Just the FACTs 2023 Volume 3
President’s Letter
I am excited to share with you FACT’s three-year strategic plan for the years 2023-2025 in this month’s newsletter. The plan, initiated in January 2023, includes three defining objectives that are critical for the effective conduct of new and ongoing mission-driven activities within the next wave of cell therapy advancements. To accomplish these objectives and prevent increased service costs, FACT hired its first Director of Development, Meredith Lambe, to develop and implement a fundraising plan to support FACT’s mission and vision over the next three years. To that end, this newsletter also describes FACT’s fundraising activities that will take place in the coming months and years.
FACT is constantly evolving, and our strategic plan will position us to continue to successfully realize our mission of improving the quality of cellular therapies for the benefit of the patients we serve. This is indeed an exciting time for our field!
Sincerely,
Catherine M. Bollard, MD
FACT President
FACT Strategic Plan Focuses on Increasing Patient Access to Quality Cellular Therapy
FACT regularly adopts three-year strategic plans to advance its organizational mission of promoting quality for patients in the evolving field of cellular therapy. On the heels of a worldwide pandemic and in anticipation of a burgeoning list of advanced therapies, FACT’s strategic plan is intended to strengthen and streamline its infrastructure to support accredited organizations and to expand beyond core accreditation activities to serve new stakeholders that are driving development in the cell therapy industry.
View the FACT 2023-2025 Strategic Plan
The defining objectives are interdependent and critical to effectively conduct ongoing mission-driven activities. Accomplishing each of these is necessary to perform excellent standards, accreditation, and education services within the next wave of advancements in cellular therapy. The defining objectives are:
Defining Objective #1: INFRASTRUCTURE
Establish an organizational structure sufficient to meet the growing demand for FACT services.
There are new stakeholders with different needs and expectations, including additional medical specialties and the pharmaceutical and biotechnology industry. FACT will adjust its operating model in order to better serve these markets, while prioritizing the ability of health care institutions, including FACT-accredited organizations, to provide cellular therapy in the context of growing regulatory and operational requirements.
Defining Objective #2: ACCREDITATION PROCESS
Streamline the FACT accreditation process to increase efficiencies for accredited organizations, volunteer inspectors, and FACT staff.
Accredited organizations and inspectors are satisfied overall with the FACT accreditation process. Via surveys, they identified opportunities for more efficient completion of initial and renewal accreditation, improved retention of inspectors and staff, and enhanced ability to meet the growing demand in number and variety of cellular therapy programs.
Defining Objective #3: GROWTH
Implement growth opportunities to advance the FACT mission in the evolving field of cellular therapy.
There are two major areas of rapid evolution in cellular therapy: 1) new indications for cellular therapies that involve an increasing number of medical specialties and a wider variety of health care facilities and 2) a rise in regulatory approved investigational or commercially licensed cellular therapy products manufactured by biotechnology or pharmaceutical companies, or by investigators at sites distant from the intended recipient’s treatment. These additional complexities create greater risks to patient safety and product efficacy, making FACT accreditation even more important for establishing and maintaining quality programs. FACT has also been recognized as a potential contributor to solving significant challenges affecting patient access. Prioritized growth opportunities include auditing services, new program-start up, and modular accreditation.
FACT Launches Fund Development Initiatives
Recently, FACT welcomed its first Director of Development, Meredith Lambe, to develop and implement a fundraising plan to support FACT’s mission and vision by enriching FACT’s education and training program, prevent increased service costs, and expand access to patient therapies.
To oversee fundraising efforts, a Fund Development Committee was established and is led by Committee Chair Alan Balch, PhD. The committee is comprised of members of the FACT’s Board of Directors including Wanxing Cui, MD, PhD, Carlos Ramos, MD, Abba Zubair MD, PhD, Patrick Hanley PhD, Carlos Bachier, MD and Navneet Majhail, MD along with FACT Chief Executive Officer Linda Miller, FACT Chief Medical Officer Phyllis Warkentin, MD, and Meredith Lambe.
