Biochemical Assay Development Using Novel MALDI High-Throughput Screening System

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Assay development was done in 384 well format using acetylcholinesterase (AChE) from electric eel and equine butyrylcholinesterase (BChE) as target enzymes. The reactions were started by adding 25 µM substrate solution and quenched by adding 1% formic acid. Each plate in the inhibition studies had inhibited controls in columns 1 and 2 containing the enzyme deactivated prior to addition of the substrate and uninhibited controls in columns 23 and 24. Tacrine hydrochloride and rivastigmine tartrate were used as the inhibitors.

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Suzhou Pharma Services

Suzhou Pharma Services, a division of Amerigen Pharmaceuticals, is a contract development and manufacturing organization focused on oral solid dose forms. With US offices located in East Brunswick, NJ and the primary manufacturing site located in Suzhou, China, we are licensed by the Chinese sFDA and the US FDA. The management team in China and the USA is comprised of highly experienced, Western trained leaders, averaging 20+ years experience with multi-national branded and generic pharmaceutical companies.

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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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WANT LESS “LIABILITY” AND MORE “RELIABILITY” FROM YOUR CLINICAL MOBILITY SOLUTION?

Article | April 20, 2021

I recently discussed the different ways that consumer-grade smartphones can compromise patients’ health, safety and overall care. However, some clinicians and healthcare administrators have indicated in recent months that they need help selecting the right enterprise-grade mobility solutions for their unique operating models and workflows. There are many different hardware and software options, and a single rugged device can come in multiple configurations. So, how do you know if you’re picking the right communication tools for your clinicians? The key is to first set performance expectations for the total mobility solution rather than the device alone.

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Do Clinical Trial Delays Mean Trouble for Pharmaceutical Stocks?

Article | April 20, 2021

Pharmaceutical stocks have been somewhat of a safe haven for investors as the coronavirus outbreak spread from China to the rest of the world. But as the pandemic deepened, now resulting in more than 782,000 cases worldwide, even these "safer" companies are beginning to feel the effects. The U.S. is now the coronavirus epicenter, with the most cases -- more than 161,000 as of today. Initial concerns for drugmakers had to do with the supply of active pharmaceutical ingredients, which often come from China. The worry was that pharmaceutical companies wouldn't be able to produce enough of their drugs for patients.

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As Pandemic Continues, Rafael Pharmaceuticals Enrolls Patients in Phase III Pancreatic Cancer Trial

Article | April 20, 2021

That simple truth about the severity of the disease is one of the reasons that Rafael Pharmaceuticals is slowly continuing with a Phase III trial in metastatic pancreatic cancer during the COVID-19 pandemic. While many companies have paused enrollment in clinical trials during the outbreak, Cranbury, N.J,-based Rafael opted to continue to enroll patients in its Phase III AVENGER 500 study of its lead compound CPI-613 (devimistat) in combination with modified Folfirinox (mFFX) as first-line therapy for the disease. Sanjeev Luther, president and chief executive officer of Rafael Pharmaceuticals, told BioSpace that the company made the decision to continue to enroll the trial, which was 75% filled, due to the short timeline patients with metastatic pancreatic cancer have. After discussing the matter of the trial with the company’s leadership team, Luther said they felt comfortable leaving the decision of whether or not the trial should continue to the conducting institute.

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Spotlight

Suzhou Pharma Services

Suzhou Pharma Services, a division of Amerigen Pharmaceuticals, is a contract development and manufacturing organization focused on oral solid dose forms. With US offices located in East Brunswick, NJ and the primary manufacturing site located in Suzhou, China, we are licensed by the Chinese sFDA and the US FDA. The management team in China and the USA is comprised of highly experienced, Western trained leaders, averaging 20+ years experience with multi-national branded and generic pharmaceutical companies.

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