Personalized medicine and next-generation sequencing (NGS) are two trends producing major swings in the healthcare industry. As previously discussed on Doe & Ingalls blog, here are some points you should be familiar with if your strategy touches upon either of these.
Sensitivity, Specificity, and Validation
Next generation, high-throughput sequencing has many applications in the laboratory but for patients everywhere, they care most about its direct impact on their health. Since genetic testing and diagnostic kits can exclusively determine a patient’s method of treatment, there are growing calls for validation from patients, care providers, and governing bodies.
Validation for next-gen sequencing can include (but is not limited to)
- Policy and interpretation documents outlining compliance with guidelines established by the FDA (and any other governing bodies)
- Installation Qualification (IQ) – verification that all equipment/software relevant to the sequencing process are according to pre-established specifications
- Operational Qualification (OQ) – evidence showing that all equipment/software functions according to User Requirement Specifications (URS)
- Performance Qualification (PQ) – proof that the sequencing process produces outputs in a reliable manner consistent with URS
- Risk Assessment – likelihood of various components failing to meet specifications and incorrectly impact a patient’s health outcome
Sensitivity and specificity thus become two major concerns for applying high-throughput sequencing in personalized medicine. Both false positives (Type I Error) and false negatives (Type II Error) can lead to healthcare providers choosing the wrong method of treatment and potentially exacerbating things further.
How to Keep Up with Demands of Personalized Medicine
Because personalized medicine is relatively young, set regulations are still being developed which leaves biotech and pharmaceuticals with little guidance. So how can you avoid future road blocks to your go-to-market strategy?
In 2015, President Obama launched a Precision Medicine Initiative with efforts to foster standardization and collaboration so that genetic-based treatments may truly thrive in healthcare. precisionFDA is one result of this trend.
According to the FDA, precisionFDA is “a community research and development portal that allows for testing, piloting, and validating existing and new bioinformatics approaches to NGS processing.” It’s an online, cloud-based portal that facilities NGS advances while simultaneously focusing on meeting the demands behind industry validation
Overall, personalized medicine has the potential to effectively treat individuals on a wide scale basis. However, if not implemented properly, it also has the potential for a great deal of harm. Therefore, the processes supporting these initiatives must be validated and streamlined.
Most of us in the biopharmaceutical industry would agree that patient safety and regulatory compliance are the key drivers within cold chain logistical systems. Organizations recognize the growing need for control of the entire cold chain. The ever changing global scenario requires highly efficient processes as a backbone to accommodate the growing needs of organizations. To learn more about maintaining temperature throughout logistical activities, download your free eBook Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics.