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 https://accredited.factglobal.org/.

Just the FACTs 2024 Volume 2

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

President’s Letter 

With tremendous enthusiasm, I announce a leadership transition and restructuring, adding even more organizational capacity to FACT. Following a months-long search and vetting process, FACT’s Board has appointed Mr. David Schmahl as Chief Executive Officer, effective April 1. David’s leadership talents, nonprofit management knowledge, and skills for driving organizational growth will be a significant addition to our already stellar Headquarters operations. Linda Miller will be shifting to a role most aligned with her professional passion, that of Chief Operating Officer for FACT. David and Linda will form an ideal partnership of talents and skills, alongside the expertise of our longstanding Chief Medical Officer Phyllis Warkentin, MD. I’m thrilled with the chemistry we see among these FACT leaders and their shared enthusiasm for our mission.

I am also grateful for the service of outgoing Board Member Elizabeth Shpall, MD, spanning 25 years following her role as the Inaugural FACT Board President. Thanks also to Board Members who will serve as new or reappointed leaders: Abba Zubair, MD, PhD; Navneet Majhail, MD, MS, FASTCT; Eneida Nemecek, MD; and Phillip Johnson, MMedSc(Path).

Congratulations are in order for additional esteemed FACT leaders. Paul Eldridge, PhD; Ngaire Elwood, PhD; and Joseph Schwartz, MD, MPH received well-deserved awards from prominent organizations. Thank you for being champions of cellular therapy and leading countless others.

We have more good news to share in this newsletter. FACT Consulting Services has officially launched its Audit & Assessment Services intended to alleviate the audit burden on healthcare institutions and industry while rapidly assessing new cellular therapy programs. Tata Medical Center earned the first FACT accreditation in India. Two FACT educational events are open for registration.

As evident above, FACT is fulfilling its strategic plan to strengthen infrastructure, lead the cellular therapy field effectively, and increase patient access to therapies. Thank you to the hundreds of you around the world that are contributing to our mission.

Sincerely,

Catherine Bollard, MD
FACT President


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

Committees
• 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

Inspector
• 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
Secretary
Nadim Mahmud, MD, PhD
University of Illinois Hospital and Health Sciences System

Introducing FACT Audit & Assessment Services: Streamlining Site Assessments for Enhanced Patient Access

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

By Shawn Phillips, FAAS Auditor

We are excited to announce the official launch of FACT Audit & Assessment Services (FAAS), a new solution provided by FACT Consulting Services aimed at improving site assessments in the cellular therapy industry. Our mission is simple: to optimize patient care and enhance access to cellular therapies by streamlining the auditing process for all stakeholders involved.

In response to the growing demand for efficient assessment solutions in the rapidly evolving landscape of cell and gene therapy products, FAAS offers a new approach. Our services are designed to rapidly evaluate sites’ capabilities, facilitating their integration into companies’ networks while significantly reducing the burden of duplicative audits on healthcare sites.

FAAS is positioned to provide a singular, comprehensive assessment of collection and/or treatment sites via an assessment process that will become familiar to sites, providing a single audit summary report that can be leveraged by multiple companies.

Why FAAS Matters

With the development of numerous cell and gene therapy products, the need for qualified sites has never been more urgent. FAAS addresses this need by offering:

  • Efficiency: Our streamlined assessment process saves time and resources for both healthcare sites and industry players, allowing them to focus on delivering cutting-edge treatments to patients.
  • Quality Assurance: FAAS verifies that sites meet quality standards and regulations, providing assurance to companies and patients alike.
  • Enhanced Patient Access: By reducing the audit strain on industry sites, FAAS enables them to serve a broader patient population, ultimately advancing the goal of improving patient outcomes.

