Just the FACTs, Volume 9
Suddenly the days are shorter than the nights and even in Arizona, the days are getting cooler. The fall Regional Meeting for ISCT was well attended, including non-HPC trial investigators, and the opportunity for networking was welcomed by our technologists. Once again the Quality Boot Camp was extremely popular, a joint effort by FACT and ISCT. It’s yet another reminder that FACT’s parent organizations are both major forces in traditional hematopoietic cell transplantation as well as non-HPC cell therapies. The next opportunity to see this is at the TCT meetings, and you will find the schedule of FACT-related activities at that meeting in this newsletter.
Unlike fall days, cell therapy is definitely NOT cooling down. Job offers abound for those with almost all of the skills that we have in the cell therapy community, from quality to processing to collection and clinical care. This means there is turnover (and some of us are even retiring after 30 or 40 years in the field), and so we need to constantly welcome new colleagues and help them with their education and the philosophy of the best for the patient and constant improvement.
Just like a good cell therapy program, FACT is constantly undergoing self-evaluation, and the board will be meeting for a tune-up of the focus of our strategic plan, as there are so many opportunities coming so quickly, that figuring out what we have the capacity to do and what new projects deserve prompt attention needs to be done more often than every five years.
In addition, we constantly look to volunteers to add to our inspector list, and you will read about Cord Blood Inspector recruitment, but no matter your expertise, FACT can probably use your time and effort, whether in cord blood, bone marrow transplant, or immune effector applications. As we look to the next decade (yes, another one goes in the books soon) we look to a myriad of cell therapy opportunities and activities. Join the ride!
Sincerely,
Dennis Gastineau, MD
FACT President
Clinical Trial Product Labeling: What is it, whose is it, and where is it going?
Programs must be confident in the identity of a clinical trial product. Programs have reported near misses due to labels on clinical trial products that use ambiguous identifiers, are handwritten illegibly, or do not link identifiers on the collected “starting material” with the final product that is returned to the program. When labeling is performed appropriately, clinical sites should be able to follow the chain of custody from collection to administration confirming exactly what the product is and the identity of donor and recipient.
What is it?
Cellular therapy products start with a collection (autologous or allogeneic), which is delivered either fresh or frozen to a manufacturing facility for processing, and then sent to the clinical site for administration to a recipient. This means there are at least three main points (but usually more) at which the identity of the product could be compromised. Unclear labeling of the product may result in undue delay or the inability to administer the product. Some manufacturers have agreed to use the ISBT 128 donation identifier (DIN), which can be assigned at collection and used throughout the manufacturing and administration processes.
Whose is it?
Cellular therapy (even in the case of many allogeneic cell therapy products) is personalized medicine. It is critical to get the right product to the right patient. Ambiguous identifiers prevent programs from linking a product to the correct patient. Many manufacturers have requested that only the study identifier be used on a product label. A study identifier is typically insufficient because 1) it is not unique to a specific product, 2) the meaning of the identifier is not typically known by personnel administering the product, and 3) various manufacturers may use similar or duplicative identifiers.
Where is it going?
In addition to knowing where a product is going, it is important to know where it has been. This is another purpose of unambiguous identifiers. Identifiers must allow collection facilities and manufacturers to proactively prevent product mix-ups and retroactively review records.
What does FACT expect?
FACT’s longstanding guidance on labeling of clinical trial products is that programs should comply with the IND as required, but FACT requirements that are not forbidden by or in conflict with the IND should be followed. Labels submitted as part of the Chemicals, Manufacturing, and Controls (CMC) section of Investigational New Drug (IND) applications or equivalent are approved by the appropriate regulatory authority (e.g., Food and Drug Administration [FDA] in the United States).
The seventh edition of the FACT-JACIE Hematopoietic Cell Therapy Standards requires full implementation of coding and labeling technologies using ISBT 128 or Eurocode. FACT believes the use of ISBT 128 is the most effective coding and labeling system that can be used for any type of cellular therapy product. Many research labels approved by regulatory authorities will not fully utilize this system.
However, the use of the donation identifier (DIN) at a minimum can be useful. The DIN is currently used on two commercially available chimeric antigen receptor (CAR) T-cell products, which demonstrates its effectiveness and feasibility as an identifier for commercial products.
