Albert Arias, MD, chief of addiction psychiatry at Carilion Clinic, has received an award from the National Institute on Drug Abuse (NIDA) at the National Institutes of Health to research how psilocybin, a psychedelic compound being studied for several psychiatric and substance use disorders, can offer a new approach for people with cocaine use disorder.

The initial $623,000 award is part of a phased project to evaluate whether psilocybin can help reduce cocaine use when administered in a carefully controlled clinical research setting combined with structured psychotherapy. Subsequent funding to support the larger clinical phase of the research could bring the total award to $3.5 million.

“Cocaine use disorder can have devastating consequences for patients, their families and communities, yet we still do not have an FDA-approved medication to treat it,” Dr. Arias said. “This study gives us an opportunity to rigorously investigate a promising but still experimental approach and determine whether it may ultimately have a role in helping patients reduce or stop cocaine use.”

The research comes amid growing scientific interest in the therapeutic potential of psychedelic compounds. Previous research has suggested possible benefits of psychedelic-assisted treatment for conditions including alcohol and nicotine use disorders, but clinical research involving stimulant use disorders remains limited.

The first phase of research will examine safety, tolerability, feasibility, dosing, and early signals of efficacy. If successful, the project will move into a larger clinical trial designed to test efficacy and better understand why some patients may respond better than others.

The NIDA award expands Carilion’s growing research in addiction psychiatry and reflects the health system’s commitment to investigating new approaches for patients affected by substance use disorders.

“Research is especially important when patients and clinicians have limited treatment options,” Dr. Arias said. “Our goal is not to assume that psilocybin works, but to ask the question carefully, scientifically and safely. If we find evidence of benefit, it could provide the foundation for larger studies and, eventually, new treatment options.”

This month features several outstanding educational opportunities, including two symposia sponsored by the Fralin Biomedical Research Institute at VTC. We encourage everyone to take advantage of these events to learn, connect, and engage with colleagues across the research community.

September 23-24: Precision Therapeutics for Schizophrenia: Integrating Computational Phenotyping with Next-Generation Pharmacology convenes scientists, clinicians, and healthcare leaders spanning circuit neuroscience to late-stage clinical development, advancing the shift toward personalized care. The two-day meeting will address three thematic areas: next-generation pharmacology for schizophrenia, computational approaches to patient stratification, and mechanistic neuroscience. We hope the event will have the right people at the table to drive collaboration and outcomes for patients. 

October 30- ACRP Virginia Chapter Annual Fall Symposium.  The ACRP Virginia Chapter will host its annual full-day event this fall, providing the opportunity to earn up to 7 educational contact hours featuring a dynamic lineup of educational sessions, panel discussions, and focused roundtables on the latest developments, challenges, and opportunities in clinical research. Key Considerations Under ICH E6 (R3) will be presented by ACRP’s new CEO, David M. Vulcano, MSW, MBA, CIP, RAC, FACRP.

🎊 Celebrating Milestones

 Please join us in congratulating our colleagues celebrating their anniversary at Carilion!

10-Year Anniversary

Diedre (Dee) Myers- 7/25

Happy Anniversary and thank you for being part of the team! Carilion’s 2025 Medical Laboratory Science program.

Current Open Positions

Grant Funded Department of Medicine Clinical Research Unit - Clinical Research Coordinator III (Roanoke, Virginia)

Clinical Research Coordinator IV - Oncology (Roanoke, Virginia)

Clinical Research Coordinator IV (Roanoke, Virginia)

Effort Certification Reminder

Effort Certification is a quarterly, required process for employees whose pay is charged to or cost‑shared on a sponsored project (i.e., grant or clinical trial). Timely completion is important to ensure compliance with sponsor and federal requirements. 

Each quarter, you’ll receive a Workday task asking you to review and certify that your effort reasonably reflects the work you performed during the reporting period. Rest assured that the information has already been reviewed and vetted by your Sponsored Project Manager and can be certified as‑is. If something doesn’t look right, please contact your Sponsored Project Manager immediately.

Carilion Clinic TriNetX Virtual Training Schedule

Carilion offers instructor-led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please get in touch with HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so!  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Sept 9, 1:30 – 3pm
• Sept 23, 10:30am - noon

TriNetX User Agreement:  https://redcap.link/v5pw9j7j

For more information visit:https://redcapweb.carilionclinic.org/redcap/surveys/?s=dcUCIpMAzk8BqKH2

* Carilion Clinic Research and Development is honored to partner with a growing list of prestigious national and statewide research centers and healthcare organizations. Find out more about our collaborative research initiatives; explore our unique public-private partnerships with the Virginia Tech Carilion (VTC) School of Medicine, Virginia Tech, Fralin Biomedical Research Institute, Radford University Carilion, and others. Connect with our team to discuss opportunities to collaborate with our experts or become a participant.

Christopher Cullom Named Chief Operating Officer.

Christopher Cullom, MSHA, MBA, FACHE, joined Carilion Clinic as chief operating officer, bringing nearly 20 years of executive leadership experience across nationally recognized academic health systems, integrated delivery networks and community-based organizations. 

Most recently, Cullom served as chief operating officer for Thomas Jefferson University Hospitals in Philadelphia, part of Jefferson Health. He also held several leadership roles with Trinity Health Mid-Atlantic, University of Pennsylvania Health System, Tenet Healthcare, and University of Florida Health Jacksonville.     

Cullom earned a Master of Science in Healthcare Administration and a Master of Business Administration from the University of Alabama at Birmingham. He is a fellow of the American College of Healthcare Executives. 

