By Kate Coleman, Arriello
Merger and acquisition activity remains rife in the pharma sector, 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 we approach the end of 2023, and companies finesse their road maps for 2024, this article assesses the multiple priorities vying for attention.
1. Optimize 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 that positively position companies to spot and mitigate issues in advance.
Although many companies consider themselves to have good quality risk management programs 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 organization by making it possible to anticipate and mitigate risks in advance.
The point of the updated guidance is to remind manufacturers of the purpose of quality risk management, so they embed risk-based decision-making into everything they do.
2. Join Forces To Address Supply Chain Security.
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 when 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 that are essential to manufacturing might be unusual and single-sourced from a far-flung country.
To avoid supply chain-based risks when an individual manufacturer’s demand is in very small volumes or 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.
Ultimately, as blockbuster drugs give way to more targeted and complex therapies, companies (especially newer ones) need to be realistic about where they sit in the food chain: They can't rely on enthusiasm alone to ensure they can get the product out to the market, especially where they don't have the economic power to shore up supply.
3. Address Sustainability And Single-Use Plastic.
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 favors 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. Align Quality And Commercial Considerations.
As patents on 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 up front. Understanding how they would ideally commercialize the finished product and keep quality considerations aligned throughout can be pivotal in getting to market faster.
5. Focus On Microbiology Skills.
The global skills crisis is as evident in life sciences as it is 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 overseeing newer employees through difficult projects so they can recognize and preempt future issues.
6. Bring AI Into The Mix.
AI will be a major area to watch going forward. Its potential in the product development space 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.
Maximizing this potential must begin with making sure data is well organized, reliable, and secure before introducing AI. Then quality risk management will knit everything together.
About The Author:
Kate Coleman is VP of quality at Arriello. She has more than 20 years of 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, Coleman has served as a practicing Qualified Person (QP), principal consultant, and qualified lead auditor. She is also a subject matter expert in risk management, new facility design/start-up, and quality control. In her previous role before joining Arriello, she was senior director for quality management and compliance and head of QMC. Coleman can be reached by email at Kate.firstname.lastname@example.org