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accreditation statistics

2018 Third Quarter Accreditations

Cellular Therapy Entities

  • Accredited: 231
  • Applicants: 6

Cord Blood Banks

  • Accredited: 54
  • Applicants: 9

During the third quarter of 2018, 20 entities received FACT accreditation. For details regarding these accreditations, view the full accreditation report.

A complete list of accredited organizations can be found at www.factwebsite.org.

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.