Flow Cytometry In Drug Development Infographic

|

article image
Flow Cytometry is a critical and informative part of all phases of drug development. Knowing which assays to run at each critical stage gate, can streamline your journey to the successful development of your therapeutic.

Spotlight

Alimera Sciences

Alimera, founded in June 2003, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in aging populations. Alimera's commitment to retina specialists and their patients is manifest in its product and in its development portfolio designed to treat early- and late-stage diseases. For more information, please visit www.alimerasciences.com.

OTHER ARTICLES
VIEWS AND ANALYSIS

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.

Read More

Global Antiviral Drugs Market Growth: Is Antiviral Drug the Best Coronavirus Treatment?

Article | April 20, 2021

The global antiviral drugs market has witnessed a rapid surge in demand due to the ongoing Covid-19 pandemic worldwide. So is antiviral drug the best coronavirus treatment? It is still too early to have that conclusion as many medical research and clinical trials are still trying to find the effectiveness and potential side effects of using antiviral drugs to treat coronavirus. But experts believe that antiviral drug might be the best hope for reduce the coronavirus transmission around the world at this stage. However, due to the current difficult situation of the supply chain in many lockdown countries and regions, there is a global shortage on the antiviral drugs supply. With researchers and manufacturers working hard to find and provide effective coronavirus treatment, it is expected that the global antiviral drugs market will have a significant growth over the near future. Antiviral drugs are a type of medication used specifically for treating viral infections, such as human immunodeficiency virus (HIV), hepatitis, and influenza.

Read More

3 Big Pharma Stocks Plunging the Most During the Coronavirus Stock Market Crash: Are They Buys?

Article | April 20, 2021

Big pharma stocks have been clobbered during the coronavirus-caused stock market crash. You can count the number of drugmakers with market caps of $25 billion or more whose shares haven't dropped by double-digit percentages on one hand -- and have several fingers left over. Three big pharma stocks have plunged the most: AbbVie (NYSE:ABBV), Bristol Myers Squibb (NYSE:BMY), and Pfizer (NYSE:PFE). But are these stocks smart picks to buy right now?

Read More

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

Article | April 20, 2021

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.

Read More

Spotlight

Alimera Sciences

Alimera, founded in June 2003, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in aging populations. Alimera's commitment to retina specialists and their patients is manifest in its product and in its development portfolio designed to treat early- and late-stage diseases. For more information, please visit www.alimerasciences.com.

Events