Just the FACTs, 2019 Volume 1
2019 is upon us and with it comes the promise of growth and change. As part of our own expansion and growth, we’re excited to publish the Just the FACTs newsletter on a monthly basis. We hope that you will find great value in its content. Each month we will feature educational articles, industry news, and upcoming events and activities. The Just the FACTs newsletter has become a trusted resource for our constituents and its online capabilities make it even more useful. Articles in this volume include:
- Clinical Research and Commercial Products are Both within Scope of FACT Standards
- FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
- FACT-JACIE Stepwise Accreditation Program
- Announcing New FACT Board Members
- FACT-ASBMT Quality Boot Camp 2019
- Upcoming Educational Events
I hope you find our information interesting and useful. We look forward to working with all of you in 2019!
Sincerely,
Dennis A. Gastineau, MD
FACT President
Clinical Research and Commercial Products are Both within Scope of FACT Standards
Although clinical research has been a major part of the blood and marrow transplant (BMT) field since its inception, recent developments have prompted questions regarding the scope of FACT Standards. The number of programs participating in research of new cellular therapy products beyond minimally manipulated hematopoietic progenitor cells (HPCs) is increasing. Furthermore, two immune effector cell (IEC) products are now commercial and treated as “standard of care.”
FACT Standards apply to both clinical research and standard of care cellular therapy products. If an accredited program provides both types of products, then it must comply with FACT Standards for both. There is not an option to be accredited for only one or the other.
Both cellular therapy products administered within the context of clinical research, and products administered within regulatory licensure (such as Kymriah® and Yescarta®), must comply with FACT Standards as they are applicable to the requirements. Products must be collected and processed using controlled and documented procedures; personnel must be trained and competent; recipient and donor health must be evaluated and managed; facilities, equipment, supplies, and reagents must meet specifications; and records must be created and maintained.
Both clinical research and licensed cellular therapy products must be incorporated into the program’s quality management (QM) program. As more products are administered, this is challenging due to the involvement of additional providers and companies, increasing data collection and reporting requirements, varying protocols, and more. These challenges, though, are the very reasons why a QM program can help the program! Evaluating, creating, and documenting procedures and protocols, training staff on those procedures, and maintaining a centralized mechanism to access documents and records will assist the program with maintaining control of its services.
The FACT Immune Effector Cell Task Force acknowledges these challenges and seeks to provide resources and education to assist programs experiencing the growing types of products administered. For example, see the article from a past Just the FACTs newsletter regarding reporting adverse events for commercial products and the IEC resources webpage. The task force is also hosting a webinar on January 30, 2019 to describe programs’ approaches to using nonconforming commercial products. These resources are based on real-world program experiences, and we appreciate the questions and feedback programs have provided FACT as we all learn more about these exciting new developments in cellular therapy.
David Porter, MD, Director of Cell Therapy and Transplantation at Penn Medicine (second from left), Member of FACT’s IEC Task Force, presents “CAR-T Cells: On the road to a cure” at the University of Nebraska Medical Center Hematologic Malignancies Research Meeting. With him are Julie Vose, MD, MBA, James Armitage, MD, and Phyllis Warkentin, MD.
FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
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-JACIE Stepwise Accreditation Program
A joint FACT-JACIE Stepwise Accreditation program has been developed to globally improve hematopoietic cell therapy quality, enhance safety for donors and patients, and make transplantation accessible to qualified patients. The approach consists of three incremental steps to accreditation to enable programs to focus on their quality systems first and ensure operations for patient and donor safety. The second phase builds on the established foundation to develop a complete quality management program and provide for efficacious care. The final step evaluates the effectiveness of the quality program, ensures reporting to the appropriate regulatory and accrediting agencies, and evaluates clinical outcomes.
Twelve blood and marrow transplant (BMT) centers in Latin America were identified to participate in the initial pilot program.
The first transplant center to be inspected under the FACT-JACIE Stepwise Accreditation Program has offered to share their first-hand experience with the process. While FACT’s standard policy is to not release this information prior to completion of the accreditation process, the program may elect to release results at their own choosing. It is inspiring to hear of the hard work and accomplishments of new programs embarking on their accreditation journey.
The new joint accreditation process also provides an opportunity for continuing education for both applicants and inspectors. At times, subtle differences in interpretation of FACT-JACIE Standards can occur. Professional discussion about potential interpretation is always interesting, educational, and useful to make the next edition of Standards more clear. It also points to the critical role of the Accreditation Committee in maintaining consistency in interpretation and in management of the decisions related to compliance.
