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Last week, Sano had the privilege of travelling to Boston for the Chief Medical Officer Summit 360°, where our Co-founder and COO, Charlotte Guzzo, shared her expertise on a panel focused on practical approaches to patient engagement. This event provided a platform for rich discussions on the shifting paradigms of drug development and precision medicine. Here, we’ll share an overview of key discussions and insights from the conference, emphasising the innovative strategies highlighted during the panels.
Insights on drug discovery and regulatory changes
Harvard Business School professor Gary Pisano's presentation was notably impactful; in it, he discussed how the landscape of drug discovery might soon be dominated by key players with extensive datasets and computational power. He predicted that AI could reduce the FDA’s lengthy regulatory decisions to a matter of days, signifying a monumental shift in how medical advancements reach the market.
Advancements in clinical trial design
One of the summit's recurring themes was the need for "lightweight protocols" in clinical trial design. This approach advocates for starting with the bare essentials in trial protocols and only adding components that are necessary for the study's objectives, rather than adhering to complex requirements traditionally included based on precedent. This method aims to serve patients better and reduce the frequency and impact of protocol amendments.
Protocol amendments in clinical trials can be particularly challenging due to the rigorous regulatory scrutiny they must undergo. Each change requires approval from regulatory bodies and ethical review boards, ensuring that the amendments don't compromise patient safety or the scientific integrity of the study. Additionally, making these changes can disrupt ongoing trial processes, require retraining of staff, and potentially extend the study's timeline, increasing costs and complexity.
Patient-centric engagement strategies
During her panel, Charlotte discussed the importance of integrating the patient voice early in the development process. She highlighted the need to recognise patients as key stakeholders, not just subjects, which can transform trial designs by incorporating their real-world experiences and needs. This approach not only enhances the relevance of the data collected but also increases trial efficiency and patient satisfaction.
Charlotte also addressed the challenge of designing trials that are truly patient-centric, questioning the common practice of setting stringent eligibility criteria that might exclude potential participants based on comorbidities or other unrelated criteria. Her insights on building patient profiles that more accurately reflect the real patient population resonated deeply with the audience, underlining the necessity of more inclusive research practices.
To learn more about the work we're doing to streamline precision medicine research, get in touch below!