< PreviousAI IN DRUG DISCOVERY 20 Pharma Business International www.pbiforum.net T here’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. 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 Artificial intelligence is changing the face of drug discovery and development, saving time and money, and paving the way for precision medicine. A prescription 22 Á 20-23.qxp_Layout 1 07/06/2019 13:00 Page 1Pharma Business International 21 www.pbiforum.net AI IN DRUG DISCOVERY © Shutterstock /Elnur for precision 20-23.qxp_Layout 1 07/06/2019 13:00 Page 2AI IN DRUG DISCOVERY 22 Pharma Business International www.pbiforum.net 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 potential to whittle down the research and development spend of new drugs. AI has the power to extrapolate patterns from massive amounts of information, 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. 20-23.qxp_Layout 1 07/06/2019 13:00 Page 3Pharma Business International 23 www.pbiforum.net AI IN DRUG DISCOVERY © Shutterstock /any_keen 20-23.qxp_Layout 1 07/06/2019 13:00 Page 4FUNDING DISCOVERY 24 Pharma Business International www.pbiforum.net Some might say that near half of all inventions were serendipitous, happy accidents that contribute to our collective comfort and understanding. While that may in some ways be applicable to the pharmaceutical and life sciences industries, innovations here are typically much more complex and protracted affairs. Setting aside regulatory and ethical challenges, there remains the issue of funding – specifically who’s paying for research, materials, staff, clinical trials and so on. Even the biggest pharmaceutical players are required to secure funding to bankroll drug development or to move a novel new substance into clinical trial. But for research firms and small-scale developers, funding is the very lifeblood of their research and development programmes. Fortunately, there’s a number of different avenues open to companies, researchers and other organisations, whether they get the required amount from one source or from a combination. Although the European Medicines Agency (EMA), the European Union agency for the evaluation and supervision of medicinal products, doesn’t fund research or drug development directly, it can and does provide support to medicine developers that may be helpful for researchers applying for funding under the European Commission’s Horizon 2020 Programme. The largest ever EU funded programme for research and innovation, Horizon 2020 has a budget of almost €80 billion and runs until 2020 with the aim of trying to find and fund new, safer and more effective human medicines and interventions. An organisation that does provide direct funding is Innovate UK, a public body driving science and technology innovations to grow the economy. Since 2007, the organisation - billed as the UK’s innovation agency - has invested £1.5 billion in innovation, a figure that has been matched by a further £1.5 billion in partner and business funding. During this period, it has helped more than 5,000 companies across the industrial spectrum, medical, pharmaceutical and life sciences companies among them. It does this through direct investment in organisations but also through innovation competitions. Yet it’s not only companies Innovate UK provides funding for, but other innovation orientated organisations – including Medicines Discovery Catapult. This independent not-for-profit organisation is a national facility connecting the UK community to accelerate innovative drug discovery. It provides scientific capabilities and acts as a gateway to specialist facilities, technology and expertise, supporting SMEs to dive development and the widespread use of new approaches for the discovery and early development of new medicines. Part of the organisation’s literature is that traditional models of development medicines are “no longer fit for purpose”. It’s currently estimated that it takes an average of 13.5 years to take a new drug to a patient at a typical cost of over £1.2 billion. The challenge, the Medicines Discovery Catapult says, is to do this faster and cheaper without compromising patient safety, a mission it endeavours to accomplish by providing and applying new scientific systems, uses of data and methods of working. The price of innovation Pharma Business International explores the various ways in which medicines and drug discovery are funded. 26 Á 24-27.qxp_Layout 1 07/06/2019 13:02 Page 1Pharma Business International 25 www.pbiforum.net FUNDING DISCOVERY © Shutterstock /plutmaverick 24-27.qxp_Layout 1 07/06/2019 13:02 Page 2FUNDING DISCOVERY 26 Pharma Business International www.pbiforum.net Charity organisations, such as the British Heart Foundation and Cancer Research UK, exist to raise money to fund research and medical breakthroughs. The latter, which is the largest independent funder of cancer research in Europe, allows organisations to apply for grants as well as enabling researchers to involve patients in their studies. It funds a broad portfolio of investigator-led research – from individual projects and fellowships, to large-scale team science programmes, multidisciplinary collaborations and international consortia. While there’s grant funding, the charity also makes long-term investments in state-of-the-art facilities and resources. Of course, much of the funding that charity organisations can provide to industry, academia and other organisations comes from the public. Direct donations – whether online or in collections in stores or on the streets – are part of this, but so are campaigns such as coffee mornings, sponsored walks or runs and a myriad of other approaches. When fundraising campaigns capture the public interest and go viral online, they really do have the power to bankroll important research and help change lives. Readers will no doubt recall the infamous ‘Ice Bucket Challenge’ from the summer of 2014. In short, participants would tip a bucket of cold water over themselves to mimic the sensation of motor neurone disease and nominate others to follow. The campaign raised an impressive $115 million which was used to fund several important research products. But public funding isn’t immune to the pricing and funding issues the plague the wider pharmaceutical industry. Last year, health campaigners called on the British government to make major changes to the way medicines are researched and developed. The calls followed the release of analysis exploring the cost of leading cancer drugs to the NHS. It showed that £458 million was spent in 2017/18 on paying pharmaceutical companies for medicines that had been developed with public funding. Released by Missing Medicines Coalition, the figures show that three of five of the most expensive cancer drugs to the NHS in 2017/18 – Trastuzumab, by Roche; Rituximab, also by Roche; and Pembrolizumab, by Merck – were developed from publicly-funded research. As a result, the public are paying twice for medicine, first in research and then again in high prices set by the pharmaceutical industry. In the specified year, NHS England spent a record £18.2 billion on medicines, a twenty-eight per cent rise since 2010. Clearly, something has to change. “Millions of people across the country run marathons, make donations or volunteer their time to help fight against cancer, and every penny counts. So why is the government letting big pharma charge such vast amounts for drugs where public funding has paid for research?” said Radhika Patel, a campaigner at Global Justice Now. Evidently, the Medicines Discovery Catapult is right – the old model needs updating. And just like the research and developments all the above help fund, innovation is needed. © Shutterstock /Jane Rix 24-27.qxp_Layout 1 07/06/2019 13:02 Page 3© Shutterstock /lightpoet 24-27.qxp_Layout 1 07/06/2019 13:02 Page 4 INTELLECTUAL PROPERTY AND PATENTS 28 Pharma Business International www.pbiforum.net Intellectual property (or IP) is integral to the pharmaceutical industry’s long-term survival. It is where the big investment is, and is the cause of many mergers and acquisitions within the industry. However, there have been numerous challenges to this and to IP within the industry – and many Governments are siding against pharma. In the US, for instance, there have been several patent challenges in recent years, with many of these going through the US The intellectual property market 30 Á © Shutterstock /Akimov Igor Any pharmaceutical company is only as great as their intellectual property – but shakeups across the world are making the act of keeping an IP difficult. 28-31.qxp_Layout 1 07/06/2019 13:03 Page 1© Shutterstock /Hywit Dimyadi 28-31.qxp_Layout 1 07/06/2019 13:03 Page 2Next >