By The Kinetix Group, Powered by Petauri
Welcome to the Petauri PACT Executive Briefing, where in 3-minutes we highlight healthcare’s critical market access issues, policies, challenges, or trends. This resource offers condensed, 3-minute
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Balancing Early Detection and Incidental Findings in Lung Cancer Screening
Lung cancer is the leading cause of cancer-related deaths globally. While the 5-year survival rate for locally advanced lung cancer is under 5%, early-stage diagnosis can elevate this rate to as high as 60%. Mortality risk factors include age, smoking history, environmental conditions, and social determinants of health.
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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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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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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.
https://tkgpact.com/executive-briefings/
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Introduction to Gene-Editing Therapy: CRISPR
CRISPR is a relatively new medical advancement that was inspired by the natural defense mechanism found in some microbes, such as bacteria. To protect themselves against invaders like viruses, these microbes capture snippets of the intruder’s DNA and store them away as segments called CRISPRs, or Clustered Regularly Interspersed Short Palindromic Repeats. If the same germ tries to attack again, those DNA segments (turned into short pieces of RNA) help an enzyme called Cas find and slice up the invader’s DNA.
In the laboratory, the CRISPR process consists of two main components: a DNA-cutting enzyme called “Cas9” modified with an added guide RNA. The guide RNA is engineered to mirror the target DNA of the gene to be edited. The guide RNA seeks for and locates, the target DNA. When the guide RNA finds an exact match, the Cas9 enzyme cuts, or modifies the target DNA.
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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Introduction to Targeted Therapies: CAR T-cell Therapy
T-cell Transfer Therapy is a special type of immunotherapy that takes a person’s own T-cells (a type of immune cell), adds specific antigens to the T-cells that can identify the cancer cells, and puts them back into the person’s body. Cancer cells express unique antigens (signaling proteins). T-cells are programmed in the lab to find those signals and deliver a cancer stopping treatment right to the individual cancer cell. There are two main types of T-cell transfer therapy: tumor-infiltrating lymphocytes (TIL) and CAR T-cell Therapy.
Targeted therapies are evolving rapidly and are increasingly more patient specific, as well as significantly more complex to manufacture and deliver. With any of these therapies, life science companies may need to thoughtfully consider strategies for addressing market access needs, patient journey issues, and the complexities of clinical care delivery protocols.
Need more information? Please email us at [email protected]
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/
Send us a text
Provider Insights on the Impact of 340B Pricing.
We frequently get asked for insights on how the 340B Drug Pricing Program may... or may not... be impacting the prescribing choices of participating covered entities. The Health Resources and Services Administration (HRSA) administers this federal program which is intended to help safety-net providers carry out their missions to serve their communities.
The Kinetix Group (TKG) recently conducted a market access research study to gain insights from healthcare providers on how the 340B program is impacting care delivery in covered entities. You can reach out to us for the full study, but a few of the highlights from our study are included in this briefing
You can download the full Executive Briefing at: https://tkgpact.com/executive-briefings/
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Today’s topic is the The Federal NOPAIN Act.
The Federal “Non-Opioids Prevent Addiction In the Nation Act” (or, the “NOPAIN Act”), Senate bill S.586, was signed into law in December 2022. It takes effect this coming January as part of the Centers for Medicare and Medicaid Services 2025 OPPS proposed rule.
The NOPAIN Act directs CMS to reimburse hospital and surgical centers separately for non-opioid, post-surgical pain control, in hopes of reducing or replacing opioid consumption. By separating, or “unbundling,” payment for non-opioid pain control, hospitals and surgical centers may receive additional reimbursement for non-opioid alternatives, encouraging the use of substitute means of pain control. This helps to ensure that non-opioid options are more widely available to individuals as a post-surgical treatment option.
You can download the full Executive Briefing at: https://tkgpact.com/executive-briefings/
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The High-Value Pharmacy Enterprise Framework.
The High-Value Pharmacy Enterprise Framework is a collection of evidence-based and expert recommended best practices designed to enhance health system pharmacy operations by ensuring safe, effective, and patient-centered medication management throughout the health-system pharmacy enterprise. It is gaining in popularity due to the many patient safety, operational, and cost efficiencies it brings to health systems that embrace the model.
The HVPE framework is built around 8 Domains of essential pharmacy practice elements that are established best practices for health-system pharmacies. The framework contains a total of 94 operational statements and 336 performance measures within these 8 domains.
You can download the full Executive Briefing at: https://tkgpact.com/executive-briefings/
Or, feel free to email us at [email protected]
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Introduction to Targeted Therapies: Monoclonal Antibodies
Targeted Therapy is the foundation of Precision Medicine. Targeted therapy is a type of personalized treatment that targets specific proteins that control how cells grow, divide, and spread.
Antibodies are produced naturally by our body and help the immune system recognize cells that cause disease, such as bacteria and viruses, and mark them for destruction. Antibodies can be engineered in the laboratory to find and attach themselves to specific targets, called antigens, found on cancer cells. They are made to recognize and bind only to a very specific antigen target.
This week's episode highlights three important terms you may be hearing: Antibody-Drug Conjugates, Monoclonal Antibodies, and Bispecific Antibodies.
You can download the full Executive Briefing at: https://tkgpact.com/executive-briefings/
Or, feel free to email us at [email protected]
The podcast currently has 61 episodes available.