Letter from the President
In a time of turbulence and change, it is more true than ever that knowledge is power. – John F. Kennedy
Change is all around us. It can be as natural as the falling leaves making way for falling snow, or the emergence of blossoms making way for the summer sun for those of us far enough from the equator. It can be as disruptive as a worldwide pandemic as we have all recently experienced. The changes in cellular therapy are a combination of both – the natural progression of science that builds upon past advances in medicine and the disruptive paradigm shifts that require us to do things differently. In this newsletter volume, we aim to clarify a couple of topics that are both natural and disruptive extensions of the work we do.
One is labeling. As cellular therapy products are collected for more uses and produced by a growing field of manufacturing sources, we must be able to adapt how these products are labeled. FACT requires full implementation of ISBT 128 coding and labeling, and the new “split ISBT 128 label” format developed for the “collection for further manufacturing” is also in compliance with FACT Standards. We, therefore, provide assurances that facilities may adopt the use of this label at the request of industry manufacturers and information on how to obtain assistance with the validation process.
Another topic relates to the use of CIBMTR’s Transplant Center-Specific Survival Report to evaluate clinical outcomes for U.S. allogeneic programs. This report is the most objective measure available of one-year survival rates. Its algorithm is transparent and vetted, and it is a resource for transplant Programs, and the field, to improve patient outcomes. We pulled an old article “from the archives” to explain more about this report and how it can be of use to Programs.
We understand that these topics focused on labeling formats and survival scoring for a complex therapy bring about change which may sometimes seem daunting. We hope these clarifications will equip readers with new knowledge that embraces advancements intended to ultimately improve the safety and quality of cellular therapy.
Catherine M. Bollard, MD
Letter from the President
After decades of discovering new therapies, improving quality, and increasing patient access, the FACT community of accredited organizations and expert inspectors has much wisdom to share. Fortunately, several opportunities exist for us to provide advice and direct the future of cellular therapy. It is our responsibility to take advantage of those opportunities.
Over the past several years, FACT has submitted numerous comments to regulatory agencies, participated in multistakeholder groups, and has built relationships with industry. We can therefore assure you that your input is incredibly valued. We also know that our field is one in which we all are open to new ideas for the sake of advancing cellular therapies for the patients. Our unwavering commitment, though, is to safety and quality. To that end, I encourage you to please continue to provide feedback (especially when requested!) and advocate for the importance of accreditation. In this newsletter, we have included several announcements that include requests for comments from the United States Food and Drug Administration (FDA) and the Standards Coordinating Body, as well as updates from the FACT Professional Relations Committee.
Finally, to highlight FACT’s goal to recognize the value of communicating and sharing the knowledge from our accredited organizations and inspectorate within our own network, we are inviting guest authors to contribute to our “Just the FACTs” newsletter. I therefore encourage you to read the piece written by Eunice Kim and Heather Steinmetz on “Qualification and Validation” that is adapted from a well-received presentation from a previous FACT event. If you would like to submit an article or article topic for consideration for inclusion in the newsletter please do not hesitate to reach out to: email@example.com. Once again, I want to thank you for all you do to enhance the cell therapy field to ultimately improve outcomes for the patients we serve!
Catherine Bollard, MD
Letter from the President
In this month’s newsletter, there are updates regarding Standards from a variety of organizations, including ICCBBA, the United States Food and Drug Administration (FDA), and, of course, FACT. We work diligently to remain aware of and participate in public comment periods to advocate for the benefit of our accredited organizations and partners. I encourage all of you to also submit requested feedback whether as an individual, as part of your healthcare institution, or within your professional activities. The very nature of the FACT community is peer review and input, and it is important to apply this same principle to external organizations whose activities have an impact on our daily work caring for patients.
I also extend my congratulations to King Abdulaziz Medical City – Riyadh, Saudi Arabia for earning FACT accreditation! This is the first cellular therapy accreditation awarded by FACT in Saudi Arabia, and we commend the program for its dedication to achieving this confirmation of quality. FACT continues to offer its support globally to encourage accreditation and quality cellular therapy programs for patients everywhere.
