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Navigating drug and device development: VCU Bench to Community series charts a path for medical innovation

Every day, millions of people in health care, from oncologists to rehabilitation specialists to dentists, use the tools at their disposal to help patients get better.

“And everyone runs into times when they say, what if?” said L. Franklin Bost, MBA. “What if I had something better? What if I could give someone better treatment? What if I could improve this patient’s health care, or many patients’ health care?”

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L. Franklin Bost, MBA, speaks to attendees of the Bench to Community Seminar Series.

Maybe there’s a device that doesn’t quite do what a surgeon wants it to do, a machine that doesn’t fit a nurse’s needs, or a treatment that a researcher thinks a new drug formulation could improve.

In his 30-year industry career, Bost worked through many such challenges faced by medical practitioners. Later, as a VCU College of Engineering professor and co-director of the VCU Institute for Engineering and Medicine, he became a leader in medical device development and commercialization. Now his experience – and that of several other leaders in the field – is preserved in a six-part seminar series for faculty and clinicians looking for guidance in the complex process of medical device and drug development.

Hosted by the Institute for Engineering and Medicine, the Wright Center for Clinical and Translational Research and the Office of the Vice President for Research and Innovation, the Bench to Community series provides a framework and pathways for inventors whose ideas could lead to innovations in medical care that improve health care for all patients.

“It’s not a journey that you go on alone,” Bost said. “It’s a journey you go on with a multitude of partners.”

Videos of the series are open to the public and available for viewing at Kaltura. (CME credit is available for VCU physicians, surgeons and nurses who watch the recordings. They can email cmeinfo@vcuhealth.org with the course code found within the video.) Read More

Wright Center series trains next generation of community-engaged researchers

How would you react if someone started a conversation by saying what was wrong with you and your family?

Probably not well. And that’s exactly what health researchers often do, when they try to talk to community members, said Maghboeba Mosavel, Ph.D, an associate professor at the VCU School of Medicine’s Department of Health Behavior and Policy.

“We go into communities and we tell them what the data says: ‘The county health rankings say that you have the worst health outcomes in this county,’” she said. “Well, they likely know that things are bad, and some things are good, too. They live in that neighborhood.”

Mosavel shared her experience in December in the first of the Wright Center’s Community Engaged Research Seminar Series. The inaugural three-part series was geared toward early career faculty at VCU whose research seeks to study and improve community health, as well as work in partnership with community groups and outside institutions. More than 75 researchers from across multiple disciplines attended the series, which is now available for all to view online.

Mosavel kicked things off with an introductory session: What is community engagement and why does it matter? Among other things, she said, “it’s a major social justice issue when we’re talking about marginalized, disenfranchised communities that, as researchers, we want to ‘study’ but we have never truly engaged with them in a meaningful way.

“And communities have not seen the benefit of the research that they have participated in.”

Her presentation gave examples of how to rectify that gap between research and results.

Amanda Hall, Ph.D., director of community-engaged research and special projects, followed up Mosavel’s introduction with a presentation on how VCU supports community-engaged research.

In January, the second session on developing and sustaining community relationships had Vanessa Sheppard, Ph.D., and Emily Zimmerman, Ph.D., M.P.H. as presenters. And the third session on ethical and practical considerations in community-engaged research featured Alex Krist, M.D., M.P.H., the Wright Center’s community-engaged research co-lead.

The speakers represented decades of combined experience in clinical and translational research that brings the community into projects in meaningful ways. They offered practical tips and real-world examples of community engagement, in addition to the theory and objectives.

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Maghboeba Mosavel, Ph.D, an associate professor at the VCU School of Medicine’s Department of Health Behavior and Policy, kicked off the Community Engaged Research Seminar Series.

“Community-engaged research is a phrase that’s sometimes thrown around without context or substance,” said Rob DiRenzo, M.S., faculty development manager at the Wright Center and the series co-lead. “The series sought to give real meaning to the phrase, and our speakers were well-positioned to do that.”

A pre-series survey showed that over half of the registrants were already engaged in some form of community-engaged research.

“We saw that researchers at our institution were hungry for more training on this topic,” said Rachel Hunley, M.A., community engagement program manager at the Wright Center and series co-lead. “We hope this series can be a model for future ones here at VCU and other institutions.”

“I really like this series,” said one participant in a post-session survey. “Even though I’ve done [community engaged research] before, it really helps to get back to the basics and do it right from the beginning as I start a new partnership.”

