Arriello’s Kate Coleman discusses how best to tackle the five key priorities for getting the most from your approach to quality and risk in 2024.

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 are expiring, triggering a rise in biosimilar manufacture. As new molecules pass through the pre-clinical stage and move towards clinical trials, developers must consider formal requirements including Quality GxP measures as part of their Clinical strategies.

As we approach the end of 2023, and companies finesse their roadmaps for 2024, there are five priorities vying for attention.

1. Embed risk-based decision-making.

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 before they occur.

The point of the updated guidance is to remind manufacturers of the purpose of quality risk management, so that they embed risk-based decision-making into everything they do.

2. Mitigating supply chain risk.

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 on the need for ready access to vaccines and medicines, the disruption caused by wars in Ukraine and now Israel, as well as growing economic uncertainty, provide 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 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, for instance.

• Addressing consumption.

Environmental, social and corporate governance (ESG) is high on the agenda for most industries today. However the biologics industry 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 need to be a balance – so that measures that are keeping patients safe are not contaminating entire communities.

• Design quality into processes.

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 pre-clinical 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 up front. Understanding how they would ideally commercialise the finished product, and keep quality considerations aligned throughout, can be pivotal in getting to market faster, for instance through the right partnerships, e.g. with Marketing Authorisation Holders,  licence holders, and organisations providing strategy and scientific advice.

• Attracting the right people.

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, who have grown up in the ‘gig economy’ have more of an expectation that they will move around to gain a broad spectrum of experience, and 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, so we can attract not just keen scientists but also lateral thinkers, people that can connect the dots across different functions, rather than just concentrating on one thing.

The powerful combination of AI and great data

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. But 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.

Start with a focus on quality risk management – and risk management in general – to help exploit the full potential of company information. Add AI into the mix, along with validated data, to help streamline choices and reduce risk.

About the author

Kate Coleman is VP of Quality at Arriello. She has over 20 years’ experience in Quality Assurance, Sterility Assurance and Microbiology Quality Control, and has worked across ATMPs, Biologics, Sterile Fill Finish, Vaccines, APIs and Oral Dose platforms.

Over her career to date, Kate has served as a practising QP, Principal Consultant, and qualified Lead Auditor. She is also a subject matter expert in Risk Management, New Facility Design/Start Up, Quality Control and Sterility Assurance. In her previous role before joining Arriello, she was Senior Director for Quality Management and Compliance, and Head of QMC.

Kate is particularly passionate about the interdependence of Regulatory and Quality, as companies develop their strategies and processes and look more holistically at what they need, rather than operating in silos.

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