GMKBThe Implementing GeNomics In pracTicE Pragmatic Trials Network (IGNITE PTN), also known as IGNITE II, is an NIH-funded network dedicated to supporting the implementation of genomics in healthcare. The network is comprised of five clinical groups that help promote the mission of IGNITE through support from a coordinating center, working groups (such as the Data and Safety Monitoring Board and Patient/Participant Advisory Board), affiliate members, and an external scientific panel.
Coordinating Center
PRINCIPAL INVESTIGATORS:
Christina Wyatt, MD
Professor of Medicine
Core Faculty Member, DCRI
Duke University School of Medicine
Hrishikesh Chakraborty, DrPH
Professor of Biostatistics and Bioinformatics
Director, Pragmatic Clinical Trial Biostatistics, DCRI
Co-Director, Quantitative Core, Center for AIDS Research
Duke University School of Medicine
ABOUT
Housed within the Duke Clinical Research Institute, the overarching goal of the Coordinating Center (CC) is to ensure the success of IGNITE in designing, implementing and completing its genomic medicine pragmatic clinical trial (PCT) agenda. The CC will do this by providing genomic medicine and clinical trials expertise and leadership as well as the infrastructure, processes, state-of-the-art technology and data science solutions. The CC will serve as a catalyst for collaboration, both within and externally to IGNITE with the goal of demonstrating the network’s value to a broader group of genomic medicine stakeholders in order to promote a more rapid uptake of genomic medicine in clinical practice.
The CC provides a wide range of supporting activities, including:
- Providing strategic organizational leadership to develop a novel, flexible and adaptable genomic PCT network;
- Implementing an administrative management structure for the network that enables seamless communication, information sharing and optimum network productivity;
- Ensuring optimal and adaptable PCT design, participant recruitment and data collection;
- Developing a comprehensive analysis framework for evaluating the implementation and clinical effectiveness of the genomic medicine interventions; and
- Communicating and disseminating knowledge beyond the network.
KEY PERSONNEL
Christina Wyatt, MD – Associate Professor of Medicine, Duke University School of Medicine; Core Faculty Member at the Duke Clinical Research Institute
Hrishikesh Chakraborty, DrPH – Professor of Biostatistics and Bioinformatics; Director of Pragmatic Clinical Trial Biostatistics, Duke Clinical Research Institute; Co-Director of Quantitative Core, Center for AIDS Research (CFAR)
Bhargav Srinivas Adagarla – Senior Bioinformatician
Beth Harris – ADOPT-PGx Project Leader
Lilin She, PhD – Biostatistician
Rachel Myers, PhD – Research Scientist
Lori Orlando, MD, MHS – Associate Professor of Medicine
Carol Pereira, BS – Clinical Data Program Manager
Nina Sperber, PhD – Assistant Professor in Population Health Sciences
Kady-Ann Steen-Burrell, PhD – Clinical Trials Operations Lead, GUARDD-US Project Leader, IGNITE CC Program Director
Sarah George, BS – Associate Project Leader
Jaclyn Holland – Lead Clinical Research Associate
Rania Metry – Data Manager
Yashika Johnson – Clinical Research Associate
Clinical Groups
Indiana University Health
PRINCIPAL INVESTIGATORS:
Todd Skaar, PhD
Professor of Medicine
Division of Clinical Pharmacology
Indiana University School of Medicine
Paul Dexter, MD
Associate Professor of Clinical Medicine
Division of General Internal Medicine
Indiana University School of Medicine
ABOUT
Indiana University Health is a national leader in medical research and education. It has >3,000 full-time faculty who receive >$500 million annually in external research grants and awards. With more than 60 academic departments and specialty divisions across nine campuses statewide and strong clinical partnerships with Indiana’s most advanced hospitals and physician networks, the school is continuously advancing its mission to prepare healers and transform health in Indiana and throughout the world. It also has the largest medical student class in the country.