As chief operating officer, Cullom will partner with teams across Carilion to advance the organization's mission while continuing to strengthen operational performance, access to care, and the experiences of patients and employees. 

Dr. Jonathan Carmouche Appointed Chair of Orthopaedic Surgery.

Jonathan Carmouche, MD, MBA, was appointed chair of the Department of Orthopaedic Surgery for Carilion Clinic and the Virginia Tech Carilion School of Medicine after serving as interim chair since January.

Dr. Carmouche has practiced in Roanoke for more than 18 years and has held numerous leadership roles across the organization. His previous positions include vice chair of the Department of Orthopaedic Surgery, vice chair for research, section chief of Spine Surgery, Scoliosis, Pediatric Orthopaedics and Orthopaedic Physical Medicine and Rehabilitation, interim section chief of Orthopaedic Trauma, and chief of Orthopaedic Surgery at Carilion Roanoke Memorial Hospital.

Dr. Carmouche earned his medical degree from The George Washington University School of Medicine and completed his orthopaedic surgery residency and research fellowship at the University of Rochester. He completed a fellowship in Adult and Pediatric Scoliosis and Spine Surgery at Twin Cities Spine Center and later earned an MBA from the University of Virginia Darden School of Business.

In addition to his clinical leadership, Dr. Carmouche serves as professor of Orthopaedic Surgery at the Virginia Tech Carilion School of Medicine.

The study, published in BMJ Neurology Open, examined the relationship between the post-seizure episodes and longer-term mental health disorders. Using information from patients’ medical records, researchers compared the outcomes of patients who experienced temporary psychotic symptoms after a seizure with similar patients who did not.

"For years, we've known these episodes can happen after a seizure, but we didn't know what they might mean for a person's long-term mental health," said Varsha Nandwana, MD, a neurologist at Carilion Clinic and lead author of the study. “Our findings suggest they shouldn't simply be viewed as something that comes and goes. They may identify patients who would benefit from closer follow-up."

While the study did not confirm that these episodes cause mental illness, the findings show a strong link between the two conditions and could change the way doctors care for patients with epilepsy. Rather than ending treatment once the symptoms disappear, clinicians may consider monitoring patients' mental health more closely in the months and years that follow. Earlier recognition of psychiatric symptoms could lead to earlier treatment and support.

"This study reminds us that epilepsy can affect more than neurological function, it can also affect mental health. By paying attention to these warning signs, we may be able to identify patients who need additional care sooner and perhaps understand the origin of mental illness better," said Aashit Shah, MD, chief of neurology at Carilion and professor of medicine at the Virginia Tech Carilion School of Medicine, a collaborator on the study.

The study was led by Nandwana in collaboration with Shah and Anita Kablinger, MD, vice chair of research for Carilion Clinic’s Department of Psychiatry and Behavioral Medicine; Geetika Bajpai, assistant professor of neurology at the University of North Carolina at Chapel Hill; and Ching-Fang Sun, child and adolescent psychiatry fellow at the University of Washington School of Medicine and Seattle Children's Hospital.

The study was funded by the Carilion Clinic Department of Medicine.

Original study: DOI:10.1136/bmjno-2025-001473

As President and Chief Executive Officer, Steve Arner oversees Carilion Clinic, a $2.9 billion not-for-profit integrated health system headquartered in Roanoke, Virginia, serving more than 1 million people in Virginia and West Virginia.

Carilion Clinic includes seven hospitals ranging from the third largest in Virginia to mid-sized community and small rural or critical access hospitals. Carilion also operates complementary business lines, including home health, imaging services, pharmacies and free-standing surgical clinics and has a large physician group with more than 1,000 employed physicians.

Before becoming CEO in 2024, Mr. Arner served as Chief Operating Officer, managing the operations of Carilion Medical Center and physician practices, for 12 years.

He began his career at Carilion in 1996 as a financial analyst and has served as budget manager, Human Resources compensation and analytics director, hospital administrator at Carilion Rockbridge Community Hospital and senior vice president of Cardiothoracic and Vascular Services.

Mr. Arner served as the past chair of the board of directors for the Virginia Hospital and Healthcare Association and is the past state delegate of the American Hospital Association Regional Policy Board. He serves on the strategic planning committee for the America’s Essential Hospitals board of directors and is also on the board of directors for the Feeding America Southwest Virginia. In addition to his work at Carilion, Mr. Arner was an associate in CIGNA’s HealthCare Leadership Program from 2002 to 2003.

In addition to leading Carilion’s in-house legal department, Nick Conte oversees Carilion’s governmental and external affairs, philanthropy and claims management areas.  He also participates in Carilion’s VTC and rural health initiatives. As Chief Legal Officer, he advises Carilion’s various boards of directors and executive teams on a broad range of matters. 

Prior to joining Carilion, Mr. Conte was a Principal with Woods Rogers PLC, the largest law firm headquartered west of Richmond, where he served as its Chair/CEO. While at Woods Rogers, his practice focused on representation of public, private, and not-for-profit enterprises and their Boards and leaders.

Mr. Conte serves on the Virginia Health Care Foundation Board and the American Hospital Association’s Price Transparency Task Force.  He also serves on the Board of the Bank of Botetourt and on the boards of a variety of community organizations, including VERGE, Taubman Museum of Art, Virginia Western Community College Foundation, and the Roanoke Symphony Orchestra.

As Chief Operating Officer, Christopher Cullom partners with teams across Carilion to advance the organization's mission while continuing to strengthen operational performance, access to care, and the experiences of patients and employees.

He brings nearly 20 years of executive leadership experience across nationally recognized academic health systems, integrated delivery networks and community-based organizations.

