06Jun

Biomedical sensors long ago moved out of the hospital and into an assortment of recreational exercise devices monitoring heart rate, blood pressure, respiration and other vital signs.

Body sensor image - blog.jpg

Whether medical or recreational activity trackers, these sensors require some sort of carrier — think wristbands or EKG electrode patches — which limits their effectiveness and can make them uncomfortable when worn for extended periods. They can also be hard to place and often have poor signal quality.

Now, right out of science fiction, engineers at Penn State, China’s Harbin Institute of Technology and other Chinese institutions have come up with a way to print the sensors and their electronics directly on human skin.

Up to now, the only way to bond nanoparticles together to create flexible electronics was through a process requiring temperatures hotter than the hottest home oven. The new process uses common materials that allow the particles to bond at room temperature.

The resulting sensor is flexible, smooth and durable enough to remain on the skin until peeled off with hot water. The devices can then be recycled and reused.

Lead researcher, Penn State Engineering Professor Huanyu Cheng, explained that the bonding process uses polyvinyl alcohol paste — the main ingredient in peelable face masks — and calcium carbonate — the key ingredient of eggshells.

The sensors, he said, “Are capable of precisely and continuously capturing temperature, humidity, blood oxygen levels and heart performance signals.”

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Green Key
Jun 6, 2023

Rare Diseases Trial Network Moves Closer to Reality

As many as 30 million Americans may be living with a “rare disease,” officially defined as a condition affecting fewer than 200,000 people.

The Genetic and Rare Diseases Information Center says there are some 7,000 known rare diseases. Most are genetic. Only about 10% of all rare diseases have an approved treatment.

To hasten the development of drugs and therapies, the Food and Drug Administration in 2019 began an initiative to “to facilitate a cooperative approach and common standardized platforms to better characterize rare diseases, incorporate the patient’s perspective in clinical outcome assessment measures, and build clinical trial readiness in the pre-competitive space.”

Dubbed the Rare Disease Cures Accelerator, the initial focus of the program is building “an integrated database and analytics hub designed to promote the secure sharing of existing patient-level data and encourage the standardization of new data collection.”

A second key part was to award grants “develop standard core sets of clinical outcome assessments (COAs) and endpoints for specific disease indications.”

In May, the FDA asked for input from industry, rare disease organizations, patients and others regarding the “implementation and sustainment of global clinical trials networks.”

“As drug development for rare diseases can be challenging due to the small number of patients and limited understanding of the variability and progression of the diseases, the FDA is committed to developing bold new approaches to harness the infrastructure of global clinical trial networks,” said Anand Shah, FDA deputy commissioner for medical and scientific affairs.

A recent report on Regulatory Focus, the website of the Regulatory Affairs Professionals Society, said the stakeholders who commented “called for regulatory clarity, smart use of existing resources, and a move toward harmonized trial standards and assessments.”

Several comments addressed the need to ensure the quality of the data collected as well as reducing and eliminating some of the challenges unique to rare disease trials.

On behalf of the Biotechnology Innovation Organization, Danielle Friend, senior director of science and regulatory affairs, said the networks need to support “the collection of high-quality data that are endorsed by the agency for regulatory decision-making.” She said a rare disease network must recognize and address “heterogeneity in rare diseases, lack of harmonization among global regulators in rare disease regulatory policy, and current inconsistencies in clinical trial network operation.” The FDA plan also should consider combining rare diseases into a single trial when possible.

The National Organization for Rare Diseases echoed those comments, and, according to Regulatory Focus, said “Increased collaboration and a focus on increasing the speed and success of clinical trials can have the effect of ‘breaking down the silos of activity currently taking place in rare disease research.’”

Now the FDA will analyze the comments, incorporating them into a development plan for its trials networks program. No timeline was given for this phase of the program.

Photo by CDC on Unsplash

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Green Key

Director of Green Key Pharma Receives RAPS’ Community Leadership Award

Director of Green Key Pharma, Lindsey Summers, is a co-recipient of the Regulatory Affairs Professional Society (RAPS) 2021 Community Leadership Award!