biomarkers Archives - Medical Design Sourcing

Alzheimer’s at an inflection point as drug and diagnostics breakthroughs emerge

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Alzheimer’s disease research appears to be hitting its stride, thanks to recent therapeutic advances in drug development and the emergence of biomarkers to detect the condition. “All the pieces of the puzzle of precision medicine, which is already quite common in oncology, are now in place,” said Hartmuth Kolb, vice president, neuroscience biomarkers and R&D global imaging at Johnson & Johnson Innovative Medicine.

There’s urgency to stem the tide of the disease, which not only can be heart-wrenching for patients and caregivers, but also its financial burden. The cost of caring for individuals living with Alzheimer’s or other dementias in the U.S. could hit $345 billion in 2023, according to the Alzheimer’s Association, marking a $24 billion increase over the prior year.

Aiming to stop the cascade

FDA has approved two amyloid-targeting antibodies, lecanemab and …

In data we trust: AI’s growing influence on drug development

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The journey to developing a successful drug, theoretically, may appear linear: you discover the right drug, find the suitable patient and administer it at the right time. The reality, however, often deviates from this straightforward path. Aligning these three variables remains notoriously difficult, often leading to elongated timelines strewn with failures, sometimes extending over a decade with costs often in the billion-dollar range.

In recent years, the use of AI in drug discovery and development has grown swiftly, marking a significant shift in how we understand, discover and develop new drugs. The technology promises to chip away at timelines and save the industry billions of dollars eventually. But those promises aren’t exactly new. Even before ChatGPT became popular, many drug developers were working with high-end algorithms to “try to really hone in on databases,” said Andrew…

Accelerating Alzheimer’s research: ADDF’s chief scientific officer reflects on the Lauder Foundation’s $200M gift

Beta-amyloid plaques and tau in the brain. [Image from National Institute of Aging]

The Estée Lauder family has donated $200 million to the Alzheimer’s Drug Discovery Foundation (ADDF), a nonprofit they founded in 1998 to support Alzheimer’s research. The gift is the largest ADDF has received.

“We’ve deployed about $270 million so far for about 700 programs in 19 countries of drug discovery and development over the past 25 years,” said Dr. Howard Fillit, co-founder and chief science officer of the nonprofit.

The Lauder gift will sustain ADDF’s philanthropic model for the next 10 or 15 years, Fillit said. “We want to use our donors’ money solely for the advancement of the development of new drugs for Alzheimer’s disease,” he explained. The organization ensures that every cent of each dollar donated goes towards drug research, with no deductions for administrative costs, salaries, rent…

Bioanalytical method development and validation using Quanterix’s Simoa platform

[Image courtesy of WuXi AppTec]

The accepted definition of a biomarker is a “defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.” This definition was derived from a 2016 partnership between the U.S. FDA and the National Institutes of Health (NIH). Biomarkers are not diagnostic tools—they do not assess how a patient feels, functions or survives—they are simply indicators. At present, seven categories of biomarkers provide various indications:

Monitoring: measured continuously to assess disease status. Response: demonstrating a beneficial or harmful biological response. Predictive: identifying individuals more likely to have a disease than similar individuals. Safety: measuring the presence or extent of toxicity before or after exposure to a drug. Diagnostic: confir…

Are predictive diagnostics the Doppler radar of disease?

Image courtesy of Wikipedia

What do cupcakes have to do with oncology, and more specifically, predictive diagnostics?

Before I explain, I’ll provide some context. I recently came across an image that illustrated the difference between how Doppler radar detects conditions for a Tornado Watch versus a Tornado Warning using cupcakes.1 One side of the graphic shows each of the ingredients measured in individual containers. This visual represents when you have everything you need to make a cupcake; in weather terms, the conditions are favorable for a cupcake. A cupcake watch could be declared, but no fully-baked, devourable cupcake is visible yet. On the other side of the image, once the ingredients are assembled and baked, it’s much clearer that we have an actual cupcake on our hands and, therefore, a warning would be in place. For meteorologists, this is when Doppler radar has detected a full tornado, com…