< PreviousM&A ROUND-UP 10 Pharma Business International www.pbiforum.net development and commercialization of transfection reagents, such as TransIT- VirusGEN. Transfection reagents play a critical role in the production of viral vector-based gene therapies. “Viral vector-based cell and gene therapies have demonstrated their potential with more than 20 approvals over the last 10 years and will continue to advance, with a projected growth of 30 percent until 2028,” said Matthias Heinzel, Member of the Executive Board of Merck and CEO Life Science. “This acquisition, combined with our comprehensive portfolio, enables us to provide a truly differentiated and integrated offering to meet the growing demand for these life-saving therapies.” “We have been driving innovation in nucleic acid delivery for two decades,” added Dale Gordon, CEO of Mirus Bio. “Merck’s broad portfolio, scale and global reach, combined with our leading transfection reagents, will help take our business to even greater heights and allow us to serve more customers, and ultimately patients, worldwide.” Biogen - HI-Bio Meanwhile, Biogen is set to acquire Jeito Capital company HI-Bio, a clinical- stage portfolio biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs), for $1.15 billion upfront and up to $650 million in potential milestone payments. HI-Bio has several late-stage clinical development programs for felzartamab, its lead clinical therapeutic candidate, which are aimed at the treatment of four indications of severe IMDs (antibody- mediated rejection (AMR), IgA nephropathy (IgAN), lupus nephritis (LN) and primary membranous nephropathy (PMN)). Travis Murdoch, M.D., CEO of HI-Bio, said: “With its deep development and commercialization capabilities, Biogen is in a position to accelerate the development of new medicines, including felzartamab, for patients with severe immune-mediated diseases. We are excited to combine the HI-Bio team’s expertise with Biogen’s global footprint.” Johnson & Johnson - Proteologix In another deal concerning IMDs, Johnson & Johnson has swooped for Proteologix, a privately-held biotechnology company focused on bispecific antibodies for IMDs, for $850 million in cash, with potential for an additional milestone payment. Proteologix’s portfolio includes PX128, a bispecific antibody targeting IL-13 plus TSLP, which is ready to enter phase 1 development for moderate to severe Pharma Business International 11 www.pbiforum.net M&A ROUND-UP atopic dermatitis (AD) and moderate to severe asthma, and PX130, a bispecific antibody targeting IL-13 plus IL-22, which is in preclinical development for moderate to severe AD. Since AD and asthma are both heterogeneous diseases with different disease-driving pathways in distinct patient subpopulations, targeting multiple pathways offers the potential to deliver high-bar efficacy and remission. PX128 inhibits IL-13-mediated Th2 skin inflammation, an important disease- driving pathway in AD and asthma, as well as TSLP, a mediator of tissue inflammation in AD and asthma. Like PX128, PX130 inhibits IL-13-mediated Th2 skin inflammation. PX130 also inhibits IL-22 to restore the skin barrier and prevent inflammation from environmental triggers, such as allergens. Both assets are designed for infrequent dosing intervals, which offers convenience patients prefer. Together, these pipeline additions demonstrate a strategic approach to build a portfolio of differentiated and complementary bispecifics. Novartis - Mariana Oncology Moreover, Novartis is snapping up Mariana Oncology, a preclinical-stage biotechnology company developing novel radioligand therapies (RLTs) to treat cancers with high unmet patient need. The transaction bolsters the Novartis RLT pipeline and expands the company’s research infrastructure and clinical supply capabilities, supporting Novartis strategic priorities in oncology and RLT platform innovation. The acquisition encompasses a robust portfolio of RLT programs spanning lead optimization to early development across a range of solid tumor indications like breast, prostate and lung cancer – including development candidate MC- 339, an actinium-based RLT being investigated in small cell lung cancer. Under the terms of the agreement, Novartis will make an upfront payment of $1 billion and additional $750 million in payments upon completion of pre- specified milestones. ONO Pharmaceutical - Deciphera Pharmaceuticals Finally, Deciphera Pharmaceuticals, a biopharmaceutical company discovering, developing, and commercializing new medicines to improve the lives of people with cancer, has entered into a definitive merger agreement with ONO Pharmaceutical. ONO will acquire all outstanding shares of Deciphera common stock for $25.60 per share in cash through a tender offer followed by a merger of Deciphera with a wholly- owned subsidiary of ONO, for a total equity value of $2.4 billion. Deciphera brings specialized research and development capabilities in kinase drug discovery, well-established commercial and sales platforms in the United States and Europe, and global clinical development capabilities. In addition to QINLOCK – Deciphera’s switch-control inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST), which is approved in the United States and over 40 other countries, Deciphera also brings a mature, diverse pipeline of best-or-first in class potential medicines, including vimseltinib, DCC-3116 (an ULK inhibitor) and multiple additional oncology candidates. Vimseltinib is a highly selective switch- control kinase inhibitor with successful pivotal clinical data for the potential to be a best-in-class and first-in-class agent for the treatment of tenosynovial giant cell tumor (TGCT), and potentially other indications. The acquisition is expected to enable ONO to build a robust presence in oncology, one of its key priority areas, and also support ONO’s efforts to become a Global Specialty Pharma company. These deals account for just a handful of those recently announced since our last issue, with M&A in the pharma industry fruitful. © stock.adobe.com/wacomkaPROCESS, CONTROL AND AUTOMATION 12 Pharma Business International www.pbiforum.net Necessary automation Necessary automation Pharma Business International 13 www.pbiforum.net PROCESS, CONTROL AND AUTOMATION © stock.adobe.com/I Viewfinder A s companies struggle to get to grasp with labour shortages, heightened demand of products and the challenges the industry is facing, it should come as no surprise that the process control and automation industry is reaping the benefits. Automation is not a new term but it’s still a subject that is so often misunderstood by companies. It is a constantly evolving phenomenon that needs constant work to stay at the head of the game, but also one which doesn’t always make that obvious. An automated line will continue to work even if it is inefficient, and it will look for all intents and purposes like it’s doing it well. In truth, it probably is doing it better than humans could, but it might not be operating as effectively as it could be. In short, while the move toward automation is obvious, the optimisation of it is anything but. There’s no one part of the pharmaceutical process that is specifically designed for automation – it is used in manufacturing, packaging, and can also be used in distribution centres and in warehouses where applicable. However, the primary focus is often on manufacturing and packaging, with the goal of optimising a factory floor to produce products faster, with a higher degree of accuracy, and with reduced risks of problems involving contaminants, hygiene and/or other issues. Quality is often less of a concern given that all products should be expected to be of heightened quality when properly automated and assuming correct control and ingredients. One of the most important methods by which to optimise automation is to understand that the process is more than just the machinery involved, and much more about the processes that tie it together. In many cases, this refers to software systems. Digital control of processes at every stage of the process allows for rapid monitoring, identification of problems, and action to address such. Industry 4.0 (also known as the fourth industrial revolution) has taken too long to be adopted by many, faced in no small part by resistance from labour groups, unions, but also governments not wanting to face the losses of jobs implied by such a change. Automation is about more than just efficiency, however. It is used extensively and almost by necessity in many forms of quality control. The quality production of medications and other pharmaceuticals depends on how well you monitor and control processes, but the focus and attention to detail needed for this task, especially on a large scale, inevitably becomes difficult to manage with manual solutions or human labour. To make sure your laboratory procedure, manufacturing practice and beyond meet the exacting standards enforced by the industry, automation is often – if not always – an essential tool for supervising your products in the making every step of the way. Automated monitoring can be achieved by computerised systems Automation often focuses on manufacturing efficiency, but there are processes in pharmaceutical manufacturing where it is closer to a necessity. 14 ÁPROCESS, CONTROL AND AUTOMATION 14 Pharma Business International www.pbiforum.net which adjust controls whenever the need arises. This boosts interconnectivity for a smooth yet detailed view of every process contributing to development, manufacture and quality control. Whenever there’s an error or flaw in proceedings, sophisticated warning systems can be applied alongside event reporting systems and status updates, leaving little to no space for mistakes and dangers to go undetected. There are multiple stages at which pharma manufacturers are required to gather data about quality, performance and overall consistency, and there just as many ways to go about this. There are a multitude of benefits to an automated line of processes, which we will go into later. But the materials and ingredients in a product and the processes they go through can be automatically monitored for effective control as well, either in-line, on-line, at-line or off-line. In-line control has systems integrated directly into the manufacturing process, and typically within the production line or equipment itself, allowing real-time monitoring of critical parameters. Examples of this may include sensors for temperature, pressure and flow rates, or automated control systems for adjusting process variables, with any of these enabling immediate adjustments and interventions to maintain stability and quality. On-line systems are closely related; these involve continuous monitoring and control of process parameters through dedicated instrumentation which, while separate Pharma Business International 15 www.pbiforum.net PROCESS, CONTROL AND AUTOMATION from the main production line, is still connected to the process equipment. Data can be collected in real-time here also, but processes are instead analysed remotely or within a centralised control room. Control signals may then be sent from there to the process equipment, to adjust parameters based on the information collected. Off-line systems take a step away from the bustle of the production line, instead monitoring activities from a different location. In these instances, samples or test materials are periodically collected from the manufacturing process and analysed in a separate laboratory or testing facility. This approach allows for detailed analysis and quality control checks, though it does not provide immediate feedback. However, the outside view of processes from this mode of testing can be used either for overall process optimisation, or for identifying long-term improvements. Finally, at-line monitoring for control purposes combines aspects of the in-line and off-line methods, collecting samples or test materials at specified points within the production process and analysing them in a nearby laboratory or testing area. This hybridised approach provides a balance between real-time feedback and detailed analysis, allowing for timely adjustments and quality checks in a manner that may not give instant feedback like fully in-line systems, but allows for thorough investigation into potential improvements to process and control. © stock.adobe.com/GorodenkoffTRAINING AND SKILLS DEVELOPMENT 16 Pharma Business International www.pbiforum.net R ecruitment is an area in which almost every pharmaceutical business is struggling in one way or another. In fact, there have been reports that numerous high-profile acquisitions in recent years have been primarily focused on securing new employees, with the IP on hand being just a convenient extra. Clinical research is an area of particular note. A recent study conducted by Cancer Research UK (CRUK) found that 74% of clinical researchers admitted that it was becoming increasingly difficult to return meaningful research within an 18 month period. The situation is further complicated by the fact that doctors have to take time out their careers to study clinical research to earn the PhD, and this is difficult for many to manage, be that for financial reasons or because doctors are also becoming rarer and in higher demand. In a sense, the problem recruiting almost has a supply chain of its own, with doctors and nurses being too high in demand to take time to study for PhDs in specialist subjects that are also in demand. In fact, to take the example of clinical research further, it was noted that in the UK many doctors who do find time and go on to earn a PhD in clinical research don’t actually contribute to clinical research after the fact. Many are too busy with other aspects of their jobs, and while the UK’s NHS is famously underperforming, that doesn’t mean the same factors aren’t being seen in other countries as well. Ageing populations across the world compounded by the A lack of talent Pharma firms are struggling to find recruits with the right degrees and specialisations, and the problem shows no signs of going away. 18 Á A lack of talent Pharma Business International 17 www.pbiforum.net TRAINING AND SKILLS DEVELOPMENT © stock.adobe.com/StockPhotoProTRAINING AND SKILLS DEVELOPMENT 18 Pharma Business International www.pbiforum.net weaker immune systems caused in the wake of COVID have put pressure on the medical sector, and there isn’t enough investment in training and teaching new people valuable degrees. CRUK has attempted to address the issue in their own way by offering £58 million in funding for clinician scientist training in what they hope will “bridge the gap between scientific research carried out in laboratories and clinical research tested on patients.” This is primarily related to cancer given they are a cancer charity, but it is already a bad sign if a charity has to step in to help promote the training of professionals in one of the wealthiest industries in the world. It should be businesses that are leading the charge and, it should be noted, some are. Training initiatives involving bursaries and scholarships in universities are still commonplace in the pharma industry, especially for high-demand positions, but a lot of other industries are also jumping on the bandwagon here – primarily engineering, coding, and more recently AI coding and studies. This increased competition for prospective graduates is by no means unhealthy, but it doesn’t do much to address the shortage in the first place – and while those benefiting from scholarships will be grateful for them, it is unlikely to bring more people into university or to fix the problem beyond a singular key role scenario. Assuming a company can bring in one or two scholarship students every year, that still won’t be enough to cut the shortage down. In terms of developing new teams there have been some advances in technology that came about as a necessity of the pandemic and lockdown. VR and AR training were put into use during those times to some success, but the technology was relatively new and many businesses were inexperienced in how to implement it. Time has developed that experience however, and there are many training companies now specialising in distance learning and VR simulation for training purposes. These can simulate real-life examples of work in a pharmaceutical environment, even simulating stress- factors and crisis moments, and allow new staff (or candidates for recruitment) to show off their skills and how they would act in such a situation. Mobile learning, like working, has seen a meteoric rise since the lockdown, and businesses may need to adopt it more with regards to recruitment as well. While it’s always better to have a candidate come in so they can be judged on body language, clothing and their personality, this is neither convenient nor realistic. Remote interviews may have to become the norm. A norm that has to change however, is the profile of the pharma industry. The sector has, as said earlier, experienced a rise in popularity after discovering the vaccine for COVID-19, but it also faces misinformation and pressure from conspiracy theorists and politicians. More needs to be done to promote a career in the pharma industry, both in terms of the wealth and jobs available – most high paying compared to other sectors – but also more needs to be done to convince people that the work can be fulfilling and interesting. STEM studies have suffered a lot over the last ten years, partly because the sciences seem “boring” to younger students. More needs to be done to show off the kind of work undertaken, and how interesting it can be. This will hopefully cause interest in careers in the industry to grow, but it is only possible if more in the sector reach out to schools and show off the kind of work they do. It is not enough to say the money is there and the jobs are myriad, because that doesn’t mean much to children between the ages of 11-16. With how conscious teenagers are of others and the environment, it might do more to entice them if companies start talking about what they have “achieved” rather than how much they have “earned”, and just how big an impact the sector has on people around the globe. Pharma Business International 19 www.pbiforum.net TRAINING AND SKILLS DEVELOPMENT © stock.adobe.com/GorodenkoffNext >