It was great to see many of you at the TCT meetings in Orlando (I didn’t pack a warm enough jacket!) where the solid emergence of cell therapies was in constant evidence. The Quality Boot Camp was another smashing success, as were the applicant and inspector training courses at the FACT Inspection & Accreditation Workshop, and the cellular therapy leadership courses. I had an opportunity to make a presentation on FACT Immune Effector Cell Accreditation to the administrative track, which evoked many questions, some showing the importance of educating our administrative colleagues in the importance of coordinated, comprehensive, quality-driven care to optimize outcomes for our patients and the role community-driven accreditation plays. We had a chance to express our thanks to Mark Litzow for his many years of service on the FACT Board of Directors and as the first FACT Technology Committee chair. You are already missed, Mark! Travel restrictions and meeting cancellations are coming at a rapid pace and paper goods are flying off the shelves as COVID19 cases increase. Our patients would be among the greatest affected—if you are ill take care of yourself and stay home for their sake.
Hand wave from greater than 6 feet—see you soon.
Dennis Gastineau, MD
College of American Pathologists Recognized as an Accrediting Organization Providing Histocompatibility Services Appropriate for Hematopoietic Cellular Therapy Transplant Patients
By: Andra Moehring, MHA, FACT Standards Development Manager
The Seventh Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration require (B2.14) “Clinical Programs performing allogeneic transplantation shall use HLA laboratories that are … accredited by the American Society for Histocompatibility and Immunogenetics (ASHI), the European Federation for Immunogenetics (EFI), or other accrediting organizations providing histocompatibility services appropriate for hematopoietic cellular therapy transplant patients.” Similar standards exist in the FACT Common Standards (B2.9), the NetCord-FACT Cord Blood Standards (B5.6), and in the FACT Immune Effector Cell Standards (B2.9).
To facilitate a fair and objective assessment of appropriateness, the HLA Typing Accreditation Committee of FACT, JACIE, NetCord, and NMDP developed Guidelines for Histocompatibility Typing Standards and Accreditation Programs. These Guidelines will be reviewed every three years and revised appropriately. Each applicant accrediting organization is required to submit documentation to FACT for review by the HLA Typing Accreditation Committee that demonstrates appropriateness of its standards and accreditation program for the relevant population.
The College of American Pathologists (CAP) submitted its documentation to FACT for review. During the review and feedback process, it was clear that CAP had a significant commitment to being recognized by FACT as an accrediting organization providing histocompatibility services appropriate for hematopoietic cellular therapy transplant patients.
The FACT Board of Directors voted to approve CAP as an accrediting organization providing histocompatibility services appropriate for hematopoietic cellular therapy transplant patients. With this approval, CAP will be accepted in FACT Accreditation applications and included in FACT Standards. CAP will include the HLA Typing Accreditation Committee during its review and revisions of Standards and Checklists on an annual basis to ensure continued appropriateness for inclusion in FACT’s Standards and Accreditation Program.
The Foundation for the Accreditation of Cellular Therapy (FACT) is pleased to announce the addition of three new members to the Board of Directors: Alan Balch, Patrick Hanley, and Nadim Mahmud. The Board provides leadership for carrying out FACT’s mission to improve the quality of cellular therapy through peer-developed standards, education and accreditation for the benefit of patients.
FACT Chief Executive Officer, Linda Miller, announced, “I am pleased to welcome our three newest members to our Board of Directors. They each have a unique background, with diverse experiences that make them an asset to FACT’s Board of Directors and to the organization as a whole.”
Alan Balch, PhD is the Chief Executive Officer of the Patient Advocate Foundation and National Patient Advocate Foundation. Dr. Balch will serve as FACT’s Public Director.
