancer center programs, including University of Colorado, University of North Carolina, Vanderbilt University, New York University, and the University of Southern California. His other previous positions include chairman of the Department of Medicine at Roswell Park Cancer Institute and director of the GI Oncology Program at USC Norris Comprehensive Cancer Center.
Dr. Leichman completed a fellowship in medical oncology and a residency in internal medicine at Wayne State University School of Medicine, where he also earned his medical degree. He is board-certified in internal medicine and medical oncology. He is a member of the American Society of Clinical Oncology and the American Association for Cancer Research.
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