< PreviousINNOVATION 30 Pharma Business International www.pbiforum.net Next-gen innovation 30-33.qxp_Layout 1 10/06/2021 09:59 Page 1Pharma Business International 31 www.pbiforum.net INNOVATION There’s a strange dichotomy when it comes to new technologies in the pharmaceutical industry. Of course, it’s an industry that has always prioritised innovation and the advancement of our collective knowledge and embracing new technologies that help further those aims. And yet, the industry has also been slow to adapt in other areas, perhaps most noticeably with social media. Hardly the cornerstone of laboratory research, but there are a great many advantages to companies utilising a social media presence. Industry-wide adoption of digital technologies may have started slow, but we’ve reached a turning point in which terms like artificial intelligence are becoming rapidly associated with drug discovery and development. The apotheosis of this shift arguably occurred back in 2018 after Amazon acquired online pharmacy business PillPack. It appeared as though nothing was going to halt the tech giant’s move into the healthcare market. Walmart, the multinational retail corporation and one of Amazon’s biggest rivals, had previously been circling PillPack as part of its own expansion plans but had to concede defeat after Amazon entered the fray with a much more enticing offer – one just shy of $1 billion dollars. The game-changing move from the ‘Big Four’ tech company has brought together the fields of technology and healthcare like never before, offering a real vote of confidence for the burgeoning online pharmacy market. In 2014, the global online pharmacy market was worth an estimated $29 billion. Forecasts predict that by 2023, it will reach around $128 billion. Unsurprisingly, both tech and healthcare companies are keen to get a slice of the pie. Amazon’s efforts follow in the wake of Google parent company Alphabet’s own move into the healthcare sector, with the conglomerate launching two life sciences companies – Calico and Verily – over the last five years, both of them focussed on using technology in drug discovery and development. Innovations in artificial intelligence are already having a profound effect on drug discovery, aiding research and shortening time to market. 32 Á 30-33.qxp_Layout 1 10/06/2021 09:59 Page 2INNOVATION 32 Pharma Business International www.pbiforum.net It’s a trend that’s being reciprocated on both sides. As surely as technology companies are moving into the fields of pharma, healthcare and medicine, so too are pharma companies integrating with technology, be that through collaboration, in-house innovation or acquisition. Over the last decade, all of the ten ‘Big Pharma’ companies – including Janssen, Merck, Novartis and GlaxoSmithKline – have all either expressly collaborated with or acquired artificial intelligence technologies. One doesn’t need a market analyst to see that there’s a major shift taking place. 2018 was a turning point in more ways that just Amazon’s aforementioned acquisition. Here in the UK, it saw Business Secretary Greg Clark announce the opening of five new centres of excellence for digital pathology and imaging – a major push for the nation’s burgeoning AI sector. Last year, for example, investment from venture capital firms into the UK’s AI sector reached a record £888 million. These new centres will now together develop more intelligent analysis of medical imaging which, it is hoped, will pave the way for better clinical decisions for patients, as well as freeing up staff time for the over- encumbered NHS. At present, nine out of ten drugs fail to make it to clinical trials and more yet fail to make it through to the approval stage, driving the costs of drug discovery and development sky high. Pharmaceutical companies looking to recoup these costs will often pass them down to patients, making many treatments unaffordable. But artificial intelligence, machine learning and big data possess the 30-33.qxp_Layout 1 10/06/2021 09:59 Page 3Pharma Business International 33 www.pbiforum.net INNOVATION potential to whittle down the research and development spend of new drugs. AI has the power to extrapolate patterns from massive amounts of big data, offering researchers valuable and actionable data. This approach provides a solid bedrock on which to develop new precision medicines that are much better tailored to patient needs. Or, in some cases, identify pre- existing treatments based on big data that simply couldn’t have been uncovered without the aid of AI. Action Against AMD, a research collaboration formed by four sight loss charities in the UK, recently partnered with London’s BenevolentAI to undertake AI-powered research to uncover new treatments to age-related macular degeneration (AMD). The company’s ‘Benevolent Platform’ comprehensively reviewed the millions of scientific papers, clinical trials information and additional data sets related to AMD with a view to identifying potential gene targets and treatments. The research identified seven pre-existing drugs, either already in development of being used to treat other conditions, that have the potential to be repurposed to treat macular degeneration. This was on top of new gene targets identified by the analysis for investigation. Artificial intelligence is a critical tool in the future discovery and development of new drugs and medical treatments. With all the major pharmaceutical companies expressing an interest in the technology, it’s clear this is much more than a passing trend and will be as commonplace to new drug development in the future as high-throughput screening and rational drug design are today. © Shutterstock /metamorworks 30-33.qxp_Layout 1 10/06/2021 09:59 Page 4CAPSULES 34 Pharma Business International www.pbiforum.net The second most common drug delivery dosage form - following tablets - demand for capsules continues to rise in both pharmaceutical and nutritional supplement markets. For patients, capsules are convenient, preferential next to delivery methods like injections that are considered invasive and stressful, and perceived as easier to swallow. While for developers, they are cost-effective, offer the potential of shorter development times, are relatively simple to manufacture, have high flexibility in usability and filling material, and are reliable for administering potent APIs and other compounds. A tasteless and odourless delivery system, capsules can accommodate a plethora of formulations, whether that be powder, beads, granules, semi-solid, or liquid, and can serve oral administration as a single dose, orally inhaled dry powder, or sprinkles on food. This also lends itself to the increasing focus on individual populations, such as paediatric patients, requiring easy to swallow forms, and the requirement for more different dose strengths. Capsules also offer an opportunity for brands to stand out, with a wide variety of design/colour solutions to customise products, while multiple filling options present a formulator with numerous choices for unique delivery systems, as well as the chance to separate incompatible substances in one capsule. With these benefits it is perhaps unsurprising that businesses continue to invest in expanding capsule manufacturing operations. At the end of 2020, contract development and manufacturing organisation, Lonza, revealed plans to spend In high demand A popular drug delivery dosage form holding a number of benefits for both drug developers and patients, capsules continue to evolve and are in high demand. 36 Á 34-37.qxp_Layout 1 10/06/2021 10:00 Page 1Pharma Business International 35 www.pbiforum.net CAPSULES © Shutterstock /Maxim Ermolenko 34-37.qxp_Layout 1 10/06/2021 10:00 Page 2CAPSULES 36 Pharma Business International www.pbiforum.net $93 million to expand its capsule manufacturing by fifteen per cent across eight sites to add over 30 billion doses a year to its capacity, as demand for capsules skyrockets. A number of trends are impacting capsules. The growth in patient-centric care for example has pushed for easy to swallow orals with masked taste and odour, in addition to the formulation of sprinkle capsules and mini/micro options that may also help with compliance. The rise in inhaled drugs is also pulling on capsules, as a convenient choice for dry powder inhalers, as well as combination products, which are gaining approval across the globe. Designed with multiple technologies and active ingredients to overcome formulation challenges, combination fill is presenting a variety of development options, such as immediate release with sustained or delayed release. Furthermore, drug incompatibility, stability concerns and interaction can be avoided with innovative dosage forms like capsule in a capsule, and different therapies and doses placed together in a single capsule. Hard capsules are being used to accommodate powders, pellets, mini tablets, liquids, and other capsules in one pill for fixed dose combinations, multi drug resistance therapies, once a day combinations, and to avoid missing doses. Other innovations are seeing the 3D printing of drug capsules that can be triggered remotely to release contents researched, advancing control over how and where drugs are distributed in the body. Change for capsules and their use is also coming in the debate over whether to use gelatine or vegetarian capsule materials. Though there are various types of capsules in circulation, gelatine has long been the most popular choice with high mechanical robustness, ease of swallowing, and fast aqueous dissolution. Advances have however 34-37.qxp_Layout 1 10/06/2021 10:00 Page 3Pharma Business International 37 www.pbiforum.net CAPSULES provided drug developers with capsule material derived from non-animal sources (including starch, cellulose, pullulan, and carrageenan) that can offer the same characteristics/performance, are compatible with APIs and drug products, and also address growing patient preferences for cleaner-label products, and the expansion in vegan and vegetarian diets and ethical concerns. Meanwhile, affecting gelatine use, last year saw a shortage of gelatine capsules due to COVID-19 lockdowns, meat processing facility shutdowns, and pauses in travel for cattle movement and abattoirs. Hitting gelatine production, drug makers witnessed supply disruption and increasing capsule prices. Versatile Hydroxy Propyl Methyl Cellulose (HPMC) capsules have led the way as an alternative to gelatine and use is being driven particularly by nutraceuticals and dietary supplements. High in demand, the capsules are able to accommodate a range of drug products and formulations that are incompatible with gelatine capsules, and are resistant to cross linking. Moreover, HPMC capsules are able to overcome formulations where moisture impacts product activity, as they hold a comparably low inherent moisture content (where gelatine capsules are associated with high inherent moisture content which sees incompatibility issues with moisture sensitive ingredients), can withstand greater humidity and temperature conditions, and offer better stability for hygroscopic products. The decision between HPMC and gelatine capsules ultimately comes down to several factors, including costs, audience, the type of material to encapsulate, and supply stability. Capsules have evolved remarkably over the years as a versatile and flexible dosage form, keeping them in high demand. © Shutterstock /A-photographyy 34-37.qxp_Layout 1 10/06/2021 10:00 Page 4Pharmacovigilance & Drug Safety 2021 27 – 28 September Alfandega Congress Centre, Porto, Portugal The Pharmacovigilance & Drug Safety event is designed to bring you a unique opportunity to gain fresh insights into the common issues faced in the industry, highlighting the areas with the need to focus on in order to remain compliant. Moreover this conference stream will provide the opportunity to network with various industry professionals including pharmaceuticals, biologics, devices, CROs and PV service providers. 