Why FAAS Can be the Ultimate Solution

  • Proven Process: Our methodologies are based on the globally trusted FACT accreditation program for cellular therapy, providing comprehensive evaluation and guidance for corrective actions.
  • Optimizing Access: We utilize consistent audit and assessment procedures and leverage existing reports to reduce the burden of repetitive audits, accelerate site qualification, and enhance access to cellular therapy for patients.
  • Tailored Programs: We design audit and assessment programs tailored to clients’ specific needs, whether it’s scope, geography, frequency, or number of sites.
  • Balanced Approach: We strike a balance between standardization and customization, optimizing quality at non-accredited sites and leveraging existing FACT accreditation to streamline audits.
  • Addressing Challenges: Say goodbye to unclear requirements and resource allocation issues. Our services alleviate the time, workforce, and financial burden of site certification on both health care sites and industry.

Meet Our Team

Leading FAAS is Liz Ferraro, Manager of Audit and Assessment Services. She is a seasoned Quality Manager with over 30 years of experience in healthcare quality management. With a proven track record at Nebraska Medicine Apheresis Program and LifeNet Health, Liz brings a wealth of expertise to her role.

 

 

 

 

Shawn Phillips, FAAS Auditor, is a quality auditor with a clinical background in Nuclear Medicine. His experience at Roswell Park Comprehensive Cancer Institute uniquely positions him to contribute to FAAS’s mission of ensuring site excellence.

 

 

 

 

How You Can Help

We invite programs and healthcare professionals to join us in spreading the word about FAAS. By recommending FAAS to companies seeking to conduct audits, you not only support the advancement of innovative treatments but also contribute to expanding patient access to these life-changing therapies. Companies can initiate the process of developing a customized assessment program via the Needs Assessment Form on the FACT Consulting Services website. Feel free to share this link!

FAAS represents a pivotal step towards optimizing site assessments and enhancing patient access to groundbreaking treatments. Together, let’s propel the healthcare industry forward and make a meaningful difference in patients’ lives.


Tata Medical Center is First Cellular Therapy Program in India to Earn FACT Accreditation

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

FACT is pleased to announce that Tata Medical Center in Kolkata, India, received internationally recognized FACT accreditation. Directed by Jeevan Kumar, MD, MBBS, it is the first and only cellular therapy program in India to be recognized by FACT. Dr. Mammen Chandy, former Director of Tata Medical Center, committed years ago to enhancing quality throughout the program and attaining FACT accreditation. The program achieved accreditation February 29, 2024, for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation. Tata Medical Center is part of the FACT India Working Group, led by Nadim Mahmud, MD, PhD.

Dr. Mahmud states, “This marks a significant milestone for the FACT India Working Group and for India. We are encouraged by Tata Medical Center’s achievement in obtaining FACT accreditation, which demonstrates a commitment to quality and ensuring the best possible outcomes for patients undergoing stem cell transplants. We believe that other transplant centers in India will recognize the benefits and join us in pursuing FACT accreditation. I am indebted to Professor Mammen Chandy from Tata Medical Center for his wisdom in facilitating the process and advocating the need for FACT accreditation, not only for Tata Medical Center in Kolkata, but for all BMT centers in India.”

Dr. Kumar notes, “The FACT accreditation cements our commitment to provide the highest quality of patient care. It is recognition of our founding director’s vision to establish evidence based best practices in cellular therapy at Tata Medical Center. The unwavering support of the administration and our team’s hard work has resulted in successfully completing the accreditation process. It marks the inclusion of the first Indian center into the global consortium of accredited institutions. Even though the accreditation process was rigorous, it helped us to consolidate our strengths and identify opportunities for improvement. The FACT team has continuously supported us in this endeavor. The on-site inspection served as a peer-review by international experts and boosted the morale of our team members. As an active member of the FACT India Working Group, we are happy to share our experiences and quality improvement initiatives with like-minded centers in India and abroad.”

Dr. Phyllis Warkentin, FACT Chief Medical Officer, states, “Tata Medical Center’s achievement of FACT accreditation in Hematopoietic Cell Transplantation and Cellular Therapy as the first program in India to reach this milestone demonstrates its commitment to providing quality care for the patients it serves. FACT commends the leadership and staff of Tata Medical Center for their dedication and resilience in pursuit of accreditation, their contributions to the FACT India Working Group, and their leadership in the field and the region.”