Dr. Balch has nearly fifteen years of executive leadership in the non-profit sector with an emphasis on consensus-building and collaboration. He has led numerous federal advocacy efforts on a range of issues both at the legislative and regulatory level over the years. He became the CEO of both PAF and NPAF in 2013. From 2006 – 2013, he served as the Vice President of the Preventive Health Partnership — a national health promotion collaboration between the American Cancer Society, American Diabetes Association, and American Heart Association. He has led numerous federal advocacy efforts at the legislative and regulatory level including organizing and leading a coalition that successfully fought for improvements in the regulatory process for the review of cancer drugs at the Food and Drug Administration. He also contributed to the development of key federal policies related to the Affordable Care Act.
Patrick Hanley, PhD is an assistant research professor of pediatrics in the Center for Cancer and Immunology research at the Children’s Research Institute, a member of the Division of Blood and Marrow Transplantation, and a member of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. Dr. Hanley will serve as the chair of FACT’s Education Committee.
Dr. Hanley is the director of the Good Manufacturing Practices (GMP) facility where novel cell therapies developed in the Program for Cell Enhancement and Technologies for Immunotherapy (CETI) are translated and manufactured for early stage clinical trials. In addition to GMP regulations, Dr. Hanley is interested in helping to improve outcomes after stem cell transplantation – including bone marrow transplant and cord blood transplant. Along with the CETI director, Dr. Catherine Bollard, he has pioneered work in expanding virus-specific immune cells from naïve T cells, such as those present in cord blood or virus-seronegative donors. Dr. Hanley is the co-chair of the Early Stage Professionals group of the International Society for Cellular Therapy and a member of the Immunotherapy scientific committee and is interested in making cell therapies standard-of-care.
Nadim Mahmud, MD, PhD is currently serving as Professor of Medicine and Bioengineering at the University of Illinois College of Medicine at Chicago. He also serves as the Director of the Clinical Stem Cell Laboratory for the University of Illinois Hospital (UI Health) Blood and Marrow Transplant Program. Dr. Mahmud leads FACT’s international initiatives as Chair of the Global Affairs Committee.
Dr. Mahmud has more than 20 years of research experience in the field of hematopoietic stem cell biology and transplantation. Dr. Mahmud and his group have pioneered a novel way to expand the number of transplantable blood forming stem cells present in an umbilical cord blood graft by using chromatin modifying agents and have been awarded a US patent for this work.
In addition, Dr. Mahmud serves as member of the Board of Directors of the International Society for Cell and Gene Therapy (ISCT).
2019 FACT Board of Directors
Appreciation to Outgoing Board Members
The board meeting during the American Society for Hematology (ASH) conference in December was the final for departing board members. Although they are leaving the board, we will definitely be relying on their knowledge and skills moving forward. The following people have completed their terms on the board:
Ian McNiece, PhD who has served on the board for nine years as a director has served as chair of the Regenerative Medicine Task Force. His leadership has led to the development of accreditation for cell processing facilities performing more than minimal manipulation; the publication of the first edition FACT Common Standards for Cellular Therapies; initiation of the development of Cardiovascular Cell Therapy Standards; and launched the Regenerative Medicine InterCHANGE to share lessons learned from recent advancements in cell therapy with other stakeholders in the field.
Catherine Bollard, MBChB, MD who has served on the board for nine years as a director has served as chair of the Professional Relations Committee. Dr. Bollard’s charge for this committee was to enhance communication, cooperation, and scientific advancement with each of the following organizations: ISCT, ASBMT, WBMT/NETCORD, ASFA, FACT, NMDP, AABB, CAP, ASHI, ASGCT, and CBA. Dr. Bollard led the discussions for information sharing between organizations resulting in identification of collaborative opportunities, reduction in redundant efforts, and creation of alliances for more impactful results.
During its 2018 Annual Meeting in Montréal, the International Society for Cell and Gene Therapy (ISCT) bestowed the Career Achievement Award in Cellular Therapy to Nancy H. Collins, PhD. Recipients of this award are individuals who have made a significant impact during a career devoted to advancing the field of cellular therapy.