Catherine Bollard, MD
Letter from the President
“It was great to see you!” After two long years of only virtual connection, we finally were able to say this again. FACT had a wonderful time over the past few weeks seeing colleagues in person at the annual meetings of various professional societies including ISCT and the Tandem Meetings with ASTCT and CIBMTR. In some ways, it was like no time has passed, and in other ways, it was like reuniting with long-lost friends. Our popular and interactive workshops returned to their hands-on format, the quality boot camp resumed their group-based learning, and we are thrilled to have had the opportunity to train many new inspectors. I personally would like to give you a heartfelt, “Welcome to the team!”
A major theme of this newsletter is highlighting the participation of FACT members in the public review and comment periods of multiple draft publications. Calling on the expertise within several FACT committees, we have submitted comments to numerous requests from related organizations and governmental agencies as highlighted in this newsletter. As a Standards setting organization, FACT understands the importance of soliciting and providing critical feedback for the development of appropriate, relevant, and useful guidelines; therefore, we encourage your participation in this important process. Thank you as always for your engagement and support!
Catherine Bollard, MD
Letter from the President
FACT ushered in 2022 with the promise of a fresh start to a new year – and a time of transformation for our organization. Importantly, we completed our transition to independent status which will ultimately facilitate FACT’s ability to grow our organization and expand our portfolio to keep up with the rapid pace of growth in the cell therapy field. To that end, we welcomed new staff along with two new Board members, hosted a multi-stakeholder event focusing on advancing new cellular therapies, and scheduled in-person educational events for the first time in two years!
So yes, the future looks very promising indeed! This success could never have been achieved without our volunteers, colleagues, and friends building a peer-to-peer organization that encourages a culture of quality and has now provided service for patients for over 25 years! It is an incredible honor to build upon the transformational vision of our founding Board members. At the end of 2021, we reflected on our major accomplishments from our 25th anniversary year and are therefore extremely pleased to share these with you, too.
Happy New Year!
Catherine Bollard, MD
The past few years have brought many dramatic changes in cellular therapy, but some things never change. FACT’s deep appreciation for collegial, peer-to-peer collaboration remains, and has been a bedrock to our organization as we navigate challenges and opportunities. To that end, FACT is continuing to evolve as evidenced by the recent review and revision of our Bylaws by FACT’s Board of Directors to keep pace with the ever-expanding cell therapy field!
In this newsletter, articles do not necessarily announce “new” concepts, but reaffirm our commitment to principles we have long supported. Quality management principles, regulatory compliance, and interorganizational initiatives are here to stay at FACT. We review donor eligibility requirements for donor lymphocyte infusions, describe the Circular of Information for the Use of Cellular Therapy Products, explain outcome analysis requirements for new cellular therapy products, and renew our commitment to ISBT 128 coding and labeling. FACT continues to be a criterion for U.S. News & World Report’s Best Hospitals List, an inspiring partner for World Cord Blood Day, and supportive of related organizations’ efforts. We also want to acknowledge the election of one of our past Presidents, Dr. Helen Heslop, to the National Academy of Medicine!
We heard on many occasions how FACT accreditation has helped cellular therapy programs and cord blood banks navigate the COVID-19 pandemic and grow along with advances in the field. As we look to the future, we can feel confident in our ability to handle new developments because of our rich history of achieving FACT accreditation together.
Catherine Bollard, MD
A hallmark of a strong quality culture is the concept of continuous quality improvement. At FACT, we embrace that spirit and are always open to opportunities to improve our Standards, our inspection and accreditation processes, and the cellular therapy field as a whole. There are many examples of these types of activities within this newsletter.
We extend our sincerest appreciation to our volunteer Standards Committee members, volunteer inspectors, and accredited organizations for their tireless efforts this year. Two months ago, we published the eighth edition FACT-JACIE Hematopoietic Cellular Therapy Standards. It is always a labor of love. This edition was obviously no exception given the chaos of the past year; however, the committee did not deter from its work to revise and update our Standards. Both inspectors and accredited organizations alike explored the unknowns of virtual inspections. Not only have these inspections gone well, but we have implemented process improvements that have been discovered via the virtual inspection process.
Finally, please identify ways in which you can participate in the many efforts to harmonize industry requirements. You have the direct experience and expertise to leverage decades of lessons learned and accomplishments so that newer cellular therapies can experience the same growth and success as transplant. One such example, applying to be part of the standards working group on industry requirements for apheresis collection, is due by the end of this week.