Prior to joining Carilion, Mr. Cullom served as Chief Operating Officer for Thomas Jefferson University Hospitals in Philadelphia, part of Jefferson Health. He also held several leadership roles with Trinity Health Mid-Atlantic, University of Pennsylvania Health System, Tenet Healthcare, and University of Florida Health Jacksonville.

Mr. Cullom earned a Master of Science in Healthcare Administration and a Master of Business Administration from the University of Alabama at Birmingham. He is a fellow of the American College of Healthcare Executives.

Professional Membership Dues

CRCs, CRAs, and other research support staff within the Office of Research Operations and Strategic Initiatives (OROSI) may request reimbursement for eligible professional membership dues, including memberships with organizations such as the Association of Clinical Research Professionals (ACRP), by submitting an expense report through Workday.

Support Your Growth with Certification Reimbursement | Inside Carilion

When creating the expense report, use the following:

• Business Purpose: Dues, Memberships
• Company: CP01
• Cost Center: Consult with your manager about the cost center
• Expense Item: Professional Membership

The expense report will route to Vera Hollen, Grants Management Director, for approval.

This process applies to research support staff within the OROSI. Research staff hired directly by individual departments should work with their department regarding professional membership expenses, as departments may cover these fees at their discretion.

Certification Reimbursement

Certification expenses are handled differently from professional membership dues. Under Carilion's certification reimbursement policy, certifications that are required for an employee's job role are eligible for reimbursement through Human Resources.

Employees should follow the current Certification Reimbursement guidelines available through the Employee Center. Human Resources General Knowledge - Certification Reimbursement

Unable to Pay Up Front?
Employees who are unable to pay the certification expense in advance can use the link provided within the Certification Reimbursement guidance to submit an HR inquiry through Employee Center for assistance.

Remember the Difference:

Professional membership dues → Workday Expense Report

Required job certification → HR Certification Reimbursement process

Keeping these two processes separate will help ensure reimbursement requests are submitted through the appropriate channel and routed correctly.

ROXI-ASPEN: From First Participant to Top 5: A Strong Start for Our Research Team

Our research team is celebrating an exciting early milestone! Just weeks after screening our first participant on June 26, 2026, our site reached the Top 5 screening sites in August.  Reaching this milestone in such a short period of time reflects the dedication, collaboration, and hard work of everyone involved. From identifying potential participants and coordinating schedules to completing screenings and supporting participants throughout the process, each step requires a true team effort.

This achievement is especially meaningful as we continue building momentum and expanding opportunities for patients to participate in clinical research within our community.  A big thank you to everyone who has contributed to this strong start. We are excited to see what we can accomplish together as the study continues!

Department of Surgery Research Update: 

Reverser Study 
The Department of Surgery continues to demonstrate strong performance in clinical research through its participation in the international Reverser study. The study is evaluating reversal of anticoagulation, an important area of investigation for the management of patients receiving anticoagulant therapy. 

Carilion’s enrollment performance has been particularly notable. In just 12 months of being open to enrollment, Carilion has enrolled 13 participants, compared with other participating sites around the world that have been open for several years. Carilion is currently the sixth-highest enrolling site internationally, highlighting the strength of our clinical research infrastructure, investigator engagement, and study coordination. 

The team’s performance has also received recognition from the study sponsor. Director of Research, Sydney Webb, received a Study Coordination Award recognizing a study coordinator who has gone above and beyond through strong organization, proactive problem solving, and dedication to quality execution. 
 

Department of Medicine Research Update:

August 2026 saw the first participants enrolled to: 
ACCLAIM-CTA (Cardiology; PI, L Wahid; Research Team Lead, Kristin Dunford) 
This industry-sponsored trial investigates how lepodisiran affects the amount and type of plaque in the coronary blood vessels of adults who have high Lp(a) levels. 

ALPINE  (Dermatology; PI, Z Holcomb; Research Team Lead, MacKenzie Eubank) ALPINE looks at whether the new drug brepocitinib is safe and effective for the treatment of adult lichen planopilaris. In this uncommon autoimmune disease, overactive T cells attack normal hair follicles. 

Congratulations Team! 
 

Carilion investigators interested in cancer research funding are invited to attend an upcoming American Cancer Society (ACS) Extramural Discovery Science Southeast Region webinar highlighting current research funding opportunities.

The webinar will provide potential applicants with information about ACS funding opportunities ahead of the December 1, 2026 application deadline. Virginia is part of the ACS Southeast Region, making the September 17 session particularly relevant for Carilion principal investigators and research teams considering future ACS applications.

Southeast Region Webinar

Thursday, September 17, 2026
11 a.m.–12 p.m. EDT
Virtual via Microsoft Teams

Register for the Southeast Region webinar

Carilion investigators who may be interested in pursuing ACS funding are encouraged to participate and learn more about available opportunities, eligibility requirements and the upcoming application cycle. Please reach out to Melissa Mercure, PhD (mzmercure@carilionclinic.org) to discuss anticipated ACS applications.

Learn More About ACS Funding

Additional information about current American Cancer Society research funding opportunities and applicant eligibility requirements is available on the ACS Research Grants website.

• Sleep Disturbance Predicts Depressive Symptoms and Suicidal Ideation Among Psychiatrically Hospitalized Adolescents — Abhishek Reddy, Sethulakshmi Anil, Hunter Sharp, Anita Kablinger
• Digital Antecedents and Temporal Patterns of Adolescent Overdose Attempts — Abhishek Reddy
• Comparative Safety of Melatonin vs. Trazodone Initiation on 180-Day Suicidality Outcomes in Pediatric Major Depressive Disorder and Insomnia — H. Patel, K. Xing, A. Reddy, A. Kablinger
• Temporal Sequencing of Sleep Diagnoses, Depression, and Suicidal Behavior — K. Xing, H. Patel, A. Reddy, A. Kablinger

Congratulations to the entire research team! 

