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Protein Biomarkers in Practice: Strategies to Reduce Drug Development Risk

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Drug development demands scientific rigor, sustained investment, and confident decision-making under uncertainty. As programs move from early discovery into clinical development, teams must balance biological complexity, timelines, and capital allocation— often without sufficient translational insight. Selecting the wrong target or patient population can result in costly delays and increased clinical risk.

Protein biomarkers are becoming central to how pharmaceutical leaders reduce that risk and guide strategy. Unlike static genomic associations, proteins provide dynamic, functional insights into disease biology, reflecting pathway activity, target engagement, and treatment response in real-time. Advances in high-throughput proteomic technologies have transformed protein biomarkers from exploratory tools into strategic assets applied across the drug development lifecycle.

When integrated early, biomarker-driven approaches can strengthen target validation, support proof-of-mechanism studies, enable more precise patient segmentation, and provide measurable indicators of efficacy and safety. The result is more informed decision-making, improved trial design, and greater confidence as programs advance.

This eBook is designed to deliver both strategic insight and practical guidance. It opens with a White Paper informed by expert perspectives from senior translational leaders at leading pharmaceutical organizations. These experts explore how protein biomarkers mitigate risk across the drug development continuum, from early target validation to clinical trial design, by strengthening biological confidence and enhancing decision quality.

Building on these strategic insights, the eBook presents seven real-world application examples that illustrate how these approaches are implemented in practice. Together, these perspectives provide readers with actionable frameworks and concrete use cases to help reduce uncertainty, optimize patient selection, improve trial efficiency, and make more confident, data-driven decisions earlier in development.

The post Protein Biomarkers in Practice: Strategies to Reduce Drug Development Risk appeared first on GEN – Genetic Engineering and Biotechnology News.

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New webinar: Tackling drug discovery challenges in cancer research

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Cancer cells

Hosted by Drug Discovery World and supported by Sartorius and BioIVT, this webinar will explore the opportunities and challenges that exist within cancer research drug discovery and development.

You will hear from Dr Sudha Rao, Chief Scientific Officer of Kazia Therapeutics, Karol Budzik, PhD, Business Development Associate at Vyriad Therapeutics and Lars van der Veen, Chief Scientific Officer at iOnctura.

Presentations will cover how cancer treatments have shifted towards reprogramming the biology driving tumour growth, immune escape and treatment resistance, the trajectory that in vivo CAR-T treatments are taking, and how challenging tumours burdened by stroma and immune-mediated resistance can be tackled.

Q&A with the speakers follows the presentations.

Register for free now.

The post New webinar: Tackling drug discovery challenges in cancer research appeared first on Drug Discovery World (DDW).

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Psilocybin proves promising in neuropathic pain mouse study

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Amid the rise of psychedelics in the mental health space, researchers have begun to explore psilocybin as a treatment for chemotherapy-induced peripheral neuropathy.

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New Spectrometry Technique Could Aid Formulation Development

New Spectrometry Technique Could Aid Formulation Development

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A new technique combining two forms of spectrometry could help biopharmaceutical companies improve their choice of formulation buffer for antibody manufacturing by revealing how molecular forms and three-dimensional shapes of complex biologics respond to their environment. That’s the view of Christian Bleiholder, PhD, a professor at Florida State University who helped develop the technique.

According to Bleiholder, what happens structurally when a complex biological molecule, such as an antibody or viral spike protein, binds to its target is currently poorly understood.

“This is where [this approach] can help with the bioprocessing and formulation,” he says, as structural changes “can affect the lifespan [of the product] and lead to issues, such as aggregation.”

Because antibodies are complex, existing techniques tend to be powerful at different levels of complexity, he explains. Mass spectrometry is particularly powerful for distinguishing molecular composition, while structural approaches such as X-ray crystallography and cryo-electron microscopy can provide high-resolution structural information.

The challenge is understanding the link between these things within a heterogeneous sample, he says.

To overcome this, Bleiholder and his team worked with Bruker Daltonics to develop Tandem-Trapped Ion Mobility Spectrometry (Tandem-TIMS). This combines tandem ion mobility spectrometry with tandem mass spectrometry to disentangle three overlapping layers of molecular complexity: molecular form, three-dimensional shape, and binding or assembly state, he says.

He explains that, if the proteins have different structures, they can be characterized with tandem ion mobility spectrometry, and then mass spectrometry can be used to look at their molecular forms and binding states.

Going forward, Bleiholder hopes the technique can be used for formulation development but also earlier, during drug discovery of new products, such as multi-specific antibodies, to determine which molecular states are important and how those change when a biologic engages its target. He also plans to look at automating the technique.

Bleiholder spoke about using Tandem-TIMS at the Bioprocessing Summit in Boston earlier this year.

The post New Spectrometry Technique Could Aid Formulation Development appeared first on GEN – Genetic Engineering and Biotechnology News.

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