The latest Emerging Biotech Leader podcast tackles the important topic of patient-focused drug development, offering valuable insights for the biotech industry. Our host Kim Kushner engages in an insightful dialogue with Dr. Laurie Smaldone-Alsup, SVP Regulatory Science at SSI Strategy, who brings years of hands-on regulatory experience to the conversation.

Laurie’s career, spanning from pioneering HIV/AIDS treatments to her current work in rare diseases, underscores a powerful message: patients are not just beneficiaries of drug development, but essential partners in the process. She explains how early collaboration with patient advocacy groups can transform the development process, providing invaluable insights that shape everything from clinical trial design to regulatory strategies.

The discussion explores the delicate balance between scientific rigor and patient needs, particularly in the context of rare diseases. Laurie offers practical advice on educating regulators, developing meaningful endpoints, and building a solid foundation of disease understanding. Her approach challenges the notion that speed always equals progress, advocating instead for a thoughtful, patient-centric strategy that may initially seem slower but ultimately leads to more successful outcomes.

Another often overlooked challenge is getting boards and investors to support a patient-focused approach. Here Laurie shares strategies for convincing stakeholders of the long-term benefits, even when they're focused on short-term results.

This episode is a call to action for the biotech industry to reimagine drug development with patients at its core. For leaders and innovators in the field, it provides actionable strategies to enhance their approach to drug development and, ultimately, improve patients' lives.

If you'd like to discuss how you might apply these learnings to your own context, contact us now.