Building Lonza’s New Drug Product Services Laboratories

| August 24, 2017

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Lonza have built its new site, laboratories and offices in Basel, Stücki Science Park from April to September 2016. Let us invite you into a highspeed version of this built-up. Lonza Drug Product Services develops, manufactures and analyzes Drug Products for parenteral administration. Lonza’s Drug Product Services can help you address challenges in the development and commercialization of patient treatments.

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Adapt Pharma

Adapt Pharma is an innovative small business focused on developing cutting-edge treatments for patients with special medical conditions. Our mission is to provide simple, reliable, and accessible therapeutic options, ensuring that patients, and those who care for them, have access to the right treatment at the right time.

OTHER ARTICLES

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

Article | April 6, 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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Top Pharmaceutical Firms Urge FDA to Adopt Blockchain for Drug Tracking

Article | February 25, 2020

Leading market participants in the United States pharmaceutical industry, logistics firms, distributors and other stakeholders in the pharma supply chain have come together to publish a report buttressing the need for industry players to adopt blockchain for tracking prescription drugs, following the successful completion of a DLT pilot project with the Food and Drug Administration (FDA), according to reports on February 24, 2020. Though nascent, blockchain technology, the building blocks of Bitcoin (BTC) and other cryptocurrencies are fast gaining ground across various ecosystems, due to its immutability, security, privacy, and other intricate properties. In the latest development, 25 leading manufacturers of pharmaceutical products, logistics partners and other market participants in the pharma supply chain, have published a report that highlights the importance of blockchain technology in drug traceability.

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How Can Medical Cannabis Help to Manage Pain Conditions? – The Cannabis Exchange

Article | February 11, 2020

Pain management is one of the most common reasons for the use of medical cannabis products. However, despite many jurisdictions – including Canada, Germany, and the Netherlands – now allowing the prescription of medical cannabis for this purpose, there remains little ‘high-quality’ evidence to support, or oppose its efficacy. Madden et al. (2018) set out to review the evidence available in order to determine the efficacy of medical cannabis when employed in the management of various forms of musculoskeletal pain. The researchers analysed various studies that assessed the use of cannabinoids in the treatment of arthritis pain; back pain; postoperative pain; and trauma-related pain. It is estimated that up to 30% of the population may suffer from a non-cancer-related pain condition. As such a high percentage of people suffer from these conditions, the development of simple and safe therapies is an essential area of research. This is particularly important as the therapeutic options for people with chronic pain are increasingly limited.

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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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Spotlight

Adapt Pharma

Adapt Pharma is an innovative small business focused on developing cutting-edge treatments for patients with special medical conditions. Our mission is to provide simple, reliable, and accessible therapeutic options, ensuring that patients, and those who care for them, have access to the right treatment at the right time.

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