(June 15, 2017)
In biomarker-driven precision medicine clinical trials, patient samples (biospecimens) are as important as patients themselves. Sample assay results often determine patient segmentation, and support primary and key secondary objectives. The lack of proper sample tracking & management escalate risks of milestone delays and regulatory scrutiny. Drastic increase in complexity and importance of biospecimen operations demands new technological solutions and best practice operating models; we illustrate how they enable study teams to:
1) reduce the risk of biospecimen logistics becoming a bottleneck in clinical trial execution, including the incorporation of sample-related Key Risk Indicators in Risk Based Monitoring plans
2) acquire actionable and predictive insights into the “health” of clinical trial operations from a biospecimen-centric perspective
3) discover and resolve biospecimen issues earlier and more effectively
4) ensure regulatory compliance to patient informed consent regarding sample retention, use, and destruction
5) extend utilization of banked biospecimens beyond the current clinical study (e.g. translational research and biomarker discovery)
6) reduce sample storage costs and optimize storage capacity
Jian Wang, Ph.D.
Dr Jian Wang received his Ph.D. in Bioengineering from the University of Washington. For the past 20+ years, Dr. Wang developed several software products with customers in academia, government and the pharmaceutical industry. Jian has deep knowledge in the rapidly evolving field of precision medicine and its associated biomarker-driven clinical trials. As President and CEO of BioFortis, a precision medicine technology solution company, Jian delights in applying his experience to help researchers solve real-world problems. Jian believes that we can cure many, if not most, of the devastating diseases that humanity suffers from within our children's generation – a vision both he and his colleagues at BioFortis are passionate to help make into a reality.