It is understood that some manufacturers’ approved IND (or equivalent) labels must be used, but FACT-accredited programs are expected to use ISBT 128 to the extent possible. Accredited programs must define labeling responsibilities with commercial manufacturers and may wish to negotiate the use of ISBT 128. Programs may have different quality assurance approaches, and negotiations between a manufacturer and a program will often be site specific. However, patient identification procedures for almost any delivery of health care require two patient identifiers. In the absence of ISBT 128 coding and labeling, FACT encourages the use of at least two patient identifiers. Patient name and date of birth are acceptable identifiers for autologous products. Programs may have stricter requirements. In some cases, this may require that IND labels be supplemented with an additional identifier(s). The patient identifiers may be attached or on paperwork that closely accompanies the product.
We encourage clinical sites to work with commercial manufacturers to establish labeling procedures that will serve manufacturers’ needs while ultimately protecting the health and safety of the intended recipients of cellular therapy products.
FACT Announces Events at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR
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 Invites You to Join Us for a Webinar in Support of World Cord Blood Day
In anticipation of World Cord Blood Day, FACT invites you to attend a special Cord Blood webinar on Wednesday, November 14, 2019 at 10:00 am ET, 15:00 GMT, and 16:00 CET. The purpose of this webinar is to better understand immunogenetic diversity in registries and cord blood banks, as well as cord blood transplantation and emerging pathogens. This webinar is free of charge and will be presented in French. Slides will be available in both English and French. Topics include:
• Immunogenetic Diversity in Registries and Cord Blood Banks: Dr. Eliane Gluckman
• Cord Blood Transplantation and Emerging Pathogens: Is there reason for concern? Dr. Gilles Delage
• Personal experience from a cord blood recipient
FACT also encourages you to join the Save the Cord Foundation on November 15 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.
View meeting details and register
Register for Save the Cord’s live virtual conference
Instructions for joining the FACT Webinar on November 14:
- Log into Webinar
- Enter your name and email. Click “Join Now.”
- If requested, enter the event number: 666 195 982
- Adjust computer audio to desired volume.
French Translation
En partenariat avec les banques de sang de cordon de Liège et d’Héma-Québec, FACT vous convie à un séminaire en ligne à l’occasion de la Journée Mondiale du Sang de Cordon Ombilical.
En préparation de la Journée Mondiale du Sang de Cordon Ombilical, nous vous invitons à participer à un séminaire en ligne spécial qui aura lieu mercredi le 14 Novembre 2019 à 10:00 HNE, 15:00 GMT, and 16:00 CET. L’objectif de ce séminaire est de mieux comprendre la diversité immunogénétique dans les registres et les banques de sang de cordon, ainsi que les agents pathogènes émergents dans le cadre de transplantation. Ce séminaire est gratuit et sera présenté en Français. Les diapositives seront disponibles en français et en anglais.
Liste des sujets:
• Diversité immunogénétique dans les registres et banques de sang de cordon: Dr. Eliane Gluckman
• Transplantation de sang de cordon et pathogènes émergents: est-ce un sujet d’inquiétude? Dr. Gilles Delage
• Expérience personnelle du receveur d’une greffe de sang de cordon.
FACT vous encourage également à vous joindre à la Fondation Save the Cord le 15 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations pour le grand public ainsi que des présentations académiques par des chercheurs et des médecins transplanteurs réputés sur les récentes avancées et thérapies utilisant le sang de cordon ombilical.
Voir les détails et s’inscrire
S’inscrire à la conférence virtuelle Save the Cord
Instructions pour joindre le séminaire en ligne FACT du 14 novembre:
- Se connecter au séminaire
- Saisir votre nom et adresse email. Cliquer “Join Now.”
- si demandé, entrer le numéro de l’événement: 666 195 982
- Ajuster le volume de votre ordinateur au niveau désiré.
Is Your Processing Facility an ISCT Lab Member?
Join ISCT as a Lab Member to meet your operational, training, and recruitment needs.
