Sometimes a relatively small investment can lead to the development of a product or process that benefits a company, an industry, or even society as a whole. The three-point seat belt, for example, is a simple strap of nylon webbing that protects drivers and passengers from being injured in an accident. This innovation helped to transform safety standards in the automotive industry and has saved millions of lives.
Similarly, the pharmaceutical industry is focused on ensuring the safety of its customers and the effectiveness of its products. Drug manufacturers use numerous pharmacovigilance (PV) processes and systems to make sure their portfolio complies with government safety standards. PV is the practice of monitoring the effects of a drug after its release to identify previously unreported adverse reactions.
Some manufacturers are taking PV to the next level by making modest investments to automate processes. This can help drug makers draw new insights from safety data to reduce PV costs, improve product efficacy, and discover new combinations and cures that—like the three-point seat belt—could benefit their company, the pharma industry, and society.
Automation could improve case processing and signaling
Numerous industry and marketplace trends are challenging existing PV systems and processes,2 driving some pharma companies to consider more efficient and cost-effective ways to produce robust safety data and mine it for high-quality information. Deloitte recently surveyed senior executives from mid- and large-cap life sciences companies that have global portfolios of innovative therapies. We wanted to learn more about the industry’s PV practices and find out what they expect for the future. For example, some survey respondents said they are using (or considering) automation to help reduce case-processing costs and improve signaling. Here’s a closer look:
- Case processing: Driving cost out of case processing was cited as the primary goal among 90 percent of our survey respondents. Case processing can account for 40 percent to 85 percent of PV budgets. Moreover, case volumes are growing at a rate of 10-15 percent per year.3 Some manufacturers are outsourcing, taking advantage of scale, and moving aggressively to automate case processing. Survey respondents expect automation could lead to an average annual cost savings of 30 percent per Individual Case Safety Report (ICSR).
Gaining cost control over case processing, while maintaining compliance and enhancing patient safety, depends on a company’s ability to automate more of these activities. Investments into automation can increase the productivity of case-processing teams significantly. At scale, the range can be as much as 300 or 400 annual ICSRs per full-time equivalent, to 1,000 or 2,000 ICSRs per FTE. Among productivity drivers are native automation and “bolt-on” tools that can reduce the effort required to perform duplicate checks, speed up coding activities, and streamline narrative writing. However, there is limited capability to automate away entire stages within case-processing (as opposed to discrete sub-parts within stages). Further, end-to-end case automation, even for relatively simple cases, is even further from a functioning production capability, despite a number of proofs of concept being tested.
- Signaling: Survey respondents see a broad range of opportunities to improve their signal processing and investigation maturity. Half of respondents say they plan to expand these capabilities. As pharma companies drive toward true safety management, short-term signaling investments are likely to focus on visualization and longer-term efforts related to data integration as well as tool and process improvements. Using safety information to tie back into the discovery process remains a gap due to limitations with existing signal detection and management systems. The better the data quality and consistency, the better the signal detection. The ultimate goal is predictive signaling.
Automation in action
Later this summer, Deloitte will release a publication that examines why and how pharma companies are investing in automation and advanced analytics. We will show how they can gain process efficiencies, free-up resources to perform higher-value activities (e.g., benefits-risk evaluation and management, signal investigation, and real-world evidence analysis), improve quality assurance, and maximize return on their PV investment. The paper also will show that even greater gains are possible if companies buckle up and expand their technology and analytics use to create a PV system that focuses on benefit/risk management and proactive surveillance across the entire product lifecycle. Like the three-point seat belt, this approach may benefit pharma companies, the life sciences industry, and society as a whole.
If you’d like a copy of our paper or are interested in learning how Deloitte is helping our clients to achieve their vision of a transformed pharmacovigilance system, click here.
P.S. If you are at DIA this week, please check out Kelly Traverso’s presentation, Pharmacovigilance Reporting and Quality, Tuesday, June 25 from 8:00AM – 9:15AM in room 17AB. For further information and discussion, stop by the Deloitte Booth 1855, located just after the Bayside Lobby entrance.
1 Belt, Buckled, Tedium.com, December 25, 2018 (https://tedium.co/2018/12/25/seat-belt-history/)
2 Safety System Upgrades: Past and Future Trends Driving the Decision to Upgrade, Deloitte, 2018
3 According to Deloitte analysis of the survey responses. The 10-15 percent is based on historical case volumes from FDA, available at the FAERS website: https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis