FACT, ASTCT, CIBMTR, ISCT, and EBMT Publish Joint Statement Against Racism

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

Racism has no place in our society and profession. The American Society for Transplantation and Cellular Therapy (ASTCT), the Center for International Blood and Marrow Transplant Research (CIBMTR), Foundation for the Accreditation of Cellular Therapy (FACT), the International Society for Cell & Gene Therapy (ISCT), and the European Society for Blood and Marrow Transplantation (EBMT) all find these acts of racism reprehensible and inexcusable. This cannot be ignored any longer by the global community and our respective organizations.

We stand for the advancement of innovative, life-saving medicine. We know the importance of moving the needle forward in order to enact positive, powerful change. When it comes to issues of racism and violence, we realize the need for change, too.

We recognize that racism is an institutional problem in health care, and we are committed to doing our part to bridge that gap. We stand behind those who promote equality, diversity and inclusion. As a health care community, we have to do better—for not only the patients we serve, but the communities they live in as well.

As we work toward improving diversity and denouncing racism in health care and cities around the world, we commit to having the important conversations and supporting critical initiatives within our community that move us toward equality both in the transplantation, cellular and gene therapy workforce and in access to lifesaving therapies.

Please use this resource from the National Museum of African American History & Culture to educate yourself on the importance of talking about race and to find tools on combating racism in your own communities. We ask that you stand with us in denouncing racism and violence.


COVID-19 Update: FACT Accreditation

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

 

 

UPDATE: 17 March 2020

Program Directors, Medical Directors, and Quality Managers:

The health and safety of our cellular therapy community continues to be our utmost concern as we all work to mitigate the effect of the COVID-19 pandemic. Due to travel restrictions and CDC recommendations for social distancing, FACT has postponed all scheduled on-site inspections through June 30, 2020.  Rescheduling of these and additional inspections will resume when an appropriate timeline can be determined. We will continue to follow recommendations from the CDC, health officials, and governmental agencies.

There have been many questions related to delays and postponements of on-site inspections due to travel restrictions and recommendations for social distancing.

Effective immediately, the accreditation expiration date for all FACT-accredited organizations will be extended by six months. This includes all clinical hematopoietic cell transplant programs, immune effector cell programs, apheresis centers, laboratory facilities, and cord blood banks, regardless of the current expiration date. This is our current best estimate of an appropriate timeline, however, if circumstances warrant, additional extensions will be implemented. New accreditation certificates will be prepared and distributed to eliminate confusion. The official list of accredited organizations is available at factwebsite.org.

To the extent possible, programs should continue to submit documents and complete Compliance Applications during this period when on-site inspections are not being scheduled. FACT staff are available by phone or email to receive and review this information, and to provide other assistance as needed.

FACT also continues to receive questions related to patients, donors, and other COVID-19 related issues. A Frequently Asked Questions document is available at factwebsite.org.

If you have further questions or concerns, please contact me (402-559-6781; pwarkent@unmc.edu) or the FACT office (402-559-1950; fact@unmc.edu).

Published March 13, 2020

The health and well-being of our cellular therapy community, volunteers, staff, and patients is our utmost concern as new cases of Coronavirus are reported across the US and around the world.  We are continuing to monitor recent developments surrounding the coronavirus (COVID-19) pandemic and are focused on recommendations from the CDC, health officials, and government agencies.

Numerous institutions have implemented travel policies banning both domestic and international travel for their employees, including our FACT inspectorate. Organizations should anticipate postponements and delays in scheduling.  We understand the inconvenience; however, these restrictions represent the best effort to safeguard the health of all involved. We thank you for your understanding and cooperation as we work together to meet the challenges posed by COVID-19. Please be assured that organizations’ accreditation will not lapse due to these circumstances. Additional time will be allotted in the accreditation process.

Our parent society, the American Society for Transplantation and Cellular Therapy (ASTCT) and its Infectious Disease Special Interest Group have developed interim guidelines for COVID-19 management of HCT and cellular therapy patients. These guidelines will be modified as new information becomes available, including more data on epidemiology, clinical outcomes, and efficacy of drug therapies including clinical trials of novel therapeutics.

COVID-19 Interim Patient Care Guidelines 

In addition, FACT global partner The World Marrow Donor Association (WMDA), has provided international blood and tissue donor guidelines and resources for cord blood banking including:

For additional resources, please consult the World Health Organization and the Centers For Disease Control.

If you have questions, or concerns, please contact the FACT office at 402-559-1950 or fact@unmc.edu.


2020 FACT-ASTCT Quality Manager Engagement and Resiliency Survey

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

 

Resilience is the ability to recover from or adjust easily to change.  Highly resilient individuals thrive in an environment of change. The Quality Manager’s capacity to be resilient during change, a constant in their work life, is a critical skillset.

Since 2017, the FACT Quality Management Committee and the ASTCT Administrative Directors SIG Quality Working Group have collaborated to identify opportunities to increase the QM’s resiliency During that year, the quality groups developed an anonymous survey to collect data on Quality Manager personal resilience and their perceived benefits of improved resilience. The survey included a validated “Brief Resilience Scale”2 (BRS) which quantitatively measures resilience (1 = low to 5 = high).

To assess possible work stressors, Quality Managers were queried about their responsibilities, program size/complexity, and the nature of interactions with others, e.g. direct supervisors. Respondents were also asked to rank selected resources for increasing resiliency.

Since that initial survey, results have been analyzed and presented as abstracts during TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR.  Additionally, survey findings have been used to identify resources to help, among others, build resilience through improved workplace communications, workload management.   This resources list was uploaded to the FACT website at:  http://www.factwebsite.org/WorkArea/DownloadAsset.aspx?id=1898.

It’s come time to reassess…Quality managers, we need you! 

The committees are reaching out more broadly to cellular therapy program and cord blood bank Quality Managers around the world requesting that you complete a follow-up survey.   This year’s anonymous survey takes approximately 20 minutes to complete.  The survey can be accessed at the web address or by scanning the QRS code included below.

 

https://www.surveymonkey.com/r/FACT-ASTCT2020QMResiliency

 

 

 

The FACT Quality Management Committee and the ASTCT Administrative Directors SIG Quality Working Group plan to analyze information provided by respondents later this year and publish early in 2021.


NEW in 2020! ASTCT Institutional Bulk Membership for Affiliate Members

Posted in :: 2019 Volume 11 :: Monday, November 25th, 2019

ASTCT announced last month that it would be offering a new type of membership: Institutional Affiliate Membership. The new system allows institutions or organizations to purchase memberships as a group, offering a single invoice for multiple affiliate members. This type of membership offers the same benefits as an individual one: Access to the communities, ability to join a SIG or committee, and a subscription to BBMT, to name a few.

Institutional Bulk Membership can be purchased for Affiliate Members in groups of 5 or more individuals. Pricing is set at $140 per person. The Institutional Bulk Membership will go into effect on January 1, 2020. Current members may sign up to convert their membership to an Institutional Bulk Membership. Non-members should complete the form linked below, and ASTCT staff will contact you to finalize your membership.

ASTCT Institutional Bulk Membership details
ASTCT Institutional Membership Form


FACT Education Events

Posted in :: 2019 Volume 10 :: Thursday, October 31st, 2019

FACT – Héma-Québec – Liège Cord Blood Bank Cord Blood Webinar in Support of World Cord Blood Day
November 14, 2019
10:00 am ET, 15:00 GMT, 16:00 CET

In anticipation of World Cord Blood Day, FACT, along with Héma-Québec and Liège Cord Blood Bank, invites you to attend a special Cord Blood webinar on Thursday, November 14, 2019 at 10:00 am ET, 15:00 GMT, and 16:00 CET. The purpose of this webinar is to better understand immunogenetic diversity in registries and cord blood banks, as well as cord blood transplantation and emerging pathogens. This webinar is free of charge and will be presented in French. Slides will be available in both English and French. Topics include:

• Immunogenetic Diversity in Registries and Cord Blood Banks: Dr. Eliane Gluckman
• Cord Blood Transplantation and Emerging Pathogens: Is there reason for concern? Dr. Gilles Delage
• Personal experience from a cord blood recipient

FACT also encourages you to join the Save the Cord Foundation on November 15 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.