In a tribute to Dr. Collins in the ISCT Telegraft, Carolyn A. Keever-Taylor, PhD, wrote, “Nancy is well-suited for this award as illustrated by her many contributions to the field of cellular therapy, from the early days of bone marrow transplantation where she literally defined the role of Laboratory Facility Director, through to the present.” Dr. Taylor described Dr. Collins’s role in founding FACT, “Nancy played a major role in the creation of FACT, which was jointly founded by ISCT and ASBMT to be an independent body that would complete development of laboratory and clinical standards. Here too she was a founding member of the FACT Board of Directors. Nancy was instrumental in recruiting individuals from other cell processing laboratories to be actively involved in these efforts.”
FACT is incredibly grateful to Dr. Collins for the guidance, leadership, and friendship she has generously provided to inspectors, committees, and staff. The following is a list of Dr. Collins’s impressive contributions to the organization:
- Founding member of the Foundation for the Accreditation of Cellular Therapy (1995)
- Board of Directors (1996-2009), 14 years
- Inspector (1996-2015), 19 years
- Cellular therapy laboratory inspector, 19 years
- FACT-NetCord cord blood bank laboratory inspector, 16 years
- More than minimal manipulation inspector, 3 years
- Standards Development (2000-2011), 11 years
- Cellular Therapy and Cord Blood Standards committees, served as member or co-chair
- Overall chair of the 4th edition of both Cellular Therapy and Cord Blood Standards
- FACT Inspector and Facility Training Workshop presenter (multiple)
- FACT Cellular Therapy Accreditation Committee (1995-2015)
- FACT Cord Blood Accreditation Committee (2006-2015)
- FACT Quality Management Committee and Quality Handbook Committee (2008-present)
- FACT representative to multi-institutional Circular of Information for the Use of Cellular Therapy Products Committee (2007-2014)
- Consultant, FACT Consulting Services (2015-present)
Congratulations, Nancy, on this well-deserved honor!
By Mikaela VanMoorleghem, FACT Education and Training Coordinator
FACT’s success depends on the commitment of volunteer experts and their willingness to participate as peers to raise quality across providers, protect the research environment, and advance the field. We continuously rely on our inspectors to give back to the cellular therapy field by visiting their colleagues during on-site inspections, serving on FACT committees, and participating in educational events. Without this collaborative effort, FACT would not have the influence it has today.
In this issue of Just the FACTs, we recognize Paul Eldridge, PhD, Director, Cell GMP Facility UNC Bone Marrow Transplant and Cellular Therapy Program, in Chapel Hill, North Carolina, for his dedication to serving FACT.
Dr. Eldridge has been a FACT inspector for 18 years, and has performed 24 inspections. “For the past 18 years, I have enjoyed the satisfaction of participating in FACT activities. When a notice of inspector training was issued back in what now feels like the ‘early neo-lithic period,’ I volunteered with the hope of gaining some better insight about what would be required for my program to achieve accreditation. I was definitely able to meet my goal,” explains Dr. Eldridge. “I received far more than I expected by gaining access to a group of dedicated experts in hematopoietic cell transplantation with the mission of raising the quality of patient care and science in the field. The opportunity to discuss issues with sharp leaders and the prospect of visiting other facilities to observe how they have addressed needs and solved common problems has been invaluable to my professional growth and directly benefited my program.”
Dr. Eldridge currently serves as the Chair of FACT’s Standards Committee and is a member of the FACT Board of Directors. According to Dr. Eldridge, “One of the most appealing aspects of FACT as an organization is an openness to listening and soliciting ideas and viewpoints from everyone in our field. Embracing this, I have over the years become involved with various FACT working committees to address evolving needs of our community. This is a real chance to see firsthand how the mission of FACT is implemented from the kernel of an idea to the establishment of standards promoting best practices for cellular therapy. My experiences in serving on the Board of Directors, the Standards Committee, and as an inspector has been the source of much personal pride, especially when I see recognition of the success of FACT in improving the quality of our field from colleagues and patients.”