ISCT, as the global steward fostering the translation of cell and gene therapies to the clinic, providing educational resources and networking opportunities has partnered with FACT on this special offer:
- Annual base fee of $500
- Receive 3 complimentary technologist memberships with a 2020 ISCT Lab Membership
REFERRAL CODE [FACTLAB]*
FACT encourages your laboratory to take advantage of this opportunity and the following benefits:
- Registered technologist access discounted member rates for ISCT-sponsored meetings and webinars – education and training aimed at providing solutions to quality, operational, and regulatory challenges in the CGT lab
- Join the members-only ISCT LPC** Forum – Laboratory Lifeline: Principles and Practice to share ideas, best practices, experiences, mentor, and problem solve – NEW!
- Stay on top of novel and innovative scientific and clinical studies with your annual subscription to Cytotherapy®, the official journal of ISCT
- Learn about timely issues and advance in the field with your subscription to the Telegraft, the members-only bi-monthly e-newsletter
- Recruit top talent through the ISCT Career Center to meet the growing demands in your lab.
There is no better time to be part of a global cell & gene therapy community focused on translation.
JOIN NOW!
Contact meagan@isctglobal.org to activate this special offer.
*Must be a FACT-accredited lab, new lab members only. Current ISCT Lab Members not eligible for this referral program. **Lab Practices Committee
FACT Events at the ISCT North American Regional Meeting a Success!
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
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
Become a FACT Cord Blood Inspector
Members of FACT-accredited cord blood banks are aware that FACT’s mission is to promote quality clinical and laboratory practice of cellular therapy and regenerative medicine. Eligible Cord Blood Bank personnel are encouraged to serve as a volunteer FACT inspector to enjoy the following value-added benefits:
Exposure to Exemplary Practices
As an inspector, you can observe how other facilities meet FACT Standards and bring home new ideas. Interaction with inspection team members also provides the opportunity to network and collaborate.
Professional Development
Improve your knowledge of FACT requirements and serve as an asset in ensuring your organization meets Standards. “FACT Inspector” also looks great on a curriculum vitae.
Influence
Inspectors have influence over FACT policies and requirements. Input from FACT inspectors are sought in the process of developing new editions of Standards.
Free Access to FACT Educational Resources
As a volunteer, you will have free access to both in-person and online educational events with an annual value of $1,840.
Information about qualifications and how to apply to become a FACT inspector can be found at www.factwebsite.org/becomeinspector. If you have any questions, please contact Mikaela VanMoorleghem or the FACT office.
Are you ready?
FACT Education Events
ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
October 9, 2019
Webinar
The second webinar in this two-part series will be on Wednesday, October 9, 2019 at 11:00 am ET. Part two includes information from Dr. Joseph Alvarnas from City of Hope. Dr. Alvarnas will give his perspective as a hospital administrator in regard to the following:
- Agreements with Manufacturers
- Reimbursement
View meeting details and register
Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar
This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, FACT Standards Development Chair, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.
View meeting details and register
FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm
We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!
FACT will conduct a Cellular Therapy Inspection & Accreditation workshop on February 18, 2019, at the World Center Marriott in Orlando, Florida. This workshop will provide an immersive experience for personnel preparing for the accreditation process and a full day training session for FACT inspector trainees.
Register for the FACT workshop
FACT Cellular Therapy Leadership Course 101 at TCT Meetings
February 18, 2020
8:00 am – 12:00 pm
Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you recognize your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.
Register for the FACT Leadership 101 course
FACT Cellular Therapy Advanced Leadership Course 201 at TCT Meetings
February 18, 2020
1:00 pm – 4:30 pm
If you completed FACT’s Cellular Therapy Leadership 101 course and want more, the 201 course is for you.
This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cellular Therapy Leadership 101 course in the morning, or if attended in a previous year, are eligible to register for the 201 course in the afternoon.
Register for the FACT Advanced Leadership 201 course
FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm
Join us for the FACT-ASBMT Quality Boot Camp at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 19 in Orlando, FL.
Focused on issues identified by FACT compliant transplant programs, sessions will include activities and discussion designed to strengthen your quality assurance processes. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution.
Register for the FACT-ASTCT Quality Boot Camp
FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 20, 2020
5:00 pm – 7:00 pm
The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, from 5:00 pm to 7:00 pm.
Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. This program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.
Register for the FACT Global Affairs session