KEY PERSONNEL
Todd Skaar, PhD – Professor of Medicine, Division of Clinical Pharmacology
Paul Dexter, MD – Associate Professor of Clinical Medicine, Division of General Internal Medicine
John T. Callaghan, MD, PhD – Associate Professor of Medicine
Zeruesenay Desta, PhD – Professor of Medicine, Division of Clinical Pharmacology
Michael Eadon, MD – Assistant Professor of Medicine, Division of Nephrology
David Haas, MD – Professor of OB/GYN, Department of Obstetrics and Gynecology
Ann Holmes, PhD – Associate Professor, Department of Health Policy and Management, Richard M. Fairbanks School of Public Health
Leslie Hulvershorn, MD – Chair, Department of Psychiatry
Marc Rosenman, MD – Associate Professor, Lurie Children’s Hospital
Tyler Shugg, PharmD, PhD – Assistant Research Professor
Pengyue Zhang, PhD – Assistant Professor of Biostatistics and Health Data Science
EDUCATIONAL AND TRAINING OPPORTUNITIES
View the educational and training opportunities offered by Indiana University Health here.
CLINICAL SITES
Eskenazi Health
Principal Investigators: Todd Skaar, Paul Dexter, and Michael Eadon
Eskenazi Health System serves as the public hospital division of the Health & Hospital Corporation of Marion County. Eskenazi Health provides a comprehensive range of primary and specialty care services at the 315-bed hospital and outpatient facilities both on and off the Eskenazi Health downtown campus as well as at 10 Eskenazi Health Centers and 30 primary care clinics located throughout Indianapolis. Eskenazi Health’s programs have received national recognition while also offering new health care opportunities to the local community. Eskenazi Health is also home to the first adult Level I trauma center in Indiana, the only verified adult burn center in Indiana, the first community mental health center in Indiana and the Eskenazi Health Center Primary Care. Eskenazi Health serves approximately 250,000 vulnerable individuals (>40% minority) who are most commonly under-insured, uninsured, or on Medicaid.
Indiana University Health
Principal Investigators: Todd Skaar, Paul Dexter, and Michael Eadon
Indiana University Health is a nonprofit healthcare system located in Indiana. It is the largest and most comprehensive healthcare system in the state with 16 hospitals under its IU Health brand and almost 30,000 employees. A unique partnership with Indiana University School of Medicine, one of the nation’s leading medical schools, gives patients access to leading-edge medicine and treatment options that are available first, and often only, at IU Health. The IU Health system has a total capacity of 2,696 beds with annual admissions of over 115,000 and more than 2.8 million outpatient visits per year.
University of Pittsburgh
Principal Investigator: Philip Empey
University of Pittsburgh is a premier academic research university located in Pennsylvania. It is highly ranked, surpassing $1B in research-based expenditures annually and was #3 ranked recipient in NIH-funding in 2022. Together, with UPMC, a premier health system and the largest non-government employer in the state, it provides outstanding infrastructure for clinical and translational research through 40 hospitals, >8,000 licensed beds, 800 clinical locations, and access to millions of patients.
Mount Sinai
PRINCIPAL INVESTIGATOR:
Carol Horowitz, MD, MPH
Professor of Medicine and Population Health Science & Policy
Center for Community-Academic Research Partnerships
Icahn School of Medicine at Mount Sinai
ABOUT
Mount Sinai is an integrated health system committed to providing distinguished care, conducting transformative research and advancing biomedical education. Structured around seven member hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services, from community-based facilities to tertiary and quaternary care. The Health System’s seven member hospital campuses include Mount Sinai Beth Israel, Mount Sinai Queens, Mount Sinai West, Mount Sinai St. Luke’s, Mount Sinai Brooklyn, New York Eye and Ear Infirmary of Mount Sinai, and The Mount Sinai Hospital.