In the past year, Dr. Eldridge has led over 30 committee meetings; served as a FACT inspector; and presented on behalf of FACT at the first meeting of the African Blood and Marrow Transplantation Society (AFBMT) in Morocco, the American Society for Apheresis (ASFA) meeting in Chicago, and the International Society for Cell and Gene Therapy (ISCT) meeting in Montréal. Dr. Eldridge comments, “Talking with colleagues at FACT educational events and committee meetings is one of the most useful ways I have found to stay current on important topics. In my opinion, service to our patients and community is the underlying inspiration for the goals and mission of FACT. Nothing happens without help, though. When hands have been needed within FACT, I was glad to assist in acknowledgement for the benefits I have garnered.”
Andra Moehring, FACT Standards Development Specialist states, “Regardless of how many emails received or meetings attended, Dr. Eldridge always shows a positive attitude. He proves time after time that he is an exemplary leader through his plethora of knowledge and continued guidance on the FACT Standards Committee. He is responsive, considerate, kind, and fair. I have learned so much from working with him. FACT is lucky to have Dr. Eldridge as a volunteer.”
“As a global ambassador for FACT, Dr. Eldridge serves as the appointed representative to the Worldwide Network for Blood and Marrow Transplantation (WBMT),” states Linda Miller, FACT Chief Executive Officer. “Through his leadership, Dr. Eldridge ensures FACT’s mission of improving quality and safety for patients is shared with our cellular therapy colleagues throughout the world.”
Dr. Eldridge concludes, “Personally, and professionally, I have benefited immensely from FACT. I encourage everyone to consider becoming involved in the activities that keep FACT evolving and improving. The organization is only as strong as the people participating.”
FACT is well-served by an involved, conscientious, and inspiring Board of Directors, and two outgoing Board members embodied all of those characteristics. While overcoming the snowstorms that seemed to follow the BMT community, FACT expressed its appreciation to Hugo Fernandez, MD and Gillian Woollett, MA, DPhil during the Board of Directors meeting at the 2018 BMT Tandem Meetings in Salt Lake City.
We look forward to continuing our relationship with these two outstanding individuals, who will no doubt continue to make a difference. Dr. Hernandez and Dr. Woollett, thank you for your service!
Hugo Fernandez, MD
• FACT, Board Member 2009 – 2017
• FACT, Secretary 2010 – 2016
• Chair, FACT Global Affairs Committee 2010 – 2018
• Member, FACT Technology Committee 2013 – 2018
• FACT Inspector for 20 years performing 30 clinical inspections
Dr. Fernandez’ charge as Chair of the Global Affairs Committee was to provide education, assistance, and a pathway for centers establishing new BMT programs in resource-challenged areas to achieve accreditation. Since 2010, Dr. Fernandez has worked with the committee to identify opportunities to educate the global cell therapy community about the importance of FACT accreditation in establishing quality systems as the foundation for transplant programs.
Dr. Fernandez organized educational outreach sessions in countries including:
Thanks to the leadership provided by Dr. Fernandez, FACT now has accredited cell therapy programs located in seven countries (Australia, Brazil, Canada, Mexico, New Zealand, Singapore, and the United States) and counting!
Gillian Woollett, PhD
• FACT, Board Member 2009 – 2017
• FACT Public Director
• FACT Audit Committee 2009 – 2017
• Member, FACT Professional Relations Committee 2009 – 2017
• FACT Representative – ISCT Cell Therapy Liaison Committee (CTLM)
Dr. Woollett leads the FDA Policy and Regulatory Strategy Practice as a Senior Vice President at Avalere and supports clients throughout the healthcare system, from patients’ groups to biopharma companies and payers/providers.
Dr. Woollett has provided a wealth of knowledge and insight to FACT regarding:
• Scientific and regulatory policy expertise regarding medicinal products gaining FDA approval.
• USP’s Compendial Notices informing stakeholders of the changing status of USP monographs and other USP standards-setting initiatives (Dr. Woollett serves on USP’s • Nomenclature and Labeling Expert Committee),
• FDA Guidance Documents and Final Rules,
• FDA Law and Proposed Legislation, and
• FDA Center for Biologics Evaluation and Research (CBER) Guidance.
