Surgical Therapeutic Advancement Center (STAC)


STACnobacklogo

“To promote therapeutic advancements through research, development, and education in order to improve the clinical care of surgical patients.”


The Surgical Therapeutic Advancement Center (STAC) at the University of Virginia (UVA) is an academic research center dedicated to the development of innovations in the field of surgery in order to improve the clinical care of patients. Our collaborators include some 30 UVA faculty members whose efforts are coordinated through one central office under the direction of Dr. William D. Spotnitz.

Recently, Dr Spotnitz received his M.B.A. and was elected to the national business school honor society Beta Gamma Sigma.  In keeping with the mission of STAC to improve the clinical care of surgical patients, an additional effort is being made to support business development of quality surgical devices through consultation services. These consultation services are being provided over a wide range of topics from device development all the way through regulatory approval. Additional details are provided in the menu under the consultation services section.

Our clinical expertise in protocol development, implementation, execution, and publication extends throughout the surgical departments at the University of Virginia. Experience has been obtained in a wide variety of clinical trials (single and multi-center, including international) with many surgical specialties and related fields, including head and neck surgery, general surgery, orthopedic surgery, neurosurgery, plastic surgery, hematology, and radiology. The Center has particular strengths in the areas of cardiovascular and thoracic surgery, tissue adhesive research, as well as transfusion medicine. STAC is experienced with Phase I, II, III, and IV studies, and conducts all research with adherence to Good Clinical Practice (GCP) and International Committee on Harmonization (ICH) guidelines. The Center boasts certified Clinical Research Coordinators and trained support personnel dedicated to the efforts of clinical research.

Education remains a key focus point of the Center, with local, regional, national, and international presentations conducted for large and small groups. Workshops featuring clinical animal laboratory models, and clinician-to-clinician interaction are possible. All educational efforts focus on objective presentation of information in a practical, realistic format which emphasizes clinical judgment and improved patient care.

STAC exists through the nurturing support of a large number of industrial collaborators as a result of unrestricted grant funding and specific contractual agreements. Proprietary interests of individual sponsors are carefully protected. Intellectual property developed at the University of Virginia may be patented through the University Patent’s Foundation.

Services Available Through STAC Include:
  • Cell Biology Group
  • Wound Healing Laboratories
  • Proof of concept testing
  • Large and small animal models for preclinical testing
  • Efficacy evaluations
  • Comparison studies for product revision and improvement
  • Experienced laboratory staff
  • Regulatory strategy advice and assistance
  • Protocol development and revision
  • Clinical steering committee leadership
  • Site selection support and maintenance
  • Source document review and editing
  • Case Report Form review and editing
  • Clinical trial support by certified Clinical Research Coordinators with strong clinically based nursing backgrounds
  • Subject enrollment and data collection according to GCP/ICH standards
  • Data management and analysis by UVA Department of Health Evaluations Sciences
  • Scientific publication preparation
  • Organization of Continuing Medical Education conferences, workshops and guest speaker appearances
  • Formatting presentations to optimize learning for multidisciplinary/international groups including physicians, nursing, and allied health personnel as well as industry professionals
  • Creation of didactic, small group, and laboratory events
  • Facilitating Speakers’ Bureau/Guest Lecturer series
  • Preparation of peer-reviewed journal manuscripts
  • Authorship of chapters/books
  • Providing Visiting professorships/fellowships

The Tissue Adhecive Center (TAC) is a specialty center within the Surgical Therapeutic Advancement Center. TAC’s broad clinical experience over the past 25+ years with the field of tissue adhesives provides a unique expertise into the clinical uses of a variety of materials and has helped to produce a large number of publications including 80 adstracts, peer-reviewed journal articles, and books. TAC’s database of clinical tissue adhesive use within the institution provides unique insight during a period of rapid growth in this portion of the healthcare market.

The Tissue Adhesive Center (TAC) Clinical research in this field explores indications for a variety of tissue adhesives and related surgical devices including hemostatic agents, tissue sealants, wound closure systems, and drug carriers.

