Joanne Kurtzberg, MD
Director, DTRI Cell and Tissue Therapies Core
Professor of Pediatrics
Professor of Pathology
Chief, Division of Pediatric Blood and Marrow Transplantation
Co-Director, Stem Cell Laboratory
Director, Carolinas Cord Blood Bank

Dr. Kurtzberg is an internationally renowned expert in umbilical cord blood transplantation. She is Chief of the Division of Pediatric Blood and Marrow Transplantation at Duke University Medical Center in Durham, North Carolina.

Kurtzberg earned her medical degree from New York Medical College. She completed her internship at Dartmouth Medical Center and her residency at Upstate Medical Center at the State University of New York in 1980. In that same year, she began her career at Duke University Medical Center as a senior research fellow in pediatric hematology-oncology. Within three years she was appointed as an assistant professor of pediatrics. She became a professor of pediatrics in 1993 and a professor of pathology in 2003.

Kurtzberg has concentrated her work on applying basic research to the clinical setting and has published more than 200 manuscripts in peer-reviewed journals such as The New England Journal of Medicine, the Journal of Pediatrics and the Journal of Clinical Oncology.

See http://www.cancer.duke.edu/pbmt/ for more information.

N. Rebecca Haley, MD
Program Director, Cell Therapy Core - DTRI
Associate Professor of Medicine, Division of Cellular Therapy
ph: (919) 668-8644
e-mail: Rebecca.Haley@Duke.edu

At DTMI, Haley’s primary responsibility is to serve as Project Director, Cell Therapy Core for the DTMI Cell and Tissue Therapy Core led by Dr. Joanne Kurtzberg. In this role, Dr. Haley works with translational investigators in the areas of cell therapy and cancer vaccines.

Dr. Haley comes to DTMI’s Cell Therapy Core with extensive experience in initiating and managing programs with national scope in cell therapy, cord blood banking and the closely related field of transfusion medicine.

Haley has more than 20 years of experience in cellular therapy programs, serving as a policy and thought leader in the field. She worked with the American Red Cross both in transfusion medicine and in the development of cellular therapy, first as chief medical officer of the Carolinas Region, then as one of the national medical directors at Red Cross headquarters. She set up peripheral blood stem cell apheresis programs around the country and filed an IND for a novel cryopreservation of stem cells method. She also was the principal investigator for the Red Cross Cord Blood Banks under an IND where 8,000 units were collected and banked and 150 bone marrow transplants were performed. During this time she also served on national policy and standard-setting committees in cell therapy.

Beginning in 2003, Haley served as Vice President of Regulatory and Clinical Affairs at Aldagen, Inc, a local biotech company. At Aldagen, she directed filings that resulted in 510(k) approval for a diagnostic kit for measurement of stem cells with high levels of aldehyde dehydrogenase (ALDH), a unique marker for this cell population. She worked with investigators to file clinical treatment INDs using these specially selected cells in umbilical cord blood transplantation, collaborating with Dr. Joanne Kurtzberg at Duke, and in repair of chronic ischemic heart failure with Dr. Emerson Perin at the Texas Heart Institute in Houston, TX. She filed a third, multi-site IND for critical limb ischemia therapy using the ALDH-rich cells from the patients’ own bone marrow. These filings included both clinical protocols from the investigators and extensive laboratory processes detailing high-speed fluorescence sorting of cells for transplant.

Haley received her undergraduate degree from the University of North Carolina at Chapel Hill and her M.D. from Eastern Virginia Medical School in Norfolk, VA. She completed fellowships in hematology and oncology and was trained in bone marrow transplantation and cell therapy in Seattle at the University of Washington and the Fred Hutchinson Cancer Institute. She also studied at the Kennedy Center of Harvard University in a special course concerning creating public value from non-profit institutions.

Virginia Burns, Ph.D.
DTRI Project Leader, Cell Therapies Core
ph: (919) 668-4647
e-mail: Virginia.Burns@duke.edu

Burns serves as a project leader in the cell therapies core with a primary focus on establishing the GMP Compliant Cell Processing Suites in MSRB and in North Pavilion.

Virginia Burns finished her Ph.D. in chemistry at North Carolina Sate University. Prior to graduate school, she worked for 5 years holding various research and clinical based positions in both the academic and industrial settings.

After graduating from the North Carolina School of Science and Mathematics in 1995, Burns continued her education at North Carolina State University pursuing a double major in biochemistry and chemistry. During her undergraduate years, she worked extensively in the undergraduate tutorial center and as a supplemental instructor. Burns also joined the lab of Dr. Stuart Maxwell of the NCSU Biochemistry department during her senior year at NCSU where she was the recipient of an NIEHS Undergraduate Summer Research Fellowship. Through this award, Burns conducted research focused on the expression, purification and characterization of RNA associated proteins.

Burns graduated with honors and receiving bachelors’ degrees in both biochemistry and chemistry from North Carolina State University in 1999 and continued to explore her interest in research and teaching. While teaching MCAT preparatory classes to medical school hopefuls, she also gained research experience in protein chemistry, cell and tissue culture, microscopy, neurochemistry, drug metabolism and pharmacokinetics. Through this work, she developed a broad base of knowledge in biomedical science and technology with a deep appreciation for medical research.

In 2004, Burns returned to academia full time to pursue a Ph.D. in chemistry. Her interests lie broadly in the areas of drug development and drug delivery with specific interests in combinatorial chemistry and biotechnology, including nanoparticle technology, biomaterials, biosensors, and imaging. Her doctoral research focused on the development of new methodologies to target RNA for medicinal purposes and the delivery of RNA aptamers via functionalized colloidal nanoparticles. During her graduate career, she was awarded the NCSU Chemistry Departmental Outstanding Graduate Poster Award in 2006 and the NCSU Outstanding Teaching Assistant Award in 2008.

Janet Celko, MT(ASCP)
DTRI Project Facilitator, Cell and Tissue Therapy Core
Assistant Manager of Quality
ph: (919) 668-1117
e-mail: Janet.Celko@duke.edu.

The Quality group leads the way in extending best practices from a chemistry, manufacturing and controls (CMC) perspective to Investigators across campus, and will be central to the Cell Therapy Core’s success in realizing clinical and translational goals.

Celko graduated from Georgia State University in 1971 with a B.S. in Medical Technology. She spent her clinical year at Crawford Long Hospital, now a part of the Emory University Medical group, and worked as a technologist at the American Red Cross (ARC) and Crawford Long Hospital, while in Atlanta. After re-locating to Durham, Celko continued to work for the American Red Cross and served as a supervisor in testing and training. From 1992 until 2004, in the role of Education Coordinator for ARC Technical Services, she gained experience in auditing, GMP regulations, change control, and training documentation. During her tenure there, Celko was honored with the American Red Cross Tiffany Award for Employee Excellence in Management She retired with over 24 years service in March 2005.

After leaving the Red Cross, Celko began consulting for NITROX LLC, a research company studying the effects of storage on red blood cells, and worked as a fill-in technologist for Duke Transfusion Services.

The Pediatric Blood and Marrow Transplant Program and DTMI are grateful to apply Celko’s extensive and directly relevant technical experience to Duke’s already strong international position in the field of Cell and Tissue Therapy.