About the Academic Myeloma Consortium (AMyC)
Collaboration & Innovation in Cancer Research
Dedicated to Research that Advances Myeloma Treatment
What is the Academic Myeloma Consortium?
The Academic Myeloma Consortium is an innovative and focused full service research model that has combined expertise in carrying out the operational components of oncology clinical research with a group of key opinion leaders in myeloma treatment and translational research.
- Dedication to research that advances myeloma treatment
- To identify new agents and combinations which can change the treatment paradigm for myeloma
- Foster a collaborative environment for the development of innovative and strategic trials
- Support these trials from concept to completion with an experienced operational team
- Produce rapid trial results, facilitating go/no-go decisions for new treatments in myeloma
- Leverage our translational expertise to reach measurable and definitive endpoints
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 John S. Macdonald, MD at: email@example.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.
Academic Myeloma Consortium Value Proposition
The Academic Myeloma Consortium is a full service organization positioned to design, perform and analyze clinical trials with a focus on myeloma in 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 Myeloma 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 myeloma treatment program with infrastructure support
- A demonstrated commitment to myeloma treatment, especially through community access and professional support
- Outstanding and nationally recognized laboratory, treatment and research facilities
- Clinicians with expertise in myeloma research and treatment
- Ability to contribute to translational research endpoints
- Principal Investigators who are renowned clinical research leaders
The Academic Myeloma Consortium offers an innovative and focused research model that facilitates sponsor decision making for the development of new myeloma drugs.
The Leadership Team
Brian G.M. Durie, M.D.
Director of AMyC
Dr. Durie is the Director of the Academic Myeloma Consortium. Born in Scotland, Dr. Durie graduated from the University of Edinburgh Medical School in 1966. Following internships at the University of Edinburgh, Dr. Durie completed his residencies and his fellowships in Hematology and Oncology at the Mayo Clinic and the University of Minnesota. Alongside Dr. Sydney Salmon at the University of Arizona, he developed the Durie/Salmon Staging System, which is used worldwide for the evaluation of patients with myeloma. In 1981 he was appointed a full Professor of Medicine (Hematology/Oncology). Between 1989 and 1992 Dr. Durie was Professor and Head of the Department of Clinical Laboratory Hematology, Charing Cross and Westminster School of Medicine, University of London, UK. He returned to the U.S. to fulfill the position of Chairman and Medical Director with the International Myeloma Foundation, a California based non-profit organization. In 2009, Dr. Durie received the prestigious Waldenström’s Award for myeloma research. Today Dr. Durie lives and works in Los Angeles, California, where he has a Hematology/Oncology practice specializing in myeloma and related diseases. Durie is also the co-chair of the myeloma committee for the Southwest Oncology Group (SWOG).
John S. Macdonald, MD, is Senior Medical Advisor 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.