IGNITE blazes the way for genomic medicine

Getting diagnosed with a disease can be scary. Health providers work to find the right treatment plan based on the current standard of care guidelines. But what if in addition to the current evidence, doctors could also factor in each patient’s unique genetic makeup to help them diagnose more quickly and accurately, create a tailored treatment plan, or better yet, learn which patients are at a higher risk for developing specific diseases and employ methods for prevention or earlier detection? That’s the hope of genomic medicine, but researchers and clinicians are still gathering more evidence of its effectiveness before it can be widely implemented.

The IGNITE Network is looking to provide some of that evidence. The Network is comprised of a coordinating center and five multi-site clinical groups from Duke, Mt. Sinai, Vanderbilt, University of Indiana and University of Florida.

In order to provide the evidence that this type of practice will improve patient outcomes, IGNITE is conducting two large, network-wide genomic medicine pragmatic clinical trials (PCTs). These PCTs are focused around genetic risks for common chronic diseases and pharmacogenomics. PCTs are different than randomized controlled trials, or RCTs, which are great for studying the effectiveness of a treatment, but PCTs allow for bigger, more efficient clinical trials and help researchers and clinicians understand what to expect in real-world clinical settings.

Genetic testing to Understand Renal Disease Disparities across the U.S. (GUARDD-US) is a PCT that aims to determine the effect of returning apolipoprotein L1 (APOL1) genetic risk information to hypertensive African ancestry patients and their primary care providers on systolic blood pressure (SBP). The primary outcome is SBP at three months comparing patients with high-risk APOL1 variants (positives) versus no high-risk variants (negatives). The co-primary outcome is three-month SBP in positives versus those receiving delayed testing. Secondary outcomes include renal disease testing, and psycho-behavioral factors. The team will re-randomize APOL1 negative patients to a genotype-guided approach to anti-hypertensive therapy versus usual care and compare three-month SBP.

A Depression and Opioid Pragmatic Trial in Pharmacogenomics (ADOPT-PGx) is a pragmatic clinical trial that enrolls patients into three pharmacogenomics (PGx)-guided therapy scenarios: acute post-surgical pain, chronic pain, and depression. For each scenario, participants will be randomized to genotype-guided drug therapy versus usual approaches to drug therapy selection (“usual care”). Changes in patient-reported outcomes representing pain and depression control using standard patient-reported outcomes measurement information system (PROMIS) scales define the primary endpoints. Secondary analyses include safety endpoints, changes in overall well-being, and economic impact represented by differences in healthcare utilization.

Both GUARD-US and ADOPT-PGx teams will begin recruiting people for the PCTs in mid to late 2020.

The IGNITE Network has the potential to drastically change the face of healthcare. As results from the PCTS come in, clinicians all over the world may be able to see the clinical utility of genomic medicine for both risk assessment and disease treatment.

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Genomic and Precision Medicine Weekly Forum

Elizabeth McNally, M.D., Ph.D.
Director, Center for Genetic Medicine; Professor of Medicine and Biochemistry and Molecular Genetics
Northwestern University
Genetic Variation In Heart Failure: From Rare to Common and In Between

When: February 13, 2020
Where: Duke University

Genomic and Precision Medicine Weekly Forum

Rebekah Ryanne Wu, M.D.
Assistant Professor of Medicine
Duke University
Impact of Family Health History on Understanding Genomic Risk in Singaporean Populations

When: February 6, 2020
Where: Duke University

Genomic and Precision Medicine Weekly Forum

Isaac Kohane, M.D., Ph.D.
Chair, Department of Biomedical Informatics; Professor of Biomedical Informatics
Harvard Medical School
What Can We Learn from Genomics Being the Leading Application of Clinical AI?

When: January 30, 2020
Where: Duke University

Precision Medicine World Conference

PMCW is the largest annual conference dedicated to precision medicine and brings together recognized leaders, top global researchers and medical professionals, and innovators across healthcare and biotechnology sectors.

