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…
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How an integrated product development strategy can drive speed and innovation across biopharma

[Photo by Chokniti Khongchum on Pexels: https://www.pexels.com/photo/scientist-using-microscope-3938022/]

Biopharma companies are grasping the key role an integrated product development strategy can play in the drug development process. A recent industry survey found growing uptake of this multidisciplinary approach to improving efficiency and reducing costs and timelines, though the barriers to successful implementation were similar across the board.

The potential savings a strong integrated product development (IPD) strategy can provide biopharma companies cannot be underestimated, but the most significant challenge to its success requires a dramatic shift in culture.

One industry analysis found that IPD, when coupled with innovative research and development, had the ability to cut 500 days from a drug development cycle and 25% off the bottom line.

It’s a message being heard by a growing nu…

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Why growth for pharmaceutical companies can be dangerous

[Image courtesy of iStock]

Prosperity can be a double-edged sword for pharma companies. While there are obvious financial advantages to selling more drugs, growth phases often lead to an uptick in quality problems, said Craig Wylie, managing partner USA at Arthur D. Little. A solid plan is needed to help pharma companies keep track of their processes as they ramp up manufacturing scale.

One recent case in point is Emergent Biosolutions (NYSE:EBS). Early in the pandemic, the company inked deals to contract manufacture COVID-19 vaccines for Johnson & Johnson (NYSE:JNJ) and AstraZeneca (LON:AZN). Shareholders were enthralled with Emergent’s growth prospects. And on August 14, 2020, the company saw its share price hit a record high of $133.42.

The situation quickly changed when the company admitted that it had to dispose of millions of vaccine doses because of possible quality problems. Emergent has…

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Inside Genoskin’s quest to use human skin scraps to accelerate drug research

“How do you maintain human skin alive so that you can generate data from what would otherwise be trash?” asked Eric Merle, chief business innovation officer of Salem, Massachusetts–based Genoskin. “We work with surgical discards.”

Founded a decade ago, Genoskin collects human skins from cosmetic surgeries such as face-lifts and abdominal surgeries that would otherwise be waste to foster research on new drugs and cosmetics. 

“Many people worldwide are undergoing plastic surgery, yielding tissue,” Merle said. 

Keeping the skin preserved requires “pretty tight logistics,” Merle said. “We have the logistics of an organ transplant company.” 

The MANTIS spatial biology imaging platform for skin immunology. Image courtesy of Genoskin.

The resultant skin models preserve the characteristics of real human skin. 

The company has a variety of product types. One is HypoSkin, an alternative to …

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Insilico Medicine hooks up with Arvinas

Insilico Medicine (Hong Kong) has entered into an R&D pact with Arvinas (NSDQ:ARVN) to explore applications of Insilico’s AI technology to PROTACs.

By regulating protein function, PROTACS can optimize the sensitivity to drug-resistant targets, as an article in Signal Transduction and Targeted Therapy notes

Insilico and Arvinas will partner in designing treatment modalities for current and next-generation targets.

Founded in 2013, Arvinas is a pioneer of targeted protein degradation technology and related therapeutic applications.

Insilico Medicine was founded in 2014 to develop an AI-based platform for pharma and biotech.

“We look forward to collaborating with Arvinas in this innovative field and to building a lasting relationship,” said Alex Zhavoronkov, CEO of Insilico Medicine, in a statement.

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Scientists create first human-monkey embryo

In this monkey-human embryo, human cells glow in red. [Image courtesy of Weizhi Ji / Kunming University of Science and Technology]A group of scientists from the U.S. and China injected human stem cells into 132 macaque embryos, which then developed for up to 20 days.

While the research holds promise for organ transplants, studying disease and testing new drugs, it also prompts controversy.

Get the full story from our sister site, Drug Discovery & Development. 

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How to build a foundation for the next phase of Alzheimer’s disease research

[Photo by Tim Doerfler on Unsplash]

Alzheimer’s disease has one of the highest financial burdens. The Alzheimer’s Association estimates that the cost of the disease in the U.S. will hit $355 billion in 2021. 

“Not only is Alzheimer’s one of the most expensive, it’s probably one of the most devastating diseases of humans,” said Dr. Allan Levey, professor and chairman of the department of neurology at Emory University. 

However, only symptomatic treatments are available, doing nothing to slow or stop disease progression. “There’s not a single disease-modifying agent, and Alzheimer’s is now the sixth most common cause of death,” Levey said. 

[Related: Why Genuity and Emory are partnering on neurodegenerative disease research] 

The last FDA-approved drug for Alzheimer’s was approved in 2003. 

But there’s reason for…

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