What is the importance of pharmacogenomics?
Pharmacogenomics allows us to identify sources of an individual’s profile of drug response and predict the best possible treatment option for this individual.
The use of genomic information, accelerated by the sequencing of the human genome and the advent of new tools and technologies, has opened new possibilities in drug discovery and development.
Consequently, regulatory science and regulations need to be set in place appropriately.
How do you keep your clients informed of the status of their project?
Project Managers/Study Directors can keep their clients informed of their projects in many ways. Interim reports, weekly conference calls, and tracking reports are a few ways to keep the client informed.
During the project initiation phase, the Project Manager/Study Director and the Sponsor determine the involvement of the Sponsor.
Do you assign dedicated staff/contact for project and sites for a study?
Each study protocol is assigned a Project Manager/Study Director that has been trained in lab processes as well as demonstrated interpretation and laboratory proficiency testing.
The Project Manager/Study Director is the single point of contact for the Sponsor, the sites, the clinical coordinator, and the investigator (if appropriate).
What type of data transfer can Gentris support?
We can support a variety of formats including PDF files that can be password protected