< PreviousDISTRIBUTION 30 Pharma Business International www.pbiforum.net collaboration and knowledge sharing. We believe blockchain will open up new opportunities for the industry to begin sharing data more securely to advance drug discovery, ultimately making patients’ lives better.” Blockchain is one part of the wider digitisation of the supply chain, with smart solutions transforming the journey of new products. TraceLink, the trace and trace network for the life sciences industry, is making the digitisation of the supply chain its mission. The US- headquartered organisation has recently closed a $93 million investment round which it plans to use to accelerate the expanded digitisation of the global pharmaceutical supply chain. The funds will be used to integrate real-time information sharing which, TraceLink says, will create a highly predictable supply chain for the industry. TraceLink CEO Shabbir Dahod put it best when he said: “As we continue to execute on our vision to build the digital supply chain, we are making strategic investments in machine learning, artificial intelligence and blockchain, ultimately delivering an open development platform for information sharing and predictive © Shutterstock /everything possible 28-31.qxp_Layout 1 13/08/2021 11:21 Page 3Pharma Business International 31 www.pbiforum.net DISTRIBUTION analytics.” Despite these advances and encouraging figures, there are major concerns that COVID-19 may become a hindrance rather than a trigger in the technology’s future implementation and uptake. “A blockchain-based distributed ledger can provide a critical solution for streamlining product tracking and recalls, while at the same time mitigating issues such as drug shortages and counterfeiting,” said Urte Jakimaviciute, Senior Director of Market Research at GlobalData. “However, with the current crisis, blockchain may not be a top priority for the healthcare industry and any blockchain-related investments may be put on hold. Companies may shift their focus to operational resilience and agility, as well as remote workforces. While risk management in supply chains is extremely important for the pharmaceutical sector, blockchain technologies are still emerging, therefore the return on investment is hard to assess.” Blockchain implementation in pharmaceutical product supply chains is currently in early pilot stages. The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 in US prompted companies such as IBM, KPMG, Merck & Co and Walmart to explore blockchain technology. In February 2020, these companies issued a report declaring the blockchain pilot program successful in addressing the stated objectives and demonstrating compliance with the DSCSA. Nevertheless, they also highlighted a need to develop a defined industry governance framework associated with the blockchain network and standards for information exchange, such as GS1. There are number of limitations and challenges that technology providers, industry and governments need to address in order to bring blockchain developments forward. Aside from compliance, regulations and governance challenges, issues related to security for Internet of Things (IoT) devices, access control and scalability may present additional barriers and risks. Jakimaviciute said: “While blockchain provides an extremely appealing use case in pharmaceutical supply chains, due to the lack of ‘real world’ applications, the COVID-19 crisis may present a temporary setback for blockchain rather than encouraging growth.” Blockchain is fast becoming an important tool for the pharmaceutical and life science sectors, offering an integrated digital solution that offers greater levels of safety, transparency and trust between suppliers. The future of the supply chain is undoubtedly digital, but with the pandemic, there may be hurdles to overcome. 28-31.qxp_Layout 1 13/08/2021 11:21 Page 4CONTROLLING COVID 32 Pharma Business International www.pbiforum.net © Shutterstock / Lilanakani 32-35.qxp_Layout 1 13/08/2021 11:22 Page 1CONTROLLING COVID Pharma Business International 33 www.pbiforum.net COVID-19 cases continue to rise, impacting people all over the globe and seeing healthcare organisations stretched to their limits as countries try to control infection rates. As new variants spread quickly, such as the Delta variant, and new waves hit, the number of COVID-related deaths is now well past four million (at time of writing), while infections have passed 200 million worldwide. Simultaneously, many nations are relaxing restrictions, falling back on high vaccination rates to keep the virus at bay. Indeed in controlling the coronavirus pandemic, vaccines are critical, protecting against serious illness and death, as well as providing some protection from infection and transmission. Looking to boost recovery from the pandemic, younger age groups are being offered shots, with the UK recently advising sixteen- and seventeen-year-olds to come forward to receive Pfizer-BioNTech vaccines (the only vaccine currently approved for this age group in the UK). This follows moves made by the US, France, amongst other countries now vaccinating children over twelve. Meanwhile new vaccines are still in development in the fight against COVID-19, undergoing trials and releasing strong results, illustrating promise too against variants. In June for example Novavax announced results from a Phase 3 study for its protein-based vaccine (NVX-CoV2373), showing an efficacy rate of over ninety per cent, including against coronavirus variants, and that it is generally well-tolerated. The EU has sealed a deal to buy up to 200 million doses as it looks to diversify its vaccine portfolio, also presenting a further alternative to current mRNA and viral vector jabs. More vaccines, of course, remain in a preclinical phase and other stages of development. Concurrently, combining different vaccines is on the cards, due to the benefits of potentially improving protection as well as dealing with logistical problems and allowing for quicker vaccination across the world. A University of Oxford-led trial, the Com-Cov study, of 800 UK participants, giving people different vaccines (those made by AstraZeneca and Pfizer) for their first and second jabs, has released preliminary results, showing this to be safe and a key method of bolstering protection against COVID-19. Receiving the AstraZeneca vaccine first, with a twenty-eight day gap between doses, saw a larger increase in antibodies against the coronavirus’s spike protein. In this order, a better T cell response was found. This represents just one of a plethora of studies illustrating mixing vaccines achieves potent immune responses. The question of booster vaccines is also on the table to control COVID, with many pharmaceutical companies testing these shots, such as Moderna, which has recently revealed Vaccines and testing: the key to controlling COVID As new variants and waves of COVID-19 spread across the world, vaccinations and testing are crucial to managing the virus - especially as countries look to lift restrictions. 34 Á 32-35.qxp_Layout 1 13/08/2021 11:22 Page 2CONTROLLING COVID 34 Pharma Business International www.pbiforum.net results from testing a 50-microgram dose of three potential booster jabs in a Phase 2 trial. The shots have demonstrated robust antibody responses, including against the delta variant, with antibody levels approaching those in once unvaccinated people who have received two 100-microgram doses. The data is now set to be peer-reviewed. Moreover, it has been found that protection from Moderna’s two-dose vaccine, following a final analysis of a Phase 3 study, remains strong six months after full vaccination (ninety-three per cent effective). The consideration of rolling out boosters, however, has re-emphasised the issue of COVID-19 vaccine inequity. The World Health Organisation (WHO) has asked for the suspension of any vaccine boosters until at least the end of September as while many areas accelerate vaccine rollout, others are lagging behind, with distribution impacted by political, social, economic, and health factors. In low-income countries for instance just one in seventy-four people have been vaccinated, slowing recovery from the pandemic, and leaving them vulnerable to new waves of the virus and variants, where one in two people in high income countries have been vaccinated. If we look at the continent Africa, by July under two per cent of the population had been fully vaccinated. Frequent testing is also vital in managing COVID, its transmission, particularly as societies reopen, people return to work and socialise more, and in some situations, it is acting to prevent the requirement for isolation/quarantining when coming into contact with someone testing positive for the virus. Highlighting testing’s increasing importance, the UK opened its first “megalab” in July to process hundreds of thousands of COVID-19 samples every day to rapidly detect new variants and help stop the spread of the virus. Part of the UK’s NHS Test and Trace network, the laboratory will employ cutting-edge technology to process more tests and adopt the pioneering new genotype assay testing to quickly identify variants of concern and new mutations. The Government says this will allow action to be taken to suppress outbreaks as society reopens, using tools like surge testing. Researchers continue to improve and develop new ways of testing for the presence of the SARS-CoV-2 virus, focusing on reducing the time required to run a test to reach results faster, boosting the number of samples that can be run at a time, reducing testing costs, and making at-home tests easier to use, amongst other aims. For example, overcoming uncomfortable lateral flow tests utilising nose and throat swabs, which are said to dissuade the public’s use, Intelligent Fingerprinting has developed a saliva-based lateral flow test, where the cheek is swabbed and this mixed with a reagent buffer in a collection tube. The tip of the VSS-GP test strip is