< PreviousLOGISTICS & DISTRIBUTION 20 Pharma Business International www.pbiforum.net © Shutterstock /FOT OGRIN 18-21.qxp_Layout 1 10/06/2021 09:57 Page 3Pharma Business International 21 www.pbiforum.net LOGISTICS & DISTRIBUTION of the day, it’s far more expensive to keep air cool, then it is to warm it up. Doors and loading bays create an immediate but necessary breach in a warehouse’s defences, allowing the cooler air inside to escape via convection currents. What’s more, this is an inescapable consequence, as the ultimate goal of these facilities is to store and ship out pharmaceutical products as quickly as possible to their final destination. As such while it might be result in energy savings to install a number of doors between the cold storage facility, and the loading bays. This only slows down the productivity of the workers within, and how soon they can have the stock shipped out. Air curtains provide a potential solution to this problem, or at the very least minimise the loss of heat at loading bays. A cold store air curtain works by creating a curtain of air that cuts through currents, creating a barrier between the external ambient air, and the chilled temperature within a cold store. The greatest benefit of these systems is not just the ability for the air curtain to minimise energy loss through temperature contamination, but also to allow continual access for any workers. There is no door to be opened or closed, and the curtain is safe for workers to travel through as they deliver and remove palletised goods. Not only does this improve general efficiency within the cold store, but it also enables rooms to be kept at varying temperatures – important when a facility might have to cater for a wide range of pharmaceutical products, that might require varying levels of refrigerated storage. Of course there is more to efficiently running a temperature controlled storage facility than plugging up the entrances. Managing stock within the distribution centre can become increasingly more complex, as the temperatures are kept lower. For instance, machinery and systems that rely on battery power can come under risk, as continued exposure to the cold has a negative impact on batteries – typically resulting in fifty per cent degradation to batter life. This can become a larger concern with the recent move towards electric lift trucks and fork-lifts, which can see vehicles running out of juice at inopportune moments. When it comes to workers within these facilities as well, there are a host of new concerns and problems to be aware of, many of which will require some remedial training for companies moving employees to cold store facilities. In the above example of electric vehicles, staff need to be made aware that a vehicle which is marked down as having an eight-hour battery life, might struggle to manage more than four or five. Changing the labelling on these vehicles can go a long way to preventing problems, alternatively investing in batteries with larger voltages can help minimise the problems. Ultimately the supply chain is what causes a proportion of losses due to cold storage and distribution, and when it comes to plugging the gaps, these are possibly the areas to pay more attention to. 18-21.qxp_Layout 1 10/06/2021 09:57 Page 4TESTING 22 Pharma Business International www.pbiforum.net Taking clinical testing into tomorrow 22-25.qxp_Layout 1 10/06/2021 09:58 Page 1Pharma Business International 23 www.pbiforum.net TESTING © Shutterstock /Sergey Mironov The launch of a new pharmaceutical or medical product is a long road paved with exhaustive, often strenuous research and development. As one of the key stages, clinical trials are a proving ground where new therapies, treatments and medicines can be validated or discovered to be inefficient or just unfeasible on a commercial scale. In any outcome, they provide researchers, clinicians and scientists with valuable insight that will shape future research endeavours and the fate of new product launches. Clinical trials can court controversy, attracting unwarranted media attention and causing a pharmaceutical company’s shares to plummet. Though patient deaths are part of the risk involved in clinical trials, it’s the way in which trials are handled that many take umbrage with. Most clinical trials fail, with their results never finding their way into peer- review journals or in the public arena where they can be picked apart and scrutinised. Little wonder there’s been more vocal calls for changing the way in which trials are organised and, crucially, how they are reported on, irrespective or their outcome. However, instigating this far-reaching sea change isn’t only difficult to introduce, but harder still to maintain. Trials are beholden to patients or the public to generate results from which 24 Á It’s notoriously difficult to get a potential new therapeutic through clinical trials and testing, but digital technologies are helping to make testing more efficient. 22-25.qxp_Layout 1 10/06/2021 09:58 Page 2TESTING 24 Pharma Business International www.pbiforum.net new medicines live and die. The trouble is, it’s participants themselves that can leave researchers with a headache. Clinical trials are a multi-phase process. In most cases, a new drug or treatment will first be tested on a small number of volunteers, with any results being monitored and poured over before it is then tested on hundreds – perhaps even thousands – of volunteers. The bigger the pool of volunteers, however, the likelier the chance that some of them will drop out. It’s an issue that researchers must deal with during any trial and is of particular aggravation during cases where results need to be monitored over time. The average dropout rate of clinical trials comes in at around thirty per cent, which is bad enough before it’s considered that this causes eighty per cent of trials to not finish on time. Given trials are often expensive and difficult to organise and maintain, setbacks such as these can skew data, affect results and eat into funding (which is often limited and not forthcoming). Though there are very valid reasons why participants would need to drop out of a trial, such as individuals having poor – but not critical – reactions to the drug being tested and thus needing to be taken off the roster. But the biggest reason for dropouts is down to poor patient engagement between the pharmaceutical company, or the research team in charge of the trial, and the volunteers. This can be down to several reasons, such as a lack of feedback, or difficulty in allowing people to understand or follow study protocols or even a case of simple motivation. There are so many do’s and don’ts for people in these trials