The FACT Board of Directors approved its updated appointments in December, which became effective January 1, 2017. We thank these volunteers for their time and dedication to direct the activities of FACT. We are confident in their ability to continue leading FACT as a peer-driven organization that is adaptable to the needs of its constituents.
New officer appointments include:
- Vice President: Ngaire Elwood, PhD
- Secretary: Carlos Bachier, MD
Board members consist of representatives of FACT’s parent organizations, The American Society for Blood and Marrow Transplantation (ASBMT) and the International Society for Cellular Therapy (ISCT). ASBMT reappointed Mark Litzow, MD and Kimberly Kasow, DO to the Board, and ISCT reappointed Ngaire Elwood, PhD. ISCT appointed Abba Zubair, MD, as its new representative. The Board also approved expanding its composition to include a seat for a member appointed by the American Society of Apheresis (ASFA), and the nomination process is underway.
The following is a complete list of the FACT Board of Directors:
- President: Dennis Gastineau, MD; Mayo Clinic Rochester Blood and Marrow Transplant Program; Rochester, Minnesota, USA
- Vice President: Ngaire Elwood, PhD; BMDI Cord Blood Bank; Parkville, Victoria, Australia
- Past President: Helen Heslop, MD; Baylor College of Medicine, Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital; Houston, Texas, USA
- Secretary: Carlos Bachier, MD; Sarah Cannon Blood and Marrow Transplant Program; Nashville, Tennessee, USA
- Treasurer: Michael Lill, MD; Blood and Marrow Transplant Program at the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center; Los Angeles, California, USA
- Chief Medical Officer: Phyllis Warkentin, MD; Biologics Production Facility, Nebraska Medicine; Omaha, Nebraska, USA
- Catherine Bollard, MBChB, MD, FRACP, FRCPA; Children’s National Health System Blood and Marrow Transplant Program; Washington, District of Columbia, USA
- Paul Eldridge, PhD; UNC Bone Marrow Transplant and Cellular Therapy Program; Chapel Hill, North Carolina, USA
- Hugo Fernandez, MD; H. Lee Moffitt Cancer Center & Research Institute Blood and Marrow Transplant Program; Tampa, Florida, USA
- Kimberly Kasow, DO; UNC Bone Marrow Transplant and Cellular Therapy Program; Chapel Hill, North Carolina, USA
- Mark Litzow, MD; Mayo Clinic Rochester Blood and Marrow Transplant Program; Rochester, Minnesota, USA
- Ian McNiece, PhD; Miami, Florida, USA
- Donna Salzman, MD; The University of Alabama Adult and Pediatric Bone Marrow Transplantation and Cell Therapy Program; Birmingham, Alabama, USA
- Joseph Schwartz, MD, MPH; New York Presbyterian Hospital/Columbia University Medical Center – Blood and Marrow Transplant Program; New York, New York, USA
- Elizabeth Shpall, MD; MD Anderson Cord Blood Bank; Houston, Texas, USA
- Gillian Woollett, MA, DPhil; Avelere Health LLC; Washington, District of Columbia, USA
- Abba Zubair, MD; Blood and Marrow Transplantation Program of Mayo Clinic, Nemours Children’s Clinic, and Wolfson Children’s Hospital, Jacksonville, Florida, USA
During its meeting at the ASH Annual Meeting in December 2016, the FACT Board of Directors honored Carolyn Taylor, PhD, for her many years of service and wished her congratulations on her upcoming retirement.
Dr. Taylor served as a Board member for 8 years, including 4 years as Vice-President. Her many other contributions to FACT include:
- Standards Committee Chair from 2010-2013 (also served as subcommittee co-chair and past-chair),
- Cellular Therapy and Cord Blood Accreditation Committee member,
- Regenerative Medicine Task Force member,
- FACTWeb Oversight Committee member,
- HLA Typing Accreditation Committee Chair,
- FACT representative for Worldwide Network for Blood & Marrow Transplantation (WBMT),
- Inspector (26 inspections performed), and
- Presenter/FACT representative at countless in-person and online events.
