Editor’s Note: This article was published in Pharmaceutical Technology Europe’s January 2022 print issue.
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An obvious theme for 2021 has been COVID-19, but the next 12 months will see industry and its people experiencing further change.
The year 2021 has been transitional for the most part, with many stakeholders of the bio/pharma industry getting used to the ‘new normal’ or post-pandemic working life. Industry continues to drive innovation across the board, with continued efforts to tackle COVID-19 and a large number of approvals for a range of products.
Potential big changes in pharmaceutical legislation, however, are on the cards for Europe (1), as the European Commission (EC) continues working on its pharmaceutical strategy for the region, which was adopted in 2020 (2). The reformation of the pharmaceutical legislation is foreseen to be implemented by the end of 2022 and will be the first time the European Union’s rules on how drugs are made, approved, and sold have been comprehensively reviewed in 20 years (1).
For Jürgen Hönig, pharmacist, senior director, Regulatory Business Intelligence at PharmaLex, the expectations for the year have been surpassed. “Although the pandemic has tremendously influenced the social and economic environment, the pharma industry has demonstrated that by having established robust process it has been possible to maintain the supply chain,” he says. “Furthermore, it has been shown that how medicinal products for the treatment of COVID-19 and related diseases were developed in a short time using creative and holistic approaches and in compliance with regulatory requirements.”
“The obvious theme [for 2021] has been the turnaround of COVID-19 vaccines, magnifying trends already seen before and showing that promising new technologies can actually hold their promise, and that it is possible to optimize drug development to speed up delivery,” states Christian K. Schneider, MD, head of Biopharma Excellence and chief medical officer (Biopharma) at PharmaLex.
Editor’s Note: This article was published in Pharmaceutical Technology Europe’s January 2022 print issue.
A surprising trend from 2021 has been the rapid adoption of digital technologies in clinical trials, Schneider notes. The use of such technologies has enabled the decentralization of readouts in clinical trials through mobile phone applications, he adds. “Finally, we’ve seen more companies diversifying their portfolios and investing in therapies for rare diseases so that advanced therapies, and in particular, gene therapies—which were deemed experimental and risky when I was involved with the European Medicines Agency’s Committee for Advanced Therapies some 10–12 years ago—take centre stage,” Schneider continues. “Cell therapies, by comparison, may have slipped behind a bit—but will catch up.”
The year’s expectations were unsurprisingly centred around COVID-19 for Martin Lush, global vice president, Health Sciences, NSF International, who revealed that despite there being some successes for the industry over the year there were also some disappointments. In terms of achievements, the pharma industry has surpassed all expectations in turning around safe and effective vaccines at ‘high’ speed and has coped with COVID-19 disruptions remarkably well, he emphasizes.
However, the fragility of the supply chains, as demonstrated by the pandemic, has persisted with continuing drug shortages occurring, and governments have failed at unifying efforts to make the whole population safe as is being proven by the Omicron variant. “We are not safe until we are all safe,” Lush adds. “This can only be achieved by a global collaborative focus on getting as many needles in as many arms as possible, starting with Africa. Africa will remain a petri dish for COVID-19 for decades to come. More variants are mutating away as we speak. Two things are certain for 2022: more disruption and more uncertainty. If I were a CEO, I would be obsessing about how I look after my people and how I become really agile.”
Gabriela Marton, director of Regulatory Affairs, Quality and Compliance at Arriello, also agrees that 2021 progressed as anticipated, due to the pandemic and resulting focus around vaccines development. “ was a year in which all the important players in the biological pharmaceutical industry strived and, in some cases, succeeded in developing their own vaccines against the SARS-CoV-2 virus,” she says. “Those that had already achieved this in the previous year, meanwhile, continued with the task of gathering safety data to support the vaccination scheme.”
Furthermore, 2021 bore witness to restructuring of Big Pharma, in the guise of acquisitions and partnerships to support biotech business growth, thanks to the high demand for medicines to treat diseases in specialist therapeutic areas, such as oncology, autoimmune, metabolic, hormonal, cardiovascular, neurological, and inflammation and infectious, Marton states. “I would say that this is a continuation of trends seen during the past five years, but with a faster pace due to the pandemic,” she notes.
