< PreviousCOLLABORATION20 Pharma Business International www.pbiforum.netCollaborations between the pharmaceutical sector and digital technology specialists is bringing treatment and medicine into the digital age. MUTUALLY BENEFICIAL 20-23.qxp_Layout 1 05/04/2019 13:28 Page 1Pharma Business International 21www.pbiforum.netCOLLABORATIONHistorically, collaborations in the pharmaceutical industry have taken place between companies, pooling their collective resources and expertise, or between academic organisations and other specialist researchers. Consortiums will even come together, bringing the very best from industry and academia to tackle some of the biggest threats facing modern medicine with an emphasis of late on antimicrobial resistance. There’s also been a growing trend for companies looking outside of traditional pharmaceutical fields and forging relationships with companies in the digital and technology sectors. It’s a sign of the times, certainly, but also demonstrates the shift taking place in the pharmaceutical and healthcare sectors, a diversification into other fields as the lines between medicine and technology become increasingly blurred. Some forecasts predict that digital technology will unlock billions in savings for pharmaceutical companies, as well as extending their overall reach, scope and efficiency. Arguably the apotheosis of this shift came in 2018 after Amazon, who in the fourth quarter of that year reported revenues of $72.4 billion, acquired online pharmacy business PillPack. Nothing, it seemed, was going to stand in the way of Amazon entering the healthcare market. Wallmart, the US retail giant and one of Amazon’s major rivals, had been circling PillPack as part of its own plans but had to concede defeat when Amazon came along with a much more enticing offer – one just shy of $1 billion. 22 Á© Shutterstock LeoWolfert20-23.qxp_Layout 1 05/04/2019 13:28 Page 2COLLABORATION22 Pharma Business International www.pbiforum.netThe potentially game-changing move from the ‘Big Four’ technology company has brought together the fields of technology and healthcare like never before and offered a real vote of confidence for the burgeoning online pharmacy market. It follows in the wake of Google parent company Alphabet’s own healthcare efforts, with the tech company launching two life sciences companies – Calico and Verily – over the last five years. Both of these companies are 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 medicine, healthcare and pharmaceutical fields, so too are pharma companies collaborating with technology companies. In the last few years alone, companies including Janssen, Merck, Novartis and, most recently, GlaxoSmithKline, have all started working with companies specialising in artificial intelligence (AI). 2018 was a turning point in the UK especially in the adoption of AI and other disruptive and innovative digital technologies. Towards the end of the year, Business Secretary Greg Clark heralded 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 £998 million. The new centres will 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-burdened NHS. Crucially, the centres will each be a hive of collaboration, bringing together doctors, businesses and academics. AI has become a growing part of the pharmaceutical and healthcare sectors for several years now, but more recently blockchain has been tipped as the next 20-23.qxp_Layout 1 05/04/2019 13:28 Page 3Pharma Business International 23www.pbiforum.netCOLLABORATIONmajor technology to transform the industry. According to a survey from The Pistoia Alliance, a non-for-profit members’ organisation working to lower barriers to innovation in life science and healthcare R&D through collaboration, more than half of pharmaceutical companies and life sciences professionals are either using or are already experimenting with blockchain. Compare this to the twenty-two per cent when asked in 2017 and the impact the technology is having becomes evident. As is often the case in conversations around blockchain, the traceability benefits tend to steal the limelight. While that’s of course advantageous for the pharmaceutical sector, the technology may have a promising future used in the running and record keeping of clinical trials. The Canadian arm of US tech giant, IBM, has teamed up with pharma company Boehringer Ingelheim in a first-of-its-kind collaboration in Canada exploring this very issue. The two companies endeavour to test the technology in a clinical trial context to see if it provides a decentralised framework that enables data integrity, provenance, transparency and patient empowerment, as well as automation of processes – all of which would ultimately come together to improve overall trial quality and patient safety at reduce cost. A win-win situation from the sounds of it, but there’s a long and winding road of research and regulatory hurdles to overcome before blockchain is ubiquitous across the clinical trials landscape. Collaborations don’t only serve to bring together the best in knowledge and resources, but also to foster innovation. The previously disparate worlds of digital technology and pharma have over the last few years struck a harmony, and collaborations are now working together towards a common goal. We’re witnessing these industries evolving in real-time and the future looks bright for both. © Shutterstock /Panchenko Vladimir20-23.qxp_Layout 1 05/04/2019 13:28 Page 4HEALTH, SAFETY & HYGIENE24 Pharma Business International www.pbiforum.netCleanrooms are controlled environments designed for specialised industrial production, manufacturing or scientific research and, as such, have become more prevalent with the booming biopharmaceutical and biotechnology sectors. Yet despite this obvious importance, cleanrooms aren’t actually a legal requirement in the EU under good manufacturing practices when it comes to the manufacture of non-sterile medical products. As one might expect, however, they are mandatory for the manufacture and handling of sterile medical products. Referring predominantly to air quality, cleanrooms are classified by how clean the air is rather than, say, its surfaces. There’s a specified number of particles allowed per cubic metre and by controlling the environment, manufacturers and research organisations can keep pollutants such as dust, microbes, aerosol particles and chemical vapours, among others, to a minimum. In order to maintain a particle-free airflow, these environments are purposefully designed with specialised filters. It’s not enough to simply put these The need for rigorous health and hygiene levels in the pharmaceutical industry can perhaps go without saying, but some areas require more stringent levels than others – namely cleanrooms. 