More than a year has passed since national lockdowns, social distancing and face masks became a regular feature of life in countless countries around the world. The Covid-19 pandemic has, at the time of writing, claimed more than 2.8 million lives worldwide, from more than 127 million total cases.
While the startlingly rapid development and rollout of vaccines has brought the prospect of a light at the end of a very dark tunnel, the world still has some way to go before the SARS-CoV-2 roller coaster begins to plateau. Viral variants have emerged to test the immunising capabilities of first-generation vaccines, while international debate continues around how best to roll out unprecedented global vaccination programmes to all countries, no matter their level of wealth.
‘Long Covid’, meanwhile, remains a difficult-to-quantify long-term health challenge, with some people who have recovered from the virus suffering serious ongoing symptoms and organ damage – a phenomenon whose exact toll may not become clear for months or years after the initial pandemic crisis has passed.
While Covid-19 continues to transform daily reality as we know it, the life sciences industries have been adapting at a breakneck pace, initially to support the global response in the early days of the outbreak, and now to point the way towards long-term recovery. But what are some of the key lessons that life sciences companies – from medical device firms and drug developers to clinical research organisations and healthcare data specialists – can take away from the world’s pandemic year?
Essential supplies: a bottleneck in the next pandemic?
In February and March 2020, as the world began to recognise the biological precipice it was facing, personal protective equipment (PPE) was a key item on every government’s shopping list. Basic necessities for healthcare workers, from face masks and shields to protective gowns, were in short supply in many countries.
In the UK, around half of doctors working in high-risk areas reported shortages of gowns and goggles, according to a British Medical Association survey, with many advised to reuse disposable equipment as a last resort. Ventilators, a vital component of treatment for severe Covid-19 cases that require intensive care, were also painfully stretched by the sudden uptick in demand.
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To prepare for a future pandemic that is almost certain to arrive – sooner or later – governments must consider their own domestic manufacturing bases for essential equipment such as PPE and ventilators, as well as diagnostics, and whether these bases have the capacity to quickly ramp up production. While the nature of the next big biological threat can’t be predicted, countries with a strong manufacturing sector were able to respond best to the sudden outbreak of Covid-19, with the likes of South Korea and Germany able to scale up test kit production and distribution in the all-important early weeks of the pandemic.
“Globalisation has worked at one level, but what [Covid-19] has demonstrated is that it can all fall down if your suppliers are from one place only and their production goes down,” Keele University senior lecturer in medical device design Professor Peter Ogrodnik told Medical Device Network last year. “Our supply chains are all too predicated on buying the equipment from somewhere else. It’s very hard to kickstart an industry to replace that when the expertise isn’t there domestically.”
Medtech companies, of course, should be on hand to partner with governments looking to bolster domestic manufacturing, or to work on the scalability of their systems to position themselves for a similar crisis in the future.
Rapid diagnostics are vital, but reliability is key
Clearly, rapid and reliable diagnostics will always be central to an effective response to an emerging infectious disease. From point-of-care or home-based Covid-19 tests to mass screening systems and the antibody tests that can confirm that a user has already recovered from a Covid-19 infection, the ability to rapidly test citizens has been an invaluable tool to channel early cases to the appropriate care, and to build a fuller picture of the virus’s spread within and between countries.
This has brought a financial windfall for diagnostics manufacturers and medtech firms that were well placed to capitalise on the demand. Abbott Laboratories has built a portfolio of eight FDA-approved Covid-19 tests, from molecular and antigen diagnostics to serology, and reported bumper full-year profits for 2020, driven by its diagnostics business, which saw sales soar by 110% to $4.35bn in the fourth quarter of the year alone.
But reliability is the key, and many tests that have been pushed to market at record speeds have not proven fit for purpose. Key regulators in the US, Europe and beyond were under intense pressure to open the floodgates for diagnostics to become available, and that led to many cases of inaccurate or potentially misleading kits being used. In February, key figures at the FDA admitted that the agency’s early policy of allowing antibody tests to be marketed without even securing emergency use authorisation was a mistake.
“Government officials began touting the potential usefulness of these tests for reopening the economy, and insurance coverage was provided for uses not supported by science and not in keeping with the limitations that the FDA had laid out,” wrote FDA directors Jeffrey Shuren and Timothy Stenzel in February.
Post-Covid clinical trials may never be the same
Covid-19 presented a clear challenge to developers of novel therapies, vaccines and devices designed to tackle the pandemic – how do you test your drug on sufficient numbers of people without putting them in danger from a social distancing standpoint?
The digital technologies involved in decentralised clinical trials (DCTs) – clinical studies that administer medicines and monitor their response while they are at home, rather than requiring them to attend a physical trial site – have existed for years before the Covid-19 crisis, but the pandemic has turbo-charged their adoption.
According to GlobalData surveys, 60% of contract research organisations expect DCTs to be in frequent use within the next two years, and the transition has already begun. Decentralisation is one of the key clinical trial themes coming out of the industry’s Covid-related challenges, and entirely site-less trials, such as ObvioHealth and RedHill Biopharma’s Phase II/III trial of the latter’s investigational Covid-19 therapy RHB-107, are now in progress.
“The uptake of decentralised clinical trials as definitely been accelerated by Covid but I firmly believe that now they are becoming the new normal and have made us challenge our risk profiles and made us more efficient,” IQVIA senior vice president and chief digital officer Nagaraja ‘Sri’ Srivatsan told Clinical Trials Arena in February. “I think this is the way of the future and it will make the processes more efficient.”