FACT will soon execute its fund development program to broaden and enhance its educational activities and expand training to more inspectors internationally. In addition, funding will aid in conducting additional accreditation workshops to provide essential information and resources to site personnel awaiting accreditation and ultimately accelerate delivery of quality therapies to the market safely and promptly.
The fund development program encompasses three initiatives. The first initiative is a Sponsorship Program that will enable companies to support FACT training and education workshops, quality boot camps, and webinars.
The second initiative is an Affiliate Program. Companies, including pharmaceutical, biotherapy, suppliers, and technology companies, will have the opportunity to join FACT as an Affiliate to receive timely information and discounts regarding education programs, receive recognition on the FACT website and newsletter, and participate in exclusive affiliate forums to share vital information related to accreditation. Sites interested in becoming accredited may also join as an Affiliate to take advantage of FACT resources at a discounted rate and have access to information about the FACT Standards and accreditation requirements.
Lastly, FACT will be applying for grant funding with corporations, private and public foundations, and government agencies to broaden the Education Program, provide resources to low-to-middle income countries lacking necessary resources to receive accreditation, and offer scholarships to site personnel and professionals interested in attending FACT workshops. FACT will also accept individual donations to support FACT’s services.
If you are interested in sponsoring an upcoming FACT educational event, please contact Meredith Lambe at meredith.lambe@factglobal.org. The 2023 summer/fall education schedule includes:
- June 23, FACT Virtual Quality Boot Camp: Apheresis Collection, Processing, and Cord Blood Banking
- August 15, Perth, Australia. FACT Accreditation Workshop and Inspector Training Course at ISCT ANZ 2023 Regional Meeting.
- August 25-26, Puebla, Mexico. FACT Accreditation Workshop and Inspector Training Course at SMTT Mexican Society Cell & Transplantation Meeting.
- September 7, Miami, Florida. FACT Cord Blood Accreditation Workshop and Cord Blood Inspector Training Course at Cord Blood Connect Meeting.
- September 7, Houston, Texas. FACT Accreditation Workshop and Processing Inspector Training Course at ISCT North America Regional Meeting.
Thank you for your consideration to support FACT!
ICCBBA Standard for ISBT 128 Chain of Identity (CoI) Identifier Facilitates Chain of Identity
In December 2022, ICCBA published a new ISBT 128 Standard for Chain of Identity (CoI) Identifier (ST-028). This was developed based on requirements established within the Standards Coordinating Body (SCB) working group for chain of identity. The SCB working group recognized the need for a CoI Identifier when more than one donation may need to be collected to manufacture or deliver a given therapy.
The ISBT 128 CoI Identifier provides a standardized and globally unique identifier to link donations. It should be allocated before, or at the time of, collection of the first donation.
The new CoI Identifier data structure has been added to ISBT 128 Standard Technical Specification (ST-001), and the label examples were updated in ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturers (ST-018).
FACT encourages accredited organizations and industry manufacturers to consider using this new identifier. For questions or assistance, contact the ICCBBA help desk directly (support@isbt128.org).
From the Archives: FACT Encourages Adoption of New ISBT 128 Split Label for Collection for Further Manufacturing
Labeling of clinical trial and commercial cellular therapy products is of utmost importance to patient safety and desired clinical outcomes. Legible, accurate, and complete labels that maintain chain of identity have been a stalwart in cellular therapy for decades, but the permutations of labels continue. Published just a few short months ago in November 2022, this volume’s article from the archive is already worth mentioning again given many questions related to ISBT 128 coding and labeling standards.
To reiterate, FACT is supportive of the use of ISBT 128 Standard Labeling of Collection Products for Further Manufacture (ICCBBA ST-018). To maintain compliance with FACT Standards while using these labels, accredited organizations will need to upgrade their ISBT 128 software, revalidate the labeling system, and update their policies and procedures. As stated in the article, we recognize that this requires significant effort but believe it is an investment that will realize long-term savings in patient safety and process efficiencies.