Dr. Ellie Savio-Galimberti Heads to AHA Scientific Sessions 

Congratulations to Dr. Ellie Savio-Galimberti, whose abstract, “Caloric Restriction Reverses Arrhythmogenic Remodeling and Impaired Calcium Handling in Obesity Cardiomyopathy,” has been accepted for presentation during the **Emerging Mechanisms in Cardiac Electrophysiology and Arrhythmias poster session at the American Heart Association's 2026 Scientific Sessions, November 9–11 in Chicago. 

Cheers to Dr. Savio-Galimberti on this exciting accomplishment! 

Dr. Dernbach Shares Expertise at Upcoming Educational Programs 

Dr. MR Dernbach will contribute to two upcoming professional and educational programs: 

• Dignity Disorders — Catholic Medical Association (CMA) 95th Annual Educational Conference, Catholic Social Teaching Forum; Phoenix, Arizona, September 9, 2026.
• Psychological Impact of Mass Exposures — Agents of Opportunity for Terrorism: Toxic Industrial Chemicals (TICs) and Toxic Industrial Materials (TIMs), American College of Medical Toxicology (ACMT) Virtual Course; September 8, 2026.
   

Department of Surgery Research on the National and International Stage

The Department of Surgery continues to demonstrate a strong commitment to research and scholarship. Faculty, residents, fellows, medical students, and research trainees are sharing their work at leading national and international conferences.

During Academic Year 2025–26, the department produced an impressive 46 publications and 56 presentations, reflecting the breadth of scholarly activity and research engagement across the department.

Congratulations to the Department of Surgery teams contributing to this work!

The Carilion Clinic Investigator Series:

Fall Speaker Session Featuring

Dr. Megan Whitham, MD

"Pregnant Patients Belong in Research: Moving from Protection to Responsible Inclusion"

September 23^rd, 12pm-1pm

REGISTER via Microsoft Teams

Dr. Megan Whitham is the Director of Research for Obstetrics and Gynecology at Carilion Clinic and an Assistant Professor at the Virginia Tech Carilion School of Medicine. She is a board-certified physician in both maternal fetal medicine and obstetrics and gynecology whose research focuses on advancing maternal–fetal imaging and implementation science to improve early detection and management of pregnancy complications. She leads a multidisciplinary collaboration in developing ultrasound tools to evaluate placental microvascular function and identify early biomarkers of placental insufficiency.

If you or a colleague would like to be a future speaker in the series, please contact Andrea Mohr (abmohr@carilionclinic.org) for more details.

HRPO Lunch and Learn Series:

September Session (9/30): When Is IRB Review Needed? Human Subjects Research, Non-Human Subjects Research, QA/QI, and Case Studies

CLICK HERE TO REGISTER FOR SEPTEMBER SESSION

The study, published in Implementation Research and Practice, evaluated Measurement-based Care Training for Resilient Implementation in a Clinical Setting (METRIC), a digital education platform designed to train clinicians in the use of patient-reported outcome measures (PROMs).

PROMs are standardized questionnaires that allow patients to report symptoms such as depression and anxiety. When used consistently, these measures can help clinicians monitor changes in symptoms over time and make more informed treatment decisions.

The METRIC program uses educational videos, patient simulations, guidance on interpreting symptom measures, and strategies for navigating common clinical situations. Researchers found that the digital platform provided a feasible and consistent approach to clinician education and could help support the long-term integration of measurement-based care into outpatient psychiatry.

“This work represents an important step toward making evidence-based measurement practices more sustainable in routine clinical care,” said Anita Kablinger, MD, CPI, vice chair for research in Carilion Clinic’s Department of Psychiatry and Behavioral Medicine and senior author of the study.

The research brought together investigators from Carilion Clinic, Virginia Tech, the University of Colorado, and The Ohio State University Wexner Medical Center and was funded by the Carilion Clinic Department of Psychiatry and Behavioral Medicine.

Learn More:
Read the full Carilion Clinic news release on EurekAlert for more about the study and its impact. Read the EurekAlert news release

Read the study: Assessing the Implementation of a Novel Digital Measurement-Based Care Training in Behavioral Health Using the Prism Framework. Implementation Research and Practice. Published June 16, 2026. doi:10.1177/26334895261456673

1. Stephens J, Biery N, Kieber-Emmons A, Hamadani R, Allen N, Greenberg G. Association of asynchronous virtual scribe services: patient experience in primary care. J Am Board Fam Med. 2026;39(1):165305. doi:10.3122/jabfm.2026.260173R0

2. Faulhaber JR, Baffoe-Bonnie AW, Oursler KK, Vasudeva SS. Update in human immunodeficiency virus and aging. Clin Geriatr Med. 2026;42(3):559-578. doi:10.1016/j.cger.2025.09.005

3. Andrew Hartley (VTCSOM), Michael Greenage, Justin White, and Tracey Criss (senior author) Use of Electroconvulsive Therapy for Treatment-Resistant Schizophrenia in a Patient Unable to Tolerate Clozapine Due to Clozapine-Associated Hyponatremia: A Case Report Case Reports in Psychiatry, 2026. Article ID 6269931 https://doi.org/10.1155/crps/6269931 

4. Rasimas JJ, Carter GL, Dernbach MR (In Press). Psychiatric Issues in the Critically Poisoned Patient. In: Brent J, ed. Critical Care Toxicology (3rd edition).

