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accreditation statistics

As of April 6, 2022

Cellular Therapy Entities

  • Accredited: 246
  • Applicants: 19

Cord Blood Banks

  • Accredited: 56
  • Applicants: 7

Congratulations to the following organizations for achieving their initial accreditations: South Texas Blood & Tissue Center (Collections at BioBridge Global Campus), San Antonio, Texas and University of California, Irvine (UCI), Orange, California.

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

FACT Hosts Third Regenerative Medicine InterCHANGE

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

Stakeholders are motivated – and ready – to implement practical, achievable changes to advance cellular therapy and regenerative medicine. This was a theme throughout the third Regenerative Medicine InterCHANGE, hosted by FACT virtually on January 25, 2022. The event was initially scheduled to be in Miami, Florida as part of Phacilitate’s Advanced Therapies Week, but changed to a virtual format due to the ripple effect of the increase in COVID-19 cases in the previous month.

A total of 36 attendees, representing 23 organizations and various areas of subject matter expertise, participated. Participating organizations included professional societies, health care providers, industry, information technology groups, advocacy organizations, accrediting organizations, and multistakeholder groups.

The three main objectives of the event were to:

  • Discuss regulatory requirements for the collection of starting material, applying approaches taken from currently licensed cellular therapies to anticipate and influence requirements for additional cell sources being investigated.
  • Develop a collaborative approach to educational and training programs, building and supporting a thriving workforce by leveraging the resources of academia and industry sectors.
  • Identify steps in the Investigational New Drug (IND) application, licensure, or equivalent regulatory process that could be addressed to reduce time and cost requirements in order to increase patient access to cellular therapies.

Each of these objectives were the topic of panel discussions. Panelists included a wide variety of stakeholders, whose perspectives brought fresh ideas to address challenges experienced among many different types of cellular therapy products. Audience participation was excellent, with attendees sharing ideas for many actionable solutions. A summary of the discussions and identified action items is currently being drafted.

Intermingled through the event were FACT Accreditation Success Story videos. Two videos highlighted successful multistakeholder efforts, including the ISBT 128 Standard 18 for labeling collected cells intended for further manufacture and streamlined site certification processes. The third and final video was a special message from a cellular therapy patient, shared by the Cord Blood Association, who encouraged cellular therapy professionals to continue their good work and be proud of their accomplishments.

The InterCHANGE planning committee and moderators, listed below, successfully narrowed seemingly daunting challenges into solution-driven discussions:

  • Ian McNiece, PhD: Chair, FACT Regenerative Medicine Task Force and Executive Consultant at CellMED
  • Joanne Kurtzberg, MD: Member, FACT Regenerative Medicine Task Force; President, Cord Blood Association; and Director of the Marcus Center for Cellular Cures and the Carolinas Cord Blood Bank, Duke
  • Corinne Goldberg, MD: Medical Director, Carolinas and South Carolina Region of the American Red Cross
  • David Moolten, MD: Medical Director, Penn-Jersey Region of the American Red Cross
  • Colleen Delaney, MD, MSc: Vice President, Cord Blood Association and Founder and Chief Scientific Officer of Deverra Therapeutics

We look forward to sharing the full summary with the cellular therapy field in the future. In the meantime, we would like to express a hearty thank you to the following organizations for participating in the event and for all your efforts to advance quality cellular therapy for the benefit of patients.


FACT Announces Events at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

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

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

FACT Cellular Therapy Inspection and Accreditation Workshop – February 18

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
Apply to be a FACT inspector

Cellular Therapy Leadership Course 101 at TCT Meetings – February 18

Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you hone 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 Leadership Course 101

Cellular Therapy Advanced Leadership Course 201 at TCT Meetings – February 18

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 Advanced Leadership Course 201

FACT-ASTCT Cellular Therapy Quality Boot Camp – February 19

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

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 Events at the ISCT North American Regional Meeting a Success!

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

Cellular Therapy Inspection and Accreditation Workshop

FACT workshop presenter, Dr. Jean Sanders.

FACT was excited to be a part of the ISCT North American Regional Meeting in Madison, Wisconsin. Participants joined FACT on September 12, 2019, for the FACT Cellular Therapy Accreditation and Inspection workshop.   The workshop included individuals from the United States, Canada, and Australia.

Applicants discussed the challenges complying with FACT Standards and demonstrated how to overcome them; reviewed how to perform a risk assessment, practiced the use of the 5 Whys process, and evaluated the distribution of cellular therapy products. In addition, Dr. Jean Sanders presented about quality management in novel cell therapies.

