How attractive are Bio-similars for pharma companies?

PETER WALLACE | September 20, 2019

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Biosimilar therapies are copies of large-molecule, biologic drugs. They differ from generics in that they are not exact copies of the original drug but, rather, a similar molecule that delivers an equivalent clinical outcome to the branded drug. Where small molecule drugs comprise 10s of atoms, biologics (and biosimilars) comprise 10s of thousands of atoms.

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Health Interactions is an international medical education agency providing innovative, high-quality and effective healthcare communications. As we are part of Nucleus Global.

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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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A pharma outsourcing mission

Article | August 18, 2021

In a way, getting through the initial stages of a complex pharmaceutical project that is being outsourced to a contract development and manufacturing organization is like getting a rocket off the ground. Many drug developers express frustration with the time it often takes during the initial stages of working with a CDMO — from the time they first reach out to a CDMO for help until they receive a proposal. Some have described it as months of silence from when they send a request for proposal (RFP) until they have a proposal in hand. The initial stages of a relationship between drug sponsor and CDMO often do not get the attention it deserves, and valuable time is lost, delaying projects and delaying delivery of therapeutics to patients. The quick scheduling of the ACT meeting with the right attendees can deliver immediate answers to key questions needed by the drug sponsor for effective planning and can help propel projects to a successful launch.

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4 Tech Trends That Will Shape Pharma in the Coming Years

Article | May 25, 2021

Technological innovations disrupt many industries, but the speeds of their adoption in the pharma industry have become more rampant than ever. A report from global market advisory firm ABI Research predicts that by 2030, the pharma industry will have spent over $4.5 billion on digital transformation. This is due to many things, from the need to optimize production lines to patent protection. A decade from the forecasted market peak there have already been many applications of these rising tech trends. So let’s have a look at some of them: Digital monitoring system Pharma businesses need to comply with certain regulatory requirements before their drugs can be sold on the consumer market. For example, they need to be stored at a certain temperature. The state of the drugs manufactured and used during clinical trials also needs to be monitored. Fortunately, digital monitoring systems created by companies like Aptar Pharma, Primex, and Monnit, have made it easier to provide the reports regulatory boards such as the Food and Drug Administration and Central require. Aptar Pharma, for instance, offers sensors that can monitor and record the patients’ adherence level during ophthalmic clinical trials. Meanwhile, Monnit’s freezer monitoring solution provides data logs that can be filed as proof of compliance. It doesn’t matter what kind of pharma data you need — there will be a digital monitoring system that can help you collect it. Extended reality Extended reality (XR) is used to describe all real-like virtual environments that are generated by computer programs. The two most common types of XR are augmented reality (AR), where digital graphics are overlaid onto the real world, and virtual reality (VR) where the user is “transported” to a digital world through headsets. To create realistic projections, VR and AR technologies are built with complex and densely packed electrical PCB designs. From wiring the schematic to comparing physical validation rules, all of this is carefully done to ensure that the technology has all the 3D features it needs. Pharma has many uses for this kind of technology. For example, one of Augray’s solutions is to allow researchers to better visualize human models using XR. XR can also be used in lab and manufacturing training. Before letting people train onsite, XR solution providers like SoftCover VR and Labrodex Studios can create simulations that let them familiarize themselves with the equipment virtually. This is very important in the pharma industry, as one error can easily contaminate the drugs. Artificial intelligence Whether it’s for drug discovery research or clinical trials, artificial intelligence (AI) can help accelerate the process. AI is a technology that “learns.” AI programs, after they’re made, are immediately trained to detect patterns and features in the data to help collect insights. British startup Pangaea Data helps global pharma companies identify patient cohorts and trials using AI algorithms. AI can also be trained to perform mundane tasks more efficiently, like arrange clinical data for researchers or gather studies. An AI program called Atomwise does this by analyzing thousands of existing medicines and picking out the ones that can be repurposed to treat diseases it wasn’t initially made for. This was even the AI that identified two drugs that could mitigate Ebola’s effects in 2015, saving multiple lives. In the future, AI can be taught more things that will allow them to aid medical research. Additive manufacturing Additive manufacturing, commonly known as 3D printing, is an industrial production process that lets businesses create 3D products using successive layers of a specific material. Since 3D printers will literally print any object with the right blueprints, additive manufacturing has been a big help in the mass production of drugs. However, researchers are now finding more uses for additive manufacturing — one of which is in the field of precision medicine. Precision medicine takes into account the patient’s lifestyle, history record, and even genetics. Eventually, they're given medicine that’s specially tailored for their body. Since blueprints can easily be edited, combining drugs can be done faster and with more accuracy. Of course, additive manufacturing’s application in this field is still at its testing phases, but researchers are hopeful about the results. New discoveries are made in the pharma industry thanks to technology, and more will continue to do so as long as breakthroughs are made. Businesses should always be updated on these emerging trends, lest they want to be left behind by the competition.

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What to Watch in 2020: Non-Specialty Drugs

Article | March 1, 2020

Pharmaceutical manufacturers are constantly working to develop new and improved medications. Join us as we explore the non-specialty drugs you should be watching in 2020. If you missed last week’s article about the most important upcoming specialty drugs, be sure to check it out here. Approximately 40 new medications are approved by the Food and Drug Administration (FDA) every year.1 (Please note: If you’re curious about what it takes to develop a drug and bring it to market, check out our previous article). Why should you care about these new medications? Because they can affect both your organization’s pharmacy spend and your members’ cost share. For non-specialty drugs, we will focus on medications that may come to market this year, including ones that are currently being reviewed by the FDA, or that are in the last clinical trial (Phase III) stage.

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Health Interactions is an international medical education agency providing innovative, high-quality and effective healthcare communications. As we are part of Nucleus Global.

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