The BMT Program of the Private Universitary Hospital of Córdoba in Argentina, was the first centre in Latin America to be inspected as part of a pilot group participating in the FACT-JACIE Stepwise Certification Program. Patrica Abichaín, Quality Manager, explains the preparation process and the inspection that took place on November 20-21.
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First joint FACT-JACIE Inspection in Latin America: our experience.
The “Programa de Trasplante de Médula Ósea del Hospital Privado Universitario de Córdoba, Argentina”, member of the Latin America Bone Marrow Transplantation (LABMT) cooperative group, was the first centre in Latin America to be part of the pilot group in the FACT-JACIE Stepwise Certification Program. This project is an innovative proposal for centers in this geographic and economic region to provide a pathway to achieve full accreditation through a step-by-step process.
To be selected for “The Stepwise Certification Program” meant a great challenge for us. It started in July 2017, when we sent the Application Form; a few months later, we received the documentation that should be completed, including the inspection checklist, which became our working tool during several months.
In order to move forward in this process, it was a great advantage to be a joint program (Collection Unit, Processing Unit, and Clinical Unit working together in a single location), strongly motivated by the Program´s Director, who became the leader of a working team formed by the units’ directors, representatives of the units and members of an external company of Quality Consulting. The first task was to perform an internal audit to assess our situation, design a workflow, and finally start making some changes in our way of working.
Completing the inspection checklist was really a huge effort. We spent almost 3 months working on it to achieve the first version that we submitted on March 16, 2018. Fortunately, we had support from FACT and JACIE, who helped us to understand the Standards and demonstrate evidence of compliance.
In the meantime, we began to build a “Quality Management System”. The first step was to name a Quality Manager who wrote a Quality Plan in collaboration with the units’ representatives. This group, our Quality Committee, defined measurable outcomes, performed internal audits, implemented validation plans for critical processes in different areas, worked together with the institution’s Human Resources Management in creating job descriptions for keys positions, adopted both the institution’s System for Document Control (knowing with certainty the importance of this chapter in the scaffolding of a Quality Management System for both the hospital and the transplant program), and developed an Incident Reporting System encouraging personnel to know and use them; involved the institutional Bioengineering section for control and maintenance of critical equipment, as the most relevant items. To accomplish this challenge, it was extremely useful to have access to the FACT Quality Handbook, the JACIE Quality Management Guide, and documents kindly provided by generous centers from Europe and the United States.
In each unit, Standard Operating Procedures (SOPs) were written, discussed, reviewed and implemented. All of them are first version and we will update them in the near future adopting guidance provided by JACIE and FACT inspectors. Besides writing SOPs, we tried to re-organize the activities with regards to human resources, facilities and equipment. We also introduced simple statistical tools in order to follow-up on our measurable outcomes.
During this time, we reviewed and updated the checklist to find the best evidence for each standard. Closer to the inspection date, we multiplied our efforts to be on time!
The onsite inspection took place on November 20–21, 2018 and was performed by a team of four international inspectors (United States, Spain and Norway) from FACT and JACIE. The inspection was performed in a rigorous and friendly way. To note, this was the first time that inspectors of both accreditation organizations worked together on a joint inspection. We could appreciate subtle differences in the interpretation of some standards, which, in turn, enriched the inspection experience in our opinion. Additionally, we took advantage of the exchange of opinions among colleagues in the field of transplantation, which was very useful for us.
At the end, the closing remarks were extremely helpful; we took note of our strengths and our weaknesses, mostly in Quality Management. We are now waiting for the Inspection Report, but in the meantime, we continue working in accordance with the inspectors’ observations and non-conformities found during inspection.
In summary, this was a great experience. We learned that the most challenging thing was to achieve staff motivation and cultural change, but the inspection itself gave us strong encouragement to continue working in order to achieve the FACT-JACIE First Step Certification in the next few months.
Announcing New FACT Board Members
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.
FACT-ASBMT Quality Boot Camp 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
Upcoming Educational Events
Exceptional Release of Commercial Cellular Therapy Products
January 30, 2019
Webinar
Join FACT on January 30, 2019, at 11:00 am ET, 1600 GMT, for a webinar titled, Exceptional Release of Commercial Cellular Therapy Products. Autologous cellular therapy products can be irreplaceable, and exceptional release of nonconforming products may be necessary to the well-being of patients. FACT-accredited programs are increasingly using autologous products that are licensed by regulatory authorities, and sometimes these products do not meet specifications. In this webinar, presenters will discuss FACT requirements for exceptional release, and then share their centers’ processes for release of nonconforming commercial cellular therapy products in the United States.