Instructions for joining the FACT Webinar on November 14:
1. Log into webinar:
https://factwebsite.webex.com/factwebsite/onstage/g.php?MTID=eda55e6eaf311dc8ea9de4e66281dde89
2. Enter your name and email. Click “Join Now.”
3. If requested, enter the event number: 666 195 982
4. Adjust computer audio to desired volume.
_____________________________________________

French Translation

En préparation de la Journée Mondiale du Sang de Cordon Ombilical, nous vous invitons à participer à un séminaire en ligne spécial qui aura lieu jeudi le 14 Novembre 2019 à 10:00 HNE, 15:00 GMT, and 16:00 CET. L’objectif de ce séminaire est de mieux comprendre la diversité immunogénétique dans les registres et les banques de sang de cordon, ainsi que les agents pathogènes émergents dans le cadre de transplantation. Ce séminaire est gratuit et sera présenté en Français. Les diapositives seront disponibles en français et en anglais.
Liste des sujets:

• Diversité immunogénétique dans les registres et banques de sang de cordon: Dr. Eliane Gluckman
• Transplantation de sang de cordon et pathogènes émergents: est-ce un sujet d’inquiétude? Dr. Gilles Delage
• Expérience personnelle du receveur d’une greffe de sang de cordon.

FACT vous encourage également à vous joindre à la Fondation Save the Cord le 15 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations pour le grand public ainsi que des présentations académiques par des chercheurs et des médecins transplanteurs réputés sur les récentes avancées et thérapies utilisant le sang de cordon ombilical.

1. Se connecter au séminaire:
https://factwebsite.webex.com/factwebsite/onstage/g.php?MTID=eda55e6eaf311dc8ea9de4e66281dde89
2. Saisir votre nom et adresse email. Cliquer “Join Now.”
3. si demandé, entrer le numéro de l’événement: 666 195 982
4. Ajuster le volume de votre ordinateur au niveau désiré.

FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm

We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will clarify the intent of the FACT-JACIE Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.

Register for the FACT workshop

FACT Cellular Therapy Leadership Course 101 at TCT Meetings
February 18, 2020
8:00 am – 12:00 pm

Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you recognize your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.

Register for the FACT Leadership 101 course

FACT Cellular Therapy Advanced Leadership Course 201 at TCT Meetings
February 18, 2020
1:00 pm – 4:30 pm

If you completed FACT’s Cellular Therapy Leadership 101 course and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cellular Therapy Leadership 101 course in the morning, or if attended in a previous year, are eligible to register for the 201 course in the afternoon.

Register for the FACT Advanced Leadership 201 course

FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm

Join us for the FACT-ASBMT Quality Boot Camp at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 19 in Orlando, FL.

Focused on issues identified by FACT compliant transplant programs, sessions will include activities and discussion designed to strengthen your quality assurance processes. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution.

Register for the FACT-ASTCT Quality Boot Camp

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 20, 2020
5:00 pm – 7:00 pm

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, from 5:00 pm to 7:00 pm.

Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. This program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

Register for the FACT Global Affairs session

FACT Cord Blood Inspection & Accreditation Workshop
May 26, 2020
8:00 am – 5:00 pm

This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.

The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.

Apply to train as a FACT inspector.  If approved, you can attend the workshop FREE of charge!

Register for the FACT workshop


FACT Education Events

Posted in :: 2019 Volume 9 :: Thursday, September 26th, 2019

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
October 9, 2019
Webinar

The second webinar in this two-part series will be on Wednesday, October 9, 2019 at 11:00 am ET. Part two includes information from Dr. Joseph Alvarnas from City of Hope. Dr. Alvarnas will give his perspective as a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement

View meeting details and register

Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar

This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, FACT Standards Development Chair, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register

FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm

We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!

FACT will conduct a Cellular Therapy Inspection & Accreditation workshop on February 18, 2019, at the World Center Marriott in Orlando, Florida. This workshop will provide an immersive experience for personnel preparing for the accreditation process and a full day training session for FACT inspector trainees.

Register for the FACT workshop

FACT Cellular Therapy Leadership Course 101 at TCT Meetings
February 18, 2020
8:00 am – 12:00 pm

Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you recognize your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.

Register for the FACT Leadership 101 course

FACT Cellular Therapy Advanced Leadership Course 201 at TCT Meetings
February 18, 2020
1:00 pm – 4:30 pm

If you completed FACT’s Cellular Therapy Leadership 101 course and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cellular Therapy Leadership 101 course in the morning, or if attended in a previous year, are eligible to register for the 201 course in the afternoon.

Register for the FACT Advanced Leadership 201 course

FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm

Join us for the FACT-ASBMT Quality Boot Camp at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 19 in Orlando, FL.

Focused on issues identified by FACT compliant transplant programs, sessions will include activities and discussion designed to strengthen your quality assurance processes. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution.