FACT India Working Group

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

By Nadim Mahmud, MD, PhD
University of Illinois College of Medicine, Chicago

India has a population of more than 1.4 billion, and about 105 bone marrow transplant (BMT) centers performing approximately 2,000 stem cell transplants annually. In North America, Europe, or Australia there are more than 300 transplants performed per 10 million people. Based on this transplant utilization number, India may need to perform about an estimated 39,000 transplants per year. Since only 2,000 transplants are performed, a gap of 37,000 transplants per year exists. Thus, there remains a huge gap in capacity to perform BMT for its population need. On the other hand, even for 105 existing BMT centers, there is a notable lack of trained transplant physicians, nurses, and quality managers.

The first BMT center in Vellore was established in 1986 (Christian Medical College), yet there had been no FACT-accredited transplant centers in India until recently. During one of my visits to the Haematocon (Indian Society of Haematology & Blood Transfusion) meeting in Bangalore, I had an informal meeting with Dr. Mammen Chandy. Dr. Mammen is also the pioneer in establishing the first BMT center in India. This conversation led to an informal visit to Tata Medical Transplant Center in Kolkata in 2017.

Since 2012, FACT has attempted to actively engage with transplant centers in India. FACT offered a workshop during the Asia-Pacific Blood and Marrow Transplantation Group (APBMT) Congress held in Hyderabad, India , outlining the benefits and scope of FACT accreditation. The FACT India Working Group (IWG) was formed in 2018 to encourage BMT centers to attempt to take part in the FACT accreditation process. A broad group of ten participating centers from various parts of India is participating in the IWG designed to address the regional needs of the country. The centers are completing self-assessments of their programs to identify any potential barriers to compliance with FACT Standards, clarify the intent of requirements, and assess their readiness for accreditation. Tata Medical Center (Kolkata) is one of the active participants in IWG.

Having BMT programs accredited by organizations like FACT would facilitate a standard quality management program outlining policies, procedures, and deviation management. Such awareness can greatly improve patient care and transplant outcomes. Having a stringent quality management program and data sharing among peer transplant groups would enable establishing outcome benchmarks to stride towards overcoming barriers.

This year, the Tata Medical Center in Kolkata is the first ever BMT center in India to be awarded FACT accreditation. This is a huge milestone for having a BMT program with an established quality management program.  There are only two other FACT-accredited BMT centers in Asia: one in Singapore and one in Saudi Arabia. As the FACT IWG chair, along with the working group’s staff liaison Sarah-Litel Smith (FACT Accreditation Supervisor) and the FACT office, we are encouraged to see interest in achieving FACT accreditation and thus fulfilling a commitment to patients undergoing stem cell transplants anywhere to have the best outcomes possible. We firmly believe that other transplant centers in India will see the benefits and join this endeavor to achieve FACT accreditation.

This was only possible due to the tremendous support and faith from the FACT Chief Operating Officer, Ms. Linda Miller, and Chief Medical Officer, Dr. Phyllis Warkentin, for IWG to carry on despite slow progress at the beginning. Personally, I am indebted to Professor Mammen Chandy from Tata Medical Center for his wisdom facilitating the process and advocating the need for FACT accreditation not only for Tata Medical Center but for all BMT centers in India. FACT is also grateful to the organizers of Haematocon, the annual conference of the Indian Society of Haematology and Blood Transfusion (ISHBT), for facilitating FACT Quality workshops over the years.


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!

 

 


Register Soon for the Virtual 2024 Fundamentals of HCT Training Course and its Benefits

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

The virtual 2024 Fundamentals of HCT Training Course will take place on April 19-20, and registration is due April 18. With this one course, attendees will receive a broad overview and introduction of hematopoietic cell transplantation and cellular immunotherapy, earn up to 15.25 continuing education hours, and have access to the 2023 Fundamentals of HCT ebook for 50% off!

Lectures are designed to develop or enhance participants’ skills required in the management of patients undergoing hematopoietic cell transplantation or cellular immunotherapy procedures. This course incorporates case-based learning to emphasize application of concepts taught through didactic lecture with a strong focus on pharmacotherapeutic management.