Beginning this fall, Dr. Kablinger and Dr. Stephanie DeLuca will lead TBMH 5104: Foundational Knowledge for Leading Clinical Trials Research, a course within the new certificate program.

The Clinical Research Graduate Certificate is designed to prepare Virginia Tech graduate students for key roles in clinical research operations while building a comprehensive understanding of how clinical research is conducted and managed in accordance with regulatory and ethical standards.

Students may choose from two specialized tracks:

• Management – Focuses on clinical data oversight, biomedical research study management, and effective communication. The track prepares students to lead, coordinate, and optimize clinical research operations across scientific, regulatory, and public domains.
• Pharmaceutical Clinical Trials – Focuses on drug development, pharmacology, and clinical applications, providing students with an understanding of the therapeutic development pipeline from discovery through clinical trials.

The certificate addresses an important educational need by providing specialized preparation for students pursuing careers in the growing field of clinical research.

Expanding Clinical Research Leadership Education 

Additional opportunities to advance clinical research education are also underway. An upcoming Surgery Grand Rounds in January will focus on physician leadership in clinical research. 

Similar presentations and educational opportunities can be developed for other departments based on their specific interests and needs. Departments interested in exploring future clinical research education topics or formats are encouraged to reach out to Dr. Anita Kablinger for additional information. 

These initiatives represent continued efforts to strengthen clinical research knowledge, professional development, and collaboration across Carilion Clinic and Virginia Tech.” 
 

What’s changing?

Under the new policy, NIH will no longer accept letters that simply endorse an application or express general enthusiasm for a proposed project. Instead, applicants should include Letters of Collaboration only when documenting a collaborator’s commitment to participate in the project or provide specific resources or materials that contribute to its success. Examples include collaborators outside the application team or commitments related to Material Transfer Agreements.

The change also eliminates the need for letters from individuals already listed as Senior/Key Personnel or Other Significant Contributors, since their roles are already documented through required biosketches. Likewise, letters from trainees or laboratory staff working under the PI—including graduate students, postdoctoral fellows, and technicians—should not be included.

New format requirements

Letters of Collaboration are intended to be brief and focused. Each letter must:

• Be no more than 100 words.
• State only the collaborator’s intent to participate or provide resources as described in the application.
• Avoid endorsements, evaluations of the proposed science, or additional project descriptions.

To help applicants, NIH has provided the following recommended template for all applications except fellowships:

“If the application submitted by [Organization Name and with PD/PI Name] as Program Director/Principal Investigator entitled [Grant Application Title] is selected for funding by NIH, it is my intent to collaborate and/or commit resources as detailed in the application.”

When does this take effect?

NIH has announced that the transition from Letters of Support to Letters of Collaboration will occur when Forms J are implemented for FY2027 applications. The timing of this change is important. While NIH Fiscal Year (FY) 2027 begins on October 1, 2026, the new requirement is not tied to the start of the fiscal year. Instead, it will take effect with the implementation of NIH Forms J. Additional guidance, including the Forms J application instructions and implementation timeline, will be released by NIH before the new forms become available.

Once Forms J are implemented, applicants should follow the new instructions even if an individual Notice of Funding Opportunity (NOFO) still references Letters of Support. The Forms J application instructions will supersede older NOFO language, and applications that continue to include traditional Letters of Support after the Forms J implementation may be returned without review.

What Carilion investigators should do now

Rather than requesting narrative endorsement letters, ask collaborators to provide the NIH-recommended statement—or similar language confirming their specific role or resource commitment.

If you have questions about how this policy may affect an upcoming NIH submission, please contact Melissa Mercure (mzmercure@carilionclinic.org) for assistance with application preparation and compliance.

The Tazewell practice opened to patients In June. The 12,000 square-foot building was constructed in partnership with the Tazewell Community Foundation, Tazewell County, and The Innovate Fund.

“This practice signifies improved primary care access close to home for our community,” said Grant Greenberg, M.D., senior vice president and chair of Family and Community Medicine. “What’s really exciting is the opportunity to build on existing capabilities with our teams to expand primary care offerings in an efficient, convenient way for patients.”

The practice's basic family services including acute visits, same-day access, chronic condition management, preventive and wellness services, treatment for minor injuries, pediatric and well-child visits, immunizations, and an on-site lab. The care team includes 2 doctors, 2 physician assistants, a nurse practitioner, and a registered nurse.

“Expanding access to trusted primary care experts continues to be a priority for our teams,” said Lindsay Collins, interim vice president of Family and Community Medicine. “With this project, we were able to customize a brand-new layout and flow to best meet the needs of our community. We look forward to welcoming patients onsite.”

Using MyChart, Carilion's secure online health management tool, patients can schedule upcoming in-person visits. Practice hours are Monday – Friday, 8 a.m. – 5 p.m. To learn more or to schedule an appointment, you can reach the practice at (276) 988-8850 or CarilionClinic.org.

Roanoke Memorial was rated as high performing in 13 procedures and conditions:

• Colon Cancer Surgery
• Ear, Nose & Throat Surgery
• Gynecological Cancer Surgery
• Heart Arrythmia
• Heart Attack
• Heart Bypass Surgery
• Hip Replacement
• Knee Replacement
• Leukemia, Lymphoma & Myeloma
• Lung Cancer Surgery
• Pacemaker Implantation
• Prostate Cancer Surgery
• TAVR

Of the 13 procedures and conditions, Carilion is proud to be rated as high performing in a new category this year: Ear, Nose and Throat Surgery. Additionally, Carilion New River Valley Medical Center earned high-performing status in Kidney Failure and Pacemaker Implantation.