Register for the FACT-ASTCT Quality Boot Camp

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 20, 2020
5:00 pm – 7:00 pm

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, from 5:00 pm to 7:00 pm.

Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. This program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

Register for the FACT Global Affairs session


CMS Releases Final Decision on National Coverage Determination for CAR T-cell Therapy for Cancers

Posted in :: 2019 Volume 8 :: Thursday, August 29th, 2019

The United States Centers for Medicare & Medicaid Services (CMS) finalized its National Coverage Determination (NCD) for CAR T-cell Therapy for Cancers on August 7, 2019. Among other changes, the decision no longer requires Coverage with Evidence Development (CED) and now allows coverage for indications on FDA-approved indications and uses recommended by a citation in CMS-approved compendia. FACT appreciates CMS’s consideration of our comments and of those submitted by several of our stakeholders. Many of the changes will promote patient access to CAR T-cell therapy.

The American Society for Transplantation and Cellular Therapy (ASTCT), one of FACT’s parent organizations, indicated that it is also pleased with many of the changes from the proposed decision memo and responded with a comment letter about suggestions for continuing to improve reimbursement for this therapy.

We believe in the utility of FACT Standards to promote safety and efficacy of CAR T-cell therapies; increase harmonization across requirements of regulators, payers, and manufacturers; and reduce burden on hospitals. We will continue to work with all of these stakeholders to do our part to promote patient access.

View the CMS Decision Memo

View the ASTCT Letter to CMS


Join ASTCT for a Webinar on Consensus Grading for CAR-T

Posted in :: 2019 Volume 8 :: Thursday, August 29th, 2019

CAR T cell therapy is considered one of the most promising new treatments for patients battling relapsed and refractory leukemia, lymphoma and other forms of cancer. The assessment and grading of CRS and ICANS have varied considerably across clinical trials, academic studies, and commercial products, which has made it difficult to compare the safety and measure toxicity across all of these settings. This also has hindered the ability of researchers to develop the best strategies to manage these toxicities. Join Drs. Stephan Grupp and Sattva Neelapu on October 2, 2019, at 2:30 pm CT, for an ASTCT webinar discussing the new definitions and grading for CRS and neurotoxicity that more accurately categorize the severity of these toxicities.

Register for webinar


Webinar Series on Implementing Commercial CAR T-cell Products

Posted in :: 2019 Volume 6 :: Thursday, June 13th, 2019

The American Society of Gene & Cell Therapy (ASGCT) has partnered with FACT and the American Society for Transplantation and Cellular Therapy (ASTCT) to bring you the two-part webinar series, “Centers’ Experience with Implementing Commercial CAR T-cell Products.”

The first webinar will be on Thursday, July 25, 2019 at 11:00 am ET.  Part one includes information from two centers regarding their journey to successful implementation of commercialized CAR T-cell products. Clinicians will address the challenges faced during the site on-boarding process, where they are in this process, commonly faced impediments to timely delivery of therapy to patients, and suggestions for centers initiating implementation of commercial CAR T-cell products. Topics in this webinar will include required training, maintenance of chain of custody, and mechanisms for reporting outcomes data. FACT accreditation will also be covered.

Part two will take place in September of 2019 and will include the perspective of a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement
  • FACT accreditation

View meeting details and register


FACT Events at the 2019 TCT Meetings Were a Success

Posted in :: 2019 Volume 3 :: Thursday, March 14th, 2019

FACT hosted several popular events at the 2019 TCT | Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR in Houston, Texas. Over 150 people joined FACT on February 19 for the Cellular Therapy Inspection and Accreditation Workshop, which included topics such as building quality into clinical immune effector cell programs, risk evaluation and mitigation strategies, using the Tracer Methodology to assess compliance with standards, common citations, reviewing clinical outcomes, and improving data management through follow-up. Also on February 19, FACT hosted two cellular therapy leadership courses for anyone who has, or aspires to, a leadership position in cell therapy.

On February 20, FACT teamed up with ASBMT to host the 4th annual Quality Boot Camp.  Over 130 people participated in the boot camp. This year’s agenda focused on topics such as dashboards and scorecards, record retention, risk assessment, integrating IECs into your HCT program, and evaluating the quality of your program through auditing. Quality experts presented core concepts, led roundtables, and answered questions to help others reach their quality management goals.

