Let’s Get Real: How Real-World Evidence Is Driving Innovative Drug Development and Commercialization

The biopharmaceutical development landscape has transformed in recent years due, in part, to innovations in digital technologies and data networks that have exponentially increased access to real-world evidence (RWE)—patient-level data derived from real-world settings—and supported by policy and regulatory efforts to expedite clinical development.

RWE can provide a window into the lives of patients, illuminating unmet medical needs and opportunities to improve the patient’s experience at each step of their journey, from screening and diagnosis to treatment selection, access, and response monitoring. Through this window, it has the potential to drive innovation and accelerate drug development to improve patient outcomes. RWE plays an important role throughout the lifecycle of a drug, from research and development through commercialization and beyond.

Early Research and Development: Through the analysis of real-world data on disease prevalence, treatment patterns, and patient outcomes, biopharma companies can identify opportunities for drug development that address the needs of patients who are not well served by existing therapies. RWE can inform target selection by providing information on disease biology, treatment pathways, and patient needs. Together, these insights can help to guide pipeline and portfolio strategy.

Clinical Trials: By providing insights into the complexities of patient populations, RWE can identify patient subgroups most likely to benefit from a new treatment and inform the design of trials that more accurately reflect patient needs and capture endpoints that are meaningful for patients and healthcare professionals. RWE-driven optimization of clinical trial design and recruitment accelerates the drug development process and improves the chances of success, thus expediting the delivery of life-changing medications to more patients who need them.

Regulatory Approval: RWE is increasingly being used to support regulatory decisions, such as accelerated approval and expanded access. The use of synthetic (or historical) control arms can, in appropriate circumstances, reduce patient exposure to placebo control arms while decreasing the time, investment, and logistical challenges of conducting randomized controlled trials. Regulatory guidance informing the use of RWE in clinical development, approval, and commercialization is continually evolving and must be closely monitored and incorporated into clinical development plans.

Commercialization: Real-world data on patient outcomes and treatment patterns can help inform biopharma companies on how to demonstrate the true value of new treatments and differentiate them from existing therapies in crowded marketplaces. The insights from RWE guide the optimal use of new therapies, supporting physicians and patients with treatment decisions. RWE on the benefits of new therapies can also support market access by providing insights into their value and impact on healthcare systems.

Post-Market Surveillance: Capturing real-world outcomes in a broader spectrum of patient populations than just those included in registrational trials can reveal unexpected benefits or rare safety signals and has the potential to address health inequities resulting from trial gaps or lack of patient diversity, supporting more personalized treatment decisions. The use of RWE to guide label expansions and new indications can also improve patient outcomes and drive product growth.

BGB Group has long recognized the potential of RWE to unlock new insights and drive innovation and transformation in the biopharma landscape. As the use of RWE continues to grow, it will be essential for biopharma companies to collaborate cross-functionally to leverage the power of RWE throughout the lifecycle of a drug to develop integrated strategies that bring new therapies to market faster, demonstrate their value more effectively, and ultimately improve the lives of patients with unmet medical needs.

References:

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