Phyllis Warkentin, M.D., medical director of the Biologics Production Facility, chief medical officer of the Foundation for the Accreditation of Cellular Therapy (FACT), and professor of pathology/microbiology and pediatrics in the UNMC College of Medicine,
The first time Phyllis Warkentin, M.D., held a copy of the Foundation for the Accreditation of Cellular Therapy (FACT) Standards in her hands, it was hot off the presses -- from Kinko's.
Today, those standards for clinical transplant programs, collection facilities (bone marrow and apheresis), and cell processing laboratories are internationally accepted. That's one of the reasons Dr. Warkentin received the 2014 American Society of Blood and Marrow Transplant (ASBMT) Public Service Award in February.
About the award
Dr. Warkentin is the first member of the society to receive the award, which recognizes support and efforts on behalf of cancer patients and medical research.
Previous recipients of the award have been William D. Merritt, Ph.D.; Nancy DiFronzo, Ph.D.; Robert Baitty; Claude Lenfant, M.D.; Adm. E. R. Zumwalt, Jr.; Susan Stewart; Ray Wu, Ph.D.; Richard Klausner, M.D.; The Hon. Geraldine Ferraro; Myra Jacobs; Harry Pearce; Sen. Orrin Hatch; Robert Klein, and Congressman C.W. Bill Young.
Dr. Warkentin received the award in Dallas during the ASBMT annual meeting.
It was 1995 when Dr. Warkentin volunteered to combine the transplant standards of ASBMT and the International Society for Cellular Therapy (ISCT). An original FACT board member, she took the lead, relying on other volunteers in what was, at first, a no-frills operation.
"The FACT board member who actually, physically published the first edition took the draft to Kinko's and printed out 100 copies," she said. "They told me, 'The rest are on you.'" All subsequent editions of standards and FACT publications have come through UNMC. FACT is now a UNMC-affiliated organization, with a full-time, professional staff in its international headquarters in Omaha.
James Armitage, M.D., former president of ASBMT, said Dr. Warkentin's work has been essential.
FACT has accredited more than 200 cellular therapy transplantation programs in North America, South America, Asia, Australia and New Zealand. Under Dr. Warkentin's direction, FACT collaborates with the Joint Accreditation Committee of ISCT and EBMT to provide accreditation of blood and marrow transplant programs in Europe, and expanded standards and accreditation to cord blood banking worldwide, cellular therapy for regenerative medicine products, and other collaborative initiatives.
"Sometimes you work with people for years and don't realize how accomplished they are. Phyllis, more than anybody else, is responsible for developing standards for hematopoietic stem cell transplantation," he said. "She organized FACT and helped organize the standards for doing transplants. Today, you can't do transplants in the United States if you don't meet these standards. Her work has made transplantation much safer and undoubtedly benefited thousands of patients."
Fred LeMaistre, M.D., president of ASBMT, said Dr. Warkentin's leadership was essential.
"Dr. Warkentin embraced the audacity of the vision that we could hold ourselves to a higher level of accountability, and that we, as experts in our field, had the responsibility to do so."
An important facet of FACT, Dr. Warkentin emphasized, is that the standards are voluntary.
"The idea is to be educational and collegial, to help each other," she said. "Standards set the goal; each program develops its own processes to reach that goal."