Virginia Commonwealth University researchers have collaborated on a clinical trial that identifies indicators for nonalcoholic fatty liver disease — a typically asymptomatic disease caused by fat buildup in the liver and the leading cause of liver disease in the United States.
Mohammad Siddiqui, M.D., an associate professor in the VCU School of Medicine, and researchers with expertise in cardiology, hepatology, and exercise physiology have been conducting research with a focus on the link between heart and liver damage. Their efforts have resulted in a study in which they draw a connection between patients with aggressive types of fatty liver disease and limitations in exercise capacity.
Lathika Mohanraj, Ph.D., identifies genetic biomarkers that could aid in the early detection of patients at risk for complications from bone marrow transplantation, hematologic cancers and other malignancies.
Her mother, a breast cancer survivor, was diagnosed with the disease while Mohanraj was an undergrad student in India. Living through that experience solidified her passion to pursue a career in cancer research and treatment.
“Watching my mom go through it and going to the hospital and seeing the other cancer patients there — it was a lot for me to experience at an impressionable age,” Mohanraj said. “That triggered my interest, and from then on I knew that’s what I was going to do.” Read More
A team of cardiology and psychiatry specialists from Virginia Commonwealth University has authored a new comprehensive clinical review article in the Journal of the American College of Cardiology that summarizes the latest evidence-based diagnostic criteria and treatment strategies for Takotsubo cardiomyopathy, also known as broken-heart syndrome.
Infants born very preterm, at or before 28 weeks gestation, are at high risk for developmental impairments. Physical therapy and medical specialists from Virginia Commonwealth University are leading a study in collaboration with colleagues from the University of Virginia to determine how early, evidence-based physical therapy intervention can enhance physical, social and cognitive outcomes.
The team of researchers was awarded a $2.84 million grant from the National Institutes of Health to facilitate the multi-site clinical trial, “Efficacy of Motor and Cognitive Intervention for Infants Born Preterm (SPEEDI2).”The program is based on two smaller studies using Supporting Play, Exploration and Early Developmental Intervention (SPEEDI) developed through a series of studies at Children’s Hospital of Richmond at VCU. Stacey Dusing, Ph.D., a board-certified pediatric physical therapy specialist and associate professor in the Department of Physical Therapy at VCU and the Department of Pediatrics at CHoR, is the principal investigator for the project and the impetus behind the study concept. Read More
VCU surgeon Sudha Jayaraman, M.D., and VCU School of Pharmacy assistant professor Dayanjan Wijesinghe, Ph.D., have collaborated on using mass spectrometry to analyze medications that are in trauma patients’ blood. With funding from the CCTR Endowment Fund, and other VCU sources, their objective was to assess the feasibility of using mass spectrometry in a clinical setting. With the help of VCU Innovation Gateway, they have applied for a patent on the application and set up a company to market it, Mass Diagnostix.
The interdisciplinary VCU team hopes the use of mass spectrometry to analyze patients’ medications will become common practice. They predict in a few years, use of the machines will be standard practice for hospital laboratories.
We are excited to have been able to have helped this project along its way.
For more information about this project, please go to VCU News.
About the CCTR Endowment Fund: The VCU Wright Center for Clinical and Translational Research’s Endowment Fund supports meritorious pilot and feasibility research. This mechanism can support research that applies discoveries generated in the laboratory and preclinical studies to the development of clinical trials. It also may fund proposals that seek to understand the biological basis for clinical manifestations. In addition, these funds may be used by faculty with well-established community academic partnerships for community engaged pilot research activities.
The next deadline for applications will be August 1, November 1 and February 1 for individual awards ($50,000) and May 1 for multi-school awards ($130,000)
Please remember to acknowledge NIH grant support in each publication, press release or other documents about research that benefited from the many resources made possible by the VCU Wright Center for Clinical and Translation Research (CCTR)’s Clinical and Translational Science Award (No. UL1TR002649 or KL2TR002648) and include a disclaimer.
The VCU Wright Center for Clinical and Translational Research’s Endowment Fund supports meritorious pilot and feasibility research. Multi-disciplinary research teams may apply for up to $130,000 to support research that involves collaborators from at least two different VCU schools. Applications including researchers from multiple disciplines are not only encouraged, but highly desirable. Application information and materials may be found at https://cctr.vcu.edu/resources/funding.html
During recent workshops, she reviewed a summary of the 2017-2018 changes, delved into case studies to better understand NIH’s expanded interpretation of the definition of a clinical trial, and provided resources for researchers to use as they develop their proposals.