Special invitations were extended to all international delegates attending the TCT Meetings for a wine and cheese reception on February 21. The FACT Global Affairs: International Accreditation session provided attendees information about the international accreditation program featuring a stepwise certification approach. The new program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

On February 21, in the session titled, Quality in HCT: Center-Specific Outcomes, Dr. Dennis Gastineau, FACT President and member of the FACT Clinical Outcomes Improvement Committee, shared guidelines for corrective action plans, and trends noted in the plans reviewed, including causes of death, challenges in root cause analysis, and ideas for improving one-year survival.

On February 22, FACT hosted a social hour for all FACT inspectors and inspector trainees in honor of their dedication and service provided to the cell therapy community. FACT relies on volunteer inspectors and appreciates their superior service, time, and expertise.

In addition to these events, FACT welcomed visitors to its exhibit booth to provide information about accreditation and educational activities.

All events were successful and FACT looks forward to the 2020 Transplantation and Cellular Therapy Meetings in Orlando, Florida!

FACT welcomed 150 attendees to the Cellular Therapy Inspection and Accreditation Workshop at the 2019 TCT Meetings.


Dr. Helen Heslop Receives Lifetime Achievement Award

Posted in :: 2019 Volume 3 :: Thursday, March 14th, 2019

Director of the Center for Cell and Gene Therapy Dr. Helen Heslop was recently recognized with the American Society for Blood and Marrow Transplantation Lifetime Achievement Award at the Transplantation & Cellular Therapy Meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood and Marrow Transplant Research.

The ASBMT Lifetime Achievement Award is presented annually and recognizes an individual who has made continuing contributions to the field of blood and marrow transplantation.

Dr. Heslop is Professor of Pediatrics and Medicine and Director of the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston Methodist Hospital and Texas Children’s Hospital. She serves on the FACT Cellular Therapy Accreditation Committee, the Immune Effector Cellular Therapy Task Force, and various other FACT committees.  Dr. Heslop is a member of the FACT Board of Directors, and served as the President of FACT from 2012 to 2016.

Read full article


Cellular Therapy Community Corner

Posted in :: 2019 Volume 3 :: Thursday, March 14th, 2019

American Society for Blood and Marrow Transplantation Updates Name to American Society for Transplantation and Cellular Therapy

The American Society for Blood and Marrow Transplantation (ASBMT), a professional society dedicated to advancing the science and clinical care for patients who require blood and marrow transplants, announced it has changed its name to the American Society for Transplantation and Cellular Therapy (ASTCT) in recognition of the rapid shift toward cellular therapies in this field of medicine. The ASTCT name will better reflect the organization’s commitment to serving as the professional home and community for healthcare providers, researchers, and other professionals who are dedicated to cures involving blood and marrow transplantation and cellular therapies.

The new name was announced at the annual Transplantation and Cellular Therapy Meetings, hosted by ASBMT and the Center for International Blood and Marrow Transplant Research (CIBMTR) from Feb. 20 to 24 in Houston, Texas. The ASTCT name was chosen to acknowledge the rapid shift toward cellular therapies, and to reflect the organization’s 25 years of leadership in that field, along with transplantation. Read full article

Post-Conference Exclusive: World Cord Blood Day 2018

As a follow-up to last November’s World Cord Blood Day virtual conference, the leading cord blood pioneers and visionaries who served as presenters have responded to many of the questions asked by attendees post-conference.

Speakers include:

  • Joanne Kurzberg,
  • Susana Cantero Peral
  • Charles Cox, Jr.
  • Juliet Barker
  • Dave Murphy
  • Monroe Burgess
  • Josephine Neuweiserhuiser-Teeler
  • Lyla Edington and Parents

Mark your calendars for the next World Cord Blood Day on November 15th, 2019!

Read Post-Conference Q & A

ASBMT Welcomes New President

Dr. Navneet Majhail is looking forward to a new beginning as the new president of ASBMT.  Dr. Majhail is he the Director of the Blood & Marrow Transplant Program at the Cleveland Clinic, and the Scientific Director of CIBMTR Health Services Research Program.  He received his medical degrees from Government Medical College, Chandigarh, India and the All India Institute of Medical Sciences, New Delhi, India. He completed a residency in internal medicine at the Cleveland Clinic Foundation, and a fellowship in hematology‐oncology at the University of Minnesota. He also obtained an MS in Clinical Research from the University of Minnesota. His research interests include survivorship issues and late effects of transplantation and health services research in hematologic malignancies and blood and marrow transplantation. FACT welcomes Dr. Majhail as the new President of ASBMT!