When: January 21 – 24, 2020
Where: Silicon Valley, CA
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Genomic and Precision Medicine Weekly Forum

Cynthia Moylan, M.D.
Associate Professor of Medicine
Duke University
The Looming NASH Epidemic: Using -omics for risk stratification and prevention

When: January 23, 2020
Where: Duke University

IGNITE Steering Committee Meeting

IGNITE will conduct a a two-day Steering Committee Meeting

When: Wednesday, January 22 – Thursday, January 23, 2020
Where: University of Florida Research & Academic Center, Lake Nona, FL

Genomic and Precision Medicine Weekly Forum

Joe Grzymski, Ph.D.
Senior Director, Applied Innovation Center; Associate Research Professor of Microbiology and Computational Biology
Desert Research Institute
The Healthy Nevada Project Genetics Study and Linking Phenotype to Genotype

When: January 16, 2020
Where: Duke University

Genomic and Precision Medicine Weekly Forum

Lisa Bastarache, M.S.
Research Assistant Professor
Vanderbilt University Medical Center
How much more can we explain with genetics? Using EHRs to find Undiagnosed Patients

When: January 9, 2020
Where: Duke University

Genomic and Precision Medicine Weekly Forum

Opeyemi Olabisi, M.D., Ph.D.
Assistant Professor of Medicine, Division of Nephrology
Duke University
Patient-stem cell-derived podocytes as tools for modeling APOL1-associated kidney disease

When: Thursday, December 19, 2019, noon – 1 P.M.
Where: Duke University

Therapeutic Genome Editing: An ASHG-AJHG Webinar

Advances in the technology of genome editing offer major opportunities in the treatment of genetic disorders, but also raise complex technical and ethical issues. This webinar will explore these considerations both for somatic and germline genome editing and will explore the future research agenda for therapeutic genome editing.

When: Wednesday, December 11, 2 – 3 P.M.

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Genomic and Precision Medicine Weekly Forum

George Church, Ph.D.
Professor of Genetics; Director, PersonalGenomes.org; Harvard University
Reading and Writing Omes

When: Thursday, December 5, 2019, noon – 1 P.M.
Where: Duke University

Precision Medicine Insights: A Webinar Series

Kristin Wiisanen, Pharm.D., FAPhA

When: Tuesday, December 3, 2019, 12 p.m. EDT

University of Florida precision medicine leaders will highlight current knowledge and trends in this series, including professional and educational opportunities, to advance the future of health care. Join us as Dr. Kristin Wiisanen, online graduate program director, discusses challenges and approaches to patient education in the era of precision medicine.

AMIA 2019 Annual Symposium

Under the overall theme of “Informatics: From Data to Knowledge to Action” the Ameican Medical Informatics Association (AMIA) Annual Symposium will build on more than 40 years of sharing pioneering research and insights for leveraging information to improve human health.

When: Saturday, Nov. 16 – Wednesday, Nov. 20, 2019
Where: Washington, D.C.

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15th Annual Personalized Medicine Conference

The 15th Annual Personalized Medicine Conference will convene the world’s leading researchers, investors, industry executives, policy experts, payers, clinicians, and patient advocates to define the landscape and outlook for personalized medicine in science, business, and policy.

When: Wednesday, Nov. 13 – Thursday, Nov. 14, 2019
Where: Boston, MA

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Genomic and Precision Medicine Weekly Forum

Hakon Hakonarson, M.D., Ph.D.
Director, Center for Applied Genomics at the Joseph Stokes Jr. Research Institute; Professor of Pediatrics; Children’s Hospital of Philadelphia

When: Thursday, November 7, 2019, noon – 1 P.M.
Where: Duke University

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Genomic and Precision Medicine Weekly Forum

Rhoda Au, Ph.D.
Professor of Anatomy & Neurobiology; Boston University

When: Thursday, October 31, 2019, noon – 1 P.M.
Where: Duke University

Exploring the Current Landscape of Consumer Genomics – A Workshop

The Roundtable on Genomics and Precision Health will host a one day public workshop to explore the current landscape of consumer genomics and implications for how genetic test information is used or may be used in research and clinical care.

