Blog Writer

Five Pharma Priorities for 2024:
Setting a Realistic Regulatory & Quality Roadmap.

Kate Coleman
Kate Coleman
VP of Quality and Compliance (Principal Consultant)

Kate has over 20 years’ experience in Quality Assurance, Sterility Assurance, Microbiology and 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 practicing QP, Principal Consultant, and qualified Lead Auditor. She is also a subject matter expert in Commercialization readiness, Supply Chain GDP, MAH Compliance, Quality 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 for Ireland and UK.

Kate is particularly passionate about the management of risk and 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.

Introduction.

The pharma industry remains volatile. So what constitutes a sensible roadmap for 2024, in light of the multiple priorities vying for attention? Here’s a quick roundup of the important considerations.

1. More proactive quality risk management.

The last year has seen the introduction of updated ICH Q9 guidance on quality risk management. This isn’t about increasing risk assessment, but about being more proactive – e.g. noting whether teams are seeing a tangible reduction in process-related/quality-related deviations, and in recalls/product issues/customer complaints. If risk management outcomes aren’t improving year on year, then the current measures need work; you need to embed risk-based decision-making into everything you do.

2. Supply chain contingencies

War in Ukraine and Gaza, new Red Sea shipping attacks, and growing economic uncertainty are a stark reminder of how fragile supply remains, post pandemic, where key sources are remote and there aren’t adequate contingencies.

Sourcing of active pharma ingredients (APIs) is a particular point of risk. In the case of Advanced Therapy Medicinal Products (ATMPs) including cell, gene, tissue-engineered and somatic-cell therapy medicines, excipients and other raw materials might be unusual and single-sourced from a far-flung country, yet essential to manufacture.

Where demand is for small volumes/of low overall value, it might be an idea to join forces with other manufacturers to shore up supply routes. Other options include manufacturing excipients internally or partnering with suppliers and providing incentives so that they fulfil the wider requirements. (Bear in mind that boosting internal production will require a significant time, cost and skills commitment.)

3. Sustainability.

Environmental, social and corporate governance (ESG) is high on the agenda for most industries today. But the biologics industry has a mixed relationship with environmental sustainability, due to the need for low bioburden or sterile manufacturing, promoting the use of single-use consumables for patient safety reasons.

Pharma does need to address its consumption of single-use plastics though, broadening the focus from patient safety in a vacuum to a strategy that includes wider protection for the environment.

4. Planning quality into the fuller product lifecycle.

The rise in manufacture of biosimilars continues a-pace. As new molecules pass through the pre-clinical stage, into clinical trials and beyond, formal requirements including quality and GxP measures must be factored into clinical then commercialization strategies.

This is about designing quality into processes up front – pivotal in getting to market faster, e.g. through the right partnerships, e.g. with Marketing Authorization Holders, license holders, and organizations providing strategy and scientific advice.

5. The pharma/quality skills crisis: building future teams.

The global skills crisis in Life Sciences is as real as in other markets, so all industry stakeholders need to be proactive in addressing the growing gaps in capability and career mindset among upcoming generations of professionals, particularly those in scientific disciplines such as microbiology.

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

This industry is crying out for lateral thinkers who are actually genuinely interested and curious in how modern pharma works; in how people get therapies; and how they’re developed and manufactured. There’s a perception that Big Pharma is all bad, and we need to address that head on.

 

AI & the role of a robust roadmap.

Finally, linked to education and with a glimpse into the near future, AI will be a major area to watch going forward. But this needs to start with spending time increasing awareness about what AI really is, and its potential in product development. That could be in predictive chemical modelling for chemical reactions, to help pinpoint the experiments needed for formulation or drug development.

The real potential will come from thinking about the information we have, making sure this is well organized, reliable and secure, and then using AI in combination with this verified and validated data to help streamline choices, reduce risk and waste, and ensure focus is on the right things.

Developing a roadmap for all of this starts with risk management, as the discipline that knits everything together.