< PreviousSOFTWARE AND IT SYSTEMS 20 Pharma Business International www.pbiforum.net © stock.adobe.com/putilov_denis 20-23.qxp_Layout 1 15/08/2022 09:21 Page 1Pharma Business International 21 www.pbiforum.net SOFTWARE AND IT SYSTEMS A s if there was any doubt that artificial intelligence (AI) is transforming the industry, all ten of the world’s biggest pharmaceutical companies are all involved at one stage or another with AI, whether that’s via direct collaboration, or funding via a venture capital arm. While big data and machine learning can be utilised right across the pharmaceutical and healthcare sectors, it’s in drug discovery where some of the most important research is taking place. The cost of discovering and developing new drugs has been climbing over the years, especially as greater regulatory scrutiny and ongoing healthcare pricing issues means that new treatments can be kept from reaching patients. Here AI can help by dealing with the massive amounts of data involved in new drug development. The overwhelming amount of health records, genetics profiles, preclinical studies and clinical trial data can all be correlated and examined en masse, and patterns found. During development stages, new data is coming in daily and with AI all of this can be added to and compared with a huge pre-existing pool of data, providing a thorough foundation to build on. Issues and inconsistencies can be identified early and gaps in research found as well as conveying where research has been clustered and allowing researchers to see where better to focus their efforts. With machine learning, data isn’t only correlated, and patterns extrapolated, but outcomes can be generated, providing pathways for drug discovery. A research team simply couldn’t do this on their own but, guided by these same researchers, AI can use all the facts generated from this massive data pool to create hypotheses that can then be tested and speed up the development process. Is the future yet? With advances in technology across the board, AI – or more specifically machine learning – were bound to come up sooner or later. We ask the questions of how viable they might be in the pharma industry. 22 Á 20-23.qxp_Layout 1 15/08/2022 09:21 Page 2SOFTWARE AND IT SYSTEMS 22 Pharma Business International www.pbiforum.net With a shorter development process, there’s less cost involved, meaning that potential new treatments can move to clinical study faster, offering a lifeline for patients. Hong Kong company Insilico Medicine developed an AI system that dramatically accelerates the drug discovery process from years to days. In the industry’s first successful experimental validation of AI for drug discovery in cells and animals, the company successfully created a series of entirely new molecules capable of combatting disorders like fibrosis. Traditionally, drug discovery begins with the testing of thousands of small molecules to get just a few lead-like molecules. Only one in ten of these pass clinical trials in human patients making process. But with Insilico’s AI, it was able to ideate and generate novel molecules from start to finish in just twenty-one days. Powered by generative chemistry utilising modern AI techniques, the company’s GENTRL can rapidly generate molecular structures with specified properties in a technique similar to that used by DeepMind (the AI company acquired by Google in 2014) to outcompete human GO players. Insilico made the source code open source to make it more broadly accessible to the public and allow other companies and research teams to leverage the technology. Just a few months after Insilico’s breakthrough, a clinical trial began in Japan exploring the first drug candidate discovered using AI. DSP-1181 is being progressed as a long- acting and potent serotonin 5-HT1A receptor agonist for obsessive- compulsive disorder as an initial 20-23.qxp_Layout 1 15/08/2022 09:21 Page 3Pharma Business International 23 www.pbiforum.net SOFTWARE AND IT SYSTEMS © stock.adobe.com/mguido indication. It was jointly created by combining Sumitomo Dainippon Pharma’s science and know-how in monoamine GPCR drug discovery, with University of Dundee spin-out Exscientia’s Centaur Chemist AI platform for drug discovery. With this AI-powered process, it required less than twelve months to complete the exploratory research phase, less than a quarter of the time of the typical average of 4.5 years using conventional research techniques. Although artificial intelligence is still in its infancy where drug discovery is concerned, the breakthroughs have already been profound. From dramatically shortening development times, to reducing costs, the technology is helping to change the way in which new drugs are discovered, developed and brought to market. As of yet there is still a lot to learn about AI – and a lot for them to learn about their given tasks – and the term “AI” is also seen as somewhat of a misnomer. The machines are in many cases little more than trial and error bots that run several million processes at once, deleting the ones that don’t work from their memory to slowly (or quickly as it turns out) improve the process via the principle of natural selection. Calling them AI skirts near boundaries some might feel are unethical, and in truth they are machines set to refine a singular process. That process could be especially useful for the pharma industry however, as pharmaceuticals has always relied on obscure fields involving vast amounts of testing under strict conditions – which is exactly where an AI will excel. 20-23.qxp_Layout 1 15/08/2022 09:21 Page 4MATERIALS HANDLING 24 Pharma Business International www.pbiforum.net Handling the issue Materials handling is more important in pharma than any other industry and the explosive growth expected for the sector proves it. 24-27.qxp_Layout 1 15/08/2022 09:22 Page 1Pharma Business International 25 www.pbiforum.net MATERIALS HANDLING T he pharmaceutical world is high-pressure enough without materials handling problems causing drops in efficiency along a manufacturing chain. The method by which material is moved from one machine to another will differ greatly depending on whether it is liquid, solid or in any other state, and the risk of contamination (either with other product or with employees) will dictate containment facilities and procedures. At all places, the amount of risk must be assessed, and that is difficult to do when you’re looking to change up an existing system. It’s much easier when starting with scratch and planning out a manufacturing line considering available space, purpose and investment, but more often than not the need for changes will come later down the line, when it’s harder to make those adjustments. Careful planning can only get a company so far after all – technology changes and updates and staying on top of it all is important. While projects that are planned out in advance are obviously more likely to succeed, work undertaken later must still involve a degree of planning. How will the adjustment be made, what equipment will be used, and how best the work be undertaken so as not to risk both the wellbeing of workers but also the functionality of the line? Less disruption is better but rushed work might lead to more later. The question of automation is not so much a question in our industry as it is in many others. There are still many manufacturers in food and drink for instance that choose to limit automation to save costs, but the need for hygiene in 27 Á © stock.adobe.com/gopixa 24-27.qxp_Layout 1 15/08/2022 09:22 Page 2MATERIALS HANDLING 26 Pharma Business International www.pbiforum.net © stock.adobe.com/copterandmom 24-27.qxp_Layout 1 15/08/2022 09:22 Page 3Pharma Business International 27 www.pbiforum.net MATERIALS HANDLING pharma means that automation remains king and is likely to keep that crown for the foreseeable future. The automated materials handling market is expected to reach a value of over $51 billion by 2025, with the expansion of third party logistics (3PL) industries leading to mass adoption of the technology. With 3PL’s being more commonly used now than ever before, the businesses are updating and upgrading their materials handling systems to cope with the influx of new business and ensure they can meet the demand. This new investment will be a driving force for the industry, both enrichening it and leading to further development which may, in time, be efficient enough for those same 3PL’s to invest again, creating a symbiotic relationship. Speaking of materials handling in warehouses and distribution centres, there has been a rise in demand for Automatic Guided Vehicles (AGVs) to transport workers and products across the vast expanse of a depot. They remove the requirement for manually operated forklifts, lessening costs for hiring workers who are qualified to operate such machinery. AGV’s can also operate for 24 hours a day. They utilise Artificial Intelligence to drive across pre- determined routes, pick up material, and transport it to another pre- determined destination. This decreases time delays, and the risk of misplaced goods, as a tracking system is integrated, which can be reviewed on a cloud-based system. AGVs are expected to reduce workplace accidents significantly, as driving automated paths and the ability to inter communicate with other AGVs reduces likelihood of collisions. It is estimated that 25% of injuries in the workplace are caused by contact with objects and equipment and reducing the need for manual handling across the production process, underscores the impact of automated vehicles in reducing these incidents. This is much harder to utilise in a manufacturing line of course, but many processing companies nowadays are seeking to make materials handling easier on their end by incorporating full systems of input and output into a single machine, modular or not, with the product at the end only needing to be collected, piped or transported out the unit however it needs to be. It’s a world of extreme competition and much innovation, and with technology being so readily available now it appears that manufacturers of processing lines are selling less on the USP of efficiency and cost, and more on the USP of convenience and lack of downtime. The theory appears to be that pharma companies will be more likely to shell out large money for a unit that can be slotted into a line with minimum disruption, than pay less for one that requires more work. Given the high-pressure environment that is the industry, they might just be right. 