Applying Model Reduction to Lessen the Complexity of Quantitative Systems Pharmacology Models

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One of the greatest challenges in drug development is the high attrition rate obtained in Phase 2 clinical trials, resulting in significantly elevated R&D costs and time. In fact, approximately 80% of new drugs that move into Phase 2—the phase when a new drug is first tested in humans—fail to demonstrate safety and efficacy.

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Align Biopharma

Align Biopharma is an industry standards group made up of more than 20 leading pharmaceutical companies and technology and service providers that are dedicated to making it faster and easier for healthcare professionals to connect with the life sciences industry. For more information, visit AlignBiopharma.org.

OTHER ARTICLES

What do you have to lose taking hydroxychloroquine for coronavirus? Potentially your life

Article | April 10, 2020

The president and some of his close advisors — desperate for a COVID-19 cure — are asking “What do you have to lose?” by taking hydroxychloroquine (HCQ), a strong medication never adequately tested for efficacy or safety in COVID-19 patients. The correct answer to the president’s question, which he doesn’t seem to want to hear, is that we have our lives to lose. The president acknowledges “I’m not a doctor” but this raises the question “What do doctors know about the drug recommended by the president? Most doctors are aware that HCQ can be effective for patients with malaria, arthritis or lupus. If they were to follow the president’s suggestion and prescribe it for COVID-19 patients, they would also like to know that it will benefit some of those patients, at least.

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Enabling Active Pharma Ingredients for Batch Balancing and Integration to SAP EWM

Article | April 10, 2020

Batch and its Classification system are two most potent weapons used in Chemical, Pharma or Medical life science industry to record the potency of a batch or technically called as Active Pharma Ingredients(API). These material consist of one or more active ingredients, concentrates, carrier materials, or impurities, and so on. The potency of the active ingredients varies from batch to batch. The active ingredient is the substance of greatest interest in the bill of materials, the proportion of which may vary from batch to batch. Therefore, during creation of a process order, the system must be able to select and adjust the batches needed to obtain the required amount of active ingredient. Take an example of a drug hydroxychloroquine which is used as potent weapon to fight COVID-19. This drug is manufactured by using API, however, the Potency of this API material vary from batch to batch. To map this kind of requirement in SAP ERP, SAP calls it as Material Quantity Calculation.

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VIEWS AND ANALYSIS

New Dimensions of Clinical Trial Optimization

Article | April 10, 2020

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

Article | April 10, 2020

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?

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Spotlight

Align Biopharma

Align Biopharma is an industry standards group made up of more than 20 leading pharmaceutical companies and technology and service providers that are dedicated to making it faster and easier for healthcare professionals to connect with the life sciences industry. For more information, visit AlignBiopharma.org.

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