Pharma’s Almanac

December, 14, 2024

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Sonja Wustrack, Managing Director of Integrated Evidence Generation, OM1

The omnipresent dynamic of 2023 has been the decline in COVID, with patients, providers, and the pharma/biopharma industry adjusting to the aftermath of the pandemic. COVID-related deaths continue to fall, currently reaching levels seen in the very early days of the pandemic and vaccines update has diminished alongside the decrease in threat. As a result, pharma companies that have focused on COVID vaccines are faced with a steep cliff and need to adjust accordingly.

Similarly, we all can attest to the permanent changes that have resulted in this historical episode. A collective shift from treatment to prevention. Patient journeys have changed with often longer times to diagnosis and treatment. Remote work and communication through digital means is here to stay and has altered the dynamic between patient and provider dramatically, while also removing barriers to access for many populations. The presentation of a clear need to rapidly stand up and execute clinical trials that are robust and inclusive. These shifts amplified even further in the context of ongoing efforts around targeted medicines, patient-centricity and representativeness and the need to get treatments/products to the right populations, quickly and safely in the real world setting.

Integrated evidence planning, underscored by the use of real-world data (RWD) and evidence (RWE), is key to moving through to the post-pandemic environment. With more constraints on funding and increasing challenges with market access, RWE can drive targeted approaches to populations where the product will be most effective and deliver the best outcomes. A thoughtful, integrated evidence-generation effort will support optimized development planning, efficient data collection efforts, and regulatory requirements and aid in engagement with providers and patient communities to demonstrate performance in the real world.