In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Ramin Farhad are joined by Bob Honigberg to further discuss the considerable challenge of achieving bold missions in healthcare. Building on their discussion from Episode 28 where they interviewed Cleerly Health founder Dr. Jim Ninh, the episode provides useful perspectives for any mission-driven biotech seeking to prove game-changing healthcare concepts. What does it take to achieve major goals that could reshape patient outcomes worldwide?

Bob emphasized the most important hurdle companies face when pursuing daring healthcare mission. He noted that "Large, well-designed studies proving impact on outcomes as well as cost are needed for clinical adoption, regulatory approval, and reimbursement. This level of evidence takes significant investment."

Bob's point highlights the challenge of gathering robust clinical data at meaningful scales. This perspective resonates throughout the conversation, as generating rigorous evidence through extensive studies is consistently referred to as the foundational requirement for proving solutions and achieving ambitious goals that could transform patient care.

Some key points were made about generating robust clinical evidence to support these missions:

• Large, well-designed clinical trials involving thousands of patients are needed to prove concepts, change practice, gain approvals and reimbursement.
• Downstream data is important to show how diagnostic or predictive tools impact treatment decisions and health outcomes. Real-world evidence of clinical utility is critical.
• Long-term studies may be required to demonstrate prevention of disease progression and cost savings over time. This level of evidence takes significant upfront investment.
• Standards of evidence will be high when trying to shift treatment paradigms or gain recommended screening status from influential bodies.

In summary, Kim, Ramin and Bob made it clear that delivering on bold missions in healthcare requires tackling the difficult challenge of generating robust clinical evidence through extensive studies. While an audacious vision can motivate teams, that alone is not enough - proven impact must be demonstrated to realize the transformation.

Tune into the full conversation, where our team unpack this issue in greater depth and discuss creative ways that industry pioneers are overcoming these barriers.