During the course of 2021, face-to-face events started taking place again after an unprecedented hiatus due to the pandemic. In attending a pharma conference, Lush revealed that despite feeling better informed on his departure, he was also highly concerned as delegates were seemingly discussing quite different topics and trends to those that were presented by the industry experts during the event.
“In short, the experts were focused on the science whilst those at the coal face were focused on their people,” Lush says. “[The workers] are worried about the possibility of massive attrition and the war for talent. They want to know more about organizational agility (via simplification), so they can pivot at the drop of a hat. They are having sleepless nights about managing, leading, and motivating their teams in a world gone crazy. They want to become expert ‘risk-based’ decision-makers. They want guidance on fast and effective change management. They want to make their organizations more risk smart and less risk-averse—but they do not know how to achieve this. The disconnect between the experts and the workers is now causing me sleepless nights!”
However, there will also be promising potential in digital technologies, according to Hönig, who believes that technologies, such as artificial intelligence (AI), digital transformation, and cloud technology, will facilitate the translation of languages and provide industry with an open platform for discussion. This aspect will, in turn, accelerate drug discovery and development, as well as allow the decentralization of clinical trials, he states.
Additionally, personalized medicine will be a prominent trend in 2022 for Hönig, who states that these medicines will help tailor options for patients and optimize the effectiveness of treatment and hence improve patient outcomes. There will also be implementation of the “lessons learnt during the pandemic,” Hönig continues, which will afford the industry smoother approval and decision processes.
A continued focus on biotech, automation, and AI development will happen over the course of 2022 as a result of the high demand in certain therapeutic areas and the need for faster ways to collect and manage data, adds Marton. “Many big pharma companies will continue down the path of externalising services for small molecules and/or known molecules maintenance, to keep their focus on novel molecules,” she explains.
There is the additional prospect of the European market gaining more interest from start-ups from the United States and small companies that have a modest portfolio of innovative products thanks to the evolving legislation in the region allowing accelerated approvals, Marton continues. “The pandemic highlighted how quickly changes can be triggered, and I expect this rhythm to be maintained,” she says.
“The emergence of pre-competitive industry consortia is promising. During the pandemic, we have seen smaller [consortia] forming around co-development, and now with new technologies, we’re seeing a growing desire by companies to join forces so that they don’t duplicate effort via individual development programmes,” Schneider highlights. “We’re starting to see evidence of regulatory agencies working together more, which I hope will lead to greater convergence of regulatory frameworks. We certainly need that to improve speed to market with new treatments. The UK Medicines and Healthcare products Regulatory Agency has now joined the Australia-Canada-Singapore-Switzerland Consortium. This has fuelled the building of a strengthening regulatory player, which may prompt a fresh look at other regulators’ frameworks towards increased harmonization and reduced complexity.”
As mentioned earlier, the EC is seeking to overhaul the pharmaceutical legislation for Europe by the end of 2022. As a part of the changes, Schneider specifies that it would be good “to see the cost/benefit of a drug or therapy (the payer’s role) addressed in the same uniform way as risk/benefit (the regulator’s role) in Europe.” Under the current rules, reimbursement is a complex issue due to the fact that each member state of the EU makes its own decision on this matter, Schneider adds. As a result of this complexity, there can be much negotiation and, hence, delay in access to medicines, he explains.
“I’d also like to see novel methodologies finding a more permissive and open climate, so that there is faster regulatory action not just for advanced therapies and small and medium-sized enterprises, but also for academia, companies of larger sizes, and those working with other therapies,” Schneider says. “A review of incentives is needed: these are currently exclusive to only a few stakeholders.”
“I would expect that the regulatory processes across the EU need to be modernized to keep pace with the new development of medicines,” asserts Peter Gough, vice president, Pharmaceutical Services, EMEA, NSF International. Certain regulatory challenges need to be addressed, Gough continues, such as point-of-care manufacturing of medicines, monitoring of supply chains to identify potential areas of shortages prior to affecting patients, improving measures to fast-track new vaccines and therapies in the event of future pandemics, and reducing bureaucracy to make the EU more attractive for investment and speed up the ability to bring innovative medicines to market.
Certain changes, such as those that have already been announced and included in the ‘Pharmaceutical Strategy for Europe’ will more than likely be implemented, Marton confirms. These changes include revisions to the centralized procedures with respect to complexity, timelines, and identification of routes for different types of products, and an even more centralized approach across EU authorities for evaluations, inspections, decisions, and so on, she adds.
“The pandemic showed that there is a need for fast evaluations, authorization, and decision-making, which the previous, 20-year-old legislation couldn’t provide for,” Marton emphasizes. “What I would like to see changed is the way that national authorities across the EU implement EU legislation. I would like to see that done faster and more clearly, so that we avoid a long and ambiguous transition period. I would like to see more guidance from national authorities on how to fulfil local requirements.”
“The rules of maintenance of marketing authorization, especially the variation system, are complex and not currently easy to navigate,” adds Hönig. “And so, a facilitation of such rules would be welcomed.”
However, Hönig cautions that any revisions should build upon the existing legal acts that have already been implemented over the past two decades and proven to be a good basis for pharmaceutical legislation. “The revision should ensure a reliable EU regulatory system which is attractive in a competitive global environment with fast decisions and transparent approval times allowing for flexibility and lean maintenance procedures,” he says. “A revision of the variation system would lead to a more efficient and less administrative regulatory procedure. Furthermore, the revision should take into account the technical development of the last decade and should foresee future developments.”
Schneider is encouraged by the fact that Europe is aware of the need for international regulatory convergence, which will help the EU become a more attractive market as it will be easier to navigate for companies with treatments already approved in other territories. “Patient centricity and empowerment are other big themes, and we’re seeing regulators becoming more directly involved here,” he notes. “For rare diseases, [patient centricity] is particularly important as a patient’s appetite for risk might differ from their doctor’s or a regulator’s, for example.”
Further issues that will be better addressed with closer collaboration of regulatory bodies and patient groups include the use of placebos and the issue of clinical trial readouts being subjective and possibly not standing up to regulatory rigour, Schneider confirms.
“Medicinal product research, development, and manufacture is a global industry, and the EU needs to help ensure that it remains attractive to both new start-up companies and Big Pharma. Most generic medicinal product manufacturing has already moved outside the EU with the resulting supply chain vulnerabilities,” Gough stresses. “If the EU gets the revised legislation right, the impact [on industry] should be positive, but if it just adds more complexity and restrictions, it will be very negative as the industry will continue to migrate to more agile regions.”
European bio/pharma is a source for innovation and development for novel medicinal products, Hönig asserts, with many EU countries home to well-equipped manufacturing sites for bio/pharmaceuticals that are proven to manufacture high-quality, safe, and efficient products. However, more recently the vulnerabilities of the supply chain have become apparent, mainly as a result of discontinuation of supply of important active ingredients or the needed finished products manufacturers in certain Asian regions, he specifies.
“The reasons for [these issues] range from a lack of raw materials, insufficient quality, price increases, problems in logistics, and political decisions,” Hönig says. “In order to become less dependent on these numerous imponderables, and to be able to guarantee EU consumers a fair and necessary supply, pharmaceutical companies will relocate production or parts of it to existing manufacturing sites in the EU or will set up new manufacturing sites.”
Existing non-harmonized reimbursement procedures are of particular concern for Hönig, who believes that in many EU member states, procedures are not fit for purpose and forming part of the underlying reasons as to why production is forced out of the region. “Certain regulatory flexibility will contribute to more security of supply,” he confirms. “Creating unnecessary regulatory and financial burdens for the industry will not contribute to a solution.”