26 ÁA safer supply chain A safer supply chain 24-27.qxp_Layout 1 05/04/2019 13:28 Page 1Pharma Business International 25www.pbiforum.netHEALTH, SAFETY & HYGIENE© Shutterstock /Gorodenkoff24-27.qxp_Layout 1 05/04/2019 13:28 Page 2HEALTH, SAFETY & HYGIENE26 Pharma Business International www.pbiforum.netfilters here and there, but rather incorporate them into the design of environment itself. Filters will be positioned in such a way that they provide adequate downstream air returns. In vertical flow rooms, for example, low wall air returns around the perimeter of the room rather than directly across it. Maintaining clean air quality is about keeping pollutants out, so staff working in these environments must undergo extensive training. Entering a cleanroom will take place through an airlock and/or air showers. Staff will also be dressed in specialised clothing, though how extensive depends on the function of the room. For some processes and operations, a lab coat, helmet or face mask may be enough, while others require bunny suits with self-contained breathing apparatus. This is prudent in cleanrooms where potentially contagious samples are being worked on, or if highly sensitive samples can be compromised if exposed even to the tiniest pollutant. This all, of course, falls under the wider personal protection equipment (or PPE) umbrella which is prevalent across all inlets of the pharmaceutical industry. Although the gloves, boots, hard hats, lab coats and masks needed might be up to scratch when it comes to function and safety, comfort has traditionally been far from a priority. But the industry is making efforts to strike a balance between dependable protection and to satisfy the need for workers to be comfortable. Workers spend entire shifts, often longer, wrapped up in myriad kinds of protective equipment. More and more, we’re seeing PPE utilising high-performance fabrics which feature moisture management and thermal regulation. Typically, PPE is taken off-the-peg, so as to speak, meaning it doesn’t always fit the way it was intended. Whether too large or too small, staff can be put at risk. There are suppliers specialising in better fitted or even tailor-made PPE which, while requiring a greater investment, will keep staff both comfortable and safe. PPE is a safeguard against numerous different hazards that can be encountered throughout the pharmaceutical supply chain, including industrial and chemical hazards, but one of the biggest is ergonomic. Data from the Health and Safety Executive (HSE), the UK government agency responsible for the encouragement, regulation and enforcement of workplace health, safety and welfare, the biggest occupational injury in the pharmaceutical industry occurs through manual handling. Of those injuries, the biggest proportion involves the back with upper arm injuries a long way behind in second place. Ergonomics is all about designing workplaces, equipment and tasks to suit workers, making the environment safer, easier and more productive. According to HSE, the main ergonomic issues in the pharmaceutical industry concerns working posture. Think stooping over a surface which is too low, or a bowed head and neck over a microscope, a lack of leg room and having to sit in fixed postures – and that’s barely scraping the surface. Fortunately these issues can be designed out, by providing staff with ample leg room, building surfaces of a suitable height, ensuring appropriate seating and so on. Doing so will create a more productive workplace that’s both comfortable and safe. 24-27.qxp_Layout 1 05/04/2019 13:28 Page 3Pharma Business International 27www.pbiforum.netHEALTH, SAFETY & HYGIENE© Shutterstock /Gorodenkoff24-27.qxp_Layout 1 05/04/2019 13:28 Page 4THE ETHICS IN GENE EDITING28 Pharma Business International www.pbiforum.netGene editing offers scientists the ability to make highly specific changes in the DNA sequence of living organisms, effectively customising its genetic make-up. Key to the new wave of gene editing technology is the molecule known as CRISPR-Cas9, which was only discovered in 2012. A kind of genetic scissors, CRISPR offers a relatively easy means of editing genes and, recently, has been used to try and treat adults with deadly diseases. But because of the huge leaps forward in this field and the overall speed of innovation, the discourse around the potential ethical, societal and safety issues is lagging behind. The conversation was thrust into the spotlight last year after a scandal in China forced scientists, governments and the general public to evaluate the ethics of gene editing. In 2018, professor He Jiankui alleged he had created the world’s first genetically edited babies, apparently altering the genes of twin girls so they could not get HIV. Jiankui studied at Rice and Stanford universities in the United States before returning to his homeland to open a lab at Southern University of Science and Technology of China in Shenzhen where he conducted his research. It built on his earlier efforts, where he edited mice, monkey and human embryos in a lab setting for years. Using CRISPR, he says he altered embryos for seven couples during fertility treatments, two of which were implanted into a woman who gave birth to the twins. Jiankui said his goal was not to cure or prevent the inherited disease but rather to try and bestow a trait to resist possible future infection with HIV – a trait that few people naturally possess. He chose HIV specifically because, he says, these infections are a big problem in China. Figures from 2015 reveal that there are over 500,000 people living with HIV in China, demonstrating the overall progress made in the tackling its HIV epidemic which ran rampant in the nineties. In questioning just what drove couples to join Jiankui’s experiment, some have pointed towards societal pressures. In China, people are encouraged to marry young and have a child as soon as possible, so Jiankui can be seen as having preyed on young couples with HIV desperate for a child. He worked with a Beijing-based AIDS support network to recruit couples with a HIV positive male and a HIV negative female and registered as many as two hundred families that expressed interest in the research. The exact motivations of these families remain unclear as the consent form signed at the time prohibits any discussion about the project with others. To date, the parents of the twin girls have not been publicly identified and have not spoken to the media. 30 ÁRedesigning DNA Since first emerging as a scientific tool in the seventies, gene editing has presented a unique ethical dilemma for the scientific community. 28-31.qxp_Layout 1 05/04/2019 13:29 Page 1Pharma Business International 29www.pbiforum.netTHE ETHICS IN GENE EDITING© Shutterstock /u3d28-31.qxp_Layout 1 05/04/2019 13:29 Page 2Next >