BeiGene

Stefano Ferrara is the Director of Clinical Science at BeiGene. His early experience as a study coordinator in hospitals both in Italy and the United States was fundamental in shaping his understanding of the needs of patients and physicians alike. This hands-on clinical exposure laid the groundwork for his leadership approach. His tenure at Celgene allowed him to engage with all aspects of clinical development and collaborate across multiple functions, further honing his comprehensive leadership skills in the pharmaceutical industry.

Through this article, Ferrara emphasizes the critical balance and strategies needed in clinical research to overcome challenges, ensuring studies remain scientifically valuable and patient-centred despite growing complexity and industry pressures.

Balancing Recruitment and Data Integrity in Clinical Studies

The first challenge is recruitment, and the second is maintaining constant data quality throughout a study. You have to support sites and investigators in order to enroll subjects, but then you need a plan to ensure data quality in the long run. The latter is more challenging, mainly if the company’s tactics are unclear.

Navigating Complexity in Modern Clinical Development

With the increased number of options, designing a development plan and protocol is going to be increasingly complex. My approach is to work more closely with selected hospitals and investigators who will help me understand the right direction. I’m curious to see if AI will help us be more productive and efficient. This, combined with careful data review, clear procedures, and tools to harmonize data from different sources, creates a stronger foundation for effective clinical development.

“My approach is to work more closely with selected hospitals and investigators who will help me understand the right direction. I’m curious to see if AI will help us be more productive and efficient”

Key Metrics to Track Clinical Program Progress

From an operational point of view, several metrics can be used from different functions, like DM and stats. As for science, the crucial question is whether the protocol still produces scientifically relevant data, e.g., it’s not obsolete. It’s difficult to decide when a protocol is still worthy of running. You can use external experts, like DMC or the steering committee, but also internally, you need to have a process to assess the risk. Real-world data is poorly used at the moment. Biomarkers are important but quite difficult to use in real time to drive changes in the protocol. This may only be possible in phase I.

Need for Competence in Clinical Research

I believe we are seeing a decrease in competence in clinical development. We don’t have enough good professionals with the expertise needed. Furthermore, there is an increased focus on commercial. Although profit is needed for a company, we need to take some risks to find some caring opportunities in more neglected cancers. This is going to be very difficult today.

Key Advice for Aspiring Leaders

It’s essential to actively listen to both investigators and patients to understand their needs, challenges, and perspectives truly. Equally important is having a clear strategy and well-defined tactics that guide decision-making and actions throughout the clinical program. By combining open communication with a transparent plan, teams can align better, address issues proactively and ensure the study stays focused on meaningful outcomes for all stakeholders involved.