Hospitals Making Drugs?

DEREK LOWE | January 19, 2018

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This story from the New York Times got a lot of attention yesterday, and understandably so. It’s fundamentally about the shortage of some generic drugs, a problem that’s been with us for some years now in one form or another. My own belief is that much of this is a regulatory problem, and I note that Scott Gottleib, the current FDA commissioner, has said that he wants to do something about the situation (or these situations, more properly, since there are several factors).

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OTHER ARTICLES

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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As Pandemic Continues, Rafael Pharmaceuticals Enrolls Patients in Phase III Pancreatic Cancer Trial

Article | February 25, 2020

That simple truth about the severity of the disease is one of the reasons that Rafael Pharmaceuticals is slowly continuing with a Phase III trial in metastatic pancreatic cancer during the COVID-19 pandemic. While many companies have paused enrollment in clinical trials during the outbreak, Cranbury, N.J,-based Rafael opted to continue to enroll patients in its Phase III AVENGER 500 study of its lead compound CPI-613 (devimistat) in combination with modified Folfirinox (mFFX) as first-line therapy for the disease. Sanjeev Luther, president and chief executive officer of Rafael Pharmaceuticals, told BioSpace that the company made the decision to continue to enroll the trial, which was 75% filled, due to the short timeline patients with metastatic pancreatic cancer have. After discussing the matter of the trial with the company’s leadership team, Luther said they felt comfortable leaving the decision of whether or not the trial should continue to the conducting institute.

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Decentralized Clinical Trials: Imperative for Pharma Sector to fight COVID19

Article | February 25, 2020

These are unprecedented times. The world is mobbed by a contagion virus, putting people’s health at risk, threatening to destabilize economies. It has already put global healthcare systems under tremendous pressures, and managed to resist efforts to contain it. Even though coronaviruses are not new, this COVID-19 strain has created panic and forced us to be locked down in our homes sans any movement for weeks, if not months. Organizations are fighting an intense battle to keep their workforce safe, minimize risk, and ensure business continuity. For the Life Sciences industry, however, the challenge is even more significant. The whole world is looking at them to come up with a vaccine and a cure. But that is easier said than done. Bringing a new drug to market is an uphill battle and requires rigorous clinical trials. This process already has regulatory challenges. With the current lockdown situation, the Pharma community is grappled with the challenge of continuing some of the critical and time-sensitive in-flight trials so that their regulatory submission, registration, and market entry are not impacted. But all may not be lost. With the right technology solution, it is possible to turn the situation around rapidly.

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PHARMA TECH

4 Tech Trends That Will Shape Pharma in the Coming Years

Article | February 25, 2020

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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Prescient is an evidence-based decision-support partner to the pharmaceutical and biotech industries whose mission is to optimally shape new product.

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