Setting a new pace for vaccine development
Given that, historically, vaccine development programmes have been known to require a decade or more before approval, few would have expected that multiple Covid-19 vaccine candidates would progress through trials and win approval from the FDA and EMA within a year of the pandemic’s onset. But front-runner vaccines from AstraZeneca/Oxford University, Pfizer/BioNTech and Moderna have done just that, with second-generation jabs from the likes of Johnson & Johnson and Novavax not far behind.
The speed at which Covid-19 vaccines have been developed and rolled out is a banner achievement for the pharma and biotech industries, and the scientific community more broadly. It is also a testament to the power of large-scale government funding and unprecedented cross-sector collaboration to achieve a universal goal.
“Collaborations happen in normal times, but the number and range of partners and the rapidity with which they have formed [to fight Covid-19] is beyond the normal,” said UCL research fellow Dr Beatrice Melinek last year. “Certainly underwriting the risk has played a major part – but I believe that many in the sector are also motivated to be part of the solution.”
2020 was also the grand debut of vaccines based on messenger RNA (mRNA) in human use – the Pfizer/BioNTech and Moderna vaccines both adopted the mRNA approach, which introduces engineered, single-stranded mRNA molecules providing the biological instructions for cells to pump out virus-killing proteins, and this has been one of the keys to the speed of their respective development. The bolstered profile of mRNA has also prompted more activity in the mRNA-based cancer vaccines space, though it will likely be some time before the technology is ready to tackle more complex oncological targets.
Of course, with lighting-speed development comes some level of safety risk, and the AZ/Oxford vaccine is currently mired in concerns over a potential link between the jab and rare blood clotting events, which has seen some countries halt vaccination in younger citizens, while an Oxford trial of the vaccine in children and adolescents has also been paused.
Equitable access is a key challenge
Vaccines and effective treatments are the way out of the Covid-19 disaster, and as World Health Organization (WHO) director-general Dr Tedros Adhanom Ghebreyesus has said, none of us are safe until everyone is safe. To reach a level of global herd immunity that could finally show the virus the door, equitable access for all countries – rich and poor – is essential.
Predictably, wealthy nations have tended to dominate orders of first-generation vaccines through exclusive bilateral deals, with many low and middle-income countries struggling to find affordable supply lines. Global programmes such as the WHO’s Access to Covid-19 Tools (ACT) accelerator and Gavi’s COVAX Facility have worked to address the imbalance, but developed nations in Europe, North America and elsewhere undoubtedly still hold the advantage in vaccine access.
Suggestions have also been made at the World Trade Organization to waive intellectual property rights, including patents, for vaccines, to allow developing nations to kickstart domestic production and diversify sources of supply. Naturally, the pharma industry and developed nations have pushed back firmly against this idea.
Adding to the challenge is the geopolitical tension that typically accompanies an international crisis, and Covid-19 has proved no exception. Protectionism is on the rise as countries compete for limited vaccine supplies, and international spats have been common, from the EU/UK disputes around exports of the AZ vaccine to US allegations of Russian government-backed disinformation campaigns targeting Western-made vaccines.
Health crises offer a chance for pharma to rebuild its public image
For an industry in the business of saving and improving lives, it’s perhaps surprising that pharma traditionally ranks near the bottom of tables when it comes to public perception and trust. But given its decisive contributions to global response to Covid-19, the pandemic may represent an opportunity to reset the conversation and bolster its embattled public image.
“I think this really is an opportunity for the pharma industry,” Practio CEO Mads Mikkelsen told Pharmaceutical Technology. “The pharma industry has been working very closely with policymakers in communicating how they’re working with the development, progression and distribution of the vaccine. I think that can all contribute to increasing the public trust in pharma companies.”
Of course, capitalising on this opportunity requires a sustained demonstration from pharma firms that they have humanity’s best interests at heart, and that may clash with the industry’s profit-related obligations to shareholders. The pandemic has, if anything, heightened tensions around drug pricing, particularly in the US, which pays for speedy access to new innovations with the highest drug prices in the world. And stories like Pfizer’s alleged bullying tactics in vaccine negotiations with Latin American countries certainly don’t help create the impression that the industry is ready to rescue its reputation.
M&A held up in recession-resistant life sciences sector
With repeated lockdowns driving projections of deep global recession from the International Monetary Fund, the life sciences sector once again proved its resilience against economic downturns in 2020.
Granted, clinical research has struggled to maintain productivity amid lockdown conditions and many companies that found themselves ill-prepared for the pandemic have been laid low. But as investors and prospective acquirers bounced back from the initial shock of Covid-19, life sciences deals have been made at a solid pace, even if they’re not quite as high-value as in 2019, a milestone year for mega-deals.
“It is becoming clear that pharma is doing less and less in-house R&D and companies are [instead] building a pipeline through acquisitions,” Goodwin lawyer and life sciences partner told Pharmaceutical Technology in February. “The M&A side will go from strength to strength and we will probably see more activity there.”
In the medical technology sector, meanwhile, the ongoing (though maturing) demand for Covid-19 diagnostics and screening technologies will likely continue to drive growth and deals activity in 2021, and the physical restrictions of 2020 made it an unprecedented growth year for digital health technologies.
“2020 set a record for the most funds ever raised in the digital health sector, with more than $14bn going to startups and disruptive technologies,” said Emocha Health CEO Sebastian Seiguer in January. “With all that cash, M&A activity will be strong in 2021.”