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The Food and Drug Administration (FDA) hearing to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) occurred on September 12-13, 2016.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).
FACT continues to celebrate its 20th year as the leading organization in standards setting and accreditation for cellular therapy, hematopoietic stem cell transplantation, and regenerative medicine. Special events highlighted FACT’s achievements at the 2016 ISCT North America Regional Meeting.
In addition to a successful cellular therapy and cord blood inspection and accreditation workshop, FACT welcomed visitors to an active exhibit booth. Attendees wearing their commemorative FACT 20th anniversary pin received small gifts and were entered in a daily drawing. Day one’s theme was FACT Fortune Friday. Participants received a FACT fortune cookie and registered to win a Logitech Wireless Keyboard. Day two was deemed FACT Saturday School Trivia. Participants answered FACT trivia questions and registered to win an Amazon TV Fire Stick. On day 3, participants enjoyed taking selfies at the booth on Selfie Sunday, and entered to win a Microsoft Band 2 Activity Tracker. FACT thanks everyone who stopped by the exhibit booth and congratulates the lucky winners!
Logitech Wireless Keyboard: Emily Hopewell, Moffitt Cancer Center, Tampa, FL
Amazon TV Fire Stick: Melissa Colon, Moffitt Cancer Center, Tampa, FL
Microsoft Band Activity Tracker: Deborah Lamontagne, Methodist University Hospital, Memphis, TN
FACT also hosted a 20th Anniversary reception at the Peabody Memphis Hotel. Many FACT colleagues, volunteers, and friends enjoyed hors d’oeuvres and drinks 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. Click on the gallery below to view full-size photos of the celebrations.
At the 2016 BMT Tandem Meetings CIBMTR General Assembly, the founding FACT Board Members were honored with an awards ceremony.
The ceremony opened with a brief history of FACT. Outgoing FACT President, Dr. Helen Heslop, said that the process of drafting standards began in the early 1990s because it seemed likely that blood and marrow transplant laboratories were going to be subject to external accreditation. “ASBMT and ISCT were, at that time, very young professional organizations, but some prescient members of these societies recognized that it was important that transplant programs devise their own accreditation system and accredit themselves. ASBMT and ISCT served as parents for FACT, which was formed as a standard setting and accrediting organization.”
“The initial board of highly committed volunteers invested much of their own time to develop standards with the goal of improving transplant outcomes,” said Dr. Heslop. “They not only had to convince the transplant community that they wanted to be accredited, but that they were willing to pay for the process. Their success in doing this attests to their leadership skills and powers of persuasion.”
Dr. Phyllis Warkentin, founding FACT Board member and current Chief Medical Officer, summarized FACT’s accomplishments over the past two decades. “From the beginning, FACT’s success has depended upon the commitment of volunteer experts and their willingness to participate as peers to raise the quality across providers, to protect the research environment, and to advance the field. FACT has accredited over 270 organizations in 23 countries on five continents. We collaborated internationally with JACIE and NetCord to publish 6 editions of hematopoietic cell therapy standards and 5 editions of cord blood banking standards. In 2015, we published the first edition of Common Standards, applicable to all cellular therapies in all phases of discovery, research, and development.”
Dr. Warkentin continued, “FACT was founded at the University of Nebraska Medical Center. Through the efforts of many, especially Dr. Jim Armitage, this affiliation has continued, and we thank the University for being our home institution for 20 years.”
“We honor the founding members of the FACT Board of Directors, whose vision created the premiere standards and accreditation body in cellular therapy. Each of these individuals came to FACT with his or her own motivation, energy, concerns, resources, and abilities; and each left a unique mark,” said Dr. Warkentin. “The common focus, however, remains raising the quality of care for our patients. Together, these 11 founders have served a total of 123 years as FACT Board members and officers, and each has also played a major role in leading accreditation planning and success at his or her own institution.”
Founding Board members were individually recognized and received a token of appreciation from incoming FACT President Dr. Dennis Gastineau and FACT Chief Executive Officer Linda Miller:
Elizabeth Shpall, MD: Founding Board President
Richard Champlin, MD: Founding Vice President
Adrian Gee, PhD: Founding Secretary
Allen Eaves, MD, PhD, FRCPC: Founding Treasurer
C. Fred LeMaistre, MD: Founding Board Member and Past President
Nancy Collins, PhD: Founding Board Member
Richard O’Reilly, MD: Founding Board Member
Scott Rowley, MD, FACP: Founding Board Member
Keith Sullivan, MD: Founding Board Member
William Vaughan, MD, FACP: Founding Board Member
Phyllis Warkentin, MD: Founding Board Member
Dr. Warkentin also recognized ASBMT as one of FACT’s founding parent societies, and outgoing ASBMT president Effie Petersdorf accepted the honor. Additionally, Alan Leahigh, former Executive Director of ASBMT and former Chief Executive Officer of FACT, and still friend and mentor to volunteers and staff of FACT, was recognized.
Dr. Warkentin closed the ceremony by saying, “Forty people have served as members of the FACT Board of Directors. This represents a significant contribution of time and talent to FACT, to our field, and to our patients. We have been entrusted with leadership positions, but each person has a unique story, and each has a unique role to play. All of us and all of you are important in the service to our patients.”
FACT is proud to announce its 20th year as the leading organization in standards setting and accreditation for cellular therapy, hematopoietic stem cell transplantation, and regenerative medicine. In addition to a successful cellular therapy inspection and accreditation workshop, quality boot camp, and two leadership courses at the 2016 BMT Tandem meetings, FACT kicked off its 20th anniversary and celebrated with numerous special events.
Throughout the BMT Tandem Meetings, FACT welcomed visitors to a lively exhibit booth. Attendees who wore their commemorative FACT 20th anniversary pin received small gifts and were entered in a daily drawing. Day one was themed Throwback Trivia Thursday. Attendees played FACT Jeopardy and entered to win a portable smart phone charger. Day two was deemed FACT Fortune Friday. Participants received a FACT fortune cookie and registered to win an Amazon TV Fire Stick. On day 3, participants enjoyed taking selfies at the booth on Selfie Saturday, and entered to win a selfie stick of their own. On the final day of the exhibit booth, Sunday Fun Day, all attendees who visited the booth enjoyed a package of Fun Dip Candy and entered to win a Microsoft Band 2 Activity Tracker. FACT thanks everyone who stopped by the exhibit booth and congratulates the lucky winners!
Portable Smart Phone Charger: Dr. Rolla Abu-Arja, Nationwide Children’s Hospital
Amazon TV Fire Stick: Brenda Frye, Mayo Clinic Rochester
Selfie Stick: Tracey Churay, University of Michigan
Microsoft Band 2 Activity Tracker: Sandra Randall, Doernbecher Children’s Hospital
FACT also hosted a 20th Anniversary reception at the Hawaii Convention Center. Many FACT colleagues, volunteers, and friends enjoyed hors d’oeuvres and drinks as FACT celebrated two decades of working together in the BMT 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. Click on the gallery below to view full-size photos of the celebrations.
FACT will celebrate its anniversary throughout 2016 and plans to host several similar events at the ISCT North America Regional Meeting in Memphis, Tennessee. Register for the Cellular Therapy and Cord Blood Inspection and Accreditation Workshop in Memphis on September 29, 2016!