3D Electron Microscopy of Synapse Building

MARSHALL UNIVERSITY | August 13, 2018

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New research from a team led by Marshall University scientist W. Christopher Risher, Ph.D., reveals novel molecular insights into how multiple cell types drive the formation and maturation of brain circuits. The brain is a highly complex organ that enables us to think, remember, move and perform simple to complicated tasks. These processes require the function of circuits in the brain made up of connections between cells called neurons. Neurons contact each other at sites known as synapses.

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Premas Biotech is a specialised protein services company offering services in cloning, expression, scale up & process development, and customised assay development. We are ISO9001:2008 company and cGMP compliant. We have done over 400 proteins in past 4.5 years. We have clients across the globe. We have worked successfully on vaccine development, vaccine carrier development, established 100 transient transfected work flow in mammalian cells, in licensed technologies to deliver >1 gram/L Mabs via transient transfected.

OTHER ARTICLES

Top Pharmaceutical Firms Urge FDA to Adopt Blockchain for Drug Tracking

Article | February 25, 2020

Leading market participants in the United States pharmaceutical industry, logistics firms, distributors and other stakeholders in the pharma supply chain have come together to publish a report buttressing the need for industry players to adopt blockchain for tracking prescription drugs, following the successful completion of a DLT pilot project with the Food and Drug Administration (FDA), according to reports on February 24, 2020. Though nascent, blockchain technology, the building blocks of Bitcoin (BTC) and other cryptocurrencies are fast gaining ground across various ecosystems, due to its immutability, security, privacy, and other intricate properties. In the latest development, 25 leading manufacturers of pharmaceutical products, logistics partners and other market participants in the pharma supply chain, have published a report that highlights the importance of blockchain technology in drug traceability.

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The Future of Pharma Beyond Blockbusters

Article | March 17, 2020

We’ve all heard the saying “treat the patient, not the disease”, and this couldn’t be truer in today’s ever-changing pharmaceutical landscape. We are living in a time of revolution – advancements in genomics and technology are improving our ability to develop precise drugs and targeted therapies, rather than focusing on a one size fits all approach. Each individual’s genetic makeup is slightly different from everyone else’s,

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Coronavirus Pandemic Brings Hundreds Of U.S. Clinical Trials To A Halt

Article | April 11, 2020

Rene Roach fired off a quick email in late March for an update on a colorectal cancer clinical trial for which she hoped to qualify. Worried about the coronavirus, she asked, almost as an afterthought, whether the study had been put on hold because of the pandemic.The answer crushed her: It had been. "That's when COVID-19 shut down everything," says Roach, 50, of Germantown, Md. Roach assumed that there would be workarounds for patients like her, who have stage IV cancer. These patients often depend on clinical trials as their best chance to knock cancer out when other therapies have failed. For now, she's being treated with traditional chemotherapy, but she was counting on the drug cocktail from the clinical trial. She figures if chemo was going to rid her body of cancer for good, it would have done so already.

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New Dimensions of Clinical Trial Optimization

Article | April 20, 2021

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization. The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options? For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design. Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices. Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them. Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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Spotlight

Premas Biotech

Premas Biotech is a specialised protein services company offering services in cloning, expression, scale up & process development, and customised assay development. We are ISO9001:2008 company and cGMP compliant. We have done over 400 proteins in past 4.5 years. We have clients across the globe. We have worked successfully on vaccine development, vaccine carrier development, established 100 transient transfected work flow in mammalian cells, in licensed technologies to deliver >1 gram/L Mabs via transient transfected.

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