By Mikaela VanMoorleghem, FACT Education and Training Coordinator
FACT Announces Events at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR
Cellular Therapy Inspection and Accreditation Workshop – February 18
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
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
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 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
4. Adjust computer audio to desiredvolume.
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
4. Ajuster le volume de votre ordinateur au niveau désiré.
WMDA-NetCord & FACT Events at the 2nd 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!
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.
Improve your knowledge of FACT requirements and serve as an asset in ensuring your organization meets Standards. “FACT Inspector” also looks great on curriculum vitae.
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?
Transplant Programs Encouraged to Invite Processing Facilities to Become ISCT Lab Members
FACT-Accredited Clinical Programs must use processing facilities that meet FACT Standards.
To assist in meeting operational, training, and recruitment needs, processing facilities are encouraged to become ISCT Lab Members.
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:
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.
Contact email@example.com 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
ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products
October 9, 2019
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
View meeting details and register
Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
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