KEY PERSONNEL
Carol Horowitz, MD, MPH – Principal Investigator, Professor, Icahn School of Medicine at Mount Sinai, Department of Population Health Science and Policy, Department of Medicine, Center for Community-Academic Research Partnerships, Dean for Gender Equity in Science and Medicine
Neil Calman, MD, FAAFP – Site Principal Investigator, President and CEO, The Institute for Family Health
Bart Ferket, MD, PhD – Co-Investigator, Assistant Professor, Icahn School of Medicine at Mount Sinai, Department of Population Health Science and Policy
Joseph Kannry, MD – Co-Investigator, Professor, Icahn School of Medicine at Mount Sinai, Department of Medicine, Lead Technical Informaticist, EMR Clinical Transformation Group, Mount Sinai Health System
Dinushika Mohottige, MD – Co-Investigator, Assistant Professor, Icahn School of Medicine at Mount Sinai, Institute of Health Equity Research, Division of Nephrology
James Murrough, MD, PhD – Co-Investigator, Associate Professor, Icahn School of Medicine at Mount Sinai, Department of Psychiatry, Department of Neuroscience
Girish Nadkarni, MD – Co-Investigator, Assistant Professor, Icahn School of Medicine at Mount Sinai, Department of Medicine, Division of Nephrology
Aniwaa Owusu Obeng, PharmD –Co-Investigator, Assistant Professor, Icahn School of Medicine at Mount Sinai, Department of Medicine, Department of General Internal Medicine
Randi Zinberg, MS – Co-Investigator, Assistant Professor, Icahn School of Medicine at Mount Sinai, Department of Genetics and Genomic Sciences, Department of Obstetrics, Gynecology and Reproductive Science
EDUCATIONAL AND TRAINING OPPORTUNITIES
View the educational and training opportunities offered by Mount Sinai here.
CLINICAL SITES
Institute for Family Health
Principal Investigator: Neil Calman
The Institute for Family Health (IFH) is a federally-qualified community health center (FQHC) network committed to high-quality, affordable health care for all. IFH strives for excellence at each of their 30 practices, most of which are located in NYC, while accepting all patients regardless of their ability to pay. They offer primary care, mental health, dental care, social work and many other services to patients of all ages and train health students and professionals at all levels.
Mount Sinai
Principal Investigator: Carol Horowitz
Mount Sinai is an integrated health system committed to providing distinguished care, conducting transformative research and advancing biomedical education. Structured around seven member hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services, from community-based facilities to tertiary and quaternary care. The Health System’s seven member hospital campuses include Mount Sinai Beth Israel, Mount Sinai Queens, Mount Sinai West, Mount Sinai St. Luke’s, Mount Sinai Brooklyn, New York Eye and Ear Infirmary of Mount Sinai, and The Mount Sinai Hospital.
Duke University
PRINICIPAL INVESTIGATOR:
Deepak Voora, MD
Professor of Medicine
Executive Team Member of Duke Center for Applied Genomics and Precision Medicine
Member of the Center for Applied Genomics & Precision Medicine
ABOUT
Duke Health, which includes the Duke University Health System, the Duke University School of Medicine and the Duke University School of Nursing, combines research, clinical care and education at many different sites throughout the region and beyond. Duke University School of Medicine is among the most research-intensive of the U.S. medical schools, and the size, quality and scope of our research enterprise contributes substantially to the reputation of the School of Medicine, Duke University and the Duke University Health System. The entire medical campus encompasses 98 clinical, research and education buildings and employs more than 2,200 academic and clinical faculty physicians and researchers. Twenty-eight buildings on campus are dedicated to School of Medicine research and education.
The Duke Precision Medicine Program aims to bring proven precision medicine technologies from the basic science portfolio to clinical settings through both research and clinical programs. The program encompasses a wide range of precision medicine technologies, including tools such as wearables and a family history risk assessment platform, as well as predictive models that incorporate multiple modalities using state-of-the-art scientific principles like machine learning. Housed in the Division of General Internal Medicine in the Duke Department of Medicine, the program team focuses on integrating ‘omic technologies – such as genomics, transcriptomics, and epigenomics – into clinical environments to enhance patient care. The team also has extensive expertise in health services research, implementation science, and complex data analysis.
KEY PERSONNEL
Lori Orlando, MD, MHS – Professor of Medicine; Director of the Precision Medicine Program in the Center for Applied Genomics & Precision Medicine
Deepak Voora, MD – Associate Professor of Medicine
EDUCATIONAL AND TRAINING OPPORTUNITIES
View the educational and training opportunities offered by Duke University here.
CLINICAL SITES
Baylor Scott & White Health
Principal Investigator: Heather Kitzman
Baylor Scott & White Health and Wellness Center, located in a large underserved urban area of Dallas, is an entity of Baylor Scott & White Health, the largest not-for-profit healthcare system in Texas. We currently have several NIH funded trials, and we are a site for All of Us, the largest study conducted by NIH to evaluate precision medicine innovations. Our research uses community participatory approaches and aims to develop innovative and cost-effective approaches to improve both patient-related and healthcare system outcomes.