Being recognized as high performing is the highest distinction (from U.S. News & World Report) a hospital can earn for a procedure and condition. It signifies that a specialty or procedure receives excellent clinical outcomes.

“These results show both the strength of our foundation and the urgency of the work ahead,” said Chief Quality Officer Suzy Kraemer, MD. “They reflect the dedication of our physicians, nurses, advanced practice providers and team members, and the progress we’re seeing in areas such as observed mortality, discharge to home and patient experience. At the same time, the rankings make clear that we must move faster and stay focused on the fundamentals of quality care: reliable processes, accurate documentation, strong communication and a consistent patient experience. Every team member has a role in improving outcomes for the patients and communities we serve.”

“These achievements reflect the collective efforts of our dedicated healthcare professionals, whose compassion, expertise, and commitment to excellence are at the core of everything we do,” said Steve Arner, president and chief executive officer of Carilion.

Mike Abbott, president of Carilion Roanoke Memorial added, “We are honored to see our teams recognized for the meaningful impact they make on the lives of patients and families throughout our communities. Their dedication to excellence, innovation, and compassionate care inspires us every day, and we remain committed to advancing the health and well-being of those we serve.”

This month features several outstanding educational opportunities, including two symposia sponsored by the Fralin Biomedical Research Institute at VTC. We encourage everyone to take advantage of these events to learn, connect, and engage with colleagues across the research community.

August 10-11: 2026 Vascular and Heart Research Symposium 
Forging New Collaborations in Vascular and Heart Research 
The Fifth Annual Vascular and Heart Research Symposium, hosted by the Fralin Biomedical Research Institute and its Center for Vascular and Heart Research, will bring together experts in cardiovascular fields from across the region.

September 23-24: Precision Therapeutics for Schizophrenia: Integrating Computational Phenotyping with Next-Generation Pharmacology convenes scientists, clinicians, and healthcare leaders spanning circuit neuroscience to late-stage clinical development, advancing the shift toward personalized care. The two-day meeting will address three thematic areas: next-generation pharmacology for schizophrenia, computational approaches to patient stratification, and mechanistic neuroscience. We hope the event will have the right people at the table to drive collaboration and outcomes for patients. 

October 30- ACRP Virginia Chapter Annual Fall Symposium.  The ACRP Virginia Chapter will host its annual full-day event this fall, providing the opportunity to earn up to 7 educational contact hours featuring a dynamic lineup of educational sessions, panel discussions, and focused roundtables on the latest developments, challenges, and opportunities in clinical research. Key Considerations Under ICH E6 (R3) will be presented by ACRP’s new CEO, David M. Vulcano, MSW, MBA, CIP, RAC, FACRP.

🎊 Celebrating Milestones

 Please join us in congratulating our colleagues celebrating their anniversary at Carilion!

10-Year Anniversary

Diedre (Dee) Myers- 7/25

Happy Anniversary and thank you for being part of the team! Carilion’s 2025 Medical Laboratory Science program.

Current Open Positions

Grant Funded Department of Medicine Clinical Research Unit - Clinical Research Coordinator III (Roanoke, Virginia)

Clinical Research Coordinator IV - Oncology (Roanoke, Virginia)

Clinical Research Coordinator IV (Roanoke, Virginia)

Effort Certification Reminder

Effort Certification is a quarterly, required process for employees whose pay is charged to or cost‑shared on a sponsored project (i.e., grant or clinical trial). Timely completion is important to ensure compliance with sponsor and federal requirements. 

Each quarter, you’ll receive a Workday task asking you to review and certify that your effort reasonably reflects the work you performed during the reporting period. Rest assured that the information has already been reviewed and vetted by your Sponsored Project Manager and can be certified as‑is. If something doesn’t look right, please contact your Sponsored Project Manager immediately.  

Carilion Clinic TriNetX Virtual Training Schedule

Carilion offers instructor-led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please get in touch with HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so!  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Aug 5, 10:30 am – noon
• Aug 20, 1:30 – 3pm
• Sept 9, 1:30 – 3pm
• Sept 23, 10:30am - noon

TriNetX User Agreement:  https://redcap.link/v5pw9j7j

For more information visit:https://redcapweb.carilionclinic.org/redcap/surveys/?s=dcUCIpMAzk8BqKH2

* Carilion Clinic Research and Development is honored to partner with a growing list of prestigious national and statewide research centers and healthcare organizations. Find out more about our collaborative research initiatives; explore our unique public-private partnerships with the Virginia Tech Carilion (VTC) School of Medicine, Virginia Tech, Fralin Biomedical Research Institute, Radford University Carilion, and others. Connect with our team to discuss opportunities to collaborate with our experts or become a participant.

Congratulations to Dr. Rob McNamara, faculty member in the Department of Psychiatry and Behavioral Medicine, on his role as Co-Investigator on a newly funded NIH R21 grant led by Dr. Huaiyang Zhong, Principal Investigator.

The project, "Advancing Chronic Pain Care in Rural Seniors: Machine Learning and Natural Language Processing to Improve Understanding, Assessment, and Comorbidity Risk Prediction," will explore innovative ways to improve the assessment and management of chronic pain among older adults living in rural communities.

By leveraging machine learning, natural language processing (NLP), and advanced predictive models, the research team aims to develop tools that provide a more comprehensive understanding of chronic pain while identifying individuals at increased risk for related conditions, such as depression. These innovations have the potential to support earlier interventions, improve clinical decision-making, and expand access to personalized care for underserved populations.

