< PreviousFINANCE 20 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 moving 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. An organisation that does provide direct funding is Innovate UK, a public body driving Turning research into reality We explore the various ways in which drug discovery and development can be funded. 22 Á 20-23.qxp_Layout 1 12/10/2020 11:01 Page 1Pharma Business International 21 www.pbiforum.net FINANCE © Shutterstock /PopT ika 20-23.qxp_Layout 1 12/10/2020 11:01 Page 2FILL FINISH MANUFACTURING 22 Pharma Business International www.pbiforum.net science and technology innovations to grow the economy. Since 2007, the organisation, billed as the UK’s innovation agency, has invested more than £1.5 billion in innovation, a figure that has been matched 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 is “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. 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 is 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 now 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 eventually raised $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. 20-23.qxp_Layout 1 12/10/2020 11:01 Page 3Pharma Business International 23 www.pbiforum.net FILL FINISH MANUFACTURING © Shutterstock /pogonici 20-23.qxp_Layout 1 12/10/2020 11:01 Page 4FILL FINISH MANUFACTURING 24 Pharma Business International www.pbiforum.net In high demand The coronavirus pandemic has brought extra demand to fill finish manufacturing, an area already seeing growth as well as new challenges and opportunities due to the rising number of drugs on the market, targeted therapeutics and smaller batch sizes. 24-27.qxp_Layout 1 12/10/2020 11:02 Page 1Pharma Business International 25 www.pbiforum.net FILL FINISH MANUFACTURING In light of COVID-19, the importance of and expanding need for fill finish manufacturing, the aseptic filling of drugs into delivery forms from vials to syringes, has been emphasised. The biopharmaceutical industry is rushing to develop vaccines and therapeutics for the novel coronavirus, and it is therefore vital that capacity for fill finish is built up, for an effective vaccine can only be so if it can be made and distributed adequately. With a requirement for shorter manufacturing timelines, fill finish manufacturing capacity is being extended while trials and development are underway. Contract development and manufacturing organisations (CDMOs) are addressing the rise in required capacity due to COVID-19 vaccines and many have entered manufacturing agreements and are making headway on capacity expansions. Programmes such as Operation Warp Speed in the US are also helping to facilitate this as part of actions and investments to accelerate the development, manufacturing, and distribution of safe and effective vaccines. In August, Grand River Aseptic Manufacturing was chosen under Operation Warp Speed, to expand domestic fill finish capacity, for example. Meanwhile, aiding fill finish manufacturing in a different way, in June, $204 million in funds was allocated to Corning to expand domestic manufacturing capacity to produce approximately 164 million Valor Glass vials per year to enable rapid filling and capping methods that can increase manufacturing throughput to ultimately reduce the overall manufacturing time for vaccines and therapies. Outside of the COVID-19-stimulated demand, fill finish manufacturing has been bolstered due to the growing number of drugs hitting the market, with CDMOs embarking on expansion projects and even 26 Á 24-27.qxp_Layout 1 12/10/2020 11:02 Page 2FILL FINISH MANUFACTURING 26 Pharma Business International www.pbiforum.net witnessing backlogs as a result. The global fill finish manufacturing market size is to reach $12.1 billion (US) by 2025, from $7.5 billion in 2020. One of the most critical steps in the drug manufacturing process, fill finish is the final manufacturing stage before a drug is delivered to a patient. When product reaches this stage it has the highest value and it is thus an area where, often, innovation and new technologies are avoided, or adopted conservatively, due to the potential for a negative impact. Diverse pipelines, targeted therapeutics, growth of smaller batch sizes in different containers, and increased recipe changeovers are requiring more flexible, agile, systems that continue to promote sterility. As opportunities and challenges arise in this, the implementation of robotic systems and automation in facilities is in demand. Numerous robotic production lines have been designed for peak flexibility while retaining high aseptic process rates and come with many benefits. One such is that where traditional systems, filling containers in a single line, use up substantial cleanroom space, robots can travel across a 3D space, which would normally involve a lot of mechanical parts, and are capable of completing a number jobs in one go by moving to different process stations instead of remaining in line, filling containers. Space savings can be achieved as a result. In addition use of robotics in fill finish benefits from reduced human intervention. Furthermore, one machine is capable of producing several different products with little changeover time between batches reliably, and using less parts, changeover is low risk - where conventional lines have many parts that must be removed and exchanged for new parts for a new vial size, which is both time consuming and costly, in many robotic lines robots simply need the dimensions of the new vial, and a couple of touches on the human machine 24-27.qxp_Layout 1 12/10/2020 11:02 Page 3Pharma Business International 27 www.pbiforum.net FILL FINISH MANUFACTURING © Shutterstock /Dmitry Kalinovsky interface screen allows the filling of different volume of liquid into different sizes of vials. Making changeover even simpler, with recipe driven processes there is reduced room for human error. Not needing physical adjustments or tool changes, recipes when utilising robotic production lines can be chosen and altered from the human machine interface and guided automatically by advanced machine vision systems. New container formats can also be added to the machine easily, and this does not call for major mechanical changes to the machine. Recipe driven processes enable robots to produce multiple products at high quality levels into different containers and robotic systems can change rapidly between vial, syringe, and cartridge formats. In addition, allowing the design of gloveless isolators, these can run cleaner than conventional isolators and be completely closed, removing risks to a batch. An option here that can fully simplify operations is an all in one system like those including filling equipment, isolator, vaporised hydrogen peroxide decontamination, robot filling system, and fully automated control system with monitoring and recording of system parameters built in. These systems can operate without in-process human intervention once the isolator is cleaned and programmed for a run, enabling repeatability and precision. Any issues that occur are addressed with the control panel or robots. Further, in digitally recording and electronically storing key parameters during the manufacturing process, for example fill weight checks, data can be downloaded for use in batch documentation to remove the manual record keeping burden and as a result minimise human entry error. This proves particularly useful due to the requirement from regulatory guidelines for detailed records of all aspects of the manufacturing process. 24-27.qxp_Layout 1 12/10/2020 11:02 Page 4INHIBITORS 28 Pharma Business International www.pbiforum.net Inhibitors refer either to an agent that slows or interferes with a chemical action or a substance that reduces or suppress the activity of another substance, therefore offering a valuable therapeutic approach to treating various diseases. Unsurprisingly in the outbreak of SARS-CoV-2, investigators, scientists and pharmaceutical companies turned their attention towards inhibitors as a means of developing new therapies. Already this research approach has yielded some important and encouraging results combining pre-existing knowledge with new understanding. For example, drugs containing ethanolamine/propylamine fragments along with heterocycles have shown potential antiviral results. Meanwhile, there is the possibility of controlling COVID-19 by nucleotide analogues. Also, the e class of compounds/antibodies inhibiting interleukin-6 works in antirheumatoid drugs have been found to be useful in alleviating overactive inflammatory responses in the lungs of the patient. One of the key approaches that quickly emerged in the wake of the pandemic was investigating whether pre-existing treatments and medicines could not only mitigate and manage SARS-CoV-2, but whether it could treat it. A variety of treatments were explored in this regard such as antidepressants, antivirals and, interestingly, blood pressure drugs. Now, research part funded by the British Heart Foundation and undertaken by researchers at Kings College London found that there was no link between the use of angiotensin-converting enzyme (ACE) inhibitors, used to treat blood pressure or diabetes, and the severity of COVID-19. The use of angiotensin receptor blockers (ARBs), used to treat high blood pressure and heart failure, also did not worsen disease severity in people hospitalised with the virus. ACE inhibitors and ARBs have been of great interest to COVID-19 researchers as they increase levels of ACE2, a molecule which sits on cell surfaces within the body and acts as the doorway for the virus to enter. The efforts to inhibit COVID In the wake of the pandemic, inhibitors are being used in the ongoing fight against COVID-19 as Pharma Business International explores. 30 Á 28-31.qxp_Layout 1 12/10/2020 11:03 Page 1Pharma Business International 29 www.pbiforum.net INHIBITORS © Shutterstock /LightField Studios 28-31.qxp_Layout 1 12/10/2020 11:03 Page 2Next >