Duke Health
Principal Investigator: Lori Orlando
Duke Health, which includes the Duke University Health System, the Duke University School of Medicine and the Duke University School of Nursing, combines research, clinical care and education at many different sites throughout the region and beyond. Duke University School of Medicine is among the most research-intensive of the U.S. medical schools, and the size, quality and scope of our research enterprise contributes substantially to the reputation of the School of Medicine, Duke University and the Duke University Health System. The entire medical campus encompasses 98 clinical, research and education buildings and employs more than 2,200 academic and clinical faculty physicians and researchers. Twenty-eight buildings on campus are dedicated to School of Medicine research and education.
Louisiana Public Health Institute
Principal Investigator: Beth Nauman
Louisiana Public Health Institute is a 501(c)(3) nonprofit organization that translates evidence into strategy to optimize health ecosystems. LPHI is the coordinating center for the Research Action for Health Network (REACHnet), a clinical research network with partner health systems in Louisiana and Texas. REACHnet’s mission is to enable the conduct of multi-site research with enhanced efficiency in real-world healthcare delivery systems. To REACHnet partner sites are participating in GUARDD-US: Baylor Scott & White Health and University Medical Center New Orleans.
Southeastern Healthcare
Principal Investigator: Joseph Roberts
Southeastern Health (SH) is the largest health care provider in rural Robeson County. It has a strong history of working with Duke University as well as the University of North Carolina at Pembroke to engage in intervention science research and demonstration projects. Southeastern Health operates more than 20 primary and specialty care clinics in Robeson County. In addition, SH has additional primary care providers who are on the medical staff and participate in health and research activities whose genius is SH.
UNC Pembroke
Principal Investigator: Cherry Beasley
The University of North Carolina at Pembroke (UNCP) is in rural, southeastern North Carolina in Robeson County, a large, rural (10% smaller than the state of Rhode Island) county that is home to a racially and culturally diverse population. The combined population of American Indian, African American, and Latino residents comprise over 70% of the total population. UNCP in general and the Department of Nursing specifically has worked collaboratively with Duke University and Southeastern Health of several research projects including Improving Outcomes for Chronic Kidney Disease in Southeastern North Carolina, funded by the American Kidney Fund.
University Medical Center New Orleans
Principal Investigator: Jyotsna Fuloria
University Medical Center New Orleans is one of 5 hospitals of the LCMC Health System and the only Level 1 trauma center in the state of Louisiana. UMCNO is the primary teaching hospital of the Louisiana State University Health Sciences Center (LSUHSC) School of Medicine and the secondary teaching hospital of Tulane University School of Medicine. UMC hosts a thriving scientific community that collaborates with numerous National Institute of Health (NIH) programs and other non-profit research organizations to answer questions about new treatments and existing therapies with research spanning the biomedical spectrum, from core lab-based science and translational research to clinical trials in all major disease areas.
University of Florida
PRINCIPAL INVESTIGATORS:
Julie Johnson, PharmD
Professor of Medicine and Pharmacy
Director, Clinical and Translational Science Institute
Associate Dean, Clinical and Translational Science
Associate Vice President for Research
The Ohio State University
Larisa Cavallari, PharmD
Professor of Pharmacotherapy and Translational Research
Co-Director, Center for PGx and Precision Medicine
University of Florida
ABOUT
University of Florida Health is a medical network associated with the University of Florida. UF Health serves 1.5 million patients and is the largest comprehensive academic health center in the Southeastern US. OneFlorida Clinical Research Consortium is an enduring infrastructure to conduct patient-centered PCTs across Florida. Combined, the network includes health systems that provide care for approximately 15 million or 75 percent of all Floridians through 4,100 physician providers, 1,240 clinic/practice settings with a catchment area covering all 67 Florida counties. The Nemours Foundation supports one of the largest integrated pediatric health systems in the U.S., including 50 pediatric subspecialty clinics, 16 partner hospitals, and primary care clinics throughout Delaware, Pennsylvania, and Florida.
