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!
Watch an interview with FACT President, Catherine Bollard, MD, here: http://www.factwebsite.org/25Anniversary/
Cheers,
Cath
FACT Inspection & Accreditation Virtual Workshop and FACT-ASTCT Quality Boot Camp Draw Record Attendance
The second month of 2021 brought success through diversity; FACT held its second virtual workshop on February 4th and first virtual boot camp on February 5th. Though the pandemic prevented the conference from taking place in Hawaii, it could not stop the cellular therapy community from catching up with dearly missed colleagues over coffee and continuing to advance their programs via e-learning. Over 300 individuals joined each of the live events, which is record attendance for both the workshop and the boot camp.
We send a huge thank you to our workshop chairs, Dr. Dennis Gastineau and Dr. Jean Sanders; our boot camp chairs, Dr. Kimberly Kasow and Therese Dodd; the FACT Education and Quality Management committees; our fabulous presenters and facilitators; and, of course, our attendees for their abundance of energy and enthusiasm.
FACT Inspection & Accreditation Virtual Workshop – February 4, 2021
The workshop day was split into morning and afternoon sessions. The morning catered to individuals new to or relatively inexperienced with FACT Accreditation. The sessions included:
- An overview of FACT Accreditation
- A review of the compliance application process
- How to prepare for an inspection
- A virtual tour of an accredited clinical program
- Common challenges clinical programs encounter & how to correct the deficiencies
- How to maintain FACT Accreditation
The afternoon was prepared with more advanced content for attendees that had previously attended a workshop and were more familiar with FACT Accreditation. The sessions included:
- How to prepare for a FACT virtual inspection
- A sneak peek at the Eighth Edition for Cellular Therapy Standards
- Data management
- Outcome analysis
FACT-ASTCT Quality Boot Camp – February 5, 2021
The boot camp focused on a holistic approach to the quality system by featuring core quality concepts in the presentations and interactive sessions. The boot camp showed attendees how to navigate the quality system from start to finish. The sessions included:
- What to consider for performing a feasibility needs assessment from a new IEC program perspective
- An overview of the change control process and its development for new or changing services
- How to execute the risk assessment process and plan with help from a matrix table
- Reviewing what to validate and how the validation process works
- How to establish quality indicators
- An overview of auditing in terms of what, when, and how
- Interactive discussions to reinforce the concepts of change control, risk assessment, validation, and audits
Both the workshop and the boot camp included optional sessions at lunch. The first session was an interview with the Hospital Israelita Albert Einstein about how FACT Accreditation has benefited its program during the pandemic. The second session was a speech from incoming FACT President, Catherine Bollard, about her vision for FACT as we move forward. Jeopardy was a popular segment in both conferences as participants enjoyed reinforcing concepts discussed throughout the day in a fun and interactive method.
The end of the day closed with a third optional session led by FACT IT Business Analyst, Alisa Forsythe, during which she trained accredited users on the FACT Portal.
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We look forward to FACT’s next Processing and Apheresis Accreditation and Inspection workshop and boot camp on Thursday, May 6 and Friday, May 7, 2021!
Happy 25th Anniversary to the FACT Community!
Join FACT in celebrating 25 years of working together to improve the fields of cellular therapy, cord blood banking, and regenerative medicine. Congratulations to all FACT’s volunteer inspectors, committee members, leadership, accredited organizations, staff, and supporters for making this milestone possible.
We invite readers to sign our 25th Anniversary Guest Book and leave a greeting, photo, or video. Additional celebratory events and activities will take place throughout the year.
FACT Past Presidents Dr. Helen Heslop and Dr. Elizabeth Shpall Receive Prestigious Awards
Congratulations are in order for two dedicated FACT leaders! Dr. Helen Heslop and Dr. Elizabeth Shpall presented honorary lectures at the 2021 TCT Meetings Digital Experience.
Helen Heslop, MD, past FACT President and current Chair of the FACT Immune Effector Cell Task Force, presented the Mortimer M. Bortin Lecture on Friday, February 12, 2021. Her lecture is titled, T Cell Immunotherapy via Native and Chimeric Receptors. Read Dr. Heslop’s full bio for details on her prolific research activities and contributions to several professional societies.
Elizabeth Shpall, MD, the first FACT President and current Board member, presented the E. Donnall Thomas Lecture on Friday, February 12, 2021, with her lecture titled, Cord Blood: Forerunners and New Horizons. Dr. Shpall’s full bio outlines numerous awards for her important translational work.