What community engagement looks like varies by discipline and research question, speakers said. By its nature, community-engaged research is contextual, guided by the reality, the history, the politics of the community. Mosavel emphasized that community-engaged research requires not only collaboration, but flexibility and a willingness to change course, when community feedback requires it.

“Research has a clearly specified process: step one, step two,” Mosavel said. “But when you add community engagement, it becomes fluid, dynamic, and requires a completely different approach and commitment. Be prepared to change course.”

Mosavel urged the attendees to recognize their position and privilege and how it impacts perception.

“If you go out into the community and do community-engaged research, you’re always representing your academic institution,” she said. “And not only are you representing the academic institution, you have to be mindful of the context and historical relationships. Community-engaged researchers must recognize the larger context and do work that is mutually beneficial.”

You can watch the Wright Center’s Community Engaged Research Seminar Series on its Kaltura page.

Contact Rob DiRenzo and Rachel Hunley for questions about the series.

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Wright Center researchers co-author winning N3C poster on organ transplants and COVID-19

The Wright Center’s Amy Olex, M.S., and Evan French were co-authors on a poster that won top honors at a recent conference.

The senior bioinformatics specialist and informatics system analyst, respectively, helped produce Covid-19 In Solid Organ Transplantation (SOT): Results of The National Covid Cohort Collaborative (N3C). The poster was accepted to the Cutting Edge of Transplantation (CEoT) 2021 conference that took place Feb. 25-27.

The primary author of the poster, an associate professor at Dalhousie University and the Nova Scotia Health Authority, won the Young Innovator Award for the submission.

View the poster.

The research identified a cohort of solid organ transplant recipients who received COVID-19 tests last year and evaluated health outcomes using N3C data. The collaborative, which VCU joined last summer, securely collects and organizes clinical and diagnostic data from patients across the country to create a dataset broad enough to engage in meaningful study of the novel coronavirus. VCU researchers can access the data for their studies.

Olex leads the national Immunosuppressed or Compromised Clinical Domain Team, which mines N3C data to identify how different types, levels, and durations of immunocompromise may affect severity and outcomes of infected patients. The team was instrumental to Vinson’s, Olex’s and French’s research.

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Amy Olex, M.S., senior bioinformatics specialist, and Evan French, research informatics systems analyst

Wright Center joins network to help researchers navigate drug and device regulations

Virginia Commonwealth University, via the Wright Center for Clinical and Translational Research, has joined a network of other Clinical and Translational Science Award (CTSA) hubs that will help VCU researchers navigate the complex regulatory world of drug and device development.

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VCU is the first institution outside the Carolinas to join the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) network.

With ReGARDD, a VCU researcher has a larger regulatory pool to draw from in meeting their research needs. The network has resources, training, events, templates and guidance on navigating drug and device development in the academic setting. Researchers can register to receive upcoming educational events and updates in their inboxes on their website.

ReGARDD is led by regulatory affairs specialists and experts from North and South Carolina institutions that receive funding from the National Institutes of Health’s CTSA Program. The other institutions are the University of North Carolina at Chapel Hill, Duke University, Wake Forest School of Medicine, and RTI International and the Medical University of South Carolina.

VCU staff with regulatory expertise will pool resources with the other institutions. The network enables the sharing of ideas, lessons learned and historical information, as well as the development of successful strategies to assist the academic researcher in navigating an increasingly complex regulatory environment.

Access the ReGARDD network at their website and email indide@vcuhealth.org for guidance on drug and device development at VCU.

Find more information about VCU’s FDA regulatory program at the Office of the Vice President for Research and Innovation.

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“Don’t stay in your lane”: Five questions about Team Science with Debbie DiazGranados

Maybe you wrote it off as a buzzword when you first saw it. But Team Science has guided and shaped cutting edge research at Virginia Commonwealth University from behind the scenes for years.

Understanding it and its value, in fact, has informed the research of some of VCU’s best scientists and physicians.

“Early in my career, I had this misconception that research involved a scientist, a clinician-scientist, and his or her team, and they would just get together and come up with ideas and do a series of experiments, then write a paper and maybe write a grant,” said Patrick Nana-Sinkam, M.D., associate director for career development and mentoring at the Wright Center.

“I didn’t understand the fact that science and medicine are so complex that it’s absolutely essential that, as you seek to answer specific, complicated questions, you have to find partners. You have to partner with experts in other disciplines, experts in disciplines very different from yours.”