KEY PERSONNEL
Julie Johnson, PharmD – Professor of Medicine and Pharmacy, Director, Clinical and Translational Science Institute, Associate Dean for Clinical and Translational Science (Medicine), Associate Vice President for Research, The Ohio State University
Larisa Cavallari, PharmD – Professor of Pharmacotherapy and Translational Research and Co-Director, Center for Pharmacogenomics and Precision Medicine
Rhonda Cooper-DeHoff, PharmD, MS, FAHA, FACC, FACCP – UF Gainesville GUARDD-US Site Principal Investigator, Associate Professor and University Term Professor, Dept. of Pharmacotherapy and Translational Research and Division of Cardiovascular Medicine, Colleges of Pharmacy and Medicine, Associate Director, Center for Pharmacogenomics, University of Florida
Alexander Parker, PhD – Senior Associate Dean for Research, University of Florida College of Medicine – Jacksonville
Kathryn Blake, PharmD, BCPS, FCCP, CIP – Director, Center for Pharmacogenomics and Translational Research Chair, Institutional Review Board 2, Principal Research Scientist, Nemours Children’s Specialty Care, Jacksonville, FL
Nita A. Limdi, PharmD, PhD, MSPH, FAHA – Professor in Neurology, Associate Director for Pharmacogenomics and Implementation Science, University of Alabama, Birmingham
Haesuk Park, PhD – Associate Professor, Dept. of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida
Almut Winterstein, R.Ph, PhD, RISPE – Distinguished Professor, Director for CoDES, Director for Consortium For Medical Marijuana Clinical Outcomes Research, Dept. of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida
EDUCATIONAL AND TRAINING OPPORTUNITIES
View the educational and training opportunities offered by the University of Florida here.
CLINICAL SITES
Nemours Jacksonville and Delaware
Principal Investigator: Kathryn Blake
Nemours is a nonprofit pediatric health system dedicated to: life-changing medical care and research, helping kids grow up healthy, advocating for kids nationally, and training tomorrow’s pediatric experts. Nemours Health system has locations throughout Florida and Delaware.
UF Gainesville
Principal Investigators: Larisa Cavallari, Julie Johnson (Ohio State University), and Rhonda Cooper-DeHoff
University of Florida Health is the Southeast’s most comprehensive academic health center and part of one of the nation’s Top 10 public research universities, unique for diverse constellation of health colleges, centers and institutes, and hospitals, faculty practices and patient care programs. UF Health is headquartered in Gainesville FL, with main campuses there and Jacksonville. UF Health includes six health colleges, nine research institutes and centers, two teaching hospitals, two specialty hospitals and a host of physician medical practices and outpatient services throughout north central and northeast Florida. UF Health represents the shared vision and commitment to patient care excellence of more than 22,000 employees. UF Health Gainesville has 1,162 licensed beds with 55,373 inpatient admissions and 1.64 million physician outpatient visits in 2018.
UF Jacksonville
Principal Investigator: Alexander Parker
UF Health Jacksonville is a private, not-for-profit hospital affiliated with the University of Florida. It is part of UF Health, the Southeast’s most comprehensive academic health center, with campuses in Jacksonville and Gainesville. UF Health Jacksonville is the region’s premier academic health center, a leader in the education of health professionals, a hub for clinical research and a unique provider of high-quality patient care. UF Health Jacksonville is comprised of a 695-bed academic health center near Downtown Jacksonville, an outpatient medical complex and emergency center in North Jacksonville, UF Health Science Center Jacksonville which encompasses three UF colleges, and a network of primary and specialty care centers offering exceptional patient care throughout Northeast Florida and Southeast Georgia.
University of Alabama at Birmingham (UAB)
Principal Investigator: Nita A. Limdi
Established in 1969, UAB is a large metropolitan university with a 380-acre contiguous campus. It is a Carnegie Class-I biomedical research organization, identified by the Carnegie Foundation as one of the top twenty research institutions in the country, with $272 million in NIH support in the last year. Ranked as one of the top 21 NIH-funded institutions, UAB is dedicated to advancing medical knowledge and clinical practice through scholarly research, physician education, and compassionate quality care.