Read Dr. Majhail’s Blog


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.


President’s Letter

Posted in :: 2018 Volume 4 :: Tuesday, November 13th, 2018

FACT committees have advocated for cellular therapy organizations on several fronts this past quarter, and we are seeing results.

The Technology Committee, with the hard work of FACT’s IT Business Analyst, Alisa Forsythe, launched the new FACT Accreditation Portal on October 1st. Organizations and inspectors were candid with their feedback on the online accreditation process, and the committee and Alisa listened and were responsive to those needs. We are pleased to deliver a faster, more streamlined portal that better serves our stakeholders.

Rapid development and recent commercialization of novel cellular therapies have brought new protocols and processes to accredited organizations. The FACT Immune Effector Cell Task Force is advocating for clear, manageable, and sustainable expectations of programs that have begun providing immune effector cell therapies. The FACT Regenerative Medicine Task Force has been sharing related lessons learned with organizations working to advance regenerative medicine in order to address challenges upfront. We also continue to facilitate open communication via the Professional Relations Committee, comprised of several related organizations.

Our work with the Center for International Blood and Marrow Transplant Research (CIBMTR) and one of our parent organizations, the American Society for Blood and Marrow Transplantation (ASBMT), continues on important issues, especially data management and clinical outcomes. The FACT-CIBMTR Data Audit Committee and the Clinical Outcomes Improvement Committee have been focusing on clear articulation of expectations of accredited programs, while also working to promote quality data and outcomes improvement in a manner that is least burdensome and most effective for those programs.

The Global Affairs Committee has been traveling the globe and continues to do so in an effort to bring quality hematopoietic progenitor cell transplants to more patients. In addition to accreditation workshops in conjunction with several international meetings, FACT recently formalized a joint accreditation program in Brazil.

The Standards, Education, and Quality Committees have been busy updating Standards and continuing educational programming to assist accredited organizations with staying current in developments in the field. These efforts are integral to the practical implementation of FACT requirements.

Finally, we are immensely appreciative of the Cellular Therapy and Cord Blood Accreditation Committees, chaired by Phyllis Warkentin, MD, FACT Chief Medical Officer. As all of the committees above continue their good work, growth in the accreditation program follows. The number of cellular therapy programs seeking voluntary accreditation continues to grow, giving the Accreditation Committee more reports to review, discuss, and assess. These reports are also growing in complexity as programs provide more diverse services to their patients, and the committee has been prudent with considering these complexities and maintaining consistency in its reviews. Members of the Cellular Therapy Accreditation Committee have committed to additional time to accommodate the increasing number of reports, demonstrating their commitment to FACT’s mission of quality cellular therapy.

We welcome your participation in FACT’s peer review and accreditation, as an inspector and as a committee member.

Sincerely,


Dennis A. Gastineau, MD
FACT President


ASBMT and FACT Partnering on Project to Support Quality Managers

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

By Therese Dodd, BA, MBA, RN, CPHQ, FNAHQ, Sarah Cannon Director, Quality Improvement

The ASBMT Administrative Directors SIG Quality Working Group and the FACT Quality Management Committee are partnering on a project to identify opportunities to increase Quality Managers’ resiliency. The first step of this initiative was to develop a 59-question electronic survey, targeting HCT/CT/CBB Quality Managers, in order to collect data on their personal resilience and their perceptions of the benefits of improved resilience. Key takeaways from preliminary analysis indicate that:

• Strategic drivers for increasing Quality Manager resilience must be identified and deployed in order to recruit and retain proficient personnel who are both productive and able to support others in the program.
• Program administrators must understand the complexity and responsibility of the Quality Manager role and be engaged in supporting appropriate Quality Manager staffing levels, professional development and increased resiliency.

For complete details regarding the survey and its results, review the poster displayed at the 2018 BMT Tandem Meetings.


ASBMT Completes Busy Month of Policy Initiatives

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

Corporate Council Meeting

The American Society for Blood and Marrow Transplantation (ASBMT) leadership and past presidents met in late September with industry and BMT thought leaders at the ASBMT Corporate Council meeting.  Among the Council’s many objectives is to establish meaningful dialogue between industry leaders, healthcare providers, and the ASBMT’s leaders.  Headed by Armand Keating, MD, the Council aims to share information, advice and assistance to address specific BMT issues.