The different perspectives were crucial, Nana-Sinkam added, to his research and career arc.

“Science is too complicated for a single lab or a single, linear way of thinking,” he said. “It’s just not possible to tackle some of our most challenging, scientific questions in that manner.”

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Deborah DiazGranados, Ph.D.

The Wright Center spoke to Debbie DiazGranados, Ph.D., director of evaluation and Team Science at the Wright Center, about Team Science, research consultation and how to set researchers on a cross-disciplinary path.

How do you define Team Science to people outside of the bubble?

Team Science is about being a team player, and it’s about being a boundary-crosser, integrating knowledge from diverse disciplines or perspectives. We don’t want to stay in our lane and look at a problem from one discipline, one perspective, one individual. We want people to reach out deliberately, intentionally creating teams to solve problems.

I think of Team Science as having two critical parts: leading and working in effective teams – the nuts and bolts of collaboration – and being able to integrate knowledge, perspectives, methodologies from those on the team. It’s the process of finding those different perspectives, being open to including those different perspectives when thinking about scientific problems, and the ability to truly integrate the knowledge in a way that complements the study and the solution of a complex problem.

To solve our most complex problems faced by the entire globe, we have to work collaboratively. We can’t solve them myopically, through the lens of a single discipline.

What’s an example of a research project that has employed Team Science? 

The famous example is where theoretical physicists and applied physicists, who were truly engaging in cross-method and cross-theory work, created the Large Hadron Collider at CERN in Switzerland. That was thousands of people working on this one, enormously complex project. But that was Team Science in action — people in different areas of physics working together to make it happen.

More locally, we put on a workshop for a project recently where several teams had come together to start a new project. They came to learn skills in communication and Team Science. The workshop provided them with guidance on how to collectively brainstorm and come up with goals and next steps that the entire team could really get behind.

That workshop was a pretty clear example of observing each of the team members ask questions and clarify assumptions and communicate in ways that they hadn’t previously done — in a dedicated hour and a half time.

What does a Team Science consultation look like?

People often come to me and say, ‘I’m the PI on this grant and I feel like I’m having a hard time getting everybody on board and getting the work accomplished that we said we would accomplish.’

The default reason that people think teams don’t always function well or effectively is they think it’s a communication issue. But there’s a lot of layers to that communication ‘onion.’ Sometimes it’s not a communication issue; it’s a trust issue. And I can help people get to the root of it.

I can lead and facilitate either a workshop like the one I just described or one that’s specific to the project in question. I can help form new, cross-discipline teams or identify the core of the team-related problem that someone is trying to solve.

People also contact me to ask about leading their labs, overseeing their staff and their technicians — how best to hire them and lead them through the work that needs to be done in the lab.

But there are many other opportunities for consultation. Maybe you’re just stuck and require an external person with expertise and knowledge in the space of collaboration. That’s what I’m here for.

How do you codify cross-disciplinary collaboration into a research project, make it part of the process, especially now that so much work happens remotely?

I challenge my students and consultees to rethink this moment we’re in as an opportunity to build deeper connections with colleagues and create more intentional collaborations.

Team Science is often an afterthought for researchers, because people are trying to find solutions to diseases, environmental issues and other complex issues. They might think of it when they’re frustrated or running into problems in their study. But foresight and planning are ideal.

Teams that are effective are those who have built in processes that allow them to experience a setback or recuperate from an error and bounce back. Team Science doesn’t create error-free teams or problem-free teams, but it’s about building resilience into your work.

I’ve heard many stories of co-PIs and researchers who’ve worked with someone for 25 years and then something happened and that partnership is now so fractured that they aren’t working together anymore. Team Science consultations can help avoid that.

And that’s not to say that you’re never going to have conflict-free collaboration. It’s that you’re going to have productive conflict in a collaboration that can help push the study forward, push one another to be better scientists, better faculty members, better health care providers.

How do you evaluate the science of good teams?

It’s hard. We’re still learning to evaluate people as team scientists, because we’re still understanding collaboration and how people work together. There’s decades of research that began with research into marriages: how couples interacted, how they argued, how they engaged in conflict — that was one of the first windows into what we know about how people work together.

We can draw from that research in understanding what makes teams effective. And that’s my background — research in the space of psychology and organizational behavior.

So VCU researchers have a resource in me, at the Wright Center.

Learn more about Team Science, and contact DiazGranados for a consultation at (804) 827-0142 or deborah.diazgranados@vcuhealth.org

DiazGranados teaches CCTR 640, “Team Science Theory & Practice,” during the VCU spring semester.

