Petauri PACT Executive Briefings - 3-Minute Market Insights

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Melissa Childress, COO, Seidman Cancer Center - People & Process Driven Innovation

In this episode of TKG’s Healthcare Insights, we will be highlighting the findings from our Oncology Thought Leaders meeting discussion on People and Process Driven Innovations coming out of the COVID pandemic, and exploring some of these issues in a little more detail.
Melissa Childress is the Chief Operating Officer for the University Hospitals, Seidman Cancer Center, in Cleveland Ohio.
www.TKGOncology.com

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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.

https://tkgpact.com/executive-briefings/

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Genetic Testing – Managing Updates to Medical Management and Risk Profiling
Today’s guest is Danielle Bonadies, a master’s trained genetic counselor and the Director of Genetics for My Gene Counsel. Danielle co-authored a poster presentation at the annual conference of the National Society of Genetic Counselors in September. The study highlighted the explosive growth of genetic and genomic testing and tracked the number of notifications and updates to genetic medical management and risk profiling guidelines. Danielle shares how this study suggests just how much patients and providers may be struggling to keep up with all of the new information.
www.TKGOncology.com

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Advancing Patient-Centered Care – Part 1

Each summer, The Kinetix Group brings in several student interns, to explore the critical issues in healthcare, and learn alongside the TKG team. In this episode of TKG’s Healthcare Insights, we will be highlighting the findings from three of our summer intern’s research projects, focused on “Adopting Patient-Center Care.”

The team looked at patient centered care from four distinct perspectives: Health Equity and Social Determinants of Health; Digital Health Trends, including Telehealth; Population Health Management; and how the use of big data has helped to reshape patient care over the last year.

This year’s summer interns are Danielle Dror, from Tulane University, Prem Shah, from Temple University, and Ava Ritchie, from the University of Southern California. All three are students pursuing degrees in healthcare.
TKGOncology.com

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Oncology Thought Leaders Meeting Debrief – PART 3

A few weeks ago, we hosted our quarterly meeting of the Oncology Thought Leaders network, a part of TKG’s Networks of Excellence, where we discussed three critical issues in cancer center administration and care delivery. This is part 3 of a 3 Part discussion with our good friend, colleague, and Thought Leaders panel member, Ellen Feinstein.
The Kinetix Group is dedicated to advancing the Quadruple Aim and to that end, we have organized several strategic, Networks of Excellence, to provide our team with insights, directional focus, and opportunities to collaborate on specific research and operational work projects. The Oncology Thought Leaders Network is a group of 16 senior level oncology executives from across the country, who bring a multidisciplinary perspective to the critical issues facing the delivery of high quality cancer care. This group meets virtually each quarter, as well as provides ad hoc input and support for various client projects, grant funded research, informational podcasts, and answering
TKGOncology.com