A paradigm shift in the role and nature of evidence generation

In today’s rapidly evolving health care ecosystem, evidence generation is no longer an operational checkbox but a core strategic asset driving differentiation in the increasingly competitive biopharma industry. With rising demands for patient-centered outcomes, demonstration of long-term value of treatments, and cost transparency, biopharma companies face mounting pressures to advance traditional evidence generation methodology.

Leaders in the biopharma industry will establish a strategic evidence capability that seamlessly integrates diverse data and insights, reveals patterns and trends that inform key decisions throughout the end-to-end drug development life cycle, and enables a real-time learning system to promote continuous innovation and sustained market advantage.

The need for a more cohesive approach to evidence generation

While many biopharma organizations have adopted some form of integrated evidence planning (IEP), few have successfully deployed a truly integrated and enterprise-wide evidence capability and strategy. Today, evidence planning, generation, and dissemination efforts are often fragmented with different teams and regions working in isolation, which can lead to missed opportunities and inefficiency. Common limitations and pitfalls include:

• Data silos and underused data assets.
• Organizational barriers to cross-functional collaboration.
• Legacy technology systems and platforms.
• Misaligned incentive mechanisms promoting function-specific goals and priorities.
• Overemphasis on defining processes or deliverables without addressing digital technology and infrastructure gaps.
• Resource limitations (e.g., insufficient skills and expertise in advanced data analytics and novel real-world evidence [RWE] methods).

Propelled by groundbreaking advancements in scientific and technological innovation, significant shifts in the biopharma industry are redefining the role and nature of evidence generation. There are several factors driving a need for a more cohesive, technology-driven approach, including:

• Intensifying competition and consolidation in key therapeutic areas are increasing the need to strategically integrate diverse data sources and distill novel insights to achieve market differentiation.
• Scientific advancements in precision and personalized medicine are creating smaller, harder-to-reach patient populations and fragmented pockets of unmet patient needs.
• Rapid evolution of advanced digital technologies, artificial intelligence (AI)/machine learning (ML) capabilities, and personalized digital tools are enabling a significant proliferation of novel, yet underutilized data types and insights.
• Evolving trends in both regulatory and payer pathways demand more robust, patient-centric evidence packages and demonstration of longer-term efficacy and cost-effectiveness.

Potential benefits of an integrated evidence capability

Establishing an integrated evidence capability revolutionizes how data and insights can be leveraged throughout the drug development life cycle and across the portfolio. By employing a digital-first mindset in the development of a cohesive strategy and governance structure, we unleash transformative breakthroughs in the development and commercialization of personalized therapeutics.

Our capabilities integrate AI and GenAI to unlock the next generation of evidence planning through data integration and analysis, enhanced insight generation, and differentiated, adaptive life cycle management strategy.

In today’s digital era, the adoption of next-generation tools and technologies is pivotal to achieving advantage and operational excellence. Our digital-first approach improves efficiency while empowering organizations to respond swiftly to market changes and emerging trends, sustaining their IndustryAdvantage™.

How Deloitte can help

When developing a successful integrated evidence strategy, organizations should reflect on where they currently are in the journey. Understanding the maturity of current evidence processes and the digital ecosystem is key to charting a path forward.

Deloitte can provide differentiated expertise and experience in the design and deployment of an integrated evidence capability spanning strategy, process, and governance design; leading-edge platform customization and deployment; and ongoing operationalization support.