2nd International Women Health and Breast Cancer Conference 10 – 11 June London The 2nd International Women Health and Breast Cancer Conference welcome you to meet healthcare experts in London this summer. It provides an international forum for academicians, practitioners, health and business professionals to share latest advancement and research across the broad field of women’s health. Its focus includes the dissemination of translational research and evidence-based practices for disease prevention, diagnosis, and treatment for women across the lifespan. To find out more, visit www.iwomenhealthconference.com. BCMA Targeted Therapies 21 – 23 June Online The inaugural BCMA Targeted Therapies Summit is industry’s first dedicated discussion and networking forum focused on bringing together the thought-leaders within the BCMA field to share the latest scientific progress and address the current challenges drug developers are facing. Developed with experts from Amgen, Kite Pharma and Legend Bio and other leading organisations, join 80+ of your peers and be part of this unique opportunity to engage in cross-industry discussions. Hear from over 20 experts sharing preclinical data for next Pharma EVENTS © Shutterstock / LookerStudio International Vaccines and Virology Conference 10 – 11 June London Attendees can share research findings, promote knowledge exchange and network with a broad audience in the field of microbiology and immunology. This is an annual gathering for researchers, practitioners, and educators to share the insights and discuss the recent innovations, research, concerns as well as practical challenges encountered, and development to improve healthcare sector’s preventive and cure needs. The conference’s global goal is to deliberate and disseminate innovative ideas among academics, research and development executives, scientists, industrialists, and policymakers to deepen the comprehension and transform the knowledge into innovative solutions for patient care. For more information, email info@ivaccinesconference.com. 38 Pharma Business International www.pbiforum.net executives, global heads and solution vendors to ask a simple question: Where to NEXT? To find out more, visit https://nextpharmasummit.com/ European Epidemiological Forum 5 October Online The objective of this online conference is to familiarize the audience with the new generation BCMA targeted therapies, bringing in the patient perspective and exploring efficacy of patient response from the clinic. To find out more, visit www.bcma- targeted-therapies.com. Manufacturing Chemist Live 13 – 14 July The National Conference Centre, Solihull, UK Manufacturing Chemist Live will put professionals working in the pharmaceutical industry ahead of the curve. The two-day conference will address key pharmaceutical HPAPI processing from regulatory and compliance to operational. To find out more, visit www.10times.com/e15z-f1zg-2pp9. Pharma Japan 2021 14 – 16 September Online Join Reuters for the most influential annual forum for Japanese pharma leaders in Marketing, Commercial, Medical Affairs, RWE, and Clinical. To find out more, visit www.reutersevents.com/events/japan. Next Pharma Summit 21 – 23 September Dubrovnik, Valamar Lacroma With a clear focus on pharma commercial/medical and at the time of great uncertainty for pharma, we gather pharma © Shutterstock/joel bubble ben 38-39.qxp_Layout 1 10/06/2021 10:01 Page 1capabilities that are being made available in the field of artificial intelligence and machine learning in relation to its application to real world data. Beyond the hype, EPI Forum will address the benefits and limitations of this new approach and discuss how it can complement traditional approach to observational studies. To find out more, visit www.lsacademy.com/en. Nordic Pharmacovigilance Day 9 November Copenhagen, Denmark The Nordic Pharmacovigilance Day has become a very popular forum for a broad range of professionals engaged in strengthening the safety of medicinal products and medical devices. The 8th edition will build on the experiences from previous successful conferences presenting a program covering the current most important topics and challenges encountered within the pharmacovigilance area. Knowledgeable experts will provide excellent updates in key areas, covering recent advances in technology, science and legislation, as well as practical aspects. Sessions will be interactive and participants will be able to ask questions, engage in a dialogue and also share their own experiences. To find out more, visit www.lsacademy.com/en. www.pbiforum.net Pharma Business International 39 © Shutterstock/Fishman64 INTERPHEX 2021 October 19-21, 2021 Javits Center, New York, INTERPHEX is the event for pharma, bio, device development and manufacturing. Source, network, discover, accelerate to market and learn from expert-led technical content. Pre-register to attend or apply to exhibit now. To find out more, visit www.interphex.com. 38-39.qxp_Layout 1 10/06/2021 10:01 Page 2Next >