Ensuring the Pharmaceutical Industry is Prepared for a Future Pandemic

The COVID-19 pandemic has stretched healthcare suppliers, organisations, governments and healthcare professionals to their very limits, locking down the world like never before. Healthcare industries, which were already under huge strain across the world, have been placed under unprecedented pressure. But, as the saying goes, there’s always light at the end of the tunnel and we’re beginning to see positive signs. While there is still a threat of a second wave on the horizon, deaths and infection rates are declining and the recent discovery of dexamethasone as a viable treatment for the sickest patients has been greeted with enthusiasm by the scientific community. Similarly, Oxford University appears to be making some progress on the vaccine front, with a drug developed that’s safe and triggers an immune response.

With such a focus on drug development and also on searching for existing drugs that can help the fight against COVID-19, the pharmaceutical industry has been central and will continue to play a leading role in the months to come. However, it’s not been without difficulty. COVID-19 has had a significant impact on all sectors of the economy, including pharmaceuticals. On the one hand, new opportunities have opened up; first of all, the involvement of companies in the development of new drugs for the treatment of COVID-19, as well as in the clinical trials of these drugs and in the future in production and distribution.

Secondly, the state budgets allocated to healthcare in many countries were significantly increased and a fairly large part of this funding was directed to the procurement of medicines.

But on the other hand, despite the stereotypes that pharmaceuticals are one of the few industries for which the pandemic and subsequent quarantine have brought certain benefits, the pharmaceutical industry has suffered from quarantine no less than other industries.

Like many other industries, pharmaceuticals are often not a vertically integrated business. In order to create, properly register, produce and subsequently market a medicine, the efforts and involvement of many companies, sometimes located in different countries and on different continents, are needed.

For example, we produce a generic drug at a factory in India, buy raw materials for this drug in Japan and after production, the drug goes to a distribution warehouse located in Europe. After that, the drug is delivered to different countries, including via air delivery, all whilst bearing in mind that the drug has a rather short shelf-life and in some countries it is impossible to deliver the drug with a residual period of less than, for example, one year. This example on one specific drug shows how vulnerable the pharmaceutical business is.

Preparing Ourselves Undoubtedly, the way we have approached this pandemic will become a case study which will inspire our response to future global disease outbreaks. So, with this in mind, what are the lessons that can be learnt to ensure that the pharmaceutical industry can respond quickly and definitively to the next pandemic? The answers are many, but finding them will be key to saving lives.

1. Applying Unique Approaches to a Unique Virus Scientists and pharmaceutical experts have faced myriad challenges, as is to be expected from COVID-19’s status as a novel coronavirus. While similar in ways to the viruses that caused the SARS outbreak of 2002–2004 and the MERS outbreak that began in 2012, COVID-19 has proven to be much more transmissible, with its presence in the vast majority of countries now confirmed.

Essentially, those charged with coming up with effective treatments or a vaccine have had to start from scratch, while contending with the various restrictions brought about by global lockdowns. Combined with a growing sense of panic amongst the general public and the subsequent need to move at breakneck pace to reach a solution, it is fair to say times have been tough.

However, there have been a number of success stories that underline the vital work that the pharmaceutical industry does, and it is these that should serve as examples of how to approach the future.

2. Speed and Collaboration are Key The scientific community has come together to discover ways to protect against the virus at a speed never seen in our lifetimes. The virus having originated in China, much of the essential groundwork was also completed by the Chinese, ensuring the rest of the world at least had some degree of preparedness before the virus reached their shores.

The pace of developments since then has been relentless. Teams around the world are working furiously to develop an effective vaccine, with promising results seen already. As far as viable treatments are concerned, the evidence of remdesivir reducing patient recovery times shows significant promise, and the discovery of dexamethasone – an affordable, widely available steroid in use since the 1960s – in improving survival rates has led to the UK government approving it for immediate use.

The bottom line here is that speed and collaboration have been hugely beneficial in turning the tide against COVID-19, and will continue to be so in the ongoing battle.

It is necessary that state regulators, together with relevant organisations and with the involvement of other players in the pharmaceutical industry, develop principles for the work of the healthcare industry in general and pharmaceuticals in particular in a pandemic and other possible scenarios. In this case, everyone will understand how they act in certain conditions and procedures should be simplified, including clinical trials and drug registration. Any future pandemic will only be successfully beaten if pharmaceutical companies, experts, scientists and governments are willing to spring into action and work together for the common good.