The course is beneficial for the following:

  • Advanced Practice Providers
  • Fellows
  • In-Training Professionals
  • New Practitioners
  • Pharmacists
  • Physicians
  • Nurses

Workforce education is a major need in transplantation and cellular therapy, and FACT appreciates ASTCT’s dedication to providing this educational opportunity. It is an effective way to help key personnel achieve FACT-required continuing education hours.

Register for the HCT Fundamentals Training Course by April 18

Take Advantage of the Accompanying Offer of 50% Off the Fundamentals of HCT eBook

As part of registration for the training course, participants can also purchase the 2023 Fundamentals of HCT eBook. This book provides up-to-date clinical information and covers the entire transplant process from pre-transplant consultation to post-transplant care. The book includes 31 chapters that highlight introduction to transplant, CAR-T, stem cell mobilization, pediatrics, and more!

Learn more about the Fundamentals of HCT eBook


ISCT Releases Second Global Regulatory Report

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

ISCT published its second Global Regulatory Report, which covers Quarter 3 and Quarter 4 of 2023. This report is developed by ISCT in partnership with Citeline, and provides an overview of the cell and gene therapy regulatory landscape, including pipeline, late-stage (Phase III and pre-registration), and approved products, covering cell, genetically modified cell, and gene therapies.

Highlights of the current report include:

  • 2,960 therapies in the global pipeline (2% increase from H1 2023)
  • 80 products are under regulatory review globally of which 71 products are in Phase III clinical trials
  • 96 products approved globally (9% increase from H1 2023)
  • 6 products received their first approvals globally including.
    • Elevydis (delandistrogene moxeparvovec-rokl)
    • Lantidra (donislecel)
    • Fucaso® (equecabtagene autoleucel)
    • CNCT19 (inaticabtagene autoleucel)
    • Casgevy™ (exagamglogene autotemcel)
    • Lyfgenia™ (lovotibeglogene autotemcel)
  • Key Global Legislative/Framework Changes by US FDA, EMA, ICH, and NZ Ministry of Environment

We encourage personnel at accredited programs to review the report to learn more about what occurred in late 2023 and what is to come.

Learn more and access the Global Regulatory Report


Register for Upcoming Events!

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

We invite you to apply to train at the FACT Apheresis Collection Inspector Training Course on April 16, 2024, in conjunction with the American Society for Apheresis (ASFA) 2024 Annual Meeting scheduled for April 17 – 19, 2024, at the Resorts World, Las Vegas, NV.

Earn AMA PRA Category 1 Credit™ for attending! Inspector trainees and Inspectors can register today for this great training event.

image This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Illinois State Medical Society (ISMS) through the joint providership of Edward-Elmhurst Health and FACT. Edward-Elmhurst Health is accredited by the ISMS to provide continuing medical education for physicians. This live activity is designated for a maximum of 8.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

To register, please visit: https://learn.factglobal.org/products/2024-fact-inspector-training-at-asfa


We invite you to attend the FACT-CTTC Quality Boot Camp on Wednesday, May 1, from 8:00 am to 5:00 pm at the Victoria Conference Centre in Victoria, British Columbia. Participants will hear expert presentations and engage in roundtable activities facilitated by experienced FACT Inspectors and quality personnel.

Registration for this event is being held by Cell Therapy Transplant Canada.

The deadline to register for this special session is 11:59pm PT on April 28, 2024.

To register, please visit: https://www.cttcanada.org/page/2024meeting.


We invite you to apply to train at the FACT Processing Inspector Training Course on May 28, 2024, in conjunction with the International Society for Cell & Gene Therapy (ISCT) Conference in Vancouver, BC, held May 29 – June 1, 2024, at the Vancouver Convention Centre, West Building. Connecting with global experts from academic, regulatory, and industry in the cell and gene therapy field.

Earn AMA PRA Category 1 Credit™ for attending! Inspector trainees and Inspectors can register today for this great training event.

image This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Illinois State Medical Society (ISMS) through the joint providership of Edward-Elmhurst Health and FACT. Edward-Elmhurst Health is accredited by the ISMS to provide continuing medical education for physicians. This live activity is designated for a maximum of 8.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

To register, please visit: https://learn.factglobal.org/products/2024-fact-inspector-training-at-isct-vancouver