Inspector Trainees participated in a separate training track in which they engaged in activities to effectively perform an inspection. Trainees worked with the inspection checklist and prepared comments noting noncompliance with standards, evaluated SOPs for training and competency, developed a plan for pre-inspection, and appraised unexpected issues that come up during an inspection along with proposed resolutions.

Sincere thanks to all of the participants, the invited speakers, the local organizers, and ISCT for their support.

ISCT-FACT Cellular Therapy Quality Boot Camp

Assessing Risk Assessment

Therese Dodd, Vice Chair of the FACT Quality Management Committee, welcomed the attendees and began the day with a presentation on “Assessing the Effectiveness of Your Quality Plan.”  A roundtable session followed where scenarios were used to evaluate the effectiveness of the QM Plan.  Federico Rodriguez discussed how the “Five Whys” can be used when evaluating occurrences, whether detected during an audit or when the occurrence is identified.  One of the most popular presentations was “Integrating Risk Assessment into Your Quality Program” presented by Amy Beres and Jennifer Frank. The FACT Quality Management Committee acknowledged Aurora Health Care Autologous Stem Cell Transplant Program’s risk assessment process as a commendable practice.  The attendees practiced using the risk assessment tools and over half indicated that they will incorporate this process at their program.

The afternoon began with “Supply Qualification” presented by Deborah Griffin and Emily Hopewell.  A supply qualification assessment tool was provided and used during a hands-on exercise.  A third of the attendees plan to update their supply qualification process with the information provided.  Ed Brindle provided an interesting history of Document Control as it relates to the FACT-JACIE Hematopoietic Cellular Therapy Standards and how the UHN Blood and Marrow Transplant (BMT) Program is transitioning to an electronic document control system.  The final presentation focused on planning audits and writing an audit report presented by Heather Conway, FACT-ISCT Data Audit Committee member.  During the audit activity session attendees used ISBT’s Audit Tool, and discussed how the tool can be used in conjunction with FACT labeling requirements in an internal audit.  The day ended with an opportunity to “Ask FACT” about issues, processes, and/or documents with a presenter of their choice.  Thank you to the attendees and presenters for great discussions throughout the day!

 

Boot camp attendees using the ISBT 128 Audit Tool

Boot camp attendees assessing risks related to occurrences

FACT Exhibit Booth

FACT welcomed visitors to its exhibit booth at the ISCT North American Regional Meeting.  We enjoyed visiting with new and familiar faces!

 


WMDA-NetCord & FACT Events at the Second Annual Cord Blood Connect International Congress Were a Success

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

The WMDA and FACT hosted a pre-conference Cord Blood Day at the 2019 Cord Blood Connect International Congress in Miami, Florida on September 12. Over 50 members of the cord blood community from eleven countries attended. The day included topics such as trends in cord blood banking, emerging pathogens, harmonization of testing procedures between cord blood banks and cellular therapy laboratories, and cord blood selection services for transplant centers. Breakout sessions in the afternoon included a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track.

In addition to the WMDA-NetCord & FACT Cord Blood Day, FACT welcomed visitors to its exhibit booth!

 

 

 

 

 

All events were successful and FACT looks forward to the next Cord Blood Connect International Congress September 10-12, 2020, in Miami Beach!

WMDA-NetCord & FACT presenters: Robyn Rodwell, Dunia Jawdat, and Heidi Elmoazzen

FACT Chief Medical Officer Phyllis I. Warkentin and WMDA-NetCord & FACT Cord Blood Day Chair Ngaire Elwood

WMDA-NetCord & FACT presenters: Alexander Platz, Gesine Koegler, and Phillip Johnson

 


FACT Announces ISCT-FACT Quality Boot Camp at the 2019 ISCT North America Meeting – September 12

Posted in :: 2019 Volume 7 :: Monday, July 29th, 2019

Is your lab FACT accredited or looking to comply with FACT standards? Strengthen your quality management programs through this interactive workshop with FACT experts and real world applications.

Focused on issues identified by FACT compliant programs, these sessions will include activities and discussion regarding Document Control, Risk Assessment in the Processing Laboratory, Supply Qualification, and Audit Plans and Writing the Report. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution. This boot camp is applicable not only to academic labs but also relevant for commercial operations.

We encourage programs to send multiple personnel to attend the various FACT events on September 12. The ISCT-FACT Quality Boot Camp is essential for all quality and laboratory personnel. The FACT Cellular Therapy Inspection and Accreditation Workshop taking place on the same day, is a must-see for cell processing laboratory personnel, physicians, scientists and principal investigators, administrators and nurses.

View details and register now
View preliminary agenda


FACT Events at ISCT Were a Success!

