Accreditation Statistics

As of May 2, 2024

Cellular Therapy Entities

  • Accredited: 262
  • Applicants: 30

Cord Blood Banks

  • Accredited: 48
  • Applicants: 10


Initial Accreditations

  • Abu Dhabi Stem Cell Center, Abu Dhabi, United Arab Emirates | Cellular Therapy Product Processing with Minimal Manipulation
  • CHN - Complexo Hospitalar de Niterói, Rio de Janeiro, Brazil | Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Marrow and  Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation


A complete list of accredited organizations can be found at

Foundation for the Accreditation of Cellular Therapy Appoints New Chief Executive Officer

Posted in :: 2024 Volume 2 :: Tuesday, April 9th, 2024

FACT announced on April 2, 2024, the appointment of Mr. David Schmahl as Chief Executive Officer. Schmahl succeeds Ms. Linda Miller, who has served in the role for over two decades. Miller will remain with FACT, serving in a newly created executive role focused on operations.

FACT is the premier volunteer-governed and peer-based promoter of quality clinical care and laboratory practice in hematopoietic cell transplantation and other cellular therapies. It publishes evidence-based practice and care standards developed by world-renowned experts vested in quality improvement and progress in cellular therapy. These standards are foundational to FACT’s voluntary accreditation programs, administered throughout the world by an inspectorate of over two hundred experts active in cellular therapy clinical, apheresis, and laboratory practices and cord blood banking.

Scientific and clinical innovations are driving unprecedented growth in cellular therapy adoption and advancements, including FDA approval of select CAR T-cell therapies since 2017. FACT’s Board of Directors and headquarters staff have worked successfully to ensure the organization is resourced and structured to fulfill its mission against this backdrop of rapid growth and high demand for its programs. The appointment of Schmahl is a key component of FACT’s plans for growth. “Our entire Board of Directors and leaders of our principal member organizations are fully committed to ensuring FACT continues to drive success in the exploding field of cellular therapies. David’s appointment is celebrated by all and represents a critical expansion of our headquarters leadership capacity,” says Catherine Bollard MBChB, MD, FRACP, FRCPA.

Schmahl brings twenty years of nonprofit executive leadership experience to this role. He recently served as Chief Executive of the healthcare and scientific industry practice for Smithbucklin, the leading professional services company for nonprofit organizations. His leadership there was respected in the industry and viewed as key to their growth in the field of health and science and development of best practices in nonprofit administration and leadership. “I’m beyond grateful for the privilege of joining FACT at this critical stage of growth and innovation in cellular therapies,” says Schmahl. “I’m honored to serve its mission and work alongside industry pioneers, world-respected innovators, and dedicated headquarters staff.”

FACT’s Chief Medical Officer, Phyllis Warkentin MD, one of a handful of visionaries who founded FACT, echoes the Board’s and headquarters’ enthusiasm for this leadership transition. “This appointment represents yet another proof point of FACT’s total commitment to serving our field and improving patient care. We enthusiastically welcome David to the FACT team.”

FACT Board of Directors Honors Outgoing and Incoming Members and Officers

Posted in :: 2024 Volume 2 :: Tuesday, April 9th, 2024

During the 2024 Tandem Meetings of ASTCT and CIBMTR, the FACT Board of Directors celebrated the service of several members. These leaders serve FACT, the cellular therapy community, and patients around the world and the Board is deeply appreciative of their commitment to the FACT mission.

Outgoing Member Dr. Elizabeth Shpall Celebrates 25 Years of FACT Servant Leadership!

Elizabeth Shpall, MD, of MD Anderson Cancer Center, began her leadership at FACT as a Founding Board President and her contributions will endure throughout FACT’s future:

Board of Directors
• FACT Founding Board Member and President: 1996-2002
• FACT Past President: 2003-2011
• FACT Board Member and Executive Committee: 2015-2023

• Accreditation Committee – Cord Blood
• Standards Committee – Cord Blood, Common, Immune Effector Cells
• Immune Effector Cell Task Force
• Leadership & Nominations Committee
• Grievance Committee
• New Business Development Task Force

• FACT Inspector for over 20 years performing clinical, apheresis, and cord blood inspections.

In addition to this impressive list of activities, Dr. Shpall’s relationship building, strategic thinking, and medical acumen have truly provided a strong foundation on which FACT can build its future.

Newly Appointed Director Ensures Vital Cord Blood Banking Expertise on Board

As the Director of the Queensland Cord Blood Bank at the Mater and a FACT Inspector for over 10 years, Phillip Johnson, MMedSc(Path), will continue to provide insight into the evolving landscape of cord blood banking and exciting potential of cord-blood-derived stem cells.





Several Board Members Will Continue Serving During this Pivotal Moment of Growth for FACT

After leading FACT through organizational assessments, transition to independent status, and strategic planning, three Board members will provide continuity as we carry out the remainder of FACT’s current strategic plan. Thank you to the following leaders for your dedication!

Abba Zubair, MD, PhD
Mayo Clinic
Navneet Majhail, MD, MS, FASTCT
Sarah Cannon Cancer Institute
Eneida Nemecek, MD
Oregon Health & Science University

New Officers Will Steer the FACT Board of Directors Toward Continued Success

 Two Board members answered the call to serve in executive roles within the Board of Directors:

Vice President
Navneet Majhail, MD, MS, FASTCT
Sarah Cannon Cancer Institute
Nadim Mahmud, MD, PhD
University of Illinois Hospital and Health Sciences System

Dedicated and Accomplished FACT Leaders Awarded Well Deserved Honors: Congratulations to Paul Eldridge, Ngaire Elwood, and Joseph Schwartz!

Posted in :: 2024 Volume 2 :: Tuesday, April 9th, 2024

The following individuals have been awarded tremendous honors from the field of cellular therapy. FACT is humbled that these individuals have shared their time and talents with our organization, and holds them in high esteem.

ISCT Technologist Career Achievement & Leadership Award:

Paul Eldridge, PhD

This award recognizes a remarkable Technologist who has made significant contributions to the field of cell and gene therapy, including to ISCT itself. Dr. Eldridge has also demonstrated exceptional leadership, influencing and inspiring his peers and colleagues.

Recognizing Dr. Eldridge’s long-term commitment to his leadership at FACT as a volunteer inspector, Board member, and Standards Committee Chair, among many other roles, we agree!



Member of the Order of Australia:

Ngaire Elwood, PhD

This award was bestowed upon Dr. Elwood for her service in a particular locality or field of activity or to a particular group, specifically stem cell research and treatment.

Through her many roles at FACT, Dr. Elwood’s interest in quality therapeutic options for patients is evident and we are inspired by Dr. Elwood’s tenacity to turn her own experiences as a cancer patient into a career that has saved countless lives.

Read more about Dr. Elwood’s remarkable story.



ASFA Lecturer Award:

Joseph Schwartz, MD, MPH

The Lecturer Award of the American Society for Apheresis is bestowed upon a member of the Society who has consistently contributed to the Society as a speaker, teacher, or mentor.

Dr. Schwartz has a gift of understanding multiple perspectives while spreading awareness of apheresis professionals’ and FACT’s important roles in the evolving field of blood and marrow transplantation and cellular therapy. He is a familiar and popular figure at FACT educational events!



FACT Service Awards Presented to Ngaire Elwood, PhD and Kim Kasow, DO

Posted in :: 2023 Volume 1 :: Tuesday, March 28th, 2023

With heartfelt gratitude and admiration, FACT presented Service Awards to two outgoing Board members: Drs. Ngaire Elwood and Kim Kasow. These long-term and esteemed leaders of FACT lent a tremendous amount of energy and guidance to FACT during a time of significant organizational growth and global challenges during their tenures on the Board of Directors, and we look forward to continuing our friendship and working relationship with them into the future. Thank you, Ngaire and Kim, for all that you do for FACT and your colleagues!

Ngaire Elwood, PhD
(9 years in Leadership, 14 years as Inspector) 

Board Member:  2014-2022
Vice President: 2017-2022
Member, Education Committee: 2011-Present
Member, Cord Blood Accreditation Committee 2010 – Present
Member, Cord Blood Bank Standards Steering Committee 2009-Present
Regenerative Medicine Task Force: 2020-Present
Member, Grievance Committee: 2017-2022
Member, New Business Development Committee: 2023-Present
FACT Inspector since 2008 and performed 14 cord blood inspections

Kim Kasow, DO
(9 years in Leadership, 16 years as Inspector)

 Board Member:  2014-2022
Treasurer: 2018-2022
Chair: Finance Committee: 2018-2022
Chair: Quality Committee: 2015-Present
Member, Technology Committee: 2020 – Present
Member, Cell Therapy Standards Committee: 2019 – Present
Member, Cell Therapy Accreditation Committee 2015 – Present
Member, Grievance Committee: 2015-2022
Member, Public Relations & Marketing: 2013-2015
Member, New Business Development Task Force: 2023-Present
FACT Inspector since 2006 and performed 21 clinical inspections

FACT Expresses Deep Appreciation to Outgoing Board Members

Posted in :: 2022 Volume 1 :: Monday, March 7th, 2022

Wisdom, intelligence, dedication, and kindness are words that describe all the outgoing members of the FACT Board of Directors, who were recently recognized with service awards. These servant leaders maintained a steady presence in FACT’s early years, steered the organization into new developments in cellular therapies, and guided us through challenges such as the pandemic. They are street-smart visionaries who viewed the future with measured confidence. We genuinely thank these individuals for setting FACT up for success for years to come.