The pandemic has clearly shone a light on some supply chain issues, concurs Schneider, not least of all the issues of shipping ‘fragile’ products, such as messenger RNA vaccines, across distance. “For gene or cell therapies—individually manufactured and with a very short shelf life—we see patients needing to come to the medicine, rather than the other way round. Either this requires a very rapid and solid supply chain, or the creation of special centres near hospitals where patients can readily access the treatments they need,” Schneider emphasizes. “An appropriate regulatory framework could help enable this.”
For Marton, a number of changes that have already been evident in the bio/pharma industry over the past five years will force companies to approach their business differently. “As mentioned, the pandemic highlighted the potential for and impact of accelerated development and approval; then there’s the growing emphasis on specialist therapeutic areas,” she says. “In addition, newly-implemented clinical trial legislation will come in to support companies’ growing interest in new and innovative products.”
In Marton’s opinion, 2022 will more than likely be the year when companies will need to define their direction and targets for the future. “Legislation will bring the need for greater transparency across the supply chain and product stocks, so we can expect to see companies preparing to implement the new rules, with execution over the following years,” she adds.
When predicting what awaits the industry for 2022 and beyond, Lush reveals that COVID-19 disruption is here to stay. How disruptive the virus may be, however, will depend upon the work of the governments around the world, he asserts. “One thing is for sure—the virus is not wasting time,” Lush adds. “Pasteur famously said, ‘the Microbe will always have the final word’. We have the science and the pharma industry to prove Pasteur wrong, but we just need the political will. The ability to pivot at short notice will be key, which requires simple systems, fast (bottom-up) decision-making, and a world-class change management system to keep track of everything.”
More drug shortages will be on the cards as China and India continue to prioritize meeting domestic demands, Lush continues. “Reshoring manufacturing to improve resiliency sounds great in theory—but will take years to accomplish. Supply shortages will be with us for some time,” he says.
Post-pandemic clearance of the backlog of regulatory audits will require a more nuanced (hybrid) risk-based approach, according to Lush, which could potentially affect compliance levels. “Within the next 15 years, medicines based on mRNA platforms and technology will account for 30–35% of approved meds and turn the traditional vaccine business model on its head,” Lush adds.
Pricing pressures will ramp up as governments attempt to pay for increasing healthcare costs with very little money, Lush remarks. As a result, companies will need to simplify and reduce costs or watch margins evaporate, he specifies. Governments will also increase pressure on sustainability issues. “Sustainability ‘words’ must turn into actions,” Lush stresses. “One of the major contributing factors to this pandemic is climate change. Shockingly, the pharma industry generates 11–12% more carbon emissions than the automobile sector.”
In addition to these trends, Lush expects there to be massive growth in in-vitro diagnostics and combination products as industry “moves from a treatment-based ‘disease care’ system to a ‘prediction and prevent’ healthcare system,” he notes.
Finally, Lush iterates the importance of ‘the people’ in 2022. “When asked ‘what it takes to manufacture high-quality medicines consistently,’ my great friend and mentor, David Begg, responded, ‘It is all about the people—stupid!’ Before we make medicines, we must make (and look after) our people,” Lush summarizes. “We have to rethink our recruitment and retention strategies to make our workforce more diverse in every regard. We need more rebel thinkers and fewer clones. We cannot solve many of the challenges we face with old thinking. Of course, you do not have to do any of this—survival is not compulsory.”
1. EC, “European Health Union: Towards a Reform of EU’s Pharmaceutical Legislation,” ec.europa.eu, Press Release, 28 Sep. 2021.
2. EC, “Affordable, Accessible, and Safe Medicines for All: The Commission Presents a Pharmaceutical Strategy for Europe,” ec.europa.eu, Press Release, 25 Nov. 2020.
Felicity Thomas is the European editor for Pharmaceutical Technology Group.
Pharmaceutical Technology Europe
Vol. 34, No. 1
When referring to this article, please cite it as F. Thomas, “Changes Afoot: 2022 Outlook for Pharma and its People,” Pharmaceutical Technology Europe 34 (1) 2022.