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STAT+: China competition, ‘destruction’ at FDA gives agency chance to restructure, Rick Pazdur says

CHICAGO — Rick Pazdur, the former top oncology regulator at the Food and Drug Administration, said the damage done under recent political appointees opens a chance for new leadership to fundamentally restructure the FDA, particularly as China’s drug industry grows more competitive. 

Under leaders appointed by the Trump administration, “we’ve had a lot of destruction here, and it doesn’t mean that we have to just go back and say, well, let’s rebuild it as it was,” Pazdur said Friday night at a STAT event during the annual meeting of the American Society of Clinical Oncology. “This gives us a great opportunity of — how we want to build it, what staff we want to have, how we want the administrative structure to be.”

He said the FDA has lost many valuable experts and one way to bolster the workforce is to “think creatively,” such as bringing in academics and people in the drug industry for one- or two-year terms.

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CHICAGO — Rick Pazdur, the former top oncology regulator at the Food and Drug Administration, said the damage done under recent political appointees opens a chance for new leadership to fundamentally restructure the FDA, particularly as China’s drug industry grows more competitive. 

Under leaders appointed by the Trump administration, “we’ve had a lot of destruction here, and it doesn’t mean that we have to just go back and say, well, let’s rebuild it as it was,” Pazdur said Friday night at a STAT event during the annual meeting of the American Society of Clinical Oncology. “This gives us a great opportunity of — how we want to build it, what staff we want to have, how we want the administrative structure to be.”

He said the FDA has lost many valuable experts and one way to bolster the workforce is to “think creatively,” such as bringing in academics and people in the drug industry for one- or two-year terms.

Continue to STAT+ to read the full story…

​Read More

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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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