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Risking it all after the pandemic: How companies can pick up the slack post-COVID-19

Published on 03/11/21 at 11:20am

Pharmaceutical manufacturers have always been tasked with some of the most complex remits in the industry. Active pharmaceutical ingredients, potent products, and the various regulatory requirements turn a basic machine workflow into a treacherous pathway that must be navigated with care and understanding.

Managing the risks when producing drugs is one thing, but managing a sector, which is swayed by the whims of profit before patient populations, tests all companies worldwide. Risk management systems have evolved over the last two decades, alongside ever-moving regulatory goalposts, and companies that are prepared are more likely to thrive.

Since the COVID-19 pandemic halted almost every industry around the world, or at the very least disrupted the flow of goods and manufacturing processes, risk management systems and workflows are now under the microscope.

If we were to return to the start of the COVID-19 pandemic, what would the industry do differently? The already-stringent regulations around risk management were dealt a once-in-a-generation blow: a global pandemic. As the light brightens at the end of the tunnel, pharma manufacturers, drug producers, and R&D experts, among others, will need to show mitigative action against the possibility of another pandemic, a new COVID-19 wave, or a reinvigorated variant.

 

Managing risks in 2022

Looking ahead to 2022, relinquishing from many of the shackles countries and companies faced during the COVID-19 pandemic, the risk management sphere is likely to evolve. With Supply chain disruption, vaccine contracts being torn up, and even the rare side effects from vaccines that have become front-page news – the risks are abundant.

Mitigating these risks is a challenge. Some of those set to continue and grow in 2022 in the pharma industry, include:

 

Future pandemics and changing variants

Before COVID-19, concessions for pandemics or global disasters were not a top priority. Following the damaging impact of the pandemic on economics and finance around the world – with the main bulk of these challenges still yet to be conquered – drug companies will need to embed further mitigation into their risk management plans. This is vital to ensure operations continue without endangering the research, trial, or a population’s safety.

COVID-19 has brought age-old questions back into view when building a risk management plan. What happens if a clinical trial can no longer continue in-person as scheduled? What will we do if medicines agencies are unable to take requests for new drugs? In addition to the hold ups that have barricaded new drugs in the last 18 months, new considerations for risk management could have a positive impact on companies wishing to cover all bases in their submissions.

 

Cyberattacks

It’s been four years since the infamous cyberattack on Merck, which halted and stuttered their pharmaceutical production. It is clearly more than just a growing problem for every industry, it is a veritable threat that every company must consider.

That, however, is easier said than done. Facebook’s recent six-hour outage, that brought WhatsApp and Instagram down with it, was not linked to any cyberattack, but it was mightily obvious that even the biggest worldwide corporations can face damaging impacts.

Data security for clinical trials and patient populations is one area that needs to be protected, and those risks will likely come with escalating prices for improved security and better data protection systems.

Whether it is enlisting improved cyber training for staff or ensuring that specific people are tasked with keeping things moving, and finding solutions should a cyber attack take place, companies will need to be open to investment in this crucial area.

 

The clinical trial gamble

Scaling up a drug from discovery to approval is not an easy transaction. 2022 is likely to see the growing trend of drugs falling at the Phase I trial hurdle, as companies trade-off the need for a return on investment with the desire to force through a clinical trial that may or may not be likely to succeed in the latter stages of the trial. Bigger companies with higher budgets may find it easier to invest or intercept drugs at the earlier phases of the trial, and help to finance them. This synergy could lead to a better chance of success with the resources companies can bring to the table, but is likely to mean that smaller drug developers and producers do not claim the margins they need to call a trial a success.

 

Setting up quality risk management post-COVID-19

Amid the COVID-19 pandemic, while vaccines were passing through emergency use authorisations in the US, and marketing authorisations were being granted in the EU, the undercurrent of scrutiny remains. In 2018, Katie Dwyer wrote about the six critical risks facing the pharma industry on the Risk & Insurance website.

Among those listed was counterfeit drugs, the onrushing development of technology, and, due to the crisis encompassing the US at the time, the legal difficulties surrounding the opioid epidemic from pharma manufacturers.

One other aspect cited was the increased competition from generic drugs. Dwyer wrote: “A backlog of generic applications has stretched that 180 days much longer. The FDA’s renewed effort to clear that backlog and get generic applications through the approval process faster will flood the market with cheaper versions of high-cost drugs.”

Organising or amending a quality risk management system in pharma is subject to plenty of outside forces.

2022 and beyond will not only be about mitigating potential risks, however, it will be about navigating the regulatory world and finding the best way to bring drugs to market seamlessly.

 

The regulatory context for risk management in pharma

Pharma risk management is a relatively new concept, as WHO’s Annex 2 introduction explains:

“In the past, hazard analysis and critical control point (HACCP) methodology, traditionally a food safety management system but subsequently applied to other industries, has been the basis of WHO risk management guidance to the pharmaceutical industry.

“More recently, international guidance has emerged that is of specific relevance to the pharmaceutical industry, and which addresses the full scope of pharmaceutical industry QRM more effectively than HACCP principles, including how to structure regulatory filings using a risk-based approach. Consequently, these WHO guidelines have been developed as an update on WHO's advice to the pharmaceutical industry, taking account of this new guidance.”

While these guidelines may have initially taken inspiration for the stringent demands of the food industry, more specific pharma risk management guidelines are vital for the evolving and specific needs of every individual factor of the pharma industry.

WHO have set out guidelines that make it easier for pharma companies to develop a risk management system that is specific, concise, and ready for the approval process. This, however, brings its own complications – different drug regulations and management processes around the world prompt a varied collection of criteria. From the FDA to the EU, via the MHRA in the UK, different companies pinpoint their locations to ensure the easiest or most appropriate pathway to approval.

In 2018, a Science Direct article by Kumar N and Jha A noted: “Some traditional quality risk management exercises are focused on pharmaceutical manufacturing only, however, the ignorance of quality risk during distribution poses business challenges finally leading to market complaints, recall, rejections, and regulatory actions.”1

The article went on to list key steps to support the effective management of risks, including:

  • Make quality and risk management as key elements during supply chain
  • Establish risk mitigation tools during supply network
  • Ensure that supplier risk management is an ongoing activity, not one-time action

 

Lead by the cold chain example

The cold chain has been under the spotlight for the best part of two years. Before the COVID-19 pandemic, it was predicted by some that the need for the cold chain was in decline. In November 2020, Matt Watson of Aggreko explained in Pharmaceutical Manufacturing & Packing Sourcer magazine that, “By embracing energy-efficient practices, such as hiring cooling equipment based on present need, previous issues around wasteful permanent installations can be dispelled.

“Indeed, this approach can be emblematic of a wider paradigm shift in equipment provision that has been brought on by the coronavirus.”

Fast forward a year, and the cold chain was integral to the safety and efficacy of life-saving vaccines being transported around the world. Risk management for any supply chain is stringent, but the cold chain brings into focus temperature excursions – something that was vital to control during the vaccine transportation drive from 2020 to present.

The MHRA Inspectorate in July 2020 wrote about transportation risks involved in QRM: “Having identified that high temperature excursion is potentially a significant risk, we then predict the probability of the excursion, the impact of the excursion, and the likelihood of detection. Probability will be affected by factors such as season, geographical differences, and altitude. Initially, estimate of probability may be subjective, based only on experience and knowledge within the organisation.

“As the model develops and temperature data is accumulated, the objectivity and quality of the estimate of probability will improve. Early subjective probability therefore requires a safety factor to be included in order to mitigate against initial weakness of data and knowledge.”

ICH risk management guidelines have also been produced to offer practical advice and support to companies wishing to refresh, evaluate, and understand the risks involved throughout the drug production cycle.

Since its inception in 2005, ICH Q9 for Quality Risk Management has been used and taken on by health authorities from Brazil, Canada, Japan, Switzerland, and others alongside the FDA and the European Commission, use the ICH’s harmonised guidelines from Quality Risk Management – ICH Q9. It is this pillar of regulation that can guide a company, and help it to seamlessly bring a drug to market, all the while following the aforementioned guidelines.

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