Having worked in pharmaceutical quality and compliance for more than 30 years, we see a seismic shift in the industry. Here are a few predictions to consider for 2025 and their implications.
Prediction 1: The increased pressure we will see in onshoring manufacturing is real. This shift will allow the United States to become self-sufficient in providing patients with essential medicines, minimizing the risk of shortages or outages. However, it will place a significant burden on the global supply chain and available talent. Two key points to consider:
1) Bringing outdated facilities online will be more challenging than ever. Building new ones will require long lead times. So, a balanced approach to upgrading older facilities with modern technology (PAT and CM) will help this effort.
2) An innovative workforce will be essential to bridge traditional principles with the needs of digitally focused employees. Effective recruitment, onboarding, and upskilling will reduce risks and support meaningful learning, making virtual reality education a critical tool. Platforms like Virtuosi will replace outdated compliance modules for these purposes. The pressures of onshoring manufacturing and the evolving workforce will drive this movement. VR training that incorporates real-world scenarios will help create a confident and capable workforce.
Prediction 2: AI will become the backbone of compliance management, and Machine Learning (ML) will play a growing role in advancing drug development.
AI-powered systems will drive efficiency in deviation reporting, investigation processing, CAPA and risk management. As new systems appear, lagging companies will find themselves overwhelmed by manual inefficiencies, lengthy processing times, and high operational costs. Integrating AI into interim controls will require significant effort. CSV and digital methods for collecting and reporting data will remain a primary focus for regulatory agencies, with heightened expectations for data integrity.
ML will play a transformative role across various stages of drug development. In drug discovery, algorithms will analyze data sets to identify and predict candidate drugs while assessing their clinical effectiveness. ML will also enhance predictive modeling for pharmacokinetics and pharmacodynamics, focusing on the most viable compounds. Additionally, ML techniques can identify biomarkers to tailor therapies for specific patient groups, improving personalized medicine. Currently, ML is used to provide safety and toxicity profiles for new drugs and to integrate data from these processes, enabling more informed development decisions.
By using these capabilities, both AI and ML can significantly reduce the time to market, lower the cost of delivering new and existing medicines, and increase the likelihood of successful outcomes.
Prediction 3: Data integrity will continue to dominate regulatory inspections. As reliance on cloud and digital platforms grows, compliant data governance has become essential. Regulators are increasingly focused on the collection and integration of real-world data to gain insights beyond clinical trials and into manufacturing processes. Gaps in data integrity or governance can result in non-compliance citations or work stoppages. Challenges in this space include data quality and standardization, governance, compliance, and technical ability. This focus on data integrity will remain a key theme across the manufacturing sector.
Prediction 4: Patient-centric therapies will challenge traditional quality system frameworks. While tailored therapies offer significant benefits, they also introduce complex compliance demands. These include contamination control strategies, product testing and stability, and accurate patient dosing. In 2024, 50 percent of new biologic products submitted received a Complete Response Letter (CRL), leading to significant delays in product launches, remediation costs, and a loss of stakeholder confidence in the short term. Over time, these challenges may prevent patients from accessing much-needed therapies. Engaging experienced consultants, such as Quality Executive Partners, can help navigate these complexities. For example, QxP supported the successful launch of Trodelvy for Immunomedics, which was later acquired by Gilead for $2 billion. By addressing these challenges, companies can accelerate the delivery of life-changing therapies to patients.
Prediction 5: The concept of quality culture will become more clearly defined and cultivated across all levels of an organization, from senior leadership to new employees. Developing a strong quality culture will evolve into a key business strategy, influencing every stage of the product lifecycle—from clinical development to commercialization and post-market surveillance. The C-suite is increasingly recognizing, as regulators have long emphasized, that a robust quality culture leads to greater operational efficiency and lower overall costs.
This shift will be reflected in proactive quality management practices replacing reactive quality control measures. Employee education will focus on emphasizing why tasks are performed, rather than relying on check-the-box 'Read and Understand' training. Leveraging standardized data collected on the manufacturing floor and routinely analyzing it will enable real-time decision-making and improve the quality of medicines.
Organizations will also prioritize cross-functional collaboration to ensure quality is a shared responsibility, fostering a comprehensive approach. This will strengthen the connection between product quality and patient outcomes, reinforcing the patient-centric mission at the heart of pharmaceutical development.
QxP Vice President Christine Feaster is a 20+ year veteran in pharma quality assurance. Prior to joining QxP, Christine was a vice president of U.S. Pharmacopeia.
