The pace of breakthrough innovation will have a significant impact across the industry and require a fundamental shift in how companies develop and commercialise drugs. From transforming the pharmaceutical supply chain to leveraging artificial intelligence in commercial, organisations will embrace new ways to drive greater operational efficiency.
Here are Veeva’s top predictions for 2019, and the big changes you can expect to see, as companies look to keep pace with the investments they are making in product development.
1. Every link in the pharmaceutical supply chain will adapt to speed drug development.
As more companies drive breakthrough innovations in precision medicine and the market grows to almost $90 billion by 2023, significant changes will be required in the traditional supply chain. These groundbreaking drugs give patients hope, but also entail complicated logistical requirements. 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 patients, the supply chain will need to acclimate to the unique conditions of targeted medicines. Matt Wallach, president and co-founder
2. Drug pricing pressure will help drive new measures to improve operational efficiency.
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 US, will drive new innovations. 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 reduced costs by eliminating intermediaries.
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. Matt Wallach, president and co-founder
3. Companies will discover the key to taking full advantage of artificial intelligence in commercial.
We will move toward an AI-driven workforce as artificial intelligence becomes a standard capability across commercial applications. AI will not only continue to improve sales force effectiveness with suggestions on their next best actions, but also become more pervasive and embedded in commercial processes. For example, it will automate claims-reference linking in content management for marketing operations, and automatically recognise 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 organised their engagement and content, their data is not yet organised. 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. This year, there will be renewed focus on improving the commercial data warehouse to organise data in a standard way and keep it current, so companies can apply AI to uncover intelligent insight. Paul Shawah, senior vice president, Veeva Commercial Cloud
4. Data will flow more seamlessly between clinical trial systems and stakeholders.
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 cloud will enable clinical data management teams to see all of their data in real time and easily share information with stakeholders. Organisations can bring their data together and move toward risk-based trials – where data is collected and analysed 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. Henry Levy, general manager, Veeva Vault CDMS
5. Quality 4.0 will take a big step forward in manufacturing.
More companies will digitise 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 organisation 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. Mike Jovanis, vice president, Vault Quality
6. Continued partnership between regulators and the industry will drive faster drug approvals.
Early success with partnership programmes between health authorities and the industry will encourage ongoing collaboration to speed product approvals. Programmes 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 organisations to find new ways to improve the efficiency of trial execution, submissions development and other areas across drug development. Jim Reilly, vice president, Vault Clinical
7. The medical device industry will move clinical trial management to the cloud.
The new Medical Device Regulation (MDR) in Europe will prompt medical device manufacturers and distributors to leverage the flexibility and cost-efficiencies of modern cloud-based clinical systems. The MDR requires more clinical evidence and technical documentation, as well as a greater focus on identification, traceability and market surveillance. This will cause a jump in the number of clinical studies conducted, affecting costs, processes, outsourcing strategy and even organisational design. Device manufacturers will turn to new solutions such as electronic trial master files and clinical data management systems to compliantly and efficiently go to market. Melonie Warfel, vice president, Medical Device Strategy
8. Training will become a strategic asset to improve quality metrics.
In 2019, more organisations will execute training initiatives as a strategic part of their business. Connecting training with quality metrics requires unifying processes across quality, content and training systems for improved quality management. Organisations can then stay current on role-based qualifications as events happen and policies change, as well as have greater control over the complete life-cycle of training content. This unified approach will improve companies’ ability to measure training effectiveness and connect outcomes to other mission-critical business processes. Kent Malmros, senior director, Vault Training
9. Enterprise pharma companies will continue to launch regulatory transformation initiatives.
Moving into 2019, enterprise-wide regulatory transformation programmes will continue, and new initiatives will be launched, across large pharmaceutical companies. We expect more will look holistically at end-to-end processes spanning quality and regulatory, and improve global regulatory processes by unifying regulatory information management (RIM) technologies.
Leaders such as Bristol-Myers Squibb, Eli Lilly and GlaxoSmithKline have already re-engineered their global regulatory organisations. This year, more will move to a unified RIM model with shared global systems and processes to operate more efficiently and achieve greater control over data. John Lawrie, vice president, Vault RIM
In 2019, the industry will continue to optimise processes to develop and bring products to market that are faster and smarter. Innovations in precision medicine, drug pricing pressure, and new applications for AI will generate the most change as organisations continue to deliver a record number of breakthrough treatments and cures.
