Our panel of Veeva experts share their insights on the top six trends that will impact and transform the life sciences industry in 2019.

2018 was a record year for new drug approvals, with 59 drugs approved by the U.S. Food and Drug Administration (FDA). This record number is now the new normal. Looking ahead, we can expect to see an average of 40-60 drugs approved each year.

The pace of breakthrough innovation in life sciences will have a significant impact across the industry, requiring a fundamental shift in how companies develop and commercialize drugs. From transforming the pharmaceutical supply chain to leveraging artificial intelligence in commercial, organizations will embrace new ways to drive greater operational efficiency.

Here are Veeva’s top predictions for 2019 as companies look to keep pace with the investments they are making in product development.

Matt Wallach, President and Co-founder,“The success of precision medicines will require fundamental changes in supply chains and commercial models.”

As more companies drive breakthrough innovations in precision medicine and the market grows to more than $140 billion by 2026, significant changes will be required in the traditional supply chain. These groundbreaking drugs give patients hope but also entail complicated logistical requirements. For example, producing CAR-T cells requires a process that must be replicated in small, individual batches, which can make it difficult to scale production to meet global demand.

In response, pharmaceutical companies will create new ways to handle, store, distribute, and administer temperature- and time-sensitive products. And, since many of these therapies are specific to individual patients, the supply chain will need to acclimate to the unique conditions of targeted medicines. There’s also an opportunity to eliminate steps along the way, helping to relieve some of the financial strain that comes with change.

Big moves toward value-based pricing will prompt technology investments and new payment strategies.

Escalating pressure to bring down drug prices in Europe from expanding alliances such as the Beneluxa Initiative and Valleta Declaration, along with similar demands in the U.S., will drive new innovations. For example, companies will increase investment in real-world evidence data to develop pricing that demonstrates value to patients.

In addition, companies will contract with payers differently, like Spark did in 2018 when it introduced new payment and distribution models for its single-use therapy, Luxturna. One of these was a direct-payment system that reduces costs by eliminating intermediaries.

In 2019, it will also be critical for the industry to develop ways to improve operational efficiency. Companies will turn to more advanced technologies such as artificial intelligence and modern clinical management systems to streamline processes and increase employee productivity.

Paul Shawah, SVP, Commercial Cloud, “The buzz around AI will shift to an increased focus on data management and governance.”

Next year, we will move toward an AI-driven workforce as artificial intelligence becomes a standard capability across enterprise commercial applications. Not only will AI continue to improve sales rep effectiveness with suggestions on their next best action, but it will also become more pervasive and embedded in commercial processes. For example, AI will automate claims-reference linking in content management for marketing operations, and automatically recognize and suggest optimal inventory layouts on the shelves for retail sales.

This AI-driven workforce will become a reality as more companies put the right data foundation in place. While many companies have organized their engagement and content, their data is not yet organized. This is the largest impediment to gaining value from data through reporting, analytics, and ultimately AI. The commercial data warehouse has held the industry back for decades. Next year, there will be renewed focus on improving the commercial data warehouse to organize data in a standard way and keep it current, so companies can apply AI to uncover intelligent insights.

Henry Levy, General Manager, Veeva Vault CDMS, “Data managers will easily aggregate study data across sources to provide a real-time longitudinal view of the patient.”

As the number of data sources in clinical trials rises, companies will look to streamline the flow of data and information between stakeholders and systems. The airline industry is a prime example of connecting data automatically. For instance, flight delay information is immediately available via airport screens, mobile applications, and online. Data is shared across multiple, separate systems so travelers have access to the latest information, regardless of location or channel.

This is where we are heading in life sciences. The cloud will enable clinical data management teams to see all of their data in real-time and easily share information with stakeholders. Organizations can bring their data together and move toward risk-based trials—where data is collected and analyzed throughout a trial—for a current, holistic view of the patient. The result will be better collaboration between clinical sponsors, CROs, investigators, regulators, and even patients.

Mike Jovanis, VP, Vault Quality, “Manufacturers will digitalize operations to enable a connected shop floor and drive greater agility in managing content.”

Next year, more companies will digitize and connect quality operations to usher in Quality 4.0, which blends new technologies such as advanced data analytics, artificial intelligence, and virtual reality with quality management solutions. This new approach will help companies connect all quality processes for end-to-end visibility across the organization and reach new levels of performance and innovation.

One key area where we’ll see Quality 4.0 in action is the manufacturing shop floor. More companies will leverage mobile devices to deliver the right information to the right workers at their point of need. Modern cloud solutions are accessible across devices, connecting people, processes, and technology to drive greater user engagement, efficiency, and visibility in manufacturing operations. The shift to digital will also enable manufacturers to leverage technology in real-time for greater intelligence and smarter decision-making.

Jim Reilly, VP, Vault Clinical, “Regulatory changes underway at the FDA and advances in technology will shave years off drug approval timelines.”

Early success with partnership programs between health authorities and the industry will encourage ongoing collaboration to speed product approvals in 2019. The FDA’s accelerated approval programs, such as the Real-Time Oncology Review (RTOR) pilot, contributed to making 2018 a record year for new drug approvals, especially ones that address unmet medical needs.

Additional programs based on regulator and industry collaboration will help drive more efficient processes and bring life-changing therapies to patients faster. The industry also has an opportunity to continue this progress by improving R&D operational performance. In the coming year, expect organizations to find new ways to improve the efficiency of trial execution, submissions development, and other areas across drug development.

2019: Keeping Pace with Industry Innovations

In 2019, the industry will continue to optimize processes to develop and bring products to market faster and smarter. Innovations in precision medicine, drug pricing pressure, and new applications for artificial intelligence will generate the most change as organizations continue to deliver a record number of breakthrough treatments and cures.