The end of every year always brings predictions about what the new one may bring.
Looking to 2018, several executives at Veeva System shared with us what they think the New Year will hold.
1. Life Sciences industry unifies drug development workflows
Jen Goldsmith, senior vice president, Veeva Vault said organizations will no longer be able to defend the cost of integrating disparate applications in the New Year.
“Next year, momentum will continue as the industry brings together their applications to support their drug development processes,” she said.
“Companies will focus on streamlining their systems and processes in clinical, regulatory, and quality to eliminate functional siloes and improve efficiency and compliance across the product development lifecycle.”
2. Regulatory and quality teams get close
Change control and variation management become more difficult as companies expand globally, said John Lawrie, vice president of Veeva Vault RIM.
“In 2018, regulatory will begin automating the variation management process and start exchanging information with quality teams to eliminate information gaps,” predicts Lawrie. “This will make it easier to identify impacted product licenses, determine the required variation filings, and develop global submission strategies.”
3. Companies transform global regulatory processes
“Life sciences companies are under continued pressure to globalize,” said Lawrie. As such, companies will increasingly use regulatory information management (RIM) technologies.
“Moving to a common RIM model with shared global systems will streamline processes with local affiliates and countries to work more effectively in a global regulatory environment,” he said.
“Regional offices and individual affiliates will be able to work in the same system as headquarters, improving data quality and end-to-end business processes.”
4. Outsourcing industry modernizes the clinical environment
“As such, competition is very high, driving CROs to re-examine their operations and expand their offering to become turnkey partners to sponsors,” said Jim Reilly, vice present of clinical at Veeva Systems.
“This shift from transactional to more collaborative, strategic partnerships with sponsors has already started.”
In 2018, Reilly told us to expect to see CROs focusing on modernizing their technical and data environments in order to differentiate themselves from the competition.
5. Risk-based everything (RBX) takes over
“The shift to personalized medicine, along with the evolution of adaptive methodologies, is pushing the boundaries of traditional clinical data collection,” said Richard Young, vice president of Vault EDC.
According to research by the Tufts Center for the Study of Drug Development, the number of data sources used in drug development is projected to increase from four to six over the next three years.
Young explained that risk-based monitoring (RBM) will be replaced by risk-based everything (RBX) – a new approach wherein each data point can be analyzed to help companies make better decisions, he said.
“Modern data management systems will enable the transition to RBX and make it possible to manage the increasing volume and diversity of data sources,” added Young.
6. Enterprises adopt a cloud-first strategy in quality
“The continued outsourcing of critical manufacturing functions and high costs of quality issues are prompting companies to improve quality management,” said Mike Jovanis, vice president of Veeva Vault Quality.
“Enterprises are recognizing the value of streamlining processes across global sites, suppliers, contract manufacturers, and other partners and so beginning their move to the cloud.”
Jovanis explained there is still uncertainty surrounding the FDA’s new quality metrics initiative; however, its implementation could introduce challenges for manufacturers who would face pressure to modernize their quality systems and processes.
“As a result, organizations will leverage cloud technology to drive greater efficiency and visibility across quality processes,” he said.
Currently, the FDA’s quality metrics reporting program portal is not set to open in January 2018. The FDA issued an update which explained to “stay tuned” for additional updates.
7. Companies prepare for submissions that require documents and data
Historically, global health authorities have relied heavily on documents to conduct reviews, said Lawrie.
"Gradually, this is shifting as health authorities request a combination of content and data to get a more holistic picture of product safety and efficacy," he explained.
Structured Product Labeling (SPL) – a document markup standard adopted by FDA – as well as the Clinical Data Interchange Standards Consortium (CDISC) – the platform-independent data standards organization – are examples of this combined approach.
"More recently, upcoming regulations such as IDMP are driving sponsors to carefully examine their approach to product-related information," Lawrie added.
"As a result, more organizations will begin the transformation of their processes and systems to incorporate both content and data-related elements.
"While this transformation will support emerging health authority requirements, it will also provide significant benefit to life sciences companies around the globe through a more complete and accessible view of their products," said Lawrie.