Dr. McNamara brings more than 15 years of experience in prevention, clinical intervention, and implementation research. His expertise as both a licensed clinical psychologist and researcher will help ensure that the project's innovative methodologies remain grounded in evidence-based practice and are applicable to real-world clinical settings.

The multidisciplinary team also includes Drs. Xuan Wang (VT), Jyoti Savla (VT), and Kwok-Leung Tsui (UT-Arlington), and whose expertise spans clinical psychology, artificial intelligence, aging, healthcare analytics, and biostatistics. The project is further strengthened by an interdisciplinary advisory board of Drs. Alex Hanlon (VT BHDS), Anita Kablinger (VTCSOM), Donald Penzien (Wake Forest), Margaret Rukstatlis (VTCSOM), Elizabeth Russo-Stringer (VTCSOM), and Bob Trestman (VTCSOM), who bring combined expertise in psychiatry, chronic pain, addiction medicine, clinical trials, and healthcare data science.

Congratulations to Dr. Zhong, Dr. McNamara, and the entire research team on this significant achievement and their commitment to advancing innovative research that improves the health of the communities we serve.

Congratulations to Vera Hollen, who is working directly with Carilion leadership on the Rural Health Transformation Grant, an initiative focused on improving health outcomes for communities across rural Virginia.

As part of the first round of funding, Virginia was awarded $189.5 million to support innovative strategies that improve healthcare access and outcomes in underserved communities. Carilion's leadership team will play an important role in identifying and evaluating opportunities to collaborate with the statewide program and advance these efforts.

To learn more about the Rural Health Transformation initiative, visit: Virginia Rural Health Transformation website.

We are grateful to Vera for her leadership and dedication to this important work. Her contributions reflect Research & Development's commitment to advancing innovative solutions that improve the health of the communities we serve.

From first patient enrollments to recruitment milestones and newly launched studies, our research teams continue to make remarkable progress across Carilion's clinical research portfolio. Here are a few highlights from this month's clinical trials.

Research and Development

MoDi Twin -This study uses a new type of ultrasound technology for evaluation of blood vessels and flow of blood within the placenta. This new imaging technology will be performed in monochorionic [MoDi or MonoMono] twins, who share a placenta and may receive uneven shares of the placental blood flow or shunting of blood from one twin to the other.

Department of Medicine -Clinical Research Unit
During July, we enrolled the first patient to alloNK (Rheumatology; PI, A Bankole; Research Team Lead, M Eubank). As Carilion’s first cell therapy trial, alloNK investigates whether NK cells prepared from healthy donors and used with the monoclonal antibody rituximab deeply decrease the abnormal B cells that cause rheumatoid arthritis.

Congratulations to the entire team of the PRISM study (Infectious Diseases; PI, E Bansal; Research Team Lead, E Shava). We recently completed both our blinded and unblinded interim monitoring visits with minimal to no findings. These achievements showcase the team’s excellent preparation and collaboration. One of our newer trials, PRISM tests the safety and efficacy of the investigational product AZD5148 for preventing recurrent Clostridioides difficile infections in adults.

After celebrating the 200th enrollment to 20vPNC (Inpatient Research; PI, E Shava; Research Team Lead, J Mobley) in April, recruitment continues to be brisk, notably with 4 patients enrolled in a single day at Carilion Rockbridge, one of our satellite research sites. These achievements are particularly striking, given that initial feasibility assessments projected fewer than 100 participants enrolled. The 20vPNC trial evaluates how well this 20-valent vaccine protects elderly adults against community-acquired pneumonia due to 7 newly included isolates of Streptococcus pneumonia.

After experiencing a lull in enrollment to CONFORM (Cardiology; PI, J Foerst; Research Team Lead, Jenny Johnson) has regained momentum with alacrity. As for other structural heart trials, CONFORM’s extensive participant criteria and narrow eligible population present a particular recruitment challenge for its research teams. However, shout out to the research team, who enrolled not just 1 but 3 participants in a single day during July. The CONFORM study assesses whether a new left atrial appendage occlusion (LAAO) device works as well as other commercially available LAAO devices in patients with nonvalvular atrial fibrillation.

At the heart of every research study is a person, a family, and a story. While we often celebrate new grants, publications, and scientific discoveries, it is the lives touched by research that remind us why our work matters.

In this new recurring feature, Research Matters, we will share the stories of research participants, families, investigators, and research professionals whose experiences reflect the impact of research across our communities. These stories celebrate not only scientific progress, but also the hope, courage, and partnerships that make discovery possible.

For our inaugural feature, we are honored to share the story of Danny D. a young boy who participated in a leukemia clinical trial at Carilion.

His journey is one of resilience, hope, and the extraordinary partnership between families and research teams. Recently, his family reached out with wonderful news: Danny is thriving! After completing treatment, he has finished kindergarten and is now a rising first grader. His family shared that he is reading and writing above grade level, making new friends, enjoying T-ball, and discovering a love for music.

Along with sharing this wonderful update, Danny's family expressed their heartfelt gratitude to the physicians, nurses, research staff, and care teams who supported them throughout their journey. "All of this to say, none of this would be possible without the work and care that we received at Carilion Clinic from all of you... Through every test, poke, prod and IV drip, you all carried so much love and light into the room in the absolute darkest of times."

For those who cared for him throughout his research journey, this update is a powerful reminder that every consent discussion, study visit, laboratory sample, and data entry represents much more than a research protocol. Together, these efforts contribute to discoveries that improve treatments, offer hope to families, and help shape the future of medicine.

