The age of mainstream social media is upon us and everyone now has multiple avenues to become an influencer and to change the status quo. There’s been a significant push from patient advocacy groups to raise disease awareness, lobby governments for greater access to breakthrough treatments, and to have input into clinical trial conduct. In response, Takeda has taken great strides in incorporating a patient-centric approach to drug development through the use of minimally invasive and less frequent testing procedures while maintaining the power and rigor of the clinical trial. A secondary effort is underway to educate potential clinical trial participants about the overall conduct of the clinical trial process, justification of the need to collect biological samples or perform imaging procedures in support of safety, pharmacokinetics, or efficacy endpoints. Groups have also taken measures to incorporate AI and cutting-edge biometric avenues to further reduce patient burden.
To that end, Takeda has leveraged advances in reagents and instrumentation to afford a deeper dive into biomarker characterization—expanding efficacy and safety knowledge by incorporation of post-translational modified forms of biomarkers into translational data packages. This strategy has been particularly useful in support of rare diseases where the number of patient samples is low or in situations where we want to minimize sampling frequency where patients would experience a significant level of discomfort. As we begin to fortify datasets and validation of the approach, we envision expanding utility into the patient segmentation/stratification process pioneered in oncology to guide a precision medicine treatment paradigm to all classes of disease.