Who would’ve thought at the beginning of this year, that we would find ourselves in a dystopian scenario like the covid-19 pandemic that currently rages across the world? And, there’s no cure in sight. At least, not in a short time. Traditionally, developing life-saving medicines and vaccines is a lengthy process. From R&D to clinical trials, from regulatory approvals to upscaling: Getting a product onto the market in the Life Sciences and Pharmaceuticals industry takes time. There is always the risk of a product not making it to the market at all. In normal times, saving time in this painstakingly delicate and tedious process is essential. This goes for the companies developing vaccines and medicines, and applies even more to patients that are in need of a cure. Now, in times of corona, speeding up the process to get pharmaceuticals available to the public, is even more crucial than ever.
The past few months, the Life Sciences industry had to step up its game to create and produce a vaccine for the novel coronavirus, as well as medicine that relieves the symptoms of this disease. In August, the Dutch government even issued a statement that only a vaccine could end this crisis. Hence, the world’s gaze is fixed on the industry to reach a breakthrough. Several pharmaceutical companies worldwide are close to a solution.
For Life Sciences companies on the American and European market, the expectation is, that by the end of 2020, the first approved (and thoroughly tested) vaccines and life-saving medicines for treatment, will be available. But, everything depends on the test results. So, there are no certainties. For the development of both vaccines and medicines, time is of the essence to get the world out of the current health – and with it an economic – crisis in the foreseeable future.
Our customers Aspen, Sanquin, and Novavax are players who find themselves at the vanguard of the battle against the virus. Novavax got a 1.6-billion-dollar funding in July from the US government to fire up their Operation Warp Speed. The funding supports the late-stage clinical development, the Phase 3 clinical trial, and the large-scale manufacturing of their vaccine called NVX-CoV2373. Novavax aims to produce 100 million doses starting late 2020. Recently, together with eight other leading pharmaceutical companies, the company signed a historic pledge to uphold the integrity of the scientific process in developing a vaccine for covid-19. The covenant also mentions the necessity of ‘adhering to ethical and scientific standards regarding the conduct of clinical trials and the rigor of manufacturing processes’.
Sanquin Plasma Products is collecting blood plasma from former covid-19 patients in the hopes of finding antibodies that will help to create an effective medicine to ease corona symptoms in vulnerable patients and save lives.
Aspen is known for its anti-inflammatory drug called dexamethasone, which has the potential to save the lives of seriously ill covid-19 patients. The active ingredients for this medicine are partly produced in The Netherlands. The coronavirus triggers inflammation in the body, and dexamethasone helps to fight the infection off. Although it is not a vaccine, this medicine will help patients recover from the virus and will relieve symptoms that go along with it.
Researching, creating, testing, and validating a potential vaccine or medicine is, undeniably, the undisputed expertise of Aspen, Sanquin, and Novavax. However, helping to comply to stringent European and American regulations in a less time-consuming manner, providing transparency to ensure comprehensive quality management, establishing a solid supply chain that lets companies easily monitor formula and batches, and offering real-time insight in the end-to-end chain? Now that is the expertise of our IT and business consultants.
Besides this, we also help those companies to distribute their products fast, safe, and easily to their customers. For that purpose, we developed a proof of concept, where we combine Intelligent Robotic Process Automation with sensors that continuously control batches of vaccine or medicine during transport. If a batch gets comprised, or threatens to get comprised, IRPA processes can take appropriate measures to ensure availability in the supply chain. This tool for Cold Supply Chain Control will make for a more controlled, safer, and smarter distribution.
Our solutions help all three companies to focus more on their core business: Developing and manufacturing high quality vaccines and medicines, and distributing them with the highest standards to patients around the world. We were involved in these types of optimizations even before covid-19 entered the stage. Little did we know that the software solutions we’ve implemented would be thoroughly put to the test mere months later.
We provided Aspen with a new validated SAP landscape that ensures real-time insight in all stages of their supply chain. From production to sales to logistics. Which is vital when you have to take quick actions based on market insights. And, by integrating the former three ERP systems and fifteen applications of the company, we helped employees across the chain of Aspen to work more effectively together. Essential, now health care systems and caregivers are overburdened with covid-19 patients, and hospitals need more supplies of lifesaving medicines than ever, and faster than ever.
Sanquin opted for our solution for global batch traceability of blood plasma. Just like Aspen, it brought them real-time insight and full transparency into their chain. They are now able to generate reports on vital information of their processes and products in just a few clicks. Our solution helps the company to stay compliant, monitor the quality of their products, and it keeps their supply chain as safe as possible. Where tracing complex batches of blood plasma first took hours, it can now be done in seconds. Which is a great help in these times, where Sanquin is working on a potential cure for covid-19 symptoms in patients.
Novavax has a covid-19 vaccine production facility in the Czech Republic that is in need of a validated SAP ERP solution to support their integrated supply chain. From purchasing to logistics, from production to inspection and release, and from sales and distribution to financial reporting. At the moment, as a specialist in implementing and integrating SAP solutions in GxP environments in a validated manner, we help Novavax to realize this and bring the facilities up to standard and ready for the swift mass production of the vaccine, as soon as it gets through the pivotal phase 3 clinical trial.
For our industry, that focuses on software that is meant to accelerate business processes and let companies perform and adapt to a highly dynamic market, this pandemic is the ultimate test case. Now, we can see if our IT solutions can actually deliver what companies need to stay ahead. And so far, our systems are more than capable of keeping up with market demands. Curious what we can do for you?
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Director Life Sciences & Chemicals BNL, Global Digital Director Life Sciences, itelligence AG
Stay compliant and be ready for a new technological era with validated end-to-end visibility and traceability in life sciences. Our best practice, future-proof and integrated solutions let you gain the upper hand, while we keep validation costs at bay.
it.lifesciences as a template is based on industry specific best practices. This preconfigured SAP S/4HANA system is based on more than 25 years of experience and in-depth knowledge of the industry.
Gain full transparency. Reduce time to insight. Take control with one-click batch traceability from single plasma donation to finished product. Discover our integrated SAP industry software that smartens and accelerates the production of blood plasma derived medicines.