We are deeply grateful to the Dudley family for allowing us to share a small part of their journey. Their willingness to participate in research has contributed to advances that may benefit countless children and families in the years to come.

Watch Danny's Story: See how one family's journey through leukemia treatment and clinical research became a story of hope, resilience, and gratitude.

Danny's Cancer Journey with Carilion Clinic

Behind every research study is a person, a family, and a story. Thank you to every research participant who helps move medicine forward.

U.S. Navy Reserve Capt. Brendan Byrne, MD, never expected to be part of the elite medical recovery team chosen to care for the four Artemis II astronauts after splashdown in April. But a series of unexpected events―combined with his specialized training in hyperbaric, tactical and austere medicine―placed him aboard the U.S. Navy recovery vessel off the coast of San Diego.

As the recovery team prepared for the astronauts' return after 10 days in space, Byrne considered the wide range of medical issues they could face following prolonged exposure to zero gravity and the intense physical demands of atmospheric re-entry.

"The effect of a high-speed motor vehicle accident doesn't begin to compare to the kind of G-forces astronauts experience," Dr. Byrne said.

Dr. Byrne shared the unique clinical challenges of spaceflight as the opening speaker at the VTC Aerospace Medicine Summit earlier this month, where he joined NASA flight surgeons, military physicians and emergency medicine and other experts to challenge Carilion's 35 Emergency Medicine residents to expand their view of patient care as they begin a new academic year. 

His presentation set the tone for a day focused on practicing medicine in extreme environments and applying those lessons to emergency medicine.

Another speaker was Craig Kutz, MD, PhD, of NASA’s Johnson Space Center in Houston, who was the responding flight surgeon for the SpaceX Dragon Endeavour’s return from the International Space Station in January after 166 days due to a medical incident.

“Sea-level is boring. Space is sexy,” he said, explaining a career path that has included an undersea fellowship and stint in the Himalayas.

The summit also highlighted the challenges of caring for patients in some of the world's most remote and demanding locations. Col. Greg Stiller, MD, of the Wyoming National Guard, shared lessons from his work in Antarctica and Afghanistan. As an emergency medicine physician in Antarctica, Dr. Stiller learned to process laboratory specimens and take X-rays himself. In Afghanistan, he had to intubate a patient on the tail of a cargo plane moments before takeoff.

“Learn everything you can because you’re going to have to figure it out on the fly,” he said. That’s what makes emergency medicine interesting.”

While our residents aren’t likely to face the kinds of situations the speakers described while they are working at Carilion, they have to be ready for “whatever comes in the door,” said Seth Pekoe, DO, a third-year Emergency Medicine resident. "So much of what we do―from interventions to the way we train and respond under stress―comes from the military and the battlefield.”

The discussion then shifted from clinical challenges to leadership and decision-making under pressure. Cmdr. Matthew Doubrava, MD, a U.S. Navy flight surgeon and former senior medical officer aboard the aircraft carrier USS Harry S. Truman, introduced residents to the OODA loop, a model for making decisions in rapidly changing situations.

“We tend to think the solutions in medicine are in medicine. Yet, the most successful organizations are those that excel at decision-making,” said Dr. Doubrava.

“Decisions without actions are pointless. Actions without decisions are reckless.”

That broader perspective resonated with first-year resident Elizabeth Gienger, MD.

"I especially appreciated hearing about human factors and the systems approach to healthcare, thinking beyond the tactical level of daily patient encounters," she said.

Dr. Gienger is among the 12 new Emergency Medicine residents, who over the next 3 years will train at Carilion Roanoke Memorial Hospital―which is among the nation's top 5% of high-acuity academic emergency departments. They’ll also gain experience at our community hospitals and ambulatory sites, learn to navigate regional resources and the transfer system, and develop the leadership skills needed to succeed in today's increasingly complex healthcare environment.

Nick Tsipis, MD, Emergency Medicine physician and residency core faculty member, organized the Aerospace Medicine Summit and hopes to make it an annual event.

“What better way to inspire residents and expand their view of what we can do as physicians?” he said.

One day a week, Nicholas L. Rider, D.O., an immunology and clinical informatics specialist, sees pediatric and adult patients at Carilion Clinic’s Allergy and Immunology clinic at Tanglewood in Roanoke. 

Other days find him at the Virginia Tech Carilion School of Medicine’s CHILI (for computational human immunology lab and innovation hub), where he leads a team of researchers using complex healthcare data to gain new insights on immune disorders.

Dr. Rider is an early example of the kind of specialist physicians Carilion Clinic and Virginia Tech are joining forces to hire. He came to Carilion in 2024 from Houston’s Texas Children’s Hospital, ​​the world’s largest children’s hospital.

At Carilion’s Tanglewood Center in Roanoke, Dr. Rider treats pediatric and adult patients with ​​primary immune disease, or PI, a rare disorder affecting about 60 of every 100,000 people. Because of PI’s rarity, a large number of cases go undiagnosed—a challenge that is only magnified in rural communities.

 At CHILI, Dr. Rider’s team is using clinical data and advanced tools to study disease biology, epidemiology, and treatment inequities -- all with a shared mission to improve outcomes for people with PI, wherever they live.

Beyond directing his team’s immunology research, through his additional role as an associate chief medical information officer at Carilion, his responsibilities include building a collaborative research infrastructure combining the power of Carilion’s vast amount of privacy-protected patient data with Virginia Tech’s world-class research capabilities.

Collaborations that combine Virginia Tech’s state-of-the-art, high-performance computing capabilities, including machine learning and artificial intelligence, with Carilion’s deep patient data, “have real potential for dramatically reshaping healthcare,” Dr. Rider said.