Catherine Bollard, MD
In my first letter to the FACT community earlier this year, I explained that one of my goals is to continue FACT’s position as the lead promoter for maintaining and improving the quality of cellular therapy for the benefit of patients. The unique collaborative model established by FACT is special, and we are excited to continue advancing this model into new cell therapeutics in clinical trials and in the marketplace.
One of the first steps we are taking is to pursue independent status from FACT’s long-time home, the University of Nebraska Medical Center. This change will allow us to continue to rapidly accommodate progress in the field as we have done in years past. FACT will support the extraordinary growth in cellular therapies, indications, and stakeholders, and becoming independent is one example of our commitment to you.
It is fitting that this change will come to fruition at the time of a milestone anniversary. This newsletter highlights exciting ways we are honoring our 25-year history, including our virtual events that always receive high marks of praise and preparing to publish the eighth edition of the FACT-JACIE Standards. There are examples of accomplishments our volunteers have achieved and collegial advice our programs are always willing to share with each other.
Please join us in celebrating our 25th anniversary and the exciting opportunities ahead for FACT.
Dear Friends and Colleagues,
I am extremely excited to fully introduce myself as your new FACT President in this newsletter. It is truly an honor and privilege to serve in this capacity. For those of you who do not know me, I received my medical degree from the University of Otago, New Zealand and am Board Certified in Pediatrics and Adult/Pediatric Hematology. My background is in cell therapies for cancer and post-transplant viral infections. For the past 20 years, I have investigated the efficacy of virus and tumor specific T cells for the prophylaxis and treatment of viral infection after transplant and cancer respectively. I was formally the Director of the Pediatric Lymphoma program and the co-Director of the BMT QA Program at Texas Children’s Hospital / Baylor College of Medicine (Houston, TX). In 2013, I was recruited to head the new Program for Cell Enhancement and Technologies for Immunotherapy (CETI) and The Center for Cancer and Immunology Research at Children’s National Hospital and The George Washington University (Washington, DC).
Taking over the President role from Dr. Dennis Gastineau as 2021 begins, and at a time that cell therapy is rapidly evolving and expanding to new applications, is extremely energizing for me. Since the inception of FACT, the scope of cell therapy has extended beyond its original application in hematopoietic stem cell transplantation to embrace diverse immune cell therapies and therapies using non-hematopoietic cells in the broad area of regenerative medicine. Technological advances have placed many of these treatments in the “mainstream” or at least within a reach of generalized application. Therefore, I see it as crucial that FACT continues to establish itself as the lead promoter for maintaining and improving the quality of all cell therapies through “peer-developed standards, education and accreditation for the benefit of patients”.
Hence, my vision is to ensure that the unique collaborative model FACT has established continues to be fostered and advanced as new cell therapeutics are developed and/or reach the marketplace. It is critical to support the translational and practical aspects of cell therapy in all its facets. I am therefore excited to work with the FACT community to promote the things that FACT does best to ensure that all cell therapies are administered with the highest quality standards to maximize patient safety. Specifically, as an ISCT Past President and a former Director at Large on the ASTCT (formerly ASBMT) Board, I look forward to continuing to foster FACT’s strong ties with its parent societies as well as enhancing collaborations with other key societies such as the Cord Blood Association (CBA) and the American Society for Gene & Cell Therapy (ASGCT). Further, I see the need to strengthen and initiate partnerships with international accreditation bodies as has been achieved already with our partner JACIE. I perceive that strong collaborations with regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) will be vital in the next 5-10 years as cell therapy moves far beyond the blood and marrow (BMT) model.
In closing, I would also like to take this opportunity to profoundly thank Dennis Gastineau for his dedication and commitment to FACT over his tenure. Thank you, Dennis, for all your hard work over this time and I look forward to continuing to work with you in your Past President role!
Finally, as a New Zealander who has worked in Australasia, Europe, South Africa, and the US, I hope I can provide, as your President, a genuine international perspective. I look forward to serving FACT and working with the entire FACT community to the very best of my ability.
