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The IQVIA Institute recently reported that there were 15,501 Illegal Online Pharmacies, or I-O-P’s, collectively selling approximately 85 million illegal prescriptions, with an estimated value of $34 billion dollars. At the time of the study, these IOP’s were actively marketing 70% (5,085) of the 7,310 legally prescribed medicines dispensed to patients in the USA.

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Antimicrobial Resistance Could Surpass Cancer as the Leading Cause of Death by 2050.

Antimicrobial Resistance is globally recognized as one of the greatest health threats of the 21st century, and yet... we hardly hear anything about it. It’s directly responsible for 1.27 million deaths in 2019 and contributing to 4.95 million deaths overall. Social distancing reduced that number to around 1.14 million in 2021, however by 2050 Antimicrobial Resistance is projected to be associated with over 8 million deaths per year2. According to the World Health Organization (WHO), by 2050 AMR could lead to more deaths than cancer.

Antimicrobial medicines are the cornerstone of modern medicine. They are used to prevent and treat infectious diseases in humans, animals, and plants, and includes antibiotics, antivirals, antifungals, and antiparasitics. Antimicrobial Resistance occurs when bacteria, viruses, fungi, and parasites develop resistance to these medicines and no longer respond to the treatment. As a result of drug resistance, antibiotics and other antimicrobial medicines become ineffective and infections become difficult or impossible to treat, increasing the risk of disease spread, severe illness, disability, and death.

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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 Insights@thekinetixgroup.com

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/