to adhere to, that poorly provided material and lists on what they can and cannot do are likely to frustrate and, therefore, cause them to drop out. © Shutterstock /Den Rise 22-25.qxp_Layout 1 10/06/2021 09:58 Page 3Pharma Business International 25 www.pbiforum.net TESTING There’s no excuse for this in the digital age, however, with apps and social media at a company’s disposal to interact with patients at a moment’ notice. But they’re simply not being utilised. Pharma’s reticence in adopting social media is no secret, though companies are coming around and finding that engaging with consumers and patients via social media is having a meaningful impact. Applying this same approach to clinical trials could create a more harmonious and informed relationship between companies and participants which, in turn, should help to curtail dropouts. Another issue among participates is adherence to the rules of the study. This could be failing to take a set amount of medicine during set times of the day. Given patients can often struggle with medicine adherence at the best of times, they can perhaps be forgiven for slip-ups during clinical trials. Again, digital technologies are helping. There’s a slew of apps designed specifically to help patients take the right amount of medicine on time, which can be utilised for trials. Indeed, companies may wish to create their own app for exactly this purpose and, in doing so, have another set of data to collate. Clinical trials are a time-consuming and costly endeavour but a critical stage in the life of any new medicine, treatment and therapy. Despite this importance, they are beset by setbacks and challenges. Adherence and engagement are two of the biggest issues, but digital technology is helping to create a more transparent and efficient environment in which clinical trials can flourish. With the pressing need for COVID-19 treatments, the pandemic could well serve as a catalyst to transform the way in which clinical trials are undertaken and run. © Shutterstock /sfam_photo 22-25.qxp_Layout 1 10/06/2021 09:58 Page 4FROM DISCOVERY TO MARKET 26 Pharma Business International www.pbiforum.net Bringing new drugs to market is an expensive process. Statistics suggest that for every 5,000 new compounds brought to pre-clinical testing, only one makes it through to final approval. Considering the costs behind those 5,000, it’s easy to see why pharmaceutical companies spend so much on patent acquisition, and why modern medicine is so slow to adapt. A recent article by the NCBI (National Center for Biotechnology Information) put the cost of bringing a drug to market is at $800 million. This takes into account the various hurdles, test and administrative and bureaucratic hurdles a new drug has to jump through and paints a difficult picture for any company wanting to introduce a new drug. It does not take into account drug development, which is labelled as being closer to $2.6 billion. However, recent developments in IT, Blockchain and even artificial learning may provide relief for some. The technology, some of which is still in an early stage, can help streamline many processes. An artificial learning system for instance can process equations several thousand times faster than a human team and can simulate a set series of events hundreds of thousands of times over. In a recent study, Japanese researchers created an artificial intelligence deep neural network to extract information on protein dynamics from images collected by a cryo-electron microscopy. Discovery to market It goes without saying that drug discovery and bringing new products to market is a gruelling process. Recent developments, in no small part driven by COVID-19, may make this process easier in future. 28 Á 26-29.qxp_Layout 1 10/06/2021 09:58 Page 1Pharma Business International 27 www.pbiforum.net FROM DISCOVERY TO MARKET 26-29.qxp_Layout 1 10/06/2021 09:58 Page 2FROM DISCOVERY TO MARKET 28 Pharma Business International www.pbiforum.net Since many drugs work by binding to target proteins, more information on protein dynamics is a commercially viable discovery for any pharma company, and the researchers are confident that the deep neural network will be able to analyse the high-resolution images thousands of times faster than humans could, and without the same element of human error. “By relying only on cryo-EM maps, DEFMap successfully provided dynamics information equivalent to that determined from molecular dynamics (MD) simulations and experimental approaches at the atomic and residue levels,” the researchers said in their study. “Additionally, DEFMap could detect dynamics changes associated with molecular recognition and the accompanying allosteric conformational stabilizations, which trigger various biological events such as signal transduction and enzyme catalysis.” There are already successful proofs of concepts for AI usage in drug development as well. DSP-1181 was a compound created by an AI in a joint venture between Exscientia and Sumitomo Dainippon Pharma to treat OCD. The drug was developed in an astonishing twelve months, far faster than the industry average, and has already received regulatory clearance to undergo clinical trials. If nothing else, this is proof that the concept of AI 26-29.qxp_Layout 1 10/06/2021 09:58 Page 3Pharma Business International 29 www.pbiforum.net FROM DISCOVERY TO MARKET © Shutterstock /PowerUp usage in bringing drugs to market is feasible. COVID-19 may make this more a staple in our future as well. Where before Governments have been content to wait and make pharma companies take years to push a drug through testing, rapidly changing diseases, new variants and the public scare that came from coronavirus may force countries to have a more proactive outlook. AI has already been used in the coronavirus pandemic as well, with some companies using it not to develop drugs but to identify potential candidates for testing of vaccines. Even this, the ability to go through hundreds of thousands of applications and identify the perfect subjects, is a valuable tool that many pharmaceutical companies may soon wonder how they operated without. The advent of AI usage in medicine may have begun in 2007, when an AI named “Adam” became the first non- human entity to discover and record new scientific knowledge when it identified the function of a yeast gene. By 2021, it is already being used in commercial and pandemic control. The market is expected to grow, and these forms of “narrow AI” (Artificial intelligence designed to focus on a narrow problem, usually one thing, and analyse it millions of times over for a solution) may soon become a staple of the industry. 26-29.qxp_Layout 1 10/06/2021 09:58 Page 4Next >