24-27.qxp_Layout 1 15/08/2022 09:22 Page 4Vector Development for Cell & Gene Therapy Summit 24 - 25 August Boston, USA The Vector Development for Cell and Gene Therapy Summit is focused exclusively on addressing challenges in vector improvement for both ex vivo and in vivo approaches. Bringing together key industry leaders and covering a range of topics including capsid optimisation using AAV vectors, process optimisation using lentiviral and adenoviral vectors, innovative non-viral delivery options and the importance of vector serotype for improved durability, it’s a key opportunity to gain the actionable insights you’ll need to optimise your manufacturing process and improve tissue-specific targeting and safety profiles for your pipeline. Aseptic Processing Conference 19 - 20 September London, UK The aseptic processing industry has seen consistent growth in recent years, with advances in innovative therapeutics, the introduction of novel techniques and personnel protocols, the integration of robotics and Pharma EVENTS © stock.adobe.com/ photon_photo 28 Pharma Business International www.pbiforum.net and policy professionals. Bench scientists and technical professionals can gain insights from drug regulators to help expedite approvals and speed to market, and learn about the latest innovations and emerging technology. Policy professionals, industry professionals and regulators have the opportunity to network with others in the industry and gain a fuller understanding of how regulations affect the real world. In automation in filling lines, and rise of rapid microbiological methods being just a few of the factors behind this. This conference will explore the novel methods and technologies pushing innovation in the field. Attend to discuss the revisions and the impact of Annex 1 on aseptic manufacturing, explore the applications of rapid micro methods in the manufacture of sterile products, discover a Risk Based Approach to Cleaning and Disinfection, delve into case studies of competence in global aseptic manufacturing, uncover the journey of Isolation Technology in a large Biotech pharmaceutical plant. EAPS2022 7 - 11 October Barcelona, Spain EAPS2022 is going to Barcelona. Join in person, or online, to learn, grow and network with renowned professionals. The event will discuss novel discoveries, the newest therapeutic techniques and diagnostic tools as well as the most up-to-date research in paediatrics. GRx+Biosims 2022 7 - 9 November North Bethesda, USA GRx+Biosims 2022 is the premier scientific and regulatory event for the U.S. generics and biosimilars industry, featuring timely programming relevant to technical, regulatory © stock.adobe.com/Sergey Nivens Connect in Pharma 14 - 15 September Geneva, Switzerland Putting patients at the centre, Connect in Pharma will bring together the key players in pharmaceutical and biotechnological production in the heart of Europe’s pharma industry – Geneva. The event is your one-stop-platform for the development, industrialization and contract manufacturing of drug delivery systems and pack & filling technology. From the concept phase to the finished product, every aspect of Connect in Pharma is designed to inspire collaboration and innovation between packaging suppliers, drug delivery systems, CMO/CDMO and filling & assembling technology. With conferences, workshops, curated networking and the latest products from the best suppliers on show, Connect in Pharma will help you to solve your challenges and build strong partnerships. 28-29.qxp_Layout 1 15/08/2022 09:22 Page 1addition, connect with global influencers, increase your knowledge base to stay on the cutting edge and learn about best practices to enhance your organization’s overall performance. Microbiome Connect USA 16 - 17 November Boston, USA The 7th Annual Microbiome Connect: USA 2022 is dedicated to showcasing the leading drug development platforms applying microbes, microbe modulators and microbial-derived components to prevent or treat human diseases or make medical diagnosis. Pharmacovigilance World 2022 22 - 23 November Online The Pharmacovigilance World 2022 conference will provide a platform for participants to discuss, share and stay updated with present state of affairs in Pharmacovigilance and Drug safety, and how it contributes to the public health. It will also allow all its participants to interact with the experts, discuss the various developments, challenges faced and innovations in the field. The conference will bring-forth the participants and the representatives from various fields of pharmacovigilance and drug safety under a common umbrella, and will provide them an opportunity to network with various industry professionals including pharmaceuticals, biologics, devices, CROs and PV service providers. www.pbiforum.net Pharma Business International 29 © stock.adobe.com/rocketclips Global Clinical Trials Connect 2022 21 - 22 September Online The Global Clinical Trials Connect 2022 will provide a platform to discuss the futuristic advancements in clinical trials and clinical research. This multidisciplinary program involves broad participation of people from the clinical trials community from around the globe who are focused on learning more about clinical research, clinical trials planning and management. Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk- based monitoring, clinical auditing & financial planning and other significant topics that play a key role in clinical trials will be addressed along with innovative sessions on new technologies, effective and quality collaborations. Women’s Health Innovation Summit 29 - 30 September Boston, USA Now in its fourth year, the Women’s Health Innovation Summit is reconvening face-to-face for its biggest networking event to date. Past annual summits have succeeded in addressing and bringing awareness to a wide range of verticals, challenges and unmet needs for women and their health. Building on this, the summit will be expanding the scope to consider what’s next in accelerating innovation, investment, research, and partnerships to continue to improve the access of quality of care for women worldwide. The mission for 2022 and beyond is to draw upon the lessons learnt and consider how to continue to drive momentum in an industry that’s gone from being considered ‘niche to essential’. 28-29.qxp_Layout 1 15/08/2022 09:22 Page 2Next >