For Many Biopharmaceutical Companies, the Future of Drug Development Lives in the Real World | Deloitte US has been saved
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By Greg Reh, Vice Chairman, US and Global Life Sciences Leader, Deloitte LLP
Many biopharmaceutical companies are putting greater emphasis on real-world evidence (RWE) to address regulatory requirements, drive the development of new therapies, and support value-based contracts, according to the results of our second annual RWE benchmarking survey.
These results, combined with examples of how the industry is starting to use RWE, help to reinforce the value of RWE and real-world data (RWD) in the delivery of more personalized, value-driven medicine.
One area in which we are seeing a lot of momentum is in clinical trials. Of the 1,800 clinical trials worldwide that involve RWE or RWD, half of them began within the last three years, and 300 were initiated in 2017, according to a recent Reuters analysis of the National Institutes of Health’s clinicaltrials.gov website. Historically, biopharma firms have relied primarily on randomized controlled trials (RCTs) to develop and test new therapies. While RCTs remain a critical component in this process, RWE sometimes offers deeper insight into how a drug or a class of drugs actually performs in the real world.
Most surveyed biopharma firms are investing in RWE
We surveyed 20 leading biopharmaceutical companies and found that nearly all of them (90 percent) have either established or are investing in RWE capabilities for use across the entire lifecycle of their products. However, we also found that only half of these companies have capabilities that are mature enough to take full advantage of RWE.
The use of RWE across key strategic business priorities, including the drug-approval process, is only going to grow in importance. The Food and Drug Administration (FDA) has been helping to move RWE forward: under both the 21st Century Cures Act and the Prescription Drug User Fee Act VI, FDA has set timetables to release guidance for the use of RWE. The 21st Century Cures Act directs FDA to establish a program to evaluate the expanded use of RWE in making regulatory decisions. During a National Academy of Sciences workshop last fall, FDA Commissioner Scott Gottlieb, M.D., said that advancing the adoption of RWE is a top priority for the agency. “As the breadth and reliability of RWE increases, so do the opportunities for FDA to also make use of this information,” he told attendees.
Three emerging RWE trends among biopharmaceutical firms
Here are a few of the interesting RWE trends that turned up in our survey results:
Are health plans and health systems keeping up?
While biopharma companies recognize the potential of RWD and RWE, many of our respondents suggested that some external stakeholders aren’t yet on board. Three-quarters of biopharma companies said some health plans and health systems haven’t yet figured out a way to use RWE, which could slow down their efforts to use the data to its potential. Biopharma firms will likely want to work with these stakeholders to break down some of these barriers. One way is to create more transparent communication by giving stakeholders better access to data.
In just the past year, the volume and variety of RWD being generated have continued to expand, according to our survey results. As the technology platforms, talent, and maturity of the tools needed to manage and derive insights from the data continue to evolve, along with the regulatory environment, I expect to see many of the barriers start to diminish. It is clear that RWE and RWD are critical to the transformation of health care, and I am excited to see their application and usage evolve.
Greg serves as the Deloitte Global Life Sciences & Health Care Industry Leader. In this role, he advises life sciences and health care clients and practice leaders within Deloitte’s global network; and is responsible for the overall industry group that conducts research and provides consulting, advisory, tax and audit services to clients in the industry. The global life sciences and health care industry group is comprised of over 20,000 colleagues in more than 90 countries that work with pharmaceutical, biotech, medtech, payer, provider and government clients. Greg also leads Deloitte’s relationship with one the world’s largest health care companies, which entails enabling and coordinating client teams around the world. Prior to his current roles, he served as the US life sciences leader; and as the global life sciences leader. Greg’s experience over the last 27 years includes working with multinational pharmaceutical, biotechnology, and chemical manufacturing organizations where he led consulting engagements in support of regulatory, clinical, commercial and manufacturing operations. His engagements focused on technology strategy and solution development; business-technology enabled transformation and the management of change. Prior to his consulting career Greg held positions at a government research lab, where he led teams in the design and development of life support devices; and was a lecturer at the University of Pennsylvania. Greg holds an MS from the University of Pennsylvania, and a BSME from Drexel University.