Inaugural Letter from FACT’s New President: Catherine M. Bollard, MBChB, MD, FRACP, FRCPA
Dear Friends and Colleagues,
I am extremely excited to introduce myself as your new FACT President. It is truly an honor and privilege to serve in this capacity. For those of you who don’t know me, I received my medical degree from the University of Otago, New Zealand and am Board Certified in Pediatrics and Adult/Pediatric Hematology. My background is in cell therapies for cancer and post transplant viral infections, and for the past 20 years I have investigated the efficacy of virus and tumor specific T cells for the prophylaxis and treatment of viral infection after transplant and cancer respectively. I was formally the Director of the Pediatric Lymphoma program and the co-Director of the BMT QA Program at Texas Children’s Hospital / Baylor College of Medicine (Houston, TX). In 2013, I was recruited to head the new Program for Cell Enhancement and Technologies for Immunotherapy (CETI) and The Center for Cancer and Immunology Research at Children’s National Hospital and The George Washington University (Washington, DC).
Taking over this role from Dennis Gastineau as 2021 begins, and at a time that cell therapy is rapidly evolving and expanding to new applications, is extremely energizing for me. I therefore look forward to outlining my 5-10 year vision for FACT in the next newsletter. I would, however, like to take this opportunity to profoundly thank Dr. Gastineau for his dedication and commitment to FACT over his tenure. Thank you, Dennis, for all your hard work over this time and I look forward to continuing to work with you in your Past President role!
Many firsts in 2020, and much to leave behind! But one “first” is the ISBT 128 labeling standard for cells collected for further manufacture. While voluntary for manufacturers, I would strongly encourage everyone to request of manufacturers that they comply with ISBT 128 labeling standards as they will contribute to the safety of our patients and to the efficiency of our laboratories, collection groups, and electronic records. If we all speak with the same voice perhaps headway will be made.
Our virtual accreditation task force continues to refine the process for virtual inspections, which we plan to begin soon. As other accrediting bodies perform virtual inspections and we all have more experience with virtual meetings, I think the overall process will not be that different. But we all look forward to the day we can do in-person inspections again, as nothing replaces the direct interactions and the ability to make new friends and acquaintances.
As we face the biggest peak yet of COVID-19 infections and the pressure at work increases, the importance of taking care of yourself away from work increases, too. Please stay safe—there is a light at the end of the tunnel – not an oncoming train, but vaccines with a level of efficacy that is truly remarkable. Happy Holidays with your friends and families!
Momentous things are happening! First, go vote if you are a US citizen, and, second, we are well into the process of initiating virtual inspections. Sharpen your voting pencils and also your quality pencils (oh, quality people don’t like pencils, so fill your ink pens) and polish off final preparations for inspections.
The process and exceptions are outlined in this newsletter. Read carefully, accredited programs and first-time applicants. We will be starting soon with a secure online process. We know this will be a lot of work for some people, and others may already have electronic systems that will facilitate the process. I know that the inspectors and programs alike will execute this as thoroughly as the in-person inspections.
Speaking of virtual meetings, our first-ever virtual applicant training meeting in September was very successful with over 160 participants from around the world and across attendant time zones. It was really a 24-hour meeting, and the questions were frequent and good—we kept the speakers busy.
It’s great to get started again, and while infections are unfortunately soaring, I think we have a way to handle this part of business again. In the meantime, wear masks at home and at work and keep each other as safe as possible.
I am really struck by the universal importance of hope in the setting of information (read truth), and I encourage you to read the article by Dina Becirovic, one of FACT’s Accreditation Coordinators. And when we think about giving our patients the best chance, Louis Pasteur is credited with “chance favors the prepared mind”—and prepare we must, for it is our preparation and systems that give complex care the best “chance” of success.
We celebrate Apheresis Awareness Day today (as I write this) and recognize World Marrow Donor Day, thanking the thousands of unselfish donors giving so others may have a better chance. Our apheresis teams are busier and busier, and donors of all kinds are needed for our ever-expanding population of transplant-eligible individuals.
Don’t forget to register and participate in our virtual workshop next week! Be sure to take advantage of the new way to network: upload a photo and information about yourself and send messages to other participants. I have a feeling we will do this more even when in-person meetings resume.
I know as another month has gone by you all have had one more month of handling the stresses of this reality. Child care challenges, two people working from home competing for the same space, internet speed, and airspace! Not to mention the irony of health-care workers furloughed during a health-care crisis, and the obvious stresses that induces. So, recognizing this, take a minute, breathe, and find an hour for yourself this week (I’d suggest more, but I have grandchildren three and under, so I know the odds of more than an hour are small). Without you the patients don’t get better. And one last request, think about and do whatever you can for everyone up and down the West Coast who have lost so much.