Webinar presenters include:
Dr. Phyllis I. Warkentin, Chief Medical Officer of FACT
Dr. Premal Lulla, Baylor College of Medicine, Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital
Dr. Elizabeth Shpall, MD Anderson Cord Blood Bank Medical Director, MD Anderson Cellular Therapy Transplant Program Director, and co-director of the MD Anderson CARTOX program.
Dr. Phillip McCarthy, of Roswell Park Comprehensive Cancer Center – Transplant and Cellular Therapy Program for Adult Inpatient, Outpatient, and Pediatric Outpatient Programs – John R. Oishei Children’s Hospital
Validation Principles and Protocols for Cellular Therapies
February 6, 2019
Webinar
Join FACT for a webinar, Validation Principles and Protocols for Cellular Therapies, on Wednesday, February 6, 2019, at 11:00 am ET, 16:00 GMT. Dr. Tom Leemhuis, Laboratory Director at Hoxworth Blood Center University of Cincinnati Academic Health Center, will discuss the Validation Principles and Protocols for Cellular Therapies, and the FACT-JACIE Seventh Edition Standards requirements.
FACT Events at the 2019 Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR
Cellular Therapy Inspection & Accreditation Workshop
February 19, 2019
Houston, Texas
The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. Clinical programs are currently adapting to immune effector cellular therapy accreditation requirements and changes in the FACT-JACIE Seventh Edition Hematopoietic Cellular Therapy Standards. This workshop will address important topics in the cellular therapy field including:
• Overview of FACT Accreditation Processes
• Common Citations Overview
• Integration of Immune Effector Cells into Accreditation
• Using the Tracer Methodology to Assess Compliance with FACT Standards
• Risk Evaluation and Mitigation Strategies (REMS)
• How to prepare for and conduct inspections
• Data Management
• Clinical Outcomes
The workshop includes two tracks: New Inspector Training and General Sessions for active inspectors, applicants, and accredited programs. The Inspector Training track includes sessions on pre-inspection review, the ins and outs of performing an on-site inspection, how to conduct an exit interview, and how to prepare an inspection report. The General Sessions will review commonly cited deficiencies in the areas of quality management, personnel, and donor selection, evaluation, and management. This track also includes sessions on how to use the Tracer Methodology to assess compliance with FACT Standards and risk evaluation and mitigation strategies. Sessions are accompanied by exercises and group discussions to apply lecture concepts to real-world experiences.
Note: Inspector trainees are required to attend the New Inspector Training Track.
Register for the FACT workshop
Cellular Therapy Leadership Course at TCT Meetings – 101
February 20, 2019
Houston, TX
Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team.
View meeting details and register
Cellular Therapy Advanced Leadership Course at TCT Meetings – 201
February 20, 2019
Houston, TX
If you completed FACT’s Cell Therapy Leadership 101 course in a previous year and want more, the 201 course is for you.
This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.
View meeting details and register online
FACT-ASBMT Quality Boot Camp
February 20, 2019
Houston, Texas
Join us for the FACT-ASBMT Quality Boot Camp at the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 20 in Houston, TX.
This year’s boot camp will focus on core quality concepts and quality processes programs have implemented. Members of the FACT Quality Committee and the ASBMT Administrative Directors SIG Quality Working Group will distribute a self-assessment prior to the TCT Meetings to review key features of your quality program and identify ongoing challenges. Strengthen your quality assurance processes by completing the self-assessment, attending the in-person workshop, and joining the roundtable discussions.
View meeting details and register
View preliminary agenda
FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 21, 2019
Houston, TX
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.
View meeting details and register
Visit FACT at Exhibit Booth 2254!
During the 2019 TCT Meetings, FACT invites you to visit us at exhibit booth #2254! FACT staff will be available to answer your questions about standards, accreditation services, inspections, and FACT consulting.
Whether you are a new inspector or a long-time friend, please stop by and say hello. We would enjoy the opportunity to thank our committee members and inspectors in person for their hard work and dedication.
2019 TCT Exhibit Booth Hours:
Wednesday, February 20
7:00 a.m. – 2:00 p.m.
Thursday, February 21
7:00 a.m. – 2:00 p.m.
Friday, February 22
7:00 a.m. – 1:00 p.m.
Saturday, February 23
7:00 a.m. – 1:30 p.m.
QM Series 9: Auditing: Summarizing and Evaluating the Data
March 6, 2019
Webinar
This webinar will be on March 6, 2019, at 11:00 am ET. Ed Brindle MSc, MLT, BMT Quality Manager at UHN Blood and Marrow Transplant Program, will discuss writing the audit report, determining WHY the errors occurred, and assigning appropriate corrective action and preventive action. This is the second webinar in the QM Series 9: Audits.
