< PreviousMANUFACTURING 30 Pharma Business International www.pbiforum.net to update the industry. Although it was formed back in 2013, the regulator’s Emerging Technology Team (ETT) has only recently finalised instructing how pharmaceutical companies can work with the group to assist in the development of advanced manufacturing technologies involved in a regulatory submission. It is intended to serve as a centralised location providing a forum for firms to engage with the FDA. Companies have been urged to take advantage of the ETT even at an early stage with advanced manufacturing touted as a sword and shield for US national security. Alongside the security and safety fears of printed medicines, the other major concern is their effectiveness. Studies conducted by Max Shtein, professor of materials science and engineering and the University of Michigan, found that the pure printed medication can destroy culture cancer cells in the lab as effectively as medication delivered by traditional means. The researchers adapted a technology from electronics manufacturing called organic vapour- jet printing. One key advantage of this technique is that it can print a very fine crystalline structure over a large surface area. This helps printed medications dissolve more easily, opening the door to a variety of potential new drugs that, at present, are shelved because they don’t dissolve well when administered with conventional approaches. “Pharma companies have libraries of millions of compounds to evaluate, and one of the first tests is solubility,” Shtein says. “About half of new compounds fail this test and are ruled out. Organic vapour jet printing could make some of them more soluble, putting them back into the pipeline.” And so we come full circle, with one of the latest innovations in this field echoing the first 3D printed prescription drug product approved in the US. Advanced manufacturing techniques aren’t just a means of upscaling production, but rather a road map to addressing the unmet needs of patients. If the notion of personalised medicine is to develop beyond industry rhetoric, than a support system to develop and deploy additive manufacturing needs to be established. Efforts from the FDA and other regulators are encouraging, as indeed are signs from industry and academia, though challenges and dangers still persist. 28-31.qxp_Layout 1 08/04/2021 12:18 Page 3Pharma Business International 31 www.pbiforum.net MANUFACTURING © Shutterstock /FabrikaSimf 28-31.qxp_Layout 1 08/04/2021 12:18 Page 4EMERGING DISEASES 32 Pharma Business International www.pbiforum.net Emerging strains © Shutterstock /Kateryna Kon Emerging strains 32-35.qxp_Layout 1 08/04/2021 12:19 Page 1Pharma Business International 33 www.pbiforum.net EMERGING DISEASES When we talk of emerging diseases, they are normally small outbreaks – devastating in their own right and deserving of research and investment into tackling, but rarely on the scale of shaking the foundations of entire countries. This is what we’ve seen with COVID, however. Make no mistake, a pandemic was predicted before this. Talk of superbugs and dense living conditions made it likely an infection disease would spread “someday” but governments were happy to ignore warnings in favour of maintaining the status quo. This is something that may well have changed. Researchers are now looking into how we can predict emerging diseases, especially emerging pandemics. In their work published in the international journal, Transboundary and Emerging Diseases, Dr Balbir B Singh, Professor Michael Ward, and Associate Professor Navneet Dhand, they found a greater diversity of pathogens affecting humans and animals in high income countries with larger land areas, denser humans populations and greater forest coverage. Increasing human population (and density) was found to be a major contributor in the development of COVID-19 has dominated global news and has many people asking if we can’t predict the next emerging pandemic. Research is already underway. 34 Á 32-35.qxp_Layout 1 08/04/2021 12:19 Page 2EMERGING DISEASES 34 Pharma Business International www.pbiforum.net zoonotic diseases. “As the human population increases, so does the demand for housing. To meet this demand, humans are encroaching on wild habitats. This increases interactions between wildlife, domestic animals and human beings which increases the potential for bugs to jump from animals to humans.” “To date, such disease models have been limited, and we continue to be frustrated in understanding why diseases continue to emerge,” said Professor Ward, an infectious diseases expert. “This information can help inform disease mitigation and may prevent the next COVID-19.” The study also looks at the role of temperature and weather in zoonotic diversity and indicates that man-made climate change, especially on the local level, can also have an impact. The researchers have suggested that sustainable development may help prevent or limit future pandemics, especially if implemented across countries by local governments. Research like this is of particular interest now given fresh strains of COVID-19 emerging and spreading across the globe. As of this date, the new strain that began in the UK is the predominant strain affecting the US. Meanwhile, a new South African strain has been found to have struck the UK, despite lockdown having eased by the 32-35.qxp_Layout 1 08/04/2021 12:19 Page 3Pharma Business International 35 www.pbiforum.net EMERGING DISEASES © Shutterstock /smolaw time of this issue’s publication. These new strains and their ability to develop in areas far away from the original source in China reinforce the information in the study above, showing how diseases can emerge in dense population areas and quickly spread. There is also news of a new strain that may have begun in India, after Health Minister Rajesh Tope reported seeing other behaviours (differing symptoms) in newer patients compared to the norm for COVID-19. While many of these strains are developing in poorer countries currently with large populations densely packed together, the strain emerging in the UK shows that more developed countries are not excluded from the risk. While the sheer infectiousness of COVID-19 may be making this worse than other emerging diseases, it still stands as a litmus test for how governments handle emerging diseases, and the findings from this generation may be used as simulation for future pandemics or even smaller outbreaks of new diseases. It is unlikely given the loss of life, public backlash and crippling impact on economies that governments will – or can even afford to – ignore the risks of future outbreaks. Pro-active action will have to be taken, and this could greatly shake up the emerging diseases market. 32-35.qxp_Layout 1 08/04/2021 12:19 Page 4The Psychedelic Therapeutics and Drug Development Conference 4 – 5 May Online The Psychedelic Therapeutics and Drug Development Conference has been organized to bring together the world’s leading researchers and leaders in academia and industry to discuss the challenges and opportunities facing those engaged in the research and development of psychedelics for various health conditions with considerable unmet need. This event will highlight the progress being made towards regulatory approval of a variety of psychedelics with the potential to treat various conditions, including inflammatory/autoimmune disorders, brain injury, pain, PTSD, anxiety, ADHD, headaches, depression, and opioid use disorder. To find out more, visit www.psychedelics-conference.com. 2nd Manufacturing Assets and Facility Management in Pharma Summit 2021 11 – 13 May Online The 2nd Manufacturing Assets & Facility Management in Pharma Summit is returning in 2021 as the only industry led meeting championing a holistic approach to asset and facility management. It will unite a global community to bring in the next generation of pharma manufacturing. From aging infrastructures to new bio-facilities, it will look at sustainable and reliable design, smart manufacturing solutions to extend asset lifecycles and help you achieve operational excellence. To find out more, visit www.manufacturing-assets-in-pharma.com. iPharma Expo 2021 14 – 15 May Mumbai, India iPharma Expo 2021 is expected to witness around 150 exhibitor’s and 1,500-2,000 visitors footfall from pharma industry. This expo will showcase the latest trends and technologies in pharmaceuticals, drugs and formulations and will bring together eminent personalities from various sectors of pharma, non-pharma and healthcare industries. To find out more, visit shorturl.at/osEW2 Pharma EVENTS © Shutterstock / New Africa Injectable Drug Delivery 12 – 13 May Online SMi is proud to present the 3rd Annual Injectable Drug Delivery Virtual Conference on 12th and 13th May 2021. Part of Europe’s leading Injectable conference series, we will assess innovations in drug product formulation and biologics, innovations in device design, quality management and connectivity for enhanced subcutaneous delivery. To find out more, visit shorturl.at/owEL1 36 Pharma Business International www.pbiforum.net 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. 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. 2nd International Women Health and Breast Cancer Conference 10 – 11 June London The 2nd International Women Health and Breast Cancer Conference welcome you to © Shutterstock/ZenkyPhoto 36-37.qxp_Layout 1 08/04/2021 12:20 Page 1BCMA 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 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. www.pbiforum.net Pharma Business International 37 © Shutterstock/Rido CPhI Discover 17 – 18 May Online If your business is in search of a new product or solution, look no further than CPhI Discover - the new online event for global pharma professionals. Our online pharma marketplace will play host to over 570 exhibitors from across the pharma manufacturing supply chain, with zones dedicated to every step, from R&D and Ingredients to Contract Manufacturing and Pharma Packaging solutions. To find out more, visit www.cphi.com/discover. 36-37.qxp_Layout 1 08/04/2021 12:20 Page 2FEATURES Antivirals exposé Logistics & distribution Testing From discovery to market Innovation Capsules Next issue: Deadline - 2nd June March 2021 REGULARS News Events M&A Round-up Eye on approvals Pharma BUSINESS INTERN ATION AL Visit us at www.pbiforum.net where you’ll find the latest news as it breaks – and why not subscribe to our newsletters so you can have the latest news emailed to your inbox, in between digital issues? @pbiforumwww.pbiforum.netcompany/pbiforum 38.qxp_Layout 1 08/04/2021 12:20 Page 1Next >