What are “3 Key Trends” shaping the CDMO industry in 2024 and beyond? Sharp Services’ director of analytical and formulation services, Rob Feltz, shares his thoughts with Contract Pharma.

The rise of digital transformation and AI
As we delve into the digital transformation and AI’s role within the pharmaceutical industry, it’s crucial to highlight the multifaceted impact of these technologies:

Investment in digital innovations
The trend towards digitalization is evident, necessary, and almost unavoidable with the observance of significant investments in end-to-end digital solutions for healthcare. In 2024, the pharmaceutical industry will see digital transformation go from nice-to-have to must-have. This will significantly impact late adopters and those with legacy paper-based quality management systems. However, simply adding a digital QMS and electronic signatures doesn’t solve the problem that more and more companies who are looking for contract service providers expect there to be digital bridges between functional groups. For example, the ERP system that provides real-time data visibility across supply chain and finance should be operationally integrated with a manufacturing execution system that optimizes the shop floor by offering real-time insights into production status, equipment performance, and quality metrics.

Similarly, your laboratory information management system that manages analytical data ensuring data integrity, traceability, and compliance, should be integrated with your document management system to provide a single platform for document storage, retrieval, and version control. Remember that any data you generate electronically should also be reviewed electronically! Lack of raw data review verification on electronic records remained high on FDA 483 observations in 2023, and we expect it to do the same in 2024 and until firms adopt modern practices.

Generative AI and AI analytics
Generative AI enhances early drug discovery by improving our understanding of biology and molecular detection. AI’s application in drug discovery, clinical trials, and patient engagement is accelerating, promising to deliver new cures worldwide. The pharmaceutical industry is expected to leverage AI & analytics across various domains, including R&D, marketing, and supply chain management. However, shifting towards a data-driven culture requires robust privacy and security frameworks. Despite the potential for significant economic value, impulsive investments in digital solutions without the infrastructure to support them can lead to project failures and financial losses. Addressing challenges such as patient data privacy, upskilling employees away from legacy systems, and ensuring continued regulatory compliance is crucial for successful digital transformation.

Economic and regulatory changes shaping the industry
The industry is expected to operate on leaner budgets, focusing on emerging markets, biologics, and specialty therapies. Towards that end, there has been a marked uptick in contract manufacturing expansion, with digital drug companies relying entirely on contract development and manufacturing organizations (CDMOs). As a result, the industry must continue to address and remediate any observed workforce gap in skills critical for development and manufacturing organizations to navigate the current environment.

Partnerships and collaborations
As the pharmaceutical industry marches through 2024, it must embrace the changes shaped by emerging trends in digital transformation, AI, and the regulatory environment. These developments promise to re-imagine the landscape of drug development and healthcare delivery and highlight the significant shifts towards sustainability, operational efficiency, and personalized medicine. In navigating this complex and evolving environment, the role of partnerships and collaborations cannot be overstated, especially in leveraging technological advances and regulatory insights to stay ahead of the curve. As stakeholders adapt to these changes and capitalize on the opportunities they present, working with experienced partners becomes increasingly crucial. The journey ahead for the pharmaceutical industry is fraught with challenges yet filled with immense potential—guided by innovation, resilience, and a commitment to excellence; it is a journey towards creating a healthier world for all.