Paul Eldridge, PhD




  • FACT Board of Directors: 2014 – 2021
  • Chair, Standards Development Committee: 2016–2021; Member 2014 – Present
  • Member, Cell Therapy Accreditation Committee 2017–Present
  • Member, Cord Blood Bank Accreditation Committee 2017–Present
  • FACT Representative: WBMT
  • FACT Inspector for 21 years; performed 27 inspections

Joseph Schwartz, MD, MBA

  • FACT Board of Directors: 2013 – 2021
  • Chair, Technology Committee: 2020 – Present
  • Chair, Standards Development Committee: 2013–2015, Member 2010-Present
  • Member, Cell Therapy Accreditation Committee 2012–Present
  • Member, Cord Blood Bank Accreditation Committee 2013–Present
  • Chair, HLA Typing Committee: 2017
  • Member, Education Committee: 2015-Present
  • Professional Relations Committee: 2014-2019
  • FACT Representative: AHCTA
  • FACT Inspector for 15 years; performed 36 inspections

Dennis Gastineau, MD

  • FACT Board of Directors
  • Past President: 2021
  • President: 2016-2020
  • President-Elect: 2014-2015
  • Vice President: 2010-2013
  • Secretary: 2009
  • Board Member: 2005-2008
  • Inaugural Chair Education Committee: 2007–2013, Member 2014-2021
  • Member, Clinical Outcomes Improvement Committee: 2015-2022
  • Member, Leadership & Nominations Committee: 2010–2021
  • Member Finance Committee: 2009
  • Member, Cell Therapy Accreditation Committee: 2007-2021
  • FACT Inspector for 20 years; performed 31 inspections

New Members Welcomed to FACT Board of Directors

Posted in :: 2022 Volume 1 :: Monday, March 7th, 2022

FACT is honored to welcome two new members to the FACT Board of Directors in 2022.

Nicole Prokopishyn, PhD, is the Cellular Therapy Lab Director of the Alberta Blood and Marrow Transplant Program: Foothills Medical Centre, Alberta Children’s Hospital, Tom Baker Cancer Centre, and Calgary Laboratory Services in Calgary Alberta. She is the FACT Standards Committee Chair and has been a FACT inspector since 2013. Wanxing Cui, MD, PhD, is the Director of the Medstar Georgetown University Hospital Cell Therapy Manufacturing Facility in Washington, D.C. He has been a FACT inspector since 2018.

We are grateful for Dr. Prokopishyn’s and Dr. Ciu’s continued service to our organization and are looking forward to their guidance in their new leadership roles.

New Members Appointed to the FACT Board of Directors

Posted in :: 2021 Volume 1 :: Friday, January 29th, 2021

Two new members representing FACT’s parent society the American Society for Transplantation and Cellular Therapy (ASTCT) join the FACT Board of Directors for three-year terms (2021-2023).

Navneet S Majhail MD, MBBS, MS is the Program Director of FACT-accredited Cleveland Clinic Blood and Marrow Transplant Program. Dr. Majhail served as ASTCT’s President from 2019-2020, and FACT will benefit from his continued leadership in this new capacity.


Eneida Nemecek, MD is a FACT inspector from FACT-accredited Northwest Marrow Transplant Program at Oregon Health & Science University, Legacy Good Samaritan Hospital and Medical Center and Doernbecher Children’s Hospital. She has also begun serving on FACT’s Clinical Outcomes Improvement Committee.

Welcome Dr. Navneet Majhail and Dr. Eneida Nemecek!

Just the FACTs, 2020 Volume 2

Posted in :: 2020 Volume 2 :: Monday, March 16th, 2020

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




FACT President


College of American Pathologists Recognized as an Accrediting Organization Providing Histocompatibility Services Appropriate for Hematopoietic Cellular Therapy Transplant Patients

Posted in :: 2019 Volume 4 :: Wednesday, April 17th, 2019

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.





Announcing New FACT Board Members

Posted in :: 2019 Volume 1 :: Wednesday, January 16th, 2019

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.

Founding FACT Board Member Nancy H. Collins, PhD Receives ISCT Career Achievement Award

Posted in :: 2018 Volume 3 :: Friday, August 24th, 2018

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!

Inspector Recognition: Dr. Paul Eldridge Volunteers with a Sincere Sense of Servant Leadership

Posted in :: 2018 Volume 3 :: Friday, August 17th, 2018

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.”

Gratitude Expressed to Outgoing FACT Board Members

Posted in :: 2018 Volume 2 :: Tuesday, May 22nd, 2018

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:

• Africa
• Argentina
• Brazil
• Chile
• India
• Japan
• Mexico
• Peru
• Taiwan
• Vietnam

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.

FACT Board of Directors Welcomes New Member and Nominates New Officers

Posted in :: 2017 Volume 1 :: Thursday, January 26th, 2017

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

FACT Board of Directors Honors Carolyn Taylor for Years of Service

Posted in :: 2017 Volume 1 :: Thursday, January 26th, 2017

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.

CAT and DAG with award CAT with cake

FACT Founding Board Members Honored at 20th Anniversary Reception

Posted in :: 2016 Volume I :: Thursday, April 14th, 2016

BMT Tandem Feb 19 2016 Jpeg-205At 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.”