Sensulin’s Biotech Dream Team Is Bringing the Lowest-Cost Smart Insulin to Market by StartUp Health for HealthTransformer.co, 7 March 2024.

Sensulin’s idea to create a “smart insulin” (glucose-responsive insulin or “GRI”) is not new. Three of the company’s co-founders were toying around with the idea in the 1990s and 2000s, and the concept has existed in academia for some time. What sets Sensulin apart is their dream team of diabetes researchers and the use of an already-approved insulin as the basis for its formulation, which will help bring glucose-responsive insulin to market.

Dan Bradbury, their Chairman & Founder, was the CEO of Amylin, which developed the first GLP-1 drugs. In 2012 Amylin was acquired by AstraZeneca and BMS for $7 billion, which is still the largest exit in the diabetes sector. Chris Rhodes, PhD, their CTO, was the CEO & Founder of Drug Delivery Experts, and as a newly minted post-doc he invented the Technosphere inhalable delivery system, which is the only non-injectable insulin approved by the FDA. He also worked at Amylin as the head of drug delivery for nearly a decade. Mike Moradi, CEO & Founder, co-founded Nanosource, a nanotechnology company acquired by Dupont.

Both of Moradi’s parents are insulin dependent. Jon Brilliant, Sensulin’s CFO, also has family members impacted by the disease. His youngest child was diagnosed with Type 1 diabetes

A person with diabetes is always living between the peaks and valleys of hyperglycemia and hypoglycemia. But Senuslin helps to calm these waves through its chemical makeup that can recognize imbalances in glucose levels and respond by either bringing blood sugar levels up or down.

“Sensulin is sort of like a chemical pancreas,” says Moradi. “When blood sugar is high, it releases more insulin. When blood sugars return to normal, it releases less, much like a healthy human pancreas.” The solution is achieved by clever chemistry. Sensulin does not use chemically-modified insulin, which distinguishes it from other glucose responsive insulin. 

Read more:Sensulin’s Biotech Dream Team Is Bringing the Lowest-Cost Smart Insulin to Market  

Roche to take on Abbott, Dexcom with its first CGM by Nick Paul Taylor for MedTechDive.com, 7 March 2024. The new sensor is designed to last for 14 days but requires finger-stick calibration.

Faced with the challenge of winning market share, Roche has identified glucose prediction as a way to differentiate its CGM from the competition. Jochen Berchtold, Roche’s franchise lead for insulin therapy solutions, said, “It’s more than just one sensor that generates the data. It’s a combination of digital assets with AI-based predictive algorithms that really support people.” 

The CGM pairs with two apps: one that displays current glucose data and another that hosts the three main algorithms that are central to Roche’s pitch for the market. One algorithm predicts if the user is at risk of hypoglycemia when they go to sleep, a feature Roche sees as a way to address the nighttime anxiety that affects some people with diabetes.

Another algorithm predicts how glucose levels will change over the next two hours. That sets the device apart from Abbott and Dexcom’s apps, which show trend arrows that predict how glucose levels will change in the next 15 and 30 minutes, respectively.

Performance data added to the skepticism of analysts. Roche reported an overall mean absolute relative difference (MARD) of 9.2% with finger sticks. Dexcom G7 and Abbott’s Freestyle Libre 3 have MARDs of 8.2% and 7.8%, respectively, without finger stick calibration. 

Read more: Roche to take on Abbott, Dexcom with its first CGM

PBMs not complying with federal probe by Erica Carbajal for BeckersHospitalReview.com, 28 February 2024.

In June 2022, the Federal Trade Commission launched a probe into the business practices of pharmacy benefit managers and how they affect drug affordability and access. No PBM has fully complied with the probe, FTC Chair Lina Khan said in a recent letter, on 13 February 2024, sent to Republican Sen. Chuck Grassley, who had inquired about an update on the status of the probe. 

“Although our compulsory orders were issued in June 2022, and May and June 2023, to date no company has turned over sufficient documents and data to be in full compliance with those orders,” Ms. Khan’s letter said. “FTC staff continues to push the PBM/GPOs to finalize the production of documents and data required by the orders as quickly as possible.” 

While the FTC expects to have materials related to the probe soon, Ms. Khan noted that the agency can take PBMs to court if they fail to fully comply with the orders, which were sent to the six largest PBMs: Caremark RX, Express Scripts, Optum Rx, Humana Pharmacy Solutions, Prime Therapeutics and MedImpact Healthcare Systems. 

On Feb. 27, the National Community Pharmacists Association released survey findings indicating nearly a third of independent pharmacies are considering shutting down this year, pointing to declining reimbursements and high back-end fees from PBMs. The group is urging Congress to support PBM reform. 

Read more: PBMs not complying with federal probe

Minutia Is Using Nanosensors and Machine Learning to Bring Cell-Based Cures for Type 1 Diabetes to Market by StartUp Health, 1 March 2024.