Areas of basic and preclinical research include wound healing, novel adhesive characterization, relevant clinical animal modeling for efficacy assessments, and device evaluation.

In keeping with the mission of the Surgical Therapeutic Advancement Center to “promote therapeutic advance-ments through research, development, and education in order to improve the clinical care of surgical patients,” an additional effort is being made by STAC to expand consultation services to industry.  These services are specifically designed to help new and medium sized companies with an entire support package for new product development and larger companies with particular areas of interest. Consultation services include:

  • Determination of surgeon needs
  • Device design
  • Device testing in bench and clinical environments
  • Financial sponsorship
  • Clinical trial execution
  • Regulatory approval
  • MSL and sales personnel organization and education
  • Post market clinical trials
  • Advisory board participation
  • Market assessment and strategy

Services can be performed off site as well as at the University of Virginia and allow STAC to provide flexible degrees of support that are tailored to each individual company’s needs. STAC has a proven track record of successful support in these areas.

Rachel Simon, RN, BSN, CCRC

Manager

Rachel earned a Bachelor of Science in Nursing degree from George Mason University in 2004. She joined the Thoracic-Cardiovascular Post-Operative Intensive Care Unit at the University of Virginia Medical Center in July 2004. In this position, she advanced to a Clinician III, acted as the Quality Improvement Coordinator, and was a member of the Thoracic and Cardiac Quality Service Team. She joined the STAC team in January 2011. Currently, Rachel is active in the PARTNER I and PARTNER II study, a transcatheter aortic valve device trial. Additionally, she works with the Cardiac Thoracic Surgery Network grant studies.

Mike Cosner, RN, BSN

Senior Clinical Research Coordinator

Mike received his Bachelor of Arts in Anthropology and a Minor in Chemistry from the College of William and Mary in 2004. He worked as a lead flight instructor for the world’s largest hang gliding school and volunteered as an Emergency Medical Technician prior to pursuing his nursing degree. Mike received a Bachelor’s of Nursing from Virginia Commonwealth University in 2009 and while there, worked as a Research Assistant on the Sedation and Ventilation Effects (SAVE) Study. He began his nursing career at the University of Virginia Health System as a registered nurse in the Thoracic Cardiovascular Post-operative Intensive Care Unit in 2010, specializing in the care of critically ill patients following major heart, lung, and vascular surgeries. In this role, Mike advanced to Clinician 2, gained CCRN certification, and “super-trained” staff members on new devices and bedside technologies. Continuing his work with cardiovascular surgery patients, Mike joined the STAC team in January 2014 and is active in clinical drug and device trials targeting stroke prevention in cardiovascular surgery patients.


Matt Kime, BS

Senior Clinical Research Coordinator

Matt received his Bachelors degree in biology with concentrations in microbiology and immunology from Virginia Tech in May 2013. During his undergraduate studies, he worked as a nurse aide at LewisGale Hospital Montgomery in Blacksburg, VA and as a research assistant for the UVA Clinical Trials Office. After graduating, Matt moved back to Charlottesville and became a Data Technician for the UVA Transplant Center Quality Department in 2013. He then became a Clinical Research Coordinator for the Department of Surgery’s Transplant Division in 2015, where he coordinated drug and device trials related to liver, kidney, pancreas, and lung transplantation and became the division team lead until August 2018. Matt spent a year as the Regulatory Specialist for the UVA Center for Diabetes Technology before joining the Department of Surgery’s Surgical Therapeutic Advancement Center in July 2019 as a Senior Clinical Research Coordinator, where he coordinates the cardiac surgery studies.