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

Chrissy Gordon: A Patient Perspective

FACT was honored to have its Cellular Therapy and Cord Blood Inspection and Accreditation Workshop in Melbourne, Australia opened by Ms. Chrissy Gordon, a recipient of an unrelated bone marrow transplant in 2000. Chrissy’s inspirational story of diagnosis, treatment, transplant, challenges, and successes over the past twenty years highlighted the importance of continuing to pursue improvements in the quality of patient care and advancing the promising developments in the field of cellular therapy.  Diagnosed with leukemia in 1999 at the age of 28, Chrissy was treated in Melbourne, but her matched donor was found half way around the globe in Omaha, Nebraska where the donation was made at the University of Nebraska Medical Center.  We first met Chrissy when she and her husband Dave visited Omaha to celebrate the 70th birthday of her marrow donor, Mr. Ken Vice of Lincoln, Nebraska.

Bone marrow transplant recipient Chrissy Gordon and her husband Dave shared her transplant story during the FACT Accreditation Workshop. 

ISCT-FACT Quality Boot Camp 2019

The 2019 ISCT Annual Meeting in Melbourne kicked off during the Pre-Conference Day with a packed house at the ISCT – FACT Quality Boot Camp on Wednesday, May 29, 2019.  Patrick Hanley, PhD presented timely information on incorporating immune effector cell activities into existing quality management programs. Guy Klamer, PhD discussed the importance of document control and common issues faced by cord blood banks.  Participants were actively engaged during an interactive session with Phillip Johnson on risk management, and were presented with several case scenarios and asked to assess the risk.  With validations being an important and challenging component of every cellular therapy facility, Robyn Rodwell, PhD and Annette Tricket, PhD provided details on the validation process and examples of their organizations’ results.  FACT’s Quality Manager, Heather Conway, addressed the important subject of auditing, focusing on the minimum requirements of an audit report and the “Five Whys.” The day concluded with a hands-on exercise using the ISBT 128 Audit Tool for Cellular Therapy.  The day was a great success and we look forward to future quality boot camps discussing core quality topics valuable to your organization. If you have ideas for future quality sessions, email  your ideas to FACT@UNMC.edu.

Quality Boot Camp participants work together on an activity applying quality principles to real-world scenarios.

 


The Countdown is on to Register for FACT Events at the ISCT Annual Meeting!

Posted in :: 2019 Volume 5 :: Friday, May 17th, 2019

Register Now and Save!

FACT Accreditation Workshop
Join your fellow cellular therapy and cord blood colleagues for several FACT events at the 2019 ISCT Annual Meeting in Melbourne, Australia.  On May 28th FACT will host a Cellular Therapy and Cord Blood Inspection and Accreditation Workshop from 8:00 am to 5:00 pm.  This workshop incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy and cord blood banking. Several hot topics include quality management in novel cell therapies, written agreements, and occurrence management.  Register before May 28th and save $100!

Fees are waived for active and trainee inspectors.  Apply to volunteer and train as a FACT inspector.

ISCT-FACT Quality Boot Camp
On May 29th ISCT and FACT will host a cellular therapy Quality Boot Camp for sessions that include activities and discussions addressing the following: IECs in Your Organizations Quality Plan and Written Agreements, Document Control, Performing Risk Assessment: Real Life Applications, Process Validation 101, and Evaluating and Reporting Audit Results. Register online for the ISCT Pre-Conference Day and attend the ISCT-FACT Cellular Therapy Quality Boot Camp! Note: ISCT Pre-Conference Day registration requires separate registration from the main ISCT Annual Meeting.

FACT Exhibit Booth
FACT representatives will be at exhibit booth #36 to provide information about FACT Standards and Accreditation. We would love to see new and familiar faces!

Exhibit Booth Dates and Times:

Wednesday, May 29th: 19:30 – 21:30
Thursday, May 30th: 09:00 – 19:30
Friday, May 31st: 09:00 – 18:30

Take advantage of these exciting FACT events by registering now! We look forward to seeing you in Melbourne!

 


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.


FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session

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

FACT International Accreditation

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 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. 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. Register to attend!


FACT-ASBMT Quality Boot Camp 2019

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


The fourth annual FACT-ASBMT Quality Boot Camp, held in conjunction with the TCT | Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR, will be held on February 20, 2019.  Join the FACT Quality Management Committee and the ASBMT Administrative Directors SIG Quality group, and learn from your quality colleagues.  This year’s boot camp includes sessions on:

  • Developing a Dashboard: Program Status at a Glance
  • Performing a Risk Assessment in the Clinical Setting
  • Embracing Standardization to Create a Cohesive and Efficient System of Documentation
  • Vendor Qualification
  • Preparing for Immune Effector Cellular Therapy Accreditation
  • BMT After – Hours Call

A short self-assessment will be distributed in preparation for the boot camp to assess your needs and identify ongoing challenges.

