FACT Standards for Immune Effector Cells
10/16/24 • 3 min
The topic for this week’s @The Kinetix Group PACT Executive Briefing is “The FACT Standards for Immune Effector Cells.” These accrediting standards were developed by the Foundation for the Accreditation of Cellular Therapy (FACT), using a consensus of experts to promote quality medical and laboratory practice across the field of immune effector cell therapy. Immune Effector Cells are cells that have been modified to effect a specific immune response, with a therapeutic intent.
Therapies made from Immune Effector Cells include genetically modified Chimeric Antigen Receptor T-cells (CAR T-cells), CAR-NK cells, and dendritic cell vaccines. This broad designation includes therapies with widely diverse manufacturing methods, therapeutic constructs, clinical indications, and safety and toxicity profiles.
In the USA, cooperative clinical trial groups require institutions entering patients on Hematopoietic Cellular Therapy (HCT) trials to have FACT accreditation. Most insurance companies require HCT programs to at least disclose FACT accreditation status as part of the application for Center of Excellence designation. As CAR-T cell products have received approvals, manufacturers have required that these products be administered in a FACT-accredited clinical program.
The focus of Immune Effector Cell Standards is the clinical unit, the collection facility responsible for starting the cellular therapy product, the cell processing and/or manufacturing facilities, and the care delivery sites for administration. These standards are as complex as the cell therapies they support and require thoughtful attention to the details as manufacturers develop their market access strategies.
Source: The Foundation for the Accreditation of Cellular Therapy (2024). FACT Standards for Immune Effector Cells Second Edition – Version 2.0; Accessed from: https://www.factglobal.org/standards/immune-effector-standards/
Need more information? As always, if you need a deeper dive into any of these topics, please don’t hesitate to reach out.
Check out @The Kinetix Group‘s growing library of TKG PACT Executive Briefings where you can listen and download the companion PDF infographics.
The topic for this week’s @The Kinetix Group PACT Executive Briefing is “The FACT Standards for Immune Effector Cells.” These accrediting standards were developed by the Foundation for the Accreditation of Cellular Therapy (FACT), using a consensus of experts to promote quality medical and laboratory practice across the field of immune effector cell therapy. Immune Effector Cells are cells that have been modified to effect a specific immune response, with a therapeutic intent.
Therapies made from Immune Effector Cells include genetically modified Chimeric Antigen Receptor T-cells (CAR T-cells), CAR-NK cells, and dendritic cell vaccines. This broad designation includes therapies with widely diverse manufacturing methods, therapeutic constructs, clinical indications, and safety and toxicity profiles.
In the USA, cooperative clinical trial groups require institutions entering patients on Hematopoietic Cellular Therapy (HCT) trials to have FACT accreditation. Most insurance companies require HCT programs to at least disclose FACT accreditation status as part of the application for Center of Excellence designation. As CAR-T cell products have received approvals, manufacturers have required that these products be administered in a FACT-accredited clinical program.
The focus of Immune Effector Cell Standards is the clinical unit, the collection facility responsible for starting the cellular therapy product, the cell processing and/or manufacturing facilities, and the care delivery sites for administration. These standards are as complex as the cell therapies they support and require thoughtful attention to the details as manufacturers develop their market access strategies.
Source: The Foundation for the Accreditation of Cellular Therapy (2024). FACT Standards for Immune Effector Cells Second Edition – Version 2.0; Accessed from: https://www.factglobal.org/standards/immune-effector-standards/
Need more information? As always, if you need a deeper dive into any of these topics, please don’t hesitate to reach out.
Check out @The Kinetix Group‘s growing library of TKG PACT Executive Briefings where you can listen and download the companion PDF infographics.
Previous Episode
Medication Adherence for Patients with Severe Mental Illness.
Medication Adherence for Patients with Severe Mental Illness.
Adherence to prescribed medication regimens improves outcomes for patients with severe mental illness, such as schizophrenia, bipolar disorders, and major depressive disorder. Psychiatric disorders are a significant public health problem: schizophrenia affects about 23 million people worldwide, bipolar disorders affect about 60 million worldwide, and major depressive disorder affects another 350 million, people worldwide. Major depressive disorder is considered by many to be the most damaging psychiatric disorder and is associated with substantial disability, morbidity, mortality, and cost.
Medication therapy is essential for the successful management of patients with serious mental illness. Medication non-adherence is highly prevalent, ranging between 63–74% in patients with schizophrenia1, about 50% in patients with bipolar disorders1, and as high as 60% in patients with major depressive disorder. About 25% of patients discontinue their medication within the first week after discharge from inpatient treatment. Further, the World Health Organization has reported that for persons with mental health issues and other, comorbid chronic diseases, medication nonadherence is 50%. Nonadherence is defined as taking less than 80% of prescribed doses, which has been validated in predicting future hospitalization rates.
Need more information? As always, if you need a deeper dive into any of these topics, please don’t hesitate to reach out.
Check out @The Kinetix Group‘s growing library of TKG PACT Executive Briefings where you can listen and download the companion PDF infographics.
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Petauri PACT Executive Briefing - New Branding!
Welcome to our updated 3-minute Executive Briefing, where we’ve rebranded our program under our new Petauri name. As you are familiar, The Kinetix Group partnered with Petauri Health, a purpose-built pharmaceutical commercialization services platform based in New York City, to expand TKG’s capabilities and enhance the resources and expertise available to our clients. Over the last 18 months, Petauri has expanded rapidly with the addition of multiple best-in-class teams bringing recognized expertise in global market access, medical affairs, patient services, and data analytics. We partner with life sciences companies to effectively engage with health systems, payers, and patients.
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