FACT and the cellular therapy community would not be what they are today without the time, expertise, and counsel Dr. Taylor selflessly gave to others. We wish her the fulfilling and enjoyable retirement that she deserves, and will appreciate the impact she had on our field for years to come.
At the 2016 BMT Tandem Meetings CIBMTR General Assembly, the founding FACT Board Members were honored with an awards ceremony.
The ceremony opened with a brief history of FACT. Outgoing FACT President, Dr. Helen Heslop, said that the process of drafting standards began in the early 1990s because it seemed likely that blood and marrow transplant laboratories were going to be subject to external accreditation. “ASBMT and ISCT were, at that time, very young professional organizations, but some prescient members of these societies recognized that it was important that transplant programs devise their own accreditation system and accredit themselves. ASBMT and ISCT served as parents for FACT, which was formed as a standard setting and accrediting organization.”
“The initial board of highly committed volunteers invested much of their own time to develop standards with the goal of improving transplant outcomes,” said Dr. Heslop. “They not only had to convince the transplant community that they wanted to be accredited, but that they were willing to pay for the process. Their success in doing this attests to their leadership skills and powers of persuasion.”
Dr. Phyllis Warkentin, founding FACT Board member and current Chief Medical Officer, summarized FACT’s accomplishments over the past two decades. “From the beginning, FACT’s success has depended upon the commitment of volunteer experts and their willingness to participate as peers to raise the quality across providers, to protect the research environment, and to advance the field. FACT has accredited over 270 organizations in 23 countries on five continents. We collaborated internationally with JACIE and NetCord to publish 6 editions of hematopoietic cell therapy standards and 5 editions of cord blood banking standards. In 2015, we published the first edition of Common Standards, applicable to all cellular therapies in all phases of discovery, research, and development.”
Dr. Warkentin continued, “FACT was founded at the University of Nebraska Medical Center. Through the efforts of many, especially Dr. Jim Armitage, this affiliation has continued, and we thank the University for being our home institution for 20 years.”
“We honor the founding members of the FACT Board of Directors, whose vision created the premiere standards and accreditation body in cellular therapy. Each of these individuals came to FACT with his or her own motivation, energy, concerns, resources, and abilities; and each left a unique mark,” said Dr. Warkentin. “The common focus, however, remains raising the quality of care for our patients. Together, these 11 founders have served a total of 123 years as FACT Board members and officers, and each has also played a major role in leading accreditation planning and success at his or her own institution.”
Founding Board members were individually recognized and received a token of appreciation from incoming FACT President Dr. Dennis Gastineau and FACT Chief Executive Officer Linda Miller:
Elizabeth Shpall, MD: Founding Board President
Richard Champlin, MD: Founding Vice President
Adrian Gee, PhD: Founding Secretary
Allen Eaves, MD, PhD, FRCPC: Founding Treasurer
C. Fred LeMaistre, MD: Founding Board Member and Past President
Nancy Collins, PhD: Founding Board Member
Richard O’Reilly, MD: Founding Board Member
Scott Rowley, MD, FACP: Founding Board Member
Keith Sullivan, MD: Founding Board Member
William Vaughan, MD, FACP: Founding Board Member
Phyllis Warkentin, MD: Founding Board Member
Dr. Warkentin also recognized ASBMT as one of FACT’s founding parent societies, and outgoing ASBMT president Effie Petersdorf accepted the honor. Additionally, Alan Leahigh, former Executive Director of ASBMT and former Chief Executive Officer of FACT, and still friend and mentor to volunteers and staff of FACT, was recognized.
Dr. Warkentin closed the ceremony by saying, “Forty people have served as members of the FACT Board of Directors. This represents a significant contribution of time and talent to FACT, to our field, and to our patients. We have been entrusted with leadership positions, but each person has a unique story, and each has a unique role to play. All of us and all of you are important in the service to our patients.”