During this year’s meeting, discussions focused on the challenges of supportive care after stem cell transplant, the role of immune cell-based therapies, engineered T Cell therapy, and ASBMT’s efforts to improve access and referral for blood and marrow transplantation (BMT).  An overview of health policy issues was also presented by ASBMT Director of Health Policy and Strategic Relations, Stephanie Farnia.

Visit the ASBMT website for more details about the Corporate Council.

Comment Submissions

ASBMT submitted several letters addressing important policy considerations to the Centers for Medicare & Medicaid Services (CMS). The letters addressed topics such as the unintended consequences of proposed changes to the outpatient prospective payment system; concerns with proposed changes to bone marrow aspiration, apheresis, and chemotherapy codes within the physician fee schedule;  and concerns anticipated during the first year of providing CAR-T therapies to the Medicare population.

Review the letters on the ASBMT website.

Legislative Day

ASBMT hosted its first Legislative Day in Washington, D.C., on Thursday, Sept. 7, in partnership with the NMDP. The goal for the day was to educate Congressional representatives on issues that affect the field of hematopoietic cell transplantation – Medicare reimbursement, physician payment, and research funding.

Additional details about the Legislative Day are available on the ASBMT website.


FACT Achieves Major Accomplishments in 2016

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

The 20th year of FACT successfully built upon its history of successes to advance cellular therapy and regenerative medicine. As physicians and scientists continue to make advancements, opportunities arise for FACT to play a supporting role to educate all programs on new approaches and therapies. The following are highlights from 2016:

1. FACT Celebrates 20th Anniversary

FACT celebrated its 20th year as the leading organization in standards setting and accreditation for cellular therapy, hematopoietic stem cell transplantation, and regenerative medicine. FACT welcomed visitors to a dynamic exhibit booth at the BMT Tandem Meetings and the ISCT Annual Meeting to celebrate with the organization. Attendees who wore their commemorative FACT 20th anniversary pin received gifts and were entered in a daily drawing for prizes.

FACT also hosted anniversary receptions at these meetings, and many FACT colleagues, volunteers, and friends enjoyed hors d’oeuvres and refreshments as FACT celebrated two decades of working together in the community to improve patient care and safety. Guests enjoyed watching a short video highlighting FACT’s past 20 years, and saw some familiar faces who have been an integral part of FACT since its beginning.

2. FACT Commences Review of Corrective Action Plans for Low One-Year Survival

The FACT Clinical Outcomes Improvement Committee began formally reviewing corrective action plans submitted by Clinical Programs that did not meet expected one-year survival as outlined by comparative data. The emphasis of the committee is to help programs identify ways to improve their outcomes for patients. After several months of reviewing corrective action plans, the committee has articulated its expectations for these plans using six guidelines:

  • The corrective action plan must identify specific causes of death.
  • The corrective action plan must provide quantitative data.
  • The assessment must identify reasonable causes of the low one-year survival rate.
  • The corrective action plan must address the identified causes.
  • There must be a measurable outcome improvement.
  • The program must provide updates on corrective actions at the time of inspection, at the time of annual reporting, or as otherwise directed by the committee.

3. FACT Presents Comments at FDA Hearing

The Food and Drug Administration (FDA) hearing to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) occurred on September 12-13, 2016. Dr. Phyllis Warkentin spoke on behalf of FACT and presented the following comments to the FDA:

  • FDA should fulfill its responsibilities to protect patients in search of cellular therapies. FACT supports its parent society, the International Society for Cellular Therapy (ISCT), in its position on unproven therapies and agrees on the importance of providing adequate education for patients. Development of professional standards and voluntary accreditation can play an important role in providing a bridge from basic research to clinical application.
  • The tiered unified approach to HCT/P regulation fails to acknowledge the complexity of some tissues with multiple native functions and many cell types. It is difficult to strictly categorize complex tissues such as adipose tissue as only structural or cellular. Dr. Warkentin offered solutions for applying regulations to such tissues.
  • There appear to be some inconsistencies in the definitions and examples of homologous use that would benefit from clarification.
  • FACT suggests that the Agency expand upon its expectation for cord tissue, to include which regulations apply and when they apply, based upon the processes in place.
  • International harmonization is important to facilitate product development and world-wide availability of cell-based therapies for patients.

4. Sixth Edition NetCord-FACT Cord Blood Standards Published

NetCord and FACT published the 6th edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration and its accompanying Accreditation Manual on July 1, 2016. These Standards became effective after 90 days, and all accredited cord blood banks were required to comply with the requirements by that time.

These Standards cover 1) collection of cord blood cells, regardless of the methodology or site of collection; 2) screening, testing, and eligibility determination of the maternal and infant donor according to Applicable Law; 3) all phases of processing, cryopreservation, and storage, including quarantine, testing, and characterization of the cord blood unit; 4) making the cord blood unit available for administration, either directly or through listing with a search registry; 5) the search process for selection of specific cord blood units; 6) reservation and release of cord blood units for clinical use;  and 7) all transport or shipment of cord blood units, whether fresh or cryopreserved.

5. Draft 1st Edition Immune Effector Cell Standards Published for Public Comment

FACT published a draft of the 1st edition FACT Standards for Immune Effector Cells for inspection and public comment in July 2016. Interim standards for the 6th edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration were also proposed to include immune effector cell programs within blood and marrow transplant units. These Standards are intended to promote quality in administration of immune effector cells and will be incorporated into a voluntary FACT accreditation in this field.

The Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.

Commenters included, among others, pharmaceutical companies, the FDA, the American Society of Cell & Gene Therapy (ASGCT), and the Society for Immunotherapy of Cancer (SITC). A total of 131 comments were received, and reviewers generally expressed support for the Standards and posed worthy questions to consider.

6. CYCORD is First Cord Blood Bank in Cyprus to Earn FACT Accreditation

CYCORD Public Allogeneic Cord Blood Bank in Cyprus received internationally recognized FACT accreditation.  CYCORD, directed by Paul Costeas, PhD, is the first and only cord blood bank in Cyprus to be recognized by FACT.  The bank received accreditation on June 13, 2016, and is accredited for banking cord blood for both public and private family use.

7. Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario is First Cellular Therapy Program in Mexico to Earn FACT Accreditation

Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario in Mexico received internationally recognized FACT accreditation. Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario, directed by David Gomez-Almaguer, MD, is the first and only cellular therapy program in Mexico to be recognized by FACT.  The program received accreditation on September 6, 2016, and is accredited for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing.

8. StemCyte India Therapeutics is First Cord Blood Bank in India to Earn FACT Accreditation

StemCyte India Therapeutics Cord Blood Bank, directed by Bhavin Kapadiya, MD, is the first and only cord blood bank in India to be recognized by FACT. The bank received accreditation on December 21, 2016, and is accredited for banking cord blood for both public and private family use.

9. FACT Hosts Quality Initiatives with Parent Organizations

FACT hosted a Quality Boot Camp at the annual meeting of the American Society for Blood and Marrow Transplantation (ASBMT). The goal of the boot camp program is to strengthen quality assurance activities through pre-meeting exercises and an in-person workshop. Members of the FACT Quality Committee encouraged registrants in the months leading to the in-person workshop to review specific aspects of their quality programs. Quality experts then presented important concepts and led roundtables that allowed participants to ask questions and help each other reach their goals during the boot camp. FACT also partnered with ISCT at their regional meeting to co-host sessions in the Quality and Operations Track. Presentations focused on outcome analysis from the processing perspective and the anatomy of an audit.

10. New Webinar Collaboration Between ASHI and FACT

FACT and the American Society for Histocompatibility (ASHI) began collaborating to offer webinars on transplant immunology. Establishing best practices in transplant immunology in different parts of the world requires both deep understanding of the unique challenges that face different parts of the world, and building on the experiences of well-established labs and international histocompatibility professional societies.

11. FACT Joins Standards Coordinating Body as a Charter Member

The Advancing Standards in Regenerative Medicine Act directs the Secretary of the United States Health and Human Services Agency to establish a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The Standards Coordinating Body (SCB) includes membership of the entire cross-section of regenerative medicine stakeholders. FACT was pleased to join as a charter member, and will organize its efforts as part of a consortium of non-government stakeholders that seeks to partner with one or more government organizations and regulatory agencies to coordinate consensus standards development efforts.  More specifically, the SCB seeks to enable more efficient and successful clinical and commercial development of cellular/gene and regenerative medicine therapies through coordinating and prioritizing development of national/international standards for measurement assurance (among other objectives).