FACT is planning a webinar to share additional information regarding this new labeling standard and will announce further details soon. In the meantime, do not hesitate to contact FACT with any questions regarding the use of the labeling standard in compliance with FACT Standards.
FACT Encourages Adoption of New ISBT 128 Split Label for Collection for Further Manufacturing
(Modified from original publication in November 2022)
Industry, ICCBBA, and FACT hear the calls from apheresis collection facilities to reduce variations in requirements for cellular starting material collection from different companies. One of the most obvious instances of variation that impact patient safety is labeling of the collected cells.
FACT requires full implementation of ISBT 128 coding and labeling. FACT also encourages accredited organizations to participate in clinical trials and provide advanced cellular therapies to their patients. Labels for clinical trial and commercial products are developed by the manufacturer (i.e., the clinical trial sponsor or the commercial manufacturer) and approved by the regulatory authority. Because compliance with Applicable Law is also required, accredited organizations must often use labels outside of ISBT 128. The risks are evident, and near-misses have been reported. Handwritten information, ambiguous identifiers, and variations in processes create risks of product mix-ups and incorrect product information.
Since 2020, FACT has been promoting the work of ICCBBA to develop an ISBT 128 label that will reduce manual transcription errors and promote chain of identity for cells that are collected for further manufacturing by an external entity. Furthermore, the use of ISBT 128 for these collections allows the use of processes, labels, equipment, and software compatible with those already in use for other types of cellular therapy products collected by apheresis facilities.
Following two rounds of public comment, ISBT 128 Standard Labeling of Collection Products for Further Manufacture (ICCBBA ST-018) was published in November 2020. This document is a supplement to the ISBT 128 Standard Technical Specification (ST001) and defines the labeling requirements for cellular therapy apheresis collection products for further processing by a clinical trials sponsor or a manufacturer. The Standard is for use in situations where the sponsor or manufacturer has adopted this Standard and has provided the necessary information to populate the relevant section of the label.
This new ISBT 128 label format, often referred to as a “split label” format, includes all information required by existing ISBT 128 requirements on the left side, and allows manufacturer-specific information on the right side. This format strikes an appropriate balance between internationally standardized information, in both eye- and machine-readable format, and the information individual companies require to maintain chain of identity and regulatory compliance.
The split ISBT 128 label for collected products for further manufacture meets FACT Standards. In fact, FACT prefers use of this label for these situations and is appreciative of the support industry has contributed to adapting their processes and regulatory filings to accommodate it. Companies seeking to adopt this standard acknowledge ISBT 128’s role in patient safety and efficiency in the cellular therapy product supply chain.
We recognize that this new ISBT 128 label format was published during the COVID pandemic, a time of high demand and workforce shortages for our accredited facilities who are still feeling the impacts. Although adopting this change will require additional effort, the long-term savings in patient safety and process efficiencies will pay off. FACT-accredited apheresis collection facilities are encouraged to review this Standard, work with their ISBT 128 vendors and Be the Match regarding implementation and validation, and inquire with clinical trial sponsors and manufacturers about their intentions for adopting it.
Upcoming FACT Educational Events
FACT Quality Boot Camp focused on quality principles for Apheresis Collection, Processing, and Cord Blood Banking
Virtual, June 23, 2023
9:00 am – 6:00 pm CT
FACT Clinical, Collection, Processing, & Cord Blood Banking Inspector Training Course
Perth, Australia, August 15, 2023
8:00 am – 5:00 pm AWST
FACT Accreditation and Quality Principles Workshop
Perth, Australia, August 15, 2023
8:00 am – 5:00 pm AWST
FACT Processing Inspector Training Course
Houston, TX, September 7, 2023
8:00 am – 5:00 pm CT
