European Pharmaceutical Review interviews Thermo Scientific at SLAS 2014

| March 7, 2014

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Freddy White, Director, European Pharmaceutical Review speaks with Scott Keefer, Manager, Product Marketing Thermo Scientific Cellular Imaging and Analysis Products at SLAS 2014.

Spotlight

Biolab Sanus Farmaceutica

Biolab is one of the 10 largest pharmaceutical companies in Brazil. The main characteristics about the trajectory is based on the commitment to offer health and quality of life to the Brazilian population. It is a market leader in Cardiology medicine prescriptions, vice-leader in the segment of Gynecology and acts with relevance in the areas of Dermatology, Orthopedics, Rheumatology and Pediatrics. With a portfolio of more than 100 products, Biolab has one of the most modern Research, Development and Innovation (R&D) Centers in Brazil and is growing as a result of partnerships with universities and national and international research laboratories, as well as commitment with actions of social responsibility and support to Brazilian culture.

OTHER ARTICLES

Five Ways to Manage Your Trial Effectively in a Fast-Changing Global Environment

Article | March 11, 2020

Over the past half-century, clinical trials have grown increasingly complex. A flood of new data from novel sources combined with more elaborate study designs and tougher regulatory standards have lengthened timelines and hiked costs, contributing to a steady decline of efficiency. It all adds up: Nearly half of all drug launches underperform revenue expectations. And if that isn’t enough, the outbreak of COVID-19 worldwide is having an effect on how life sciences companies operate their businesses, including how clinical trials are conducted. Most clinical trial research organizations have tried to adapt by tweaking a platform here, adding a new app there, but this has only yielded patchwork systems of sites, spreadsheets and dashboards that further burden the process.

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How AI and Big Data Will Disrupt Pharma’s Regulatory Compliance Standards

Article | March 4, 2020

The industry as we know it is changing. Pharmaceutical and life sciences companies across the globe are experiencing more pressure than ever to keep up with increased regulatory standards while moving at a pace that requires them to innovate in order to remain competitive. With more real-time automation and the steady increase in AI and Big Data sweeping the landscape, what used to be a slow-to-change and risk-averse industry is now expected to see a significant shift towards newer technology that focus on heightened regulatory standards. Here’s how your company can get ahead of what industry experts are calling, Pharma

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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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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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Spotlight

Biolab Sanus Farmaceutica

Biolab is one of the 10 largest pharmaceutical companies in Brazil. The main characteristics about the trajectory is based on the commitment to offer health and quality of life to the Brazilian population. It is a market leader in Cardiology medicine prescriptions, vice-leader in the segment of Gynecology and acts with relevance in the areas of Dermatology, Orthopedics, Rheumatology and Pediatrics. With a portfolio of more than 100 products, Biolab has one of the most modern Research, Development and Innovation (R&D) Centers in Brazil and is growing as a result of partnerships with universities and national and international research laboratories, as well as commitment with actions of social responsibility and support to Brazilian culture.

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