You have a week to get your comments in for the eighth edition FACT-JACIE Standards and the second edition IEC Standards. If you see issues, please submit your suggestions.
While many states in the U.S. still have rising COVID case numbers, others are showing clear signs of decreasing. Australia and New Zealand are working on more localized outbreaks, and, if there is anything to learn from New Zealand, it is that we are all in this together. The world is so small that everyone must do their part to care for each other.
See the article about the Professional Relations Committee on ways to help each other through these unusual times, and be sure to take advantage of all the educational events. A good way to keep everyone in your program up to the 10 hours of annual education!
As caregivers, I don’t need to tell you to take good care of everyone else, but take some time today to do two things: think of someone you haven’t spoken to in a while and make that contact; and consider one thing to be thankful for. I’ll start the second part: I’m thankful to be sitting next to my spouse of 44 years having just returned from a bicycle ride in the north woods of Wisconsin. What’s yours?
Hello colleagues—as COVID becomes a marathon with no real end in sight, and Zoom and Skype are as personal as we get (and our conference rooms are all being used for social distancing), we all look for the pace and combination of communication techniques that allow us to remain in touch with one another beyond our purely professional relationships. The silver lining has been a tendency to try harder to communicate and talk to those we have always meant to call, and I urge each one of you to choose one of your friends this week to call, FaceTime, Zoom, or any way to be in touch and reduce the isolation they might feel and in so doing reduce your own.
We mourn the passing of one of the pioneers of our discipline, Roger Herzig, who was attending on his transplant service. Dr. Herzig was loved by his patients, his program colleagues, as well as colleagues around the world. We all send condolences to his wife and family.
We invite you to a virtual workshop for inspection and accreditation, and the Education Committee is working hard optimizing the virtual experience for you. And don’t forget to look at the 8th Standards and send in your comments by the end of August.
Our community has continued to provide transplant services to patients needing them, and volumes of transplants are remaining remarkably high with all the competing demands on hospital resources—tell each other how much you appreciate the creativity and dedication continuing such complex care, I know our patients feel the same.
I’m grateful to see so many colleagues working so hard in these times, but try to give yourselves a break and a little time to reflect on what you are grateful for.
Dennis Gastineau, MD
First, may I recognize the fatigue everyone has by now, especially as we (at least in the United States and some European countries) are facing a rise in the number of COVID-19 cases again just as we try to reopen transplant services to our patients who so badly need them. Second, may we have kindness in our hearts as we strive for a just world, and the joint statement by FACT, ASTCT, CIBMTR, ISCT, and EBMT acknowledging and condemning racism is a step in that direction. As we pursue our daily activities may we see all people and situations through a new lens.
I think the ISCT meeting was very successful, even more remarkable because of the pivot from an in-person meeting to the new format in such a short time, and may be a sign of the future as we figure out how to communicate with one another, especially for people who have risk factors for complications of COVID infections.
Even as we physically distance, keep in touch with everyone, particularly family and loved ones, please wear masks (I’m preaching to the choir, but choir is one of the risky activities . . .) to protect one another.
Dennis Gastineau, MD
Hello to a changed world from the last time I wrote to you. As much as I’d like to talk about something else, everything we are doing is affected by COVID-19. You will see a lot of this newsletter deals with cancellations and delays. One silver lining from a programmatic standpoint is the six-month accreditation extension to all programs but that will fly by, I’m sure.
Practice changes are coming fast and the FACT FAQs are being updated frequently by Dr. Warkentin, please note the links for the FDA and always pay attention to the ASTCT for evolving clinical practice guidance. FACT is not determining these practice changes and there are not changes in standards as the practice evolves. The principles that the standards reflect remain the same.
Convalescent plasma is an exciting potential therapy for our patients, and I’m aware that our cell therapy teams have been integrally involved, from collecting plasma to making collection kit components in biosafety cabinets, so kudos to all who are stepping up/stepping outside their roles to help our patients.
Keep physical distancing and remember, just flattening the curve is like your parachute slowing you down, it doesn’t mean it’s time to take off your parachute at 5,000 feet, there’s still a ways to go . . . I’m sure I’m preaching to the choir, but keep your patients, your kids, your grandparents all safe while keeping yourself as safe as possible. To use one more simile, the canoe gets to its destination only if everyone paddles in the same direction. Let’s get our shared canoe through these rough waters paddling together.
Dennis Gastineau, MD