The biopharmaceutical industry is witnessing a transformative shift in how companies generate and utilize real-world evidence (RWE), with artificial intelligence emerging as a game-changing tool for smaller biotech firms seeking to compete with established players.
Tech-Inspired Approach to RWE Generation
Unlike traditional pharmaceutical companies that invest heavily in building internal real-world data (RWD) capabilities, smaller biotechs are adopting a more agile, technology-driven approach. This strategy leverages cloud infrastructure and AI tools to generate meaningful insights without the burden of extensive in-house resources.
"The tech industry's ethos inherently embodies a process-oriented approach, characterized by a continuous cycle of investing in specific tasks and diligently striving to generalise and extend their product's capabilities over time," explains Alexander John Büsser, head of product at Exploris Health.
Revolutionizing Data Analysis Through AI and Cloud Computing
The integration of cloud providers like AWS, Azure, and Google has democratized access to sophisticated data analysis capabilities. These platforms offer Infrastructure as a Service (IaaS), enabling resource-constrained biotechs to process large volumes of data without maintaining expensive internal infrastructure.
Natural language processing (NLP) and machine learning technologies are proving particularly valuable in enhancing RWD quality. These tools enable more accurate effect estimates in studies and strengthen the overall robustness of real-world evidence generation.
Cross-Functional Excellence and The Role of "The Translator"
Success in implementing AI-powered RWE systems requires a departure from traditional sequential project management approaches. Cross-functional teams, led by individuals with expertise in both computing and life sciences – dubbed "The Translator" – are proving essential.
"A skilled translator will act as the glue across business, science, and IT, helping the leader convert the outputs from the analyses into sensible, usable components of an enhanced value story or narrative," notes Ross Maclean, MD, PhD, executive VP and head of medical affairs at Precision Value & Health.
Adapting to Change and Future Implications
The transition to AI-powered RWE generation requires careful change management and stakeholder education. Organizations must balance the need for rapid iteration with maintaining regulatory compliance and scientific rigor. Early involvement of end-users in hypothesis design and continuous education about HEOR methods has proven crucial for successful implementation.
As healthcare stakeholders increasingly demand evidence of real-world effectiveness, this tech-inspired approach to RWE generation offers smaller biotechs a competitive edge. The combination of AI capabilities, cloud infrastructure, and cross-functional expertise is creating new opportunities for companies to generate valuable insights while optimizing resource allocation.