Kaitlyn Vecere, BS, RN, CCRC

Clinical Research Coordinator

Kaitlyn received her Bachelor of Science in Immunology and Infectious Disease and a Minor in Biology from The Pennsylvania State University in 2016. During her time at Penn State, she was first introduced to clinical research as an intern at the University of Virginia, as well as Cancer Treatment Centers of America in Philadelphia. While working as an intern with the Radiation Oncology department here at the university, she supported research efforts to evaluate the effects of dose sparing of cardiac structures by implementing the Voluntary Deep Inspiratory Breath Hold (VDIBH) protocol in patients receiving left breast radiation. While working at Cancer Treatment Centers of America, she retrieved, organized, and prepared a variety of documentation for the Stem Cell Transplant and Cellular Therapy Unit, in order to prepare for audit and accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT). Continuing her work with research, Kaitlyn joined the STAC team in June 2017, working on a variety of clinical trials coordinated in the office.


Christine Bernat, RN, BSN

Clinical Research Coordinator

Christine earned her Bachelor of Science in Nursing from the University of Virginia in 2014. She gained experience with cardiothoracic surgical patients working on 4 West and the Thoracic Cardiovascular Post-operative Intensive Care Unit. As a bedside nurse, Christine advanced to Clinician 2 and obtained her CCRN certification. Christine joined the STAC team in April 2019 and coordinates clinical drug and device trials in the cardiac and thoracic surgery populations.


S. Afua Owusu, BS, PhD

Clinical Research Coordinator

Afua attended Southern Illinois University-Carbondale (SIUC) where she earned a B.S. in Physiology with a minor in Chemistry in 2009. During her time at SIUC, she had the opportunity to conduct undergraduate scientific research in endocrinology as a Ronald E. McNair and Louis Stokes Alliances for Minority Participation scholar. Afua then participated in an NIH funded Post-baccalaureate Research Education Program at the University of Alabama at Birmingham—where she studied cardiac mitochondrial respiration redox cell signaling in the Department of Pathology. In 2015, Afua received her PhD in Physiology at Pennsylvania State University, as a Bunton-Waller Fellow and an Alfred P. Sloan scholar, investigating vitamin A metabolism in neonatal lung development and lung injury. In 2018, she completed her NIH T32 funded postdoctoral fellowship at Weill Cornell Medicine/New York Presbyterian Hospital in the Department of Genetic Medicine specializing in the areas of Personalized Medicine and Gene Therapy, elucidating vitamin A metabolism and genetic variation in the human airway epithelium of cigarette smokers. During her post-doctoral training, she earned an Advanced Certificate in Clinical & Translational Investigation and received trainee development scholarships through the American Thoracic Society. Afua joined the STAC team in June 2019 and coordinates a variety of clinical research conducted in the Department of Surgery.


China Green, BS

Clinical Research Coordinator

China received her Bachelor of Science in Biochemistry from the University of Virginia in 2014. Her interest in research began during her undergraduate fourth year when she participated in a research lab performing enzymatic assays on a protein isolated from L. delbrueckii to determine its function. After graduating, she worked as a pharmacy technician for CVS in her hometown of Covington, VA then returned to Charlottesville to work in the clinical labs at the UVA Health System. In 2016, China joined the STAC team and is active in cardiac and vascular surgery trials.


Caroline Keller

Clinical Research Coordinator Trainee

Caroline received her bachelor’s degree in Biology and Bioethics from the University of Virginia in 2019. She has worked as a surgical assistant for a private oral surgery clinic in Charlottesville for the past four years. She additionally volunteers in UVA’s department of anesthesiology research labs investigating the neurological and developmental effects of early exposure to general anesthesia. In her spare time she enjoys running and coaching her U-6 soccer team. She plans on continuing her education in the medical field in the near future. She works mainly with the Cardiac Surgery Trials for the UVA STAC office.

Contact Surgical Therapeutic Advancement Center (STAC)
STAC clinical services are coordinated through our offices located at the University of Virginia Health System.

Phone (434) 243-0315
Fax (434) 243-0318
uvastac@virginia.edu

Send U.S. Mail to:
University of Virginia Health System
Surgical Therapeutic Advancement Center
P.O. Box 801370
Charlottesville, VA 22908-1370
Send packages to:
University of Virginia Health System
Surgical Therapeutic Advancement Center
135 Hospital Drive, Cobb Hall,
Suite 1010
Charlottesville, VA 22908