The year 2024 has witnessed significant changes in the life sciences industry, characterized by seismic shifts in international regulations, a resurgence of national quality and regulatory activities, fluctuating workforce employment rates, and an expansive adoption of in-house AI practices and groundbreaking technologies.
As we look forward to 2025, our expert CAI team convened to evaluate which trends are likely to persist, discuss recommended strategies for response, and, through existing challenges and developments, confirm why maintaining operational readiness and excellence is essential for life sciences companies to ensure sustained business growth.
Outsourcing Quality Personnel Amidst Increase in FDA Audits
Since 2020, pharmaceutical facility audits have experienced prolonged delays, spanning nearly five years. However, the FDA has made considerable strides in clearing its audit backlog and is now maintaining a consistent pace in completing audits and managing ongoing oversight. As the FDA places increased focus on adhering to audit schedules and identifying deviations, pharmaceutical and biotech companies must outsource personnel specialized in quality management to ensure their facilities meet compliance requirements. Given the continued shortages of critical active pharmaceutical ingredients (APIs), engaging quality professionals is crucial to minimize further operational disruptions and continue manufacturing on schedule and on budget. – Connie Leech
Retooling the Existing Workforce for Quality Roles
In light of the FDA’s increased focus on maintaining audit and inspection schedules in 2024, we foresee pharmaceutical and biotech companies increasingly turning to external industries for quality personnel to ensure compliance and mitigate potential slowdowns in 2025. Quality professionals are more frequently transitioning across industries to take advantage of hiring surges. As facility inspections ramp up, companies—especially those located in industrial hotspots—will need to recruit and train external quality specialists in biotech-specific practices. To effectively support digital transformation, companies will need to emphasize accelerated learning and technology-oriented training to improve drug development and manufacturing processes. – Harry Benson
Combining Knowledge Graphs with Retrieval-Augmented Generation (RAG) Large Language Models (LLMs) Amongst Digital Transformation
In 2024, the implementation of in-house AI practices has experienced remarkable growth within the pharmaceutical and biotech industries. More companies are developing personalized large language models (LLMs) to provide quick and easy access to essential documentation and reduce deviations. However, the development of these customized LLMs can be a significant financial burden for small and medium-sized enterprises. A more cost-effective alternative for 2025 is combining knowledge graphs with retrieval-augmented generation (RAG) LLMs. This approach helps map relationships between documents, concepts, and entities, making it easier to retrieve contextually relevant information. As the FDA heightens its audit activities to ensure compliance, this combination will assist employees in accessing accurate information within seconds, thereby enhancing productivity and minimizing errors in decision-making. – Nick Armstrong
Onshoring Manufacturing Amidst International Regulation
As the BioSecure Act advances through the House and eventually invites discussion in the Senate, major industry players are making substantial investments—amounting to billions—in onshore manufacturing in 2024, while small and medium-sized companies are expected to follow this trend in 2025. With the increasing dependence on U.S.-based Contract Development and Manufacturing Organizations (CDMOs), companies will likely face significant rises in raw material and manufacturing costs and stricter regulatory oversight. In light of these escalating expenses, it is imperative for facilities to implement operational readiness-focused technologies and methodologies to ensure smooth project initiation and operations, ultimately minimizing errors and downtime. – Sheena Dempsey
AI Innovation in Discovery Phase Leads to Bottlenecks in Development and Manufacturing
As the adoption of AlphaFold models becomes popular in the R&D phase, breakthrough drug candidates advance rapidly through discovery and development, allowing for earlier entry into clinical trials. However, essential treatments are now facing delays during the clinical trials and manufacturing stages as facilities struggle to promptly begin construction and project initiation to keep pace with demand. With onshore political shifts and international regulatory changes likely to impact supply chains and manufacturing capabilities in 2025, companies based in the US must focus on enhancing operational readiness strategies to optimize both time and budget while also boosting capacity within their facilities. – Nick Armstrong
As we progress into 2025, the success of companies in life sciences will depend on their ability to remain agile in the face of rapid regulatory and technological change. By keeping a culture of operational excellence front and center of business operations, the industry will be able to turn challenges into opportunities that support ongoing critical advancements in drug development.