then inserted into the sample to provide a positive or negative result. Offering easier testing for children and vulnerable people, and minimising plastic waste, results are available in twenty minutes. The test uses gold immunonanoparticle technology to enable the visual detection of bound antigen via a control line and a red line on the test strip when a saliva sample is positive for the SARS-CoV-2 antigen. Through independent evaluation, the test has demonstrated one hundred per cent sensitivity in testing 150 positive clinical samples (Ct range 18.0 to 28.0), and one hundred per cent specificity following tests with 250 RT-PCR confirmed negative clinical saliva samples. © Shutterstock /V aclav Sonnek 32-35.qxp_Layout 1 13/08/2021 11:22 Page 3Pharma Business International 35 www.pbiforum.net CONTROLLING COVID © Shutterstock /EDSON DE SOUZA NASCIMENT O 32-35.qxp_Layout 1 13/08/2021 11:22 Page 4AUTOMATION 36 Pharma Business International www.pbiforum.net Manufacturing a solution 36-39.qxp_Layout 1 13/08/2021 11:23 Page 1Pharma Business International 37 www.pbiforum.net AUTOMATION Pharmaceutical manufacturing remains one of the most automated and refined of industries in the world, more be necessity than anything else. With stringent hygiene requirements, the human element has been removed from the production line at key points, and this has led to efficiency that other industries have been slow to pick up. Even the food and drink industry, which runs similar hygiene and sanitation protocols as pharmaceutical, still boasts human involvement in manufacturing, with the UK in particular falling behind European and global rivals to embrace robots and automated production lines. Costs in investment and keeping up with this automation have made maintaining lines difficult, however. There is always new technology, and with old machines becoming outdates or inefficient by comparison, there is often a need to push further, lest the competition do so in your place. Contract manufacturing has become a popular alternative as a result, essentially allowing pharma giants to outsource their manufacturing needs. Outsourcing production used to be a risky prospect, something that was only considered as a last-minute resource in a situation where an influx of demand, or a problem with your own production line had taken place. Nowadays however, with the increased technological development – and as a result the more affordable access to technology – outsourcing Keeping up with changes in manufacturing can be difficult, especially in the midst of a pandemic, which is why so many outsource such concerns to others. © Shutterstock /Panatda Saengow © Shutterstock /Panatda Saengow 39 Á 36-39.qxp_Layout 1 13/08/2021 11:23 Page 2AUTOMATION 38 Pharma Business International www.pbiforum.net 36-39.qxp_Layout 1 13/08/2021 11:23 Page 3Pharma Business International 39 www.pbiforum.net AUTOMATION pharma production is not as risky a prospect as it once was. In fact, it’s now a booming industry. Mostly handled by CMO’s (Contract Manufacturing Organisations), the healthcare CMO market is booming rapidly. This has led to many major pharmaceutical firms making the choice to utilise CMO’s for one hundred per cent of their production capabilities, greatly reducing staff costs and other overheads. When it comes to the CMO industry, major plays are the US and Europe, who have a large number of healthcare CMO’s within their territory. Germany, Italy and the UK are particularly active in the EU – with Germany having a clear lead in terms of the sheer number of CMO’s that specialise in the pharmaceutical industry. This is expected to be a compound factor of pharma giants making increased use of CMO’s. But the figure is also strengthened by the ending of a number of patents which will likely see a flurry of suppliers seeking to provide now un-patented drugs at much lower rates. The advantages of contract manufacturing, or outsourcing in general, extend beyond the variable costs of manufacturing and into overheads in staff, maintenance and even property. No manufacturing means no factory, saving space and rental costs. Of course, becoming fully reliant on outsourced manufacturing comes with its own issues, namely that of flexibility and dependency, but so long as a company does not put all their eggs in one basket, this risk is mitigated. With how fast the manufacturing industry moves, it is tempting to place the burden of keeping up on another. While it will never be as profitable in simple terms to outsource – the contract manufacturer has to make a profit somewhere, after all – pharma companies can invest the money they would have spent on capital, investment and maintaining a facility, into R&D instead, investing in the creation of new drugs that might keep them more profitable in the future. As such, while the approach is not inherently as profitable in itself, it can be more sustainable in the long run. © Shutterstock /Dmitry Kalinovsky 36-39.qxp_Layout 1 13/08/2021 11:23 Page 4Next >