When: Tuesday, October 29, 2019, 8:30 A.M.
Where: Washington, D.C.

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Genomic and Precision Medicine Weekly Forum

Gregory Gray, M.D., MPH, FIDSA
Professor of Medicine, Global Health and Environmental Health; Duke University

When: Thursday, October 24, 2019, noon – 1 P.M.
Where: Duke University

American Society of Human Genetics 2019 Annual Meeting

ASHG 2019 featured invited presentations by the world’s leading geneticists, in addition to symposia, workshops, and abstract-driven sessions about new developments in basic, translational, and clinical human genetics research and technology.

When: Tuesday, October 15 – Saturday, October 19, 2019
Where: Houston, Tx

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Genomic and Precision Medicine Weekly Forum

Joanne Ngeow, MBBS, MRCP, MPH
Senior Consultant, Division of Medical Oncology, National Cancer Centre Singapore

When: Thursday, October 10, 2019, noon – 1 P.M.
Where: Duke University

Genomic and Precision Medicine Weekly Forum

Brian Sullivan, M.D.
Medical Instructor in the Department of Medicine; Duke University

When: Thursday, October 3, 2019, noon – 1 P.M.
Where: Duke University

NHGRI Stategic Planning Workshop

Genomics in Medicine & Health

NHGRI is in the middle of a new round of strategic planning that will establish a ‘2020 vision for genomics’ and culminate in the publication of a new NHGRI strategic plan in October 2020 and is soliciting input from the broader research and public communities to help shape the 2020 strategic plan.

When: Thursday, Sept. 26 – Friday, Sept. 27, 2019, 8 A.M. – 5 P.M. both days
Where: Bethesda, MD

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Enhancing Scientific Reproducibility through Transparent Reporting – A Workshop

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine convened a public workshop to discuss the current state of transparency in reporting pre-clinical biomedical research and to explore the possibility of improving the harmonization of guidelines across journals and funding agencies so that biomedical researchers propose and report data in a consistent manner.

When: Wednesday, September 25 – Thursday, September 26, 2019; 8:30 A.M.
Where: Washington, D.C.

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IGNITE Steering Committee Meeting

IGNITE conducted a a two-day Steering Committee Meeting and joint meeting with the Data and Safety Monitoring Board

When: Wednesday, September 25 – Thursday, September 26, 2019
Where: Silver Spring, MD

Genomic and Precision Medicine Weekly Forum

Richard Gibbs, Ph.D.
Director, Human Genome Sequencing Center; Professor of Translational Biology & Molecular Medicine and Integrative Molecular and Biomolecular Sciences; Baylor College of Medicine

When: Thursday, September 19, 2019, noon – 1 P.M.
Where: Duke University

Genomic and Precision Medicine Weekly Forum

Georgia Wiesner, Ph.D.
Professor of Medicine, Vanderbilt University

When: Thursday, September 12, 2019, noon – 1 P.M.
Where: Duke University

IGNITE Steering Committee Meeting

IGNITE conducted a a two-day Steering Committee Meeting

When: Thursday, July 25 – Friday, July 26, 2019
Where: Orlando, Florida

NIH Collaboratory Grand Rounds

Moving Beyond Return of Research Results to Return of Value

Speaker: Consuelo H. Wilkins, M.D., MSCI
Vice President for Health Equity, Vanderbilt University Medical Center
Executive Director, Meharry-Vanderbilt Alliance

When: Friday, June 28, 1 – 2 P.M. EST

NIH Collaboratory Grand Rounds

Good Clinical Practice Guidance and Pragmatic Trials: Balancing the Best of Both Worlds in the Learning Health System

Speaker: Robert J. Mentz, M.D., FACC, FAHA, FHFSA
Director of the Duke Cooperative Cardiovascular Society
Assistant Program Director of the Duke Cardiovascular Disease Fellowship
Associate Professor
Duke University Medical Center and Duke Clinical Research Institute

When: Friday, June 14, 1 – 2 P.M. EST
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