View meeting details and register online
View the preliminary agenda


WMDA-NetCord & FACT Events at the Inaugural Cord Blood Connect International Congress Were a Success

Posted in :: 2018 Volume 4 :: Sunday, November 11th, 2018

The WMDA and FACT hosted a Cord Blood Day at the 2018 Cord Blood Connect International Congress in Miami, Florida on September 14. Over 50 members of the cord blood community from fourteen different countries attended. The day included topics such as global perspectives of cord blood transplants, ethical dilemmas in cord blood banking, common FACT-NetCord accreditation citations, and an overview of the WMDA cord blood bank survey. Breakout sessions in the afternoon included a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track.

The WMDA and FACT were honored to have Dr. Eliane Gluckman in attendance at the WMDA-NetCord & FACT Cord Blood Day. She performed the first successful human umbilical cord blood transplant and, with colleague Hal Broxmeyer, PhD, successfully showed that unrelated cord blood could be used as a source of hematopoietic stem cells. Dr. Gluckman received the first Cord Blood Association (CBA) Lifetime Achievement Award, celebrating the 30th anniversary of that event.

In addition to the WMDA-NetCord & FACT Cord Blood Day, FACT welcomed visitors to its exhibit booth and hosted the first Regenerative Medicine InterCHANGE, during which several societies working to advance regenerative medicine discussed their initiatives and current challenges in the regenerative medicine field.

All events were successful and FACT looks forward to the next Cord Blood Connect International Congress September 13-15, 2019, in Miami Beach!

Drs. Eliane Gluckman and Joanne Kurtzberg at the WMDA-NetCord & FACT Cord Blood Day

Dr. Joanne Kurtzberg and the first successful cord blood transplant recipient, Matthew Farrow, honored Dr. Gluckman with the CBA Lifetime Achievement Award.


FACT Regenerative Medicine InterCHANGE Generates Actionable Ideas

Posted in :: 2018 Volume 4 :: Saturday, November 10th, 2018

On September 17, 2018, FACT hosted a Regenerative Medicine InterCHANGE meeting in conjunction with the Cord Blood Connect congress in Miami Beach, Florida. Lessons learned from the commercialization of immune effector cells indicate that proactive change management is key to linking the needs and interests of all involved in advancing regenerative medicine. The purpose of the meeting was to create awareness and discuss challenges identified with the development, testing, and commercialization of novel cellular therapies in regenerative medicine.

The first half of the meeting was allocated to organizational introductions, during which each participating organization briefly presented information about its mission and initiatives related to regenerative medicine. Presenters mentioned several examples of collaboration with other attendee organizations, and audience members stated that the presentations enhanced their awareness and understanding of other stakeholders and their complementary objectives.

During the second half of the meeting, Dr. Ian McNiece, chair of the FACT Regenerative Medicine Task Force, moderated a discussion of challenges related to implementation of novel cellular therapies. Common themes throughout the discussion included data, standardization, accreditation, gaps in legislative policies, cost of goods and reimbursement, relationships between academia and industry, and early professional education.

The FACT Regenerative Medicine Task force will draft a summary of the meeting and distribute this document to all participating organizations for review and input. After all organizations complete this review, the summary will be distributed to stakeholders.


Submit Exemplary Quality Management Processes for FACT Quality Boot Camps

Posted in :: 2018 Volume 3 :: Thursday, August 16th, 2018

The FACT Quality Management Boot Camps are popular meetings during which quality management principles are discussed in detail. A hallmark of the quality boot camp format is its focus on tangible examples directly used by accredited cellular therapy programs and cord blood banks. FACT invites cellular therapy and cord blood professionals to submit examples of innovative and effective quality management processes. The FACT Quality Management Committee will review and select commendable practices for presentation at a future quality boot camp. This is a great opportunity to showcase your organization’s success with your peers.

Do you have a quality management-related process that has worked particularly well for your organization? Are you a FACT inspector that has been impressed with an organization’s process? If so, please submit a description of the process and example documents to Heather Conway at heather.conway@unmc.edu. Example processes include quality assessment activities, personnel training and competency, document control, procedural development, and other concepts related to quality management.

The next boot camp will take place during the WMDA-NetCord & FACT Cord Blood Day on September 14, 2018. Stay tuned for future boot camps in 2019!


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).