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Closing the gap in prostate and colorectal cancer disparities: a community conversation

Terrance Afer-Anderson wants to create an army of ambassadors.

The Norfolk native and prostate cancer survivor wrote, produced and directed a movie, “The Black Walnut,” to bring attention to inequities in screening and mortality rates for prostate cancer in the Black community.

“I tell men scared of the invasiveness of a prostate cancer screening, ‘You have to toughen up,’” Afer-Anderson said on Feb. 9 at a virtual community event on the topic. “And I want African-American men – and women – to help spread the word about the disparity, to get tested early.”

Research, strategies and collaboration were the topics of the day at Cancers Below the Belt, where Virginia Commonwealth University’s Debbie Cadet, Ph.D., M.S.W., moderated a panel of community leaders and experts in prostate and colorectal cancer disparities.

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Debbie Cadet, Ph.D., MSW, program manager for community health education & research at the VCU Massey Cancer Center, hosted the Feb. 9 event.

Hosted by the C. Kenneth and Dianne Wright Center for Clinical and Translational Research and VCU Massey Cancer Center, the event was the second in a quarterly series that addresses pressing topics in health equity. The November event concerned lung health.

“African-American men are nearly two times more likely to get prostate cancer and have prostate cancer that forms, grows and spreads more quickly compared to white men,” said Cadet, program manager for community health education & research at Massey’s Office of Health Equity and Disparities Research. “They are nearly three times more likely to die from prostate cancer compared to white men.”

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Wright Center associate director joins national committee on lung health

With COVID-19 affecting the lungs of patients and survivors, lung research and science has never been more important.

To help guide national review of that science, Wright Center Associate Director Patrick Nana-Sinkam, M.D., has joined the Scientific Advisory Committee of the American Lung Association.

Wright Center Associate Director Patrick Nana-Sinkam, M.D.

Founded in 1904, the oldest voluntary health organization in the country, the American Lung Association used education, advocacy and research to virtually eradicate tuberculosis in the United States. It aims to save lives by improving lung health and preventing lung disease.

The committee that Nana-Sinkam will serve on is charged with responsibility for the association’s research portfolio, oversight of their grant review process and monitoring the Airway Clinical Research Centers Network, which is the nation’s largest nonprofit network of clinical centers dedicated to asthma and COPD research. The committee also develops scientific policies and other initiatives.

Nana-Sinkam serves in a career development and mentoring role at the C. Kenneth and Dianne Wright Center for Clinical and Translational Research, guiding and supporting early career faculty in their research. He is also the chair of the Division of Pulmonary Disease and Critical Care Medicine in the Department of Internal Medicine at the VCU School of Medicine.

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Blood pressure, proteins and precision health: Three research projects funded by the Wright Center

The Wright Center has awarded three VCU researchers grants from its Endowment Fund for health sciences research.

The awards support preliminary studies that enable researchers to develop hypotheses, collect preliminary data and establish methods necessary for successful external funding.

Lana Sargent, Ph.D., RN, CRNP, assistant professor in the VCU School of Nursing’s Department of Adult Health and Nursing Systems, was awarded for her project: “The association of ambulatory blood pressure phenotypes with cognition in community-dwelling older adults: A pilot study.” Collaborators include Dave Dixon, Pharm.D., and Elvin Price, Pharm.D., Ph.D.

Weihua Qiu, Ph.D., research assistant professor in the VCU School of Pharmacy’s Department of Medicinal Chemistry, was awarded for her project: “Active mechanism of mycobacterial membrane protein large 3 and its inhibition by SQ109.” Qiu’s co-principal investigator is Youzhong Guo, Ph.D.

And Youssef Roman, Pharm.D., Ph.D., assistant professor in the VCU School of Pharmacy’s Department of Pharmacotherapy and Outcomes Science, was awarded for his project: “Cardiometabolic genomics and pharmacogenomics investigations in Filipino Americans: Steps towards precision health.” Roman will work with a community partner, the Filipino American Association of Central Virginia.

Wright Center Endowment Fund grants are awarded four times a year – three of those times to individual investigators and small groups of investigators. VCU faculty from both the MCV and Monroe Park campuses are encouraged to apply.

Congrats to Sargent, Qiu and Roman!

The next deadline for the grant is May 1, for a multi-school project funded at up to $130,000.

