< PreviousLABELLING, CODING AND MARKING 20 Pharma Business International www.pbiforum.net unique identification code onto each product after it has been packaged, which allows the individual product to be tracked from production to end consumer. This process shares more than a passing resemblance to blockchain, however blockchain is still very much in its infancy and is far from commonplace. Track and trace, on the other hand, is already offering manufacturers a robust and reliable means of following their products through the supply chain and ensuring their validity at all times. Labelling and barcodes are especially easy to employ this on, allowing manufacturers – and potentially end customers – to ascertain not only where their produce comes from, but which factory it was made in. Track and trace has frequently proven its ability to strengthen the supply chain, prove effective for manufacturers and keep patients safe from unregulated and potentially harmful products. It proves that labelling systems will remain critical going forward, as track and trace systems become more commonplace. Outside of track and trace, anti- counterfeit tabs and holographic displays on product labels can be used to let consumers know the product they are using is legitimate. However, this relies on the consumer being aware of the trick used – and thus will call on extensive marketing and informational campaigns to inform them. Furthermore, unique 2D and QR codes are a useful tool to authenticate and track products, scanned to give access to verification data. The codes act as an identifier, enabling name of product, pharmaceutical form, strength, size, type of packaging, country of origin, serial numbers, date of manufacture and expiration, manufacturer’s information, et al. This can be as simple as adverts and 18-21.qxp_Layout 1 12/04/2023 08:54 Page 3Pharma Business International 21 www.pbiforum.net LABELLING, CODING AND MARKING promotional material advising customers to “always look for the seal” or something of a similar nature, and this can help clamp down on counterfeit goods that make it through to customers. Counterfeiters will always be upgrading their own equipment to match that of manufacturers, so it’s important to stay one step ahead and monitor the situation. Without knowing what the counterfeiters are doing, there is little way to impede them. Covert solutions, meanwhile, becoming visible with specific tools, include UV and infrared light-reactive inks, thermochromic inks that display particular images under severe temperature changes, barcodes and digital watermarking with cryptic images detected with a tailored device, and taggants, invisible molecular or optical symbols added to inks and coatings, that become visible with specialised lab equipment. It is important to understand that these two methods target different people in a sense – QR codes and seals work to inform end-users and keep them aware of the validity of the product, while more covert measures will be useless to end-users and are better served when dealing with wholesalers, pharmacies and other businesses that can be told to use said equipment to check the product. RFID (radio frequency identification)- enabled labels are also coming to the fore, allowing digital visibility and monitoring due to their trackable nature, from manufacturer to shelves and homes, improving upon serial numbers and barcodes. These labels also provide product users with a more interactive experience, offering access to extra product information, videos, apps, and mobile product authentication. © stock.adobe.com/ Elenathewise© stock.adobe.com/ nordroden 18-21.qxp_Layout 1 12/04/2023 08:54 Page 4END OF LINE PACKAGING 22 Pharma Business International www.pbiforum.net A utomated and robotic end of line packaging systems are seeing a particular surge in popularity due to the labour shortages being experienced across much of the world, especially in technical roles. By using robots to take over repetitive and dull tasks, manufacturers can free up workers to focus on other, more important roles. This is particularly important when it comes to the end of the production line because it’s traditionally where a lot of delays tend to hold up lines from changeover, as all existing product needs to be cleared and packaged before a new line can begin. By the year 2032, the end of line packaging market is anticipated to reach $7.9 billion, and while much of that will be in food and beverage as well as pharma, it’s still an increase of 4.3% CAGR. More shockingly, China is expected to expand their end of line packaging facilities by 1.9x their current market value over the same period. The rapid industrialisation of China’s manufacturing facilities will see them do away with the old stigma of low-paid workers and move toward highly automated and streamlined systems. The primary purpose of end of line packaging will always be to protect the product during storage and transport, a necessity for many pharma products. Pills and blisters need to be kept protected, while medical equipment is even more susceptible to damage. Where the end users are consumers in pharmacies, even a small dent or crease in packaging can ward customers away. It’s one thing to eat a wonky banana for instance, but another to trust your health to a wonkily packaged medicine. Therefore, maintaining the appearance of Optimising end of line packaging The rapid rise of urbanisation and industrialisation in the Asia-Pacific region has led a boom in the end of line packaging industry, as ever expanding factories are working to become more efficient and cut costs. 24 Á 22-25.qxp_Layout 1 12/04/2023 08:55 Page 1Pharma Business International 23 www.pbiforum.net © stock.adobe.com/ Pugun & Photo Studio 22-25.qxp_Layout 1 12/04/2023 08:55 Page 2END OF LINE PACKAGING 24 Pharma Business International www.pbiforum.net the packaged goods within is paramount. At the same time, packaging must meet labelling standards for the countries it is to enter or pass through, which, depending on the country, can mean many hurdles to jump through. The FDA for instance requires every medical device to feature a UDI (Unique Device Identification) which must be globally recognised and capable of tracking the product from manufacturer, to distribution, to end user. This degree of traceability is by now no big surprise to the industry, but the issue is not so much the acceptance of such needs, but the application of them. While humans are prone to error, they are also more than capable of noticing when something is missing, whereas machines can more easily gloss over an error. A robot may have a problem with its labelling system and believe it has applied a label when it has not for instance. In these cases, the inclusion of vision software and extra checks – preferably automated – are needed to ensure the system operates without problem. Barcode systems can be scanned on the line with reliable accuracy, with any packaged good with no, or a badly applied label, flagged up and identified to be put back through the system again. These systems must work together not only reliably but cost-effectively, and therein lays the problem. While newer technologies tend to do a good job at cutting operating costs, their initial investment is harder to stomach. Capital is not as easily accessible as it once was, and the collapse of a bank in the recent news (even if it was not due or related to pharma) has sent shockwaves through many pension funds, investment groups, and other banks. This has led to suggestions of new regulation on investments, which may leave some wishing to hold back to see which way the wind blows. This could have a knock- on effect on pharmaceuticals within western countries, leaving Asia-pacific pharma giants and manufacturers to continue forging ahead with their optimisations. © stock.adobe.com/ Siwakorn1933 22-25.qxp_Layout 1 12/04/2023 08:55 Page 3Pharma Business International 25 www.pbiforum.net END OF LINE PACKAGING © stock.adobe.com/ sorapolujjin 22-25.qxp_Layout 1 12/04/2023 08:55 Page 4CLINICAL TRIALS 26 Pharma Business International www.pbiforum.net © stock.adobe.com/ photon_photo 26-29.qxp_Layout 1 12/04/2023 08:55 Page 1Pharma Business International 27 www.pbiforum.net CLINICAL TRIALS Unyielding integrity Decentralisation the future of clinical trials? A crucial aspect in the development of safe and effective therapeutics and medical devices, clinical trials are evolving, whether it be as a result of new technology, new regulations, or societal changes. The COVID-19 pandemic thrust clinical trials into the public eye more than ever before and brought with it innovation, a reconsideration of clinical trial design and an accelerated shift to hybrid and decentralised clinical trials, as trial organisers scrambled to ensure continuity. Decentralised trials have emerged as a vital tool in speeding up trials and improving patient experience and are picking up pace as technological advancements, infrastructure and knowledge are put in place to support their use. Bringing more of a trial’s activities to patients rather than requiring travel to study sites and hospitals, decentralised clinical trials come with a plethora of benefits, including reducing trial timing and resources, improving patient centricity and engagement, and particularly in minimising patient burden and increasing participation in a time where recruitment and retention sit as two of the most significant threats to a study’s success. Decentralised clinical trials make studies more accessible to and convenient for patients and open up geographic boundaries, with remote monitoring and minimal site visits removing the logistical and financial obstacles that appear when travelling frequently, often long distances, to study sites and hospitals, deterring patients from participating. By making clinical trial participation more accessible, less costly, and less time consuming, decentralised clinical trials increase recruitment and retention, and can be designed to better suit people’s lifestyles, while pulling in a wider, more diverse group of patients in contrast to patients who simply live close to a centre, leading to a less representative cross section of the patient population. This type of trial is additionally beneficial in presenting extra opportunities to conduct tests covering rare disease treatments that have in the past been impossible due to the wide geographical dispersal of patients. Decentralisation also has the potential to reduce trial investigators’ workloads and costs, with traditional site activities like drug administration, assessments, and data verification performed remotely by others or by patients themselves. As clinical trials evolve and recover post-pandemic, decentralised studies may be the future for the pharmaceutical industry. 28 Á 26-29.qxp_Layout 1 12/04/2023 08:56 Page 2CLINICAL TRIALS 28 Pharma Business International www.pbiforum.net With decentralised trials the industry is further evolving with the increased embrace of digital technology including telemedicine, biosensors, apps, and wearables tracking heart rate, blood pressure, oxygen, et al., as well as wearable injectors for easy at home administration. Mobile health technology for example is being utilised to support these remote studies, and is providing access to more in depth, real world and real time data, alongside more insights into patients’ experiences, and apps are facilitating virtual consultations and constant feedback between patients and clinical teams and helping manage everything from enrolment to treatment administration, while connecting patients with all the information they need about a trial, presenting medication reminders to support treatment adherence, and offering a forum through which to coach patients on using medical devices at home. Furthermore, the employment of wearables and artificial intelligence (AI)- powered systems is enabling continuous monitoring of patients at home over long periods of time, providing insights into how a drug works in the real world rather than an artificial environment, improving trial accuracy and speed of trial completion, are facilitating automated data monitoring and improved collection of data — which can be quickly shared with medical teams — and with electronic data capture in decentralised trials enhanced analysis is enabled through technologies like AI and machine learning algorithms. Trial operators can take advantage of big data as a result of the use of wearables and other medical devices and applications, which can be utilised to predict outcomes and interpret trial data more quickly and accurately. 26-29.qxp_Layout 1 12/04/2023 08:56 Page 3Pharma Business International 29 CLINICAL TRIALS Moreover, advances in AI and digital technologies are allowing the development of novel endpoints, informing decision making and better capturing the entire disease burden of patients in clinical trials. With the establishment of more complex clinical studies and demands for larger amounts of and more diverse participants making it challenging to find trial candidates, embracing innovation in clinical trials is more important than ever. The general shift towards decentralisation and employment of novel technologies will change clinical trials as we know them, allowing them to become more accessible, low burden, and better meet the needs of patients with less disruption to their lives. © stock.adobe.com/ leowolfert © stock.adobe.com/ Aleksey 159 26-29.qxp_Layout 1 12/04/2023 08:56 Page 4Next >