The Academic Thoracic Oncology Medical Investigators 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 thoracic and lung cancer with the ultimate goal of identifying new drugs to treat this disease.
What is ATOMIC?
ATOMIC stands for the Academic Thoracic Oncology Medical Investigators Consortium, an innovative and focused full service research model created to enhance the state of care for thoracic and lung cancer patients, with a goal of expediting the process of identifying and efficiently testing active new compounds for the treatment of these and related cancers. 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 Thoracic Oncology Medical Investigators Consortium’s goal is to serve as an important model for speeding time-to-market for drugs targeting all thoracic and lung 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.
ATOMIC officially launched its kick-off meeting in July 2014. The Academic Thoracic Oncology Medical Investigators 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 thoracic and lung cancer studies. 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.
ATOMIC 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 Thoracic Oncology Medical Investigators 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 thoracic and lung 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 thoracic and lung cancer research and treatment
- Ability to contribute to translational research endpoints
- Principal Investigators who are renowned clinical research leaders
The Academic Thoracic Oncology Medical Investigators Consortium offers an innovative and focused research model that facilitates sponsor decision making for the development of new cancer drugs.
Overview
The Academic Thoracic Oncology Medical Investigators 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 Thoracic Oncology Medical Investigators 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 Thoracic Oncology Medical Investigators 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
Liza C. Villaruz, M.D.
Director of ATOMIC
Dr. Liza C. Villaruz is a Professor of Medicine at the University of Pittsburgh and the UPMC Hillman Cancer Center (HCC), Section Chief of the Thoracic Medical Oncology Program and Co-Leader of the Immunotherapy and Drug Development Center (IDDC) at the UPMC HCC. She is a clinical and translational investigator in lung cancer with a focus on early drug development. She has active involvement in current clinical trials and a strong track record of successful development of institutional clinical trials with the National Cancer Institute and with industry partners.
Dr. Villaruz is board-certified in internal medicine, medical oncology and hematology at UPMC Hillman Cancer Center, and she specializes in lung cancer and thoracic malignancies. She received an undergraduate degree at the University of Notre Dame in Notre Dame, IN and a medical degree at the University of Maryland School of Medicine in Baltimore. Dr. Villaruz completed a residency in internal medicine at UPMC and a fellowship in hematology and oncology at the UPMC Hillman Cancer Center.
Dr. Villaruz is Director of the Academic Thoracic Oncology Medical Investigators Consortium (ATOMIC), a national consortium of academic institutions that design and conduct clinical trials in thoracic oncology. She is the contact Principal Investigator (cPI) of the UM1 NCI ETCTN Pittsburgh Cancer Consortium (PCC) and serves on the NCI Investigational Drug Steering Committee (IDSC).
Dr. Villaruz has a thoracic oncology outpatient clinic at the Hillman Cancer Center. She has a specialty in the use of molecular profiling in the identification of genomic alterations that are amenable to personalized lung cancer therapies. Dr. Villaruz conducts numerous clinical trials evaluating novel targeted therapeutic approaches for patients with solid tumors and in particular lung cancer. She works at the multidisciplinary level to ensure comprehensive care of all patients.
Dr. Villaruz is a member of professional organizations, including the American Society of Clinical Oncology and the International Association for the Study of Lung Cancer.
D. Ross Camidge, M.D.
Senior Advisor of ATOMIC
D. Ross Camidge, MD, PhD is Professor of Medicine/Oncology and holds the Joyce Zeff Chair in Lung Cancer Research at the University of Colorado. Dr. Camidge was educated at Cambridge University (MRC Laboratory of Molecular Biology), Cambridge, UK 1992; and Oxford University Medical School, Oxford, UK 1995. He joined the University of Colorado as a visiting professor in November of 2005, and was recruited as full-time faculty in October of 2007. He is dual-trained in both medical oncology and clinical pharmacology.
Dr. Camidge is the Director of Thoracic Oncology at the University of Colorado. His focus is in Thoracic Malignancies and Developmental Therapeutics (Phase I studies). In 2012 he was announced as the recipient of the Bonnie J. Addario International Lectureship Award as a Luminary in the quest to eradicate lung cancer. In 2013 he became the first physician to receive the Hank Baskett Sr. Spirit Award, for which he was credited as being one of the leading minds in lung cancer today. In 2014, he was nationally recognized by The Quality of Life Center at Claremont University in California as an exemplary mentor in the positive development of junior colleagues in the profession. In 2015 he became the inaugural holder of the Joyce Zeff Chair in Lung Cancer Research at the University of Colorado Cancer Center and, in 2016, the Lung Cancer Foundation presented him with the Breath Away From The Cure Award describing him as simply one of the best in treating lung cancer today.
Dr Camidge is also the National Medical Director of the Academic Thoracic Oncology Medical Investigators Consortium (ATOMIC) and a member of the National Comprehensive Cancer Network Lung Cancer Committee. He has been principal investigator on numerous clinical trials in early phase drug development and thoracic malignancies. He has authored more than 150 articles and reviews in peer-reviewed journals such as Cancer, Journal of Clinical Oncology, Journal of Thoracic Oncology and The New England Journal of Medicine. He has presented his research at multiple national and international scientific meetings.
Dr Camidge has been principal investigator on numerous clinical trials in early phase drug development and thoracic malignancies. He has authored more than 150 articles and reviews in peer-reviewed journals such as Cancer, Journal of Clinical Oncology, Journal of Thoracic Oncology and The New England Journal of Medicine. He has presented his research at multiple national and international scientific meetings.
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.
Howard L. (Jack) West, M.D.
Senior Medical Advisor for the Oncology Consortia of Criterium
Dr. West, medical oncologist, most recently posted at the Swedish Cancer Institute in Seattle is now Consultant and Senior Advisor to ATOMIC. He currently serves as a Clinical Associate Professor at City of Hope Comprehensive Cancer Center in Duarte, CA.
Dr. West received an MPhil in Experimental Biology from Cambridge University on a Fulbright Scholarship and a medical degree (magna cum laude) from Harvard Medical School, where Dr. West also conducted research as a Howard Hughes Medical Student Fellow. His postdoctoral training included an internship and residency in internal medicine at the Harvard-affiliated Brigham and Womens Hospital Boston, MA, followed by a fellowship in medical oncology at the Fred Hutchinson Cancer Research Center / University of Washington in Seattle, WA. He then spent over 16 years as Medical Director of the Thoracic Oncology Program at Swedish Cancer Institute in Seattle, WA.
In addition to his clinical work and development of telemedicine programs at City of Hope, he serves as Founder & President, Global Resource for Advancing Cancer Education (GRACE); Web Editor for JAMA Oncology; Medical Director, Thoracic Oncology Program, Swedish Cancer Institute; Medical Director, Genitourinary Oncology Program, Swedish Cancer Institute; and Medical Oncologist, Swedish Cancer Institute. He has had faculty appointments as Affiliate Investigator, Fred Hutchinson Cancer Research Center and Acting Instructor, Division of Medical Oncology, University of Washington, Seattle Cancer Care Alliance.
His professional affiliations include Southwest Oncology Group (Lung & Early Therapeutics), King County Medical Society, Washington State Medical Society, American Association for Cancer Research, International Association for the Study of Lung Cancer, Washington State Medical Oncology Society, and the American Society of Clinical Oncology. He is prolific author and accomplished presenter.
Dr. West founded and continues to serve as President of the nonprofit organization Global Resource for Advancing Cancer Education (GRACE), a source of timely, free information for patients and caregivers dealing with cancer that currently receives over 50,000 visits per month from over 100 countries around the world.
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