From Generalist to Specialist: The Changing Landscape
Andrea reflects on the significant shift in biospecimen management roles:
"20 years ago, I was involved in establishing the cellular biomarker group at Novartis, and my role spanned a lot of different responsibilities. Our group was doing almost everything: measuring the samples, developing the assays, analyzing the data, uploading the results, and many other tasks, which nowadays are split into numerous specialized roles, in some cases outsourced."
This transition from generalist to specialist roles has been driven by increasing complexity, regulatory requirements, and higher throughput in clinical studies. While specialization has its benefits, Andrea notes that it can sometimes lead to a disconnect between different aspects of the biosampling process.
The Growing Importance of Biospecimen Management
The establishment of dedicated biospecimen management departments in pharmaceutical companies highlights the growing recognition of this field's importance. Andrea observes:
"People start to see that it's needed, and it brings an additional value to have people dedicated to this field."
However, she emphasizes that the role of a biospecimen manager can vary between companies and that a standardized job description is still lacking in the industry.
Challenges and Opportunities
Andrea identifies several key challenges in biospecimen management:
Paper-based processes: The industry's reliance on paper requisition forms remains a significant hurdle. While electronic systems are the future, Andrea cautions that the transition must be carefully managed to ensure site compliance and ease of use.
Complex lab manuals: Often, lab manuals are not user-friendly for site staff. Andrea suggests simplifying instructions and creating more intuitive formats to reduce human error.
Sample tracking: Gaps in sample tracking, particularly between collection at sites and arrival at central labs, remain a concern. Andrea sees potential in new tracking tools but notes that cost-benefit considerations have slowed adoption.
Regulatory complexities: Increasing regulatory requirements are important, but especially around sample storage and future use, can sometimes hinder research progress and best use of samples.
The Future of Biospecimen Management
Looking ahead, Andrea envisions several developments:
Improved sample tracking: Comprehensive tracking from collection to analysis or disposal will become standard practice.
User-friendly electronic systems: The industry will move away from paper-based processes, but solutions must be intuitive and considerate of site workflows.
Greater awareness: There will be increased recognition of the critical role biospecimen management plays in clinical research success.
Balancing complexity and simplicity: As Andrea puts it, "It's always as easy as possible, but as complex as needed within that sequence and not the other way around."
A Call for Collaboration and Understanding
Andrea emphasizes the importance of collaboration between sponsors, sites, central labs, and analytical labs to optimize biospecimen management processes. She advocates for greater awareness of the challenges faced by each stakeholder and suggests that sponsors and managers spend time understanding site operations.
"I think biosampling is one of these functions... [that is] mostly not noticed when everything goes fine. It is noticed for example when the kits are not on time, or when too many samples are lost," Andrea notes. “Raising awareness of the importance of good biospecimen management practices is crucial for the field's advancement. Patients/subjects are giving us precious material, and we should take utmost care and ensure high quality and lowest possible sample loss.”
As the industry continues to evolve, Andrea's insights serve as a valuable guide for navigating the complex landscape of biospecimen management. Her perspective underscores the need for continuous improvement, collaboration, and a patient-centric approach in this critical aspect of clinical research.
