The life sciences industry continues to face new challenges with shifting regulatory and economic pressures, and transitions to new models of care. Because of this complexity, the need for collaboration has become greater than ever. The following three areas are having a profound effect on the industry:
RESEARCH & DEVELOPMENT
We’re witnessing a rise in scientific and medical discoveries that has created new domains that didn’t exist a decade ago. For example, system biology - an engineering approach to biological scientific research - is now a central piece to understanding complex diseases like oncology.
The industry must constantly search for ways to deliver better results that can decrease operational costs, while reducing time to market. Emerging technologies like automation and virtualization are showing promise as ways to remain competitive and advance innovation. According to FDAReview.org, currently only 8 percent of drugs make it through the development and approval process and into the market. While many insights are derived from the drug candidates that didn’t make it, there is still a significant amount of time and money spent on R&D. This is why accuracy in R&D is more important than ever. Through virtual design technology, it has become possible to test drug candidates in a virtual environment. This method of virtual testing enables researchers to identify higher quality candidates that have a better chance of getting to market. By combining in silico and physical experiments, the industry will be better armed to address these new scientific discoveries.
To accommodate the ever increasing engagement of patients and practitioners in the healthcare ecosystem, the industry as a whole is looking to enable a shift to next-generation manufacturing that will be predictive and adaptive. To be successful, companies must embrace a platform approach that will enable scalability and flexibility, while meeting the evolving regulatory, quality and operational guidelines set forth by regulatory agencies around the world.
Further, the full adoption of Internet of Things and services into production environments, along with modular, flexible, disposable and single-use components will become the norm. “Smart” factories will manage production processes in real-time from the moment an order is placed right through to outbound logistics and will be the center of the manufacturing revolution.
QUALITY AND COLLABORATION
As part of the mandate for perfection there will be a need to better manage global changes, global market registration and total quality processes to help ensure safety and achieve regulatory compliance. To accomplish this, the industry must unite.
By doing so, we can build more complex and sophisticated portfolios that are necessary to reach more patients worldwide. By eliminating organizational and information silos, we will be able to collaborate more effectively, aligning stakeholders to expand the ecosystem and leverage department expertise to get to the right information faster.
The goal is to create an integrated framework for compliant innovation, embed quality and regulatory best practices early in the development process, and to provide end-to-end product traceability throughout the lifecycle of the product. This process allows for higher quality, compliant products and faster regulatory approvals that will ultimately result in better patient outcomes.
The life sciences industry is beginning to operate in a much more collaborative environment - both internally and externally, and with different players throughout the healthcare ecosystem. Organizations that digitalize their businesses by embracing the principles and technologies that deliver digital continuity across the entire healthcare continuum will win.
By opening the door to strategies that encourage information and idea exchange, life sciences companies will be able to work to capacity and further improve the lives of patients.