What are the takeaways you want from these workshops?
The main takeaways are these: NIH has implemented many policy changes over the past year to improve transparency and accountability in human subject research, especially clinical trials. NIH uses a broad interpretation of the definition of a clinical trial. This includes certain mechanistic studies, which are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.
What are the major changes?
The funding opportunity announcement (FOAs) will specify whether clinical trials are required, optional, or not allowed.
NIH has revised their proposal form to consolidate and streamline human subjects information. Investigators must use the new Form E.
Multi-site studies must use a single IRB.
What are some of the questions you are getting?
Many investigators are asking whether their particular study qualifies as a clinical trial. Research administrators at VCU can provide guidance on this, but with so many changes occurring at once, the best source of truth is the NIH program officer.
What is your role at the Wright Center for changes like these?
My specific role is ensuring that VCU is compliant with ClinicalTrials.gov regulations, which require outreach and education, as well as input from the research community. The influence of ClinicalTrials.gov over research will likely continue to grow as long as transparency and accountability remain a priority. My goal is to make sure that we’re meeting our important reporting obligations in a way that is as painless as possible.
A pioneering European research project with assistance from a Virginia Commonwealth University clinician aims to lead to new diagnostic tests to assess patients with non-alcoholic fatty liver disease and identify those most at risk for developing severe inflammation and liver scarring.
The $40 million (€34 million) project, Liver Investigation: Testing Marker Utility in Steatohepatitis, is funded by the European Innovative Medicines Initiative 2 Joint Undertaking and brings together clinicians and scientists from prominent academic centers across Europe with companies from the European Federation of Pharmaceutical Industries and Associations. Their common goals are developing, validating and qualifying better biomarkers for testing NAFLD.
The project is coordinated by Newcastle University, UK, working closely with the lead EFPIA partner, Pfizer. LITMUS will include 47 international research partners based at leading international universities and some of the world’s largest pharmaceutical companies.
Through his appointment as a visiting professor at Newcastle University, VCU Health hepatologist Arun Sanyal, M.D., is an adviser to the LITMUS project.
“This is a very important project which will allow physicians to diagnose those who have this dangerous kind of fatty liver disease,” he said. “Currently the only way to do that is with a liver biopsy, which is painful, invasive and carries some risk.”
Affecting 20 to 30 percent of the population worldwide, NAFLD is caused by a build-up of fat in liver cells, which leads to inflammation, scarring of the liver and ultimately cirrhosis. It is strongly linked to obesity and Type 2 diabetes.
Quentin Anstee, a professor at Newcastle University’s Institute of Cellular Medicine and a consultant hepatologist at Newcastle Hospitals NHS Foundation Trust, is coordinating the LITMUS consortium.
“Non-alcoholic fatty liver disease is already the most common underlying cause of liver transplant in the United States and, with the obesity epidemic in Europe, we are very close behind,” he said. “LITMUS will unite clinicians and academic experts from centers across Europe with scientists from the leading pharmaceutical companies, all working together to develop and validate new highly-accurate blood tests and imaging techniques that can diagnose the severity of liver disease, predict how each patient’s disease will progress and monitor those changes, better or worse, as they occur.”
“Lack of easy and accurate diagnostic tests means that many patients go undiagnosed until late in the disease process. It has also held back efforts to develop new medical treatments for NAFLD,” Anstee said. “Availability of better diagnostic tests will help us to target care at an early stage of disease to the people who are going to be most severely affected. It will also help us to develop more effective medical treatments for NAFLD and to run the clinical trials that the regulatory agencies need so that they can license these medicines to be prescribed by doctors.”
Chris Day, vice-chancellor and president of Newcastle University and a consultant hepatologist, added, “Tackling non-alcoholic fatty liver disease is a major public health challenge and the award of such a large grant from the EU, allowing us to bring together pharma and academia in this way, gives us real hope of making significant advances in the diagnosis and treatment of this increasingly common and often devastating disease.”
If studies in Europe identify noninvasive methods that properly recognize patients at risk for developing liver cirrhosis, those results will need to be validated in the United States. VCU Health will be one of two sites where that will happen, Sanyal said.
Julia Brosnan, senior director of external collaborations and scientific alliances at Pfizer, who also serves as the industry project lead for LITMUS, expressed enthusiasm about the good the collaboration will do.
“This is an exciting project and we look forward to working with the other LITMUS partners to develop new diagnostic tests for NAFLD, which is too often undiagnosed in patients,” she said. “We hope the results of this project will help change that.”
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777377. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777377. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and 47 Associated Partners: AMC Amsterdam, Antaros, Antwerp University Hospital, Boehringer-Ingelheim, Center for Cooperative Research in Biosciences, Ellegaard Göttingen Minipigs, European Association for the Study of the Liver, Exalenz Bioscience, Faculdade de Medicina de Lisboa, Genfit, Hôpital Beaujon, APHP, Institute of Cardiometabolism And Nutrition, Integrated Biobank of Luxembourg, Intercept, iXscient, Lilly, Linköping University, Medical University of Vienna, National & Kapodistrian University of Athens, Newcastle University, Nordic Bioscience, Novartis Pharma AG, Novo Nordisk, Örebro University, OWL, Perspectum Diagnostics, Pfizer Ltd., RWTH Aachen University Hospital, Sanofi, Servicio Andaluz de Salud, Seville, Somalogic, Takeda Pharmaceuticals International GmbH, UMC Utrecht, Università Cattolica del Sacro Cuore, Università degli Studi di Milano, Università degli Studi di Palermo, University Hospital of Angers, University Hospital Würzburg, University Hospitals Birmingham NHS Foundation Trust, University Medical Center Mainz, University of Bern, University of Cambridge, University of Helsinki, University of Lisbon, University of Nottingham, University of Oxford, University of Torino
This release is the author’s view and that neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.
Monday, November 13th- 12 PM- 1 PM, Main Hospital, Learning Center
Please join us for the Wright Center for Clinical and Translational Research’s Discovery Dialogues seminar, “Discovering ways to make cost-effective medicines: A case study with ciprofloxacin”, presented by Dr. Perrer Tosso, Post-doctoral Fellow, Chemical and Life Science Engineering, on Monday, November 13 from noon – 1PM in the hospital’s Learning Center (Main Hospital, first floor, across from the cafeteria).
Faculty, staff, students, patients, and families are invited to attend. Light refreshments will be served. For more information, contact Pam Dillon at email@example.com.
Tuesday, November 14th- 9 AM- 12 PM, BioTech One
Learn how to communicate your research!
Scientists are increasingly called to share their research outside of traditional academic spheres. Engagement with non-academic audiences can help increase the public’s science literacy and shape impactful policy decisions. How can we share science in a way that both engages non-experts and accurately presents complex topics? To register, click here: http://vcu.libcal.com/event/3676022.
This event is sponsored by: VCU Center for Clinical and Translational Research, VCU Libraries, and Office of Research.
9 – 9:50 a.m. “Teaching journalism to scientists — and science to journalists,” Dr. Jeff South, VCU Robertson School of Media and Culture
10:00 – 10:50 a.m. Perspectives in Publishing: A Panel Presentation
11 a.m. – 12:30 p.m. Keynote Presentation: “Be Such a Scientist: Improving How We Communicate and Connect with Public Audiences,” Holly L. Menninger, PhD. Director of Public Science, College of Sciences, NC State University
Wednesday, November 29th-12 PM-1 PM
The Wright Center for Clinical and Translational Research and Tompkins-McCaw Library present the next in their lunch research seminars, “NIH Clinical Trials 2018: New Definition, New Policies,” on Wednesday, November 29, from noon – 1PM in the Tompkins-McCaw Library, Room 109.
Ms. Alanda Perry Jones, CCTR, will discuss changes to human subjects’ research for the January/February funding cycle. During this session, she will review a summary of the 2017-2018 changes, delve into case studies to better understand NIH’s expanded interpretation of the definition of a clinical trial, and provide resources for researchers to use as they develop their proposals.
Participants may bring lunch, drinks will be provided. For more information or to register, contact Pam Dillon (firstname.lastname@example.org).