Exocrine Pancreatic Insufficiency – Pipeline Review, H2 Pharmaceutical 2016

| December 29, 2016

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Global Markets Direct’s latest Pharmaceutical and Healthcare disease pipeline guide Exocrine Pancreatic Insufficiency – Pipeline Review, H2 2016, provides an overview of the Exocrine Pancreatic Insufficiency (Gastrointestinal) pipeline landscape. Exocrine pancreatic insufficiency (EPI) is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion. Symptoms include diarrhea, loose, oily stools with unabsorbed fat (steatorrhea), vitamin deficiencies, loss of appetite, and unexplained weight loss. Treatment includes pancreatic enzyme replacement therapy (PERT) and lifestyle modifications.

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Takeda

For more than 230 years, Takeda has brought hope to people around the world through our people-centered and innovation-driven approach to science and medicine. As a global pharmaceutical leader, we focus on solving unmet needs where we can make a real difference nd on putting patients first. Our therapeutics focus is oncology, gastroenterology, and the central nervous system, as well as vaccines.

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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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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?

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Merck’s Patient-Centric Clinical Trial Recruiting

Article | April 20, 2021

Everyone in pharma knows that product success depends on the results of clinical trials — but we don’t usually hear from the people who are involved in running them. Recently, four Clinical Research Managers (CRM) from Merck (known as MSD outside the United States and Canada) discussed how Merck is overcoming the barriers to clinical trial recruitment by adopting a patient-centric process — a model that affects their trials top to bottom, from design through implementation. Each of the panel members manages clinical trials, serving as the main point of interaction with the Clinical Research Associates (CRAs) on research requirements, goals, and resources, including recruiting and retention.

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

Article | April 20, 2021

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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Spotlight

Takeda

For more than 230 years, Takeda has brought hope to people around the world through our people-centered and innovation-driven approach to science and medicine. As a global pharmaceutical leader, we focus on solving unmet needs where we can make a real difference nd on putting patients first. Our therapeutics focus is oncology, gastroenterology, and the central nervous system, as well as vaccines.

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