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Left to right: Lana Sargent, Weihua Qiu and Youssef Roman
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Wright Center informaticist leads international team for COVID-19 research

Organ transplant recipients, people with HIV, those with autoimmune diseases like rheumatoid arthritis and multiple sclerosis – the COVID-19 pandemic has been especially scary for people whose immune systems are compromised or suppressed.

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Amy Olex, M.S.

They’ve fought or are fighting battles against other diseases – or even their own immune systems. And the newness of the virus means no one is sure how they would fare against it.

“There’s very little data on how immunocompromised patients will respond to COVID-19,” said Amy Olex, M.S., senior bioinformatics specialist at the VCU Wright Center for Clinical and Translational Research. “It’s resulted in patients wondering if they should suspend life-altering treatments.”

To help fill that gap in data, Olex is leading a team that will leverage a national platform of COVID-19 clinical data to guide and support research into immunocompromised patients.

The National COVID Cohort Collaborative, or N3C, led by the National Institutes of Health (NIH), securely collects and organizes clinical and diagnostic data from patients across the country to create a dataset broad enough to engage in meaningful study of the novel coronavirus.

The Wright Center joined the collaborative last summer, and VCU researchers can access the data for their studies.

“The N3C initiative and data repository has sparked national collaborations with the goal of answering many of these yet unanswered questions about COVID-19,” Olex said. “It’s already yielding vital research.”

Within N3C, a collection of Clinical Domain Teams enable researchers with shared interests to analyze N3C data and collaborate efficiently. The teams provide researchers an opportunity to collect pilot data for grant submissions, train algorithms on larger datasets and learn how to use N3C tools. With teams, researchers can build off each other’s work, collaboratively and efficiently working to improve outcomes for patients affected by COVID-19.

Olex leads the Immunosuppressed or Compromised Clinical (ISC) Domain Team. Initial research will focus on people with HIV, organ transplants and those with autoimmune disorders, including skin diseases such as atopic dermatitis and eczema. And the team will identify areas that warrant additional study.

“The ISC Team will mine the N3C data to identify how different types, levels, and durations of immunocompromise may affect severity and outcomes of infected patients,” Olex said. “The hope is that our research brings much needed clarity to healthcare providers and people who are immunosuppressed or compromised.”

Teams like ISC welcome new members. They feature researchers and experts like statisticians, informaticists and machine learning specialists who collaborate across disciplines to tackle COVID-19 and its health impacts.

N3C is hosting an open house to engage CTSA members, newcomers, and the wider translational research community beginning on Jan. 19. The event will kick off with a 1-hour symposium, followed by a week of open Clinical Domain Team meetings, including the Immunosuppressed/Compromised Domain Team.

VCU researchers can contact Amy Olex at alolex@vcu.edu with questions about immunosuppressed or compromised COVID-19 research.

Update 1/26/21: VCU researchers interested in learning more about N3C can attend two orientation sessions on Feb. 2 and 9. 

N3C key metrics dashboard Visit ncats.nih.gov/n3c for information
Image credit: NIH’s National Center for Advancing Translational Sciences
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The Wright Center is here to help with your research resolutions

Last year did not go as planned for anyone. But 2021 will slowly, we hope, bring a return to the new normal in our professional lives.

If more or better health-related research at VCU is one of your 2021 resolutions, the Wright Center can help. Find your research resolution below and see how.

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Wright Center events bring together VCU research leaders, health care providers and research professionals on timely topics.

Upcoming events include:

Bookmark the Wright Center’s calendar and make sure you’re signed up for the regular newsletter to be alerted of more upcoming events.

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The Wright Center’s funding opportunities include a few with upcoming deadlines:

  • The Endowment Fund for grant to individuals and small groups of investigations has a Feb. 1 deadline for its up-to-$50,000 award.
  • The Pilot Imaging Fund for grants up to $25,000 is accepting applications until Feb. 21 from investigators looking to use the Wright Center’s Collaborative Advanced Research Imaging (CARI) facility.
  • And the Clinical Research Voucher Program has a rolling deadline for investigators looking for funding to use VCU Health clinical research facilities and services.

Find more funding opportunities at the Office of the Vice President for Research and Innovation’s website and in RAMS-SPOT.

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Request access to a cohort discovery program that helps investigators test feasibility and collaborate with other institutions.

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Through the Wright Center, you can access Protocol Builder, a secure, cloud-based technology that helps investigators write interventional or observational research protocols. Find links and resources on protocol development. Read More