Vanderbilt University
PRINCIPAL INVESTIGATORS
Josh F. Peterson, MD, MPH
Professor of Biomedical Informatics and Medicine
Vanderbilt University
Kerri L. Cavanaugh, MD, MHS
Associate Professor of Medicine
Division of Nephrology and Hypertension
Vanderbilt University
ABOUT
The Vanderbilt Clinical Group (VCG) includes three health systems serving diverse populations: Nashville General Hospital (NGH) at Meharry Medical College (MMC), Sanford Health (SFH), and Vanderbilt University Medical Center (VUMC). The aggregate population across these three centers serves overall 2 million patients annually in the greater Middle Tennessee area as well as North and South Dakota. The investigative team includes expertise in recruitment, health equity, data science, health services, pharmacology, and the study of mental health conditions.
KEY PERSONNEL
Josh F. Peterson, MD, MPH – Professor of Biomedical Informatics and Medicine
Dan Roden, MD – Professor of Medicine, Pharmacology, and Biomedical Informatics; Senior VP for Personalized Medicine
Kerri L. Cavanaugh, MD, MHS – Associate Professor of Medicine, Division of Nephrology and Hypertension
Ebele Umeukeje, MD, MPH – Assistant Professor of Medicine, Division of Nephrology and Hypertension
Robert Greevy, PhD – Professor of Biostatistics
Jordan Baye, PharmD, MA – Associate Professor and Pharmacogenomics Clinical Pharmacist
Michelle Liu, PharmD – Pharmacotherapy Specialist
Siddharth Pratap, PhD – Associate Professor of Biomedical Informatics, Director of Bioinformatics, Meharry Medical College
Nader Bahri, MD – Assistant Professor, Division of Nephrology and Internal Medicine, Meharry Medical College
Rajbir Singh, MD – Director of Clinical and Translational Research, Meharry Medical College
Lindsay Hines, PhD – Specialist in Neuropsychology, Sanford Health
EDUCATIONAL AND TRAINING OPPORTUNITIES
View the educational and training opportunities offered by Vanderbilt University here.
CLINICAL SITES
Meharry Medical College
Principal Investigator: Rajbir Singh
Meharry Medical College (MMC), the nation’s largest private, historically African American academic health center dedicated to educating health-care professionals and biomedical scientists, opened in 1876 to train physicians to care for freed slaves. MMC is a leader in: 1) delivering community-oriented health care to the underserved and minority populations, 2) training professionals in primary care medicine, dentistry; and 3) conducting basic, clinical and applied research emphasizing conditions that disproportionately affect minority populations, specifically African Americans.
Sanford Health
Principal Investigators: Jordan Baye and Lindsay Hines
Sanford Health is an integrated, rural, not-for-profit health system headquartered in the Dakotas. It is one of the largest health systems in the nation with 43 hospitals, 250 clinics and 45 senior living facilities in nine states and three countries. Our regional headquarters in Sioux Falls, South Dakota, Fargo, North Dakota, Bismarck, North Dakota and Bemidji, Minnesota and network locations provide patients across our vast footprint with convenient access to expert medical care, leading-edge technologies and world-class facilities. Enterprise-wide, Sanford experiences an average of 5.8 million patient visits annually. Our 1,500 physicians practice in more than 80 specialty areas of medicine, collaborating with teams of other health care professionals in primary care clinics, hospitals, specialty and rehabilitation centers, laboratories, and long-term care facilities.
Vanderbilt University Medical Center
Principal Investigators: Josh F. Peterson and Kerri L. Cavanaugh
Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated to patient care, research, and the education of healthcare professionals. For decades, VUMC has been at the forefront of pharmacogenomic discovery and its translation into clinical practice. In 2010, VUMC launched PREDICT (the Pharmacogenomic Resource for Enhanced Decisions in Care & Treatment) to empower providers and patients with the genetic information and electronic medical record tools to facilitate genetically-informed clinical decision-making at the point of care. Additionally, VUMC led the implementation of pharmacogenomic testing in several community and academic settings including Meharry Medical Center, Aurora Health System, and Sanford Medical Center during IGNITE I.
Map of IGNITE Coordinating Center and Clinical Groups