New Members Appointed to the FACT Board of Directors
Two new members representing FACT’s parent society the American Society for Transplantation and Cellular Therapy (ASTCT) join the FACT Board of Directors for three-year terms (2021-2023).
Navneet S Majhail MD, MBBS, MS is the Program Director of FACT-accredited Cleveland Clinic Blood and Marrow Transplant Program. Dr. Majhail served as ASTCT’s President from 2019-2020, and FACT will benefit from his continued leadership in this new capacity.
Eneida Nemecek, MD is a FACT inspector from FACT-accredited Northwest Marrow Transplant Program at Oregon Health & Science University, Legacy Good Samaritan Hospital and Medical Center and Doernbecher Children's Hospital. She has also begun serving on FACT’s Clinical Outcomes Improvement Committee.
Welcome Dr. Navneet Majhail and Dr. Eneida Nemecek!
New Chair of Standards Development Announced
The FACT Board of Directors is pleased to announce the appointment of Dr. Nicole Prokopishyn to serve as the next Chair of Standards Development beginning with the 8th Edition of Cord Blood Standards slated to kick off in Spring 2021. Dr. Prokopishyn currently serves as the Cellular Therapy Lab Director at the Alberta Blood and Marrow Transplant Program: Foothills Medical Centre, Alberta Children's Hospital, Tom Baker Cancer Centre, and Calgary Laboratory Services, and has several years of experience serving as a member of the Standards Committee.
Dr. Prokopishyn follows the dedicated leadership of Dr. Paul Eldridge, who chaired the Standards Committee during the review and updating of each set of Standards. Thank you for your valuable contributions, Dr. Eldridge!
New Editions of FACT-JACIE Hematopoietic Cell Therapy and FACT Immune Effector Cell Standards to be Published in May
The FACT-JACIE Standards Committee, led by Paul Eldridge, PhD, is completing the final review of the draft eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. FACT committee representatives are also nearing completion of the draft second edition FACT Standards for Immune Effector Cells.
FACT thanks the many participants of the public comment period for providing useful feedback on the drafts. Approximately 770 comments, submitted by 78 participants from 20 countries, enriched the Standards development process and edits have been made in response when appropriate. FACT will provide a response to comments at the time of final publication of the Standards.
The updated editions will be published by May 17, 2021. Following a 90-day transition period, the requirements will be effective on August 16, 2021. To receive announcements of the publications and direct links to the new Standards, Accreditation Manual, and associated documents, subscribe for the FACT newsletter by creating an account at www.factwebsite.org.
U.S. Food and Drug Administration Publishes Updated Donor Eligibility Information Amid COVID-19
The U.S. Food and Drug Administration (FDA) continues to provide updates regarding donor eligibility determination amid the COVID-19 pandemic. In January, it posted an announcement with information about considerations for donor eligibility and vaccines.
The FDA does not recommend testing asymptomatic donors of human cells, tissues, and cell and tissue based products (HCT/Ps), but does offer considerations for donor screening based on information known at this time. HCT/P establishments may wish to consider whether the donor in the 28 days prior to collection:
- cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection; or
- had been diagnosed with or suspected of having COVID-19 infection; or
- had a positive diagnostic test (e.g., nasopharyngeal swab) for SARS-CoV-2 but never developed symptoms.
The FDA also states that, based on information available at this time, donors who have received non-replicating, inactivated, or RNA-based COVID-19 vaccines are not precluded from donating HCT/Ps.
Read the full announcement
ICCBBA Releases Registration and Licensing Information for ISBT 128
Interest in the new ISBT 128 coding and labeling standard, Labeling of Collection Products for Cellular Therapy Manufacturing, has led to many inquiries to ICCBBA regarding registration and licensing. To assist entities with determining how the standard applies to their scope of work and the applicable fees, ICCBBA created a flyer that outlines this information. There are also step-by-step registration instructions on its website.
We are encouraged by this interest in this new standard to improve efficiency and patient safety. Further questions can be directed to the ICCBBA help desk at iccbba@iccbba.org.
Step-by-step registration instructions
SITC Publishes Guidelines on Immune Effector Cell-Related Adverse Events
The Society for Immunotherapy of Cancer (SITC) published The Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events in the Journal for ImmunoTherapy of Cancer (JITC). Developed by an expert panel, the guideline includes recommendations for risk assessment, identification, and management for clinically significant side effects associated with immune effector cells (IECs).
This guideline was created with the assistance of several organizations, including FACT. For more details about its purpose and scope, read the full press release from SITC.
Save the Date for the Upcoming FACT Workshop and Quality Boot Camp!
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