Future Trends and Regulatory Challenges in Pharma
The global pharmaceutical industry has seen its share of challenges in recent years, from manufacturing and supply chain bottlenecks to growing demand for faster delivery of drugs to the marketplace.
What will the near future bring to the table? To help manufacturers determine where to focus their efforts, let’s take a look at some of the most impactful technology trends and regulations in pharma today.
Data digitization drives Industry 4.0 advancements
There has been a tremendous push in pharma to transition from reactive to proactive quality management. Analysts report that the global life science analytics market (descriptive analytics, predictive analytics, prescriptive analytics) is expected to double in value by 2026 ($47B up from $23B in 2020), driven by the “increased prevalence of chronic diseases, technological advancements and rising demand for improved data standardization.”1
Pharma manufacturers have been turning to the cloud to improve quality management effectiveness and efficiency. Those that have digitized data through use of a cloud-based electronic quality management solution (eQMS) are now leveraging credible, comprehensive, real-time data for predictive and proactive analytics.
The next evolution is for companies to implement Industry 4.0 technologies to speed drug discovery and development efforts. The race to develop a COVID-19 vaccine highlighted the power of artificial intelligence (AI) and machine learning (ML) as Johnson & Johnson, Moderna and Pfizer employed these technologies to swiftly get their vaccines to market.
Until now data quality has been a significant barrier to adoption of AI/ML among most pharma manufacturers. IDC notes how virtually all its surveys regarding AI adoption have found that “data quality, quantity and access are among their top challenges to scaling and operationalizing AI.” 2
The development of a pre-configured, ready to use eQMS solution for cloud-based quality management is now enabling pharma manufacturers of all sizes to break down this barrier. With confidence in their quality data integrity and the ability to access it quickly and easily within a single platform, we anticipate that more companies will pursue AI/ML applications in 2022 and beyond.
Data in the regulatory spotlight
The U.S. Food and Drug Administration (FDA) recently issued pharma industry guidance documents that will impact how companies collect, manage and submit quality data to the agency. Here are two points worth noting as we head into the new year.
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Guidance for Industry: The CARES Act added new section 510(j)(3) of the FD&C Act that requires registrants of drug establishments (or their authorized agents) to submit annual reports on the amount of each listed drug manufactured, prepared, propagated, compounded or processed for commercial distribution. The guidance describes the reporting process and required data elements.3
With very few exceptions, most pharma manufacturers will be required to submit annual reports, with data on 2020 drug distribution due on February 15, 2022, and data on 2021 due on May 16, 2022.
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products: When sponsors or other stakeholders submit real-world evidence (RWE) on the effectiveness of drug products to this proposed registry, the FDA will evaluate the reliability (e.g., accuracy, completeness, provenance) of the data, considering how it was collected, and “whether the registry personnel and processes in place during data collection and analysis provide adequate assurance that errors are minimized, and that data integrity is sufficient.”4
The RWE registry is intended to help support approval of a new indication for an approved drug or post-approval study requirements. Therefore, forward-thinking pharma manufacturers will want to ensure that the data they are submitting on their products meets the FDA’s quality standards.
Developing a Robust Quality Management Solution to Ensure Data Integrity
Data is the name of the game in 2022 and beyond. For pharma manufacturers that have already digitized their quality processes and data, or are in the process of doing so, alignmentment with FDA guidance, adoption of advanced technologies and a shift toward proactive quality management is in reach. For those who have not, now is the time to act.
References
1 Global Life Science Analytics Market: By Product: Descriptive Analytics, Predictive Analytics, Prescriptive Analytics; By End Use: Clinical Research Institutions, Pharmaceutical and Biotechnology Companies; By Application; Regional Analysis; Historical Market and Forecast (2017-2027); Competitive Landscape; Industry Events and Developments, EMR
2 The Data Dilemma and Its Impact on AI in Healthcare and Life Sciences, IDC, June 23, 2021
3 Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Guidance for Industry, FDA, October 2021
4 Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products, FDA, November 26, 2021