At Minutia, CEO & Co-founder Katy Digovich is leveraging her personal journey with T1D and experience in global health innovation to develop a novel, functional cell-based cure for Type 1 diabetes. In collaboration with co-founders Matthias Hebrok, PhD — prominent diabetes researcher and Director of the Institute for Diabetes and Organoid Technology at Helmholtz Munich — and Tuan Vo-Dinh, PhD — professor of chemistry and biomedical engineering at Duke University — Minutia’s solution builds on the last decade’s breakthrough cell transplantation innovations, leapfrogging current challenges with an unconventional application of cell-based sensors and an elegant transplant procedure.

By age 21, Digovich was rounding out her college career as a Division I basketball player at Princeton and packing her bags for Sub-Saharan Africa to conduct research on HIV.  As she worked toward this goal, she came to realize that the very condition she was living with was a death sentence in many of the countries she was serving. Without access to insulin, insulin syringes, insulin pens, insulin pumps, blood sugar meters… and the high level of health literacy that diabetes often requires, people living with diabetes in the communities she served would struggle to survive or live full, productive lives.

In 2019, Digovich began to build out a strategy for T1D under the Clinton Health Access Initiative, a privately held biotechnology company by the name of Semma Therapeutics was acquired for $950 million by the American biopharmaceutical company Vertex Pharmaceuticals. Semma had made two significant scientific advances. The first is a protocol to produce large quantities of pancreatic cells, known as islets, which secrete insulin, and have been shown to restore healthy blood glucose levels when transplanted into animal models. The second is a novel device that protects those cells from the immune system, enabling durable implantation. In short, the cells had the potential to reverse diabetes by giving T1D individuals back the cells they were missing. With their Semma acquisition, Vertex aimed to lead the way in bringing a functional T1D cure to market.

Enter Matthias Hebrok, PhD, a Hurlbut-Johnson Distinguished Professor in Diabetes Research and (at that time) Director of the Diabetes Center at the University of California, San Francisco and Tuan Vo-Dinh, PhD, a Distinguished Professor of Chemistry and Biomedical Engineering at Duke University, who invented nanosensors for use in cancer diagnostics and therapeutics.  THIS is an interesting story!!!

Read more:  Minutia Is Using Nanosensors and Machine Learning to Bring Cell-Based Cures for Type 1 Diabetes to Market

A medical tech company that handles billions of records was hacked. What you should know. by Ken Alltucker for USAToday.com, 5 March 2024.

U.S. health officials urged insurance companies to take immediate steps to ease a digital logjam after a massive data hack that snarled administrative functions for hospitals, doctors, pharmacies and millions of patients. The U.S. Department of Health and Human Services asked insurers to waive prior authorizations and Medicare’s contractors to accept paper bills from doctors and hospitals. These temporary measures aim to address administrative problems that have emerged from the data hack of an influential company owned by UnitedHealth Group.

On Feb. 21, Change Healthcare, a property of UnitedHealth Group, disclosed that hackers had disrupted operations for the company that processes 15 billion health-related transactions a year. Change Healthcare operates a digital “clearinghouse” that connects doctors, hospitals and other health providers with insurance companies that pay for medical care and authorize medical services. Since news of the hack became public last month, doctors and hospitals have been unable to bill for some services and patients have had trouble picking up prescriptions.  UnitedHealth Group said a ransomware group known as ALPHV or Blackcat was responsible for the attack that disrupted billing and care authorization systems nationwide.

The cyberattack this year is by no means an anomaly.

Last year, about 1 in 3 Americans were affected by health-related data breaches. The number of attacks has surged in recent years. They are often carried out by organized hackers operating overseas who target the computer systems of health providers and the vendors and companies that serve them. Most of the largest hacks have targeted vendors who bill, mail or provide other services for hospitals, doctors and other health providers.

Read more:  A medical tech company that handles billions of records was hacked

Patient-Centered Care for Diabetes Must Integrate Psychosocial Factors by Fran Villanueve for EndocrinologyAdvisor.com, 5 March 2024.

Patient-centered care for individuals with diabetes must emphasize psychosocial factors, self-management education, telehealth visits, and the implementation of diabetes technology, according to a position statement from the Endocrine Society.

Despite the existence of evidence-based algorithms, advanced technologies, and patient-centered care tools, few guidelines address the unique experiences of patients with diabetes. This lack of standardization inhibits the optimization of therapy and improvement of health outcomes.

To develop a framework for the successful delivery of care, patient-provider communication, therapeutic recommendations, and the use of beneficial technologies, the Endocrine Society hosted a multistakeholder expert roundtable, in which delegates from professional societies and advocacy organizations discussed multiple clinical scenarios and identified tools to address gaps in diabetes management.  The Endocrine Society encouraged clinicians to address the emotional and psychosocial needs of patients with diabetes due to the higher prevalence of anxiety, depression, and other serious mental illnesses over time. These recommendations included:

• • • Performing interventions that address psychosocial conditions and their contributing factors such as disease fears, disordered eating behaviors, and environmental risk factors such as poverty and stress;
    • Asking patients and their caregivers to summarize daily routines and sharing continuous glucose monitor (CGM) or glucometer readings to better evaluate individualized needs for modification of diet, physical activity, pharmacotherapy, or integration of technology; and,
    • Educating patients about online and in-person peer support communities and referrals for mental health professionals.

Read more:  Patient-Centered Care for Diabetes Must Integrate Psychosocial Factors

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