3. Analysing Big Data Data gathering and analysis have grown

in importance in recent years for all businesses, aiding everything from customer interactions to HR functions. For a company in the retail sector, for example, unifying a range of disparate datasets and drawing insight from them can give an organisation that all-important competitive advantage. The situation is no different for the pharmaceutical industry: when it comes to identifying the right treatments and approaches in a future pandemic, data will play a leading role.

Of course, data already provides the basis for the treatment of many diseases. Before a new medicine is approved for use, huge amounts of data from clinical studies will be examined and compared, before a final decision is made.

However, there is more we can do to make data analytics processes stronger. When independent studies on a particular drug are carried out in one country, experts in other nations may be unaware that these studies exist if they do not have the ability to find and process vast amounts of data.

This is where emerging technologies such as artificial intelligence (AI) and machine learning will make their mark. By automating data analytics and applying AI capabilities where possible, the management of large datasets becomes considerably easier, and insights can be drawn from this information much more readily. Finding ways to conquer data – coupled with the aforementioned collaboration between experts – will revolutionise the industry.

4. Optimising Logistics Sadly, when the pandemic hit, we quickly discovered that many nations and their health services were underprepared when it came to having the right equipment and infrastructure in place to respond rapidly. Testing for Covid-19 took a long time to get fully off the ground in the UK, and the early scramble for ventilators underlined the fact that the country had been caught off guard.

Logistically, the production of medicines is a major operation even outside of a pandemic. For example, a drug may be produced in India with raw materials developed in Japan, before being sent to a warehouse in Europe from which it is then distributed. This all needs to be carried out with the medicine’s short shelf-life in mind.

Currently, there are still problems with the supply of raw materials and with production. Interestingly, prior to the pandemic some organisations didn’t pay attention to the geography of where they buy raw materials, where they produce and where they deliver. Geography has always been important, mainly in terms of cost and delivery time, but the possibility of delivery not happening would never be in question. What we are seeing now is that the more geographically concentrated production activity, API, packaging production, laboratories, production sites, location of employees; the less vulnerable the business, at least from the point of view of today.

To prevent these struggles from becoming a major issue in a future outbreak, the pharmaceutical industry needs to be prepared to act quickly to scale up production of key resources – such as specialised testing kits and new medicines as soon as they are needed. Maintaining healthy stockpiles of established treatments is also key as there is always a possibility that an older medicine might be effective against a novel disease – as has been seen with dexamethasone.

This will also require governments and international health bodies to be much quicker in future in developing and implementing emergency procedures to scale up production when the need arises.

5. Regulatory Considerations The pharmaceutical industry, by necessity, is a heavily regulated one. While the challenges of the pandemic have created a need for regulatory processes to be expedited in many cases, lockdown restrictions have made it more difficult for this to be done efficiently. There are also inconsistencies across geographies in terms of if and how a state regulator will approve a particular treatment. For these problems to be ironed out, the pharma industry and the agencies responsible for regulation need to work more closely together to ensure responses can be better coordinated in future.

Increased flexibility and efficiency are the name of the game, both in terms of regulatory approval for new treatments, and logistical considerations that ensure that medicines can be manufactured and delivered in double-quick time.

Learning from What We’ve Witnessed With no end in sight to the COVID-19 crisis, it is time to take a fresh look at national laws and start discussing possible changes.

Governments around the world are taking unprecedented measures to support the economy and, in particular, healthcare. The scale is amazing – today in Western countries, support packages range from 10% to 30% of GDP and huge amounts of money are being allocated to support health systems and to develop drugs to treat COVID-19.

Any pandemic leads to increased cooperation between countries both at the government level and at the industry level, and just cooperation between pharmaceutical companies and governments should give significant progress in the fight against the pandemic. In the months and years to come, we will most likely see pharmaceutical companies together with governments developing a ‘plan B’, in case of the closure of a number of industries or countries.

Although we hear that many governments are talking about the need to establish national research centres and local pharmaceutical industries, in general, the pandemic crisis has shown the value of globalisation in the pharmaceutical field.

Ultimately, if and when we face another pandemic, it’s crucial that the pharmaceutical industry has learnt from the lessons taught by COVID-19: innovation, efficiency, data analysis and collaboration will be key, and leaders in the sector should be focusing their efforts now on how to ensure the processes are in pace to facilitate this should we find ourselves amidst another worldwide pandemic.

Vladimir Tkachenko

Vladimir Tkachenko, a pharmaceutical sciences expert, is general manager of Amaxa Pharma, a UK-headquartered pharmaceutical company focused on life-threatening therapeutic areas such as oncology and neonatology in the CIS countries. Within this role, Vladimir is responsible for the general management and success of the company, developing sales strategy, implementing managerial accounting strategy, preparing operation budgets and licensing.