The US Food and Drug Administration (FDA) approved a record number of new drugs so far this year at 56, a number that will potentially exceed 60 by the end of the year.
Henry Levy, general manager of Veeva Vault CDMS, Veeva Systems, called this a “major victory” for patients, the FDA, and organizations alike, one that was supported by accelerated approval programs, such as the real-time oncology review (RTOR) pilot, among other initiatives.
“The most positive change in 2018 was the continued increase in drug approvals and the rapid pace of breakthrough innovations getting to market,” he said. However, while approvals have increased, Levy noted that operational execution has not progressed in tandem.
Looking to 2019, Levy said the industry has “a tremendous opportunity to build upon this progress by improving R&D operational performance.”
“Pharmaceutical and medical device companies must continue to find ways to improve the efficiency of trial execution, submissions development, data management, and other key areas across drug development.”
Based on the number of approvals in 2018, Levy said there will be a “new normal” as it pertains to the average number of drug approvals, as the industry will continue to see between 40 and 60 approvals a year. Key to sustaining this approval pace in the new year will be improving processes and increasing the efficiency of daily activities.
Also to be seen in 2019, Levy said sponsors will shift from outsourcing all functions of a clinical trial to only a single function, such as monitoring or clinical data management.
“We have seen the pendulum swing back and forth from holistic outsourcing to a more controlled model with insourcing and functional service provider (FSP) and business process outsourcing (BPO) models,” he explained. “This is a response to both inconsistent results in full-service outsourcing and a reaction to new oversight requirements in ICH E6 v2 regulations.”
Read: The biggest paradigm shift in decades? ICH E6 R2
Another trend, Levy said precision medicine will continue to evolve as a significant scientific innovation. “In 2019, companies will develop targeted medicines by researching biomarkers for specific patients,” he said.
Levy noted the advancements made by companies such as Spark Therapeutics and Novartis, which have developed ways to extract tissue or blood, treat it, and return it to the patient – a process that requires a tight-knit supply chain.
“This is the epitome of targeted medicine,” said Levy. “These drugs are beginning to impact all aspects of the treatment life cycle, from clinical development to supply chain management, pricing, and commercialization.”
Of Levy’s predictions for 2019, he said increased drug approvals will have the greatest effect on patients in the short-term, “but precision and targeted medicine will have the most far-reaching and dramatic effect.”
Pricing and patient access
Conversely, the two biggest challenges in 2019 will be pricing and patient access.
“There is continued pressure in most European countries to bring down prices, as well as domestically as US healthcare remains more than 18% of the GDP,” explained Levy, who said this tension will cause “significant disruption, including reductions in workforce and corporate consolidation.”
This pressure also will drive the industry to adopt new ways to improve operational efficiencies, such as using artificial intelligence (AI) to generate insights about customers and patients, he said.
Read: 5 predictions for AI in 2019
AI could specifically be used to address patient enrollment challenges, as more than 50% of investigator sites still fail to meet patient enrollment targets, according to a recent report from the American Cancer Society.
“To solve this problem, the industry leverages prescription, electronic medical records, and big data to identify more eligible patients and sites However, there are still no effective analytics embedded in clinical data warehouses, which makes it difficult to take advantage of all the data sources available,” said Levy.
The challenges surrounding the industry’s myriad disparate data sources is one that Levy said he would address in 2019 – if he could change one thing about the industry next year.
“Pharmaceutical companies, partners, and suppliers possess a tremendous amount of data that – when advanced analytics are applied – could drive massive process efficiencies and innovations for patients,” he said. “The continued lack of pre-competitive collaboration among stakeholders to bring that data together is a barrier to driving treatments to patients faster.”
