Five alive

As we approach the end of 2023, and companies finesse their road maps for 2024, Arriello’s Kate Coleman assesses the multiple priorities vying for attention.

The pharma industry continues to be in a state of flux. Merger and acquisition activity remains rife, new regulatory updates are being rolled out all the time, and companies are still reviewing supply chain security following the pandemic, the ongoing situation in Ukraine and economic uncertainty.

Meanwhile, a whole raft of patents is expiring, triggering a rise in biosimilar manufacture. As new molecules pass through the preclinical stage and move towards clinical trials, developers must consider formal requirements including Quality GxP measures as part of their clinical strategies.

With this context considered, there are five priorities for the year ahead:

1. ICH Q9 Quality Risk Management
Regulatory updates have been coming thick and fast in life sciences in recent years, in step with the accelerating pace of change in the industry.

One of the most notable changes for drug manufacturers in 2023 has been the updated ICH Q9 guidance on quality risk management.

This provides important new impetus around the development of robust, fit-for-purpose quality risk management plans – in other words, those which positively position companies to spot and mitigate issues in advance.

Although many companies consider themselves to have good quality risk management programmes in place already, because they are performing a lot of risk assessments, this perspective is too reactive and compliance-driven.

The real question is whether existing measures are really working for the organisation, in making it possible to anticipate and mitigate risks, preventing issues before they occur.

2. Addressing supply chain risks
Although the COVID-19 pandemic is now largely behind us, there is no room for complacency. Added to the impact of this and other future global health events is the need for ready access to vaccines and medicines.

Indeed, the disruption caused by wars in Ukraine and now Israel – as well as growing economic uncertainty – provides a further reminder of how fragile supply can become where key sources are remote and there aren’t adequate contingencies.

Sourcing of active pharma ingredients (APIs) represents a particular point of risk for medicinal product manufacturers.

In the case of advanced therapy medicinal products (ATMPs) including cell, gene, tissue-engineered and somatic-cell therapy medicines, excipients (non-active ingredients) and other raw materials might be unusual and single-sourced from a far-flung country, yet essential to manufacture.

To avoid supply chain-based risks, where an individual manufacturer’s demand is only for very small volumes/of low overall value, it may be necessary for manufacturers to join forces in order to shore up their supply routes, if they can find a way to do this without compromising their intellectual property.

Banding together to boost combined demand could help build the business case for alternative suppliers to enter the market.

An important consideration in boosting internal production is the time, cost and skills commitment of establishing a new GMP-compliant manufacturing facility.

From fulfilling the latest regulatory criteria to ensuring the new facility is bespoke to the current need (and has the scope to grow in future), to attracting the right scientific experts, the investment involved is likely to be considerable.

3. Sustainable consumption
Environmental, social and corporate governance (ESG) is high on the agenda for most industries today.

The biologics industry, however, has a mixed relationship with environmental sustainability, given the need for low bioburden or sterile manufacturing, which currently favours the use of single-use consumables from a patient safety perspective.

Yet pharma does need to address its consumption of single-use plastics, broadening its focus from patient safety in a vacuum to include wider protection for the environment, with a consistent end-to-end strategy that leaves no room for accusations of greenwashing.

Although patient safety will always be paramount, which inevitably influences contamination control throughout transportation and storage, there needs to be a balance – so that measures that are keeping patients safe are not contaminating entire communities.

4. Quality by design
As patents on a whole raft of established drugs expire, we continue to see a rise in the manufacture of biosimilars.

As new molecules pass through the preclinical stage, into clinical trials and beyond, developers must consider formal requirements including quality and GxP measures as part of their clinical and then commercial strategies.

For companies to position themselves as major shareholders in new markets, they need to design quality into their processes upfront.

Understanding how they would ideally commercialise the finished product, and keep quality considerations aligned throughout, can be pivotal in getting to market faster.

This could be through the right partnerships, e.g., with marketing authorisation holders, licence holders and organisations providing strategy and scientific advice.

5. Focus on skilled staff
The global skills crisis is as evident in life sciences as in so many other markets, and it is incumbent on the industry, as well as on education institutions, to be proactive in addressing the growing gaps in both capability and career mindset among upcoming generations of teams, particularly those in scientific disciplines such as microbiology.

Younger team members – those who have grown up in the ‘gig economy’ – have more of an expectation about ‘moving around’ to gain a broad spectrum of experience.

This can pose problems where skills, experience and staying power are key to maintaining consistently high standards in quality and risk management.

This means seeing through difficult projects so that they recognise and can pre-empt future issues, for instance.

In cell therapy, for example, products by definition can’t be sterilised, so it is vital that nothing can get into a product while it’s being manufactured.

The people who specialise in ensuring this are the microbiologist, and the sterility assurance and the biotech personnel – yet those experts are in short supply.

Rather than continuing to push up salary expectations, the industry needs to work with education establishments to encourage a greater understanding of this industry and the exciting opportunities it presents.

This involves not just keen scientists but also lateral thinkers, people that can connect the dots across different functions, rather than just concentrating on one thing.

Finally, linked to the theme of education and with a glimpse into the near future, the whole emergence of AI will be a major area to watch going forward.

This needs to start with spending time educating people about what AI really is, and its potential in the product development space.

That could be in predictive chemical modelling for chemical reactions, so that teams can more precisely pinpoint the experiments that may be needed for formulation or drug development.

Risk management is at the heart of making sure information is well organised, reliable and secure, as a foundation for AI to help streamline choices, reduce risk and waste, and focus on the correct priorities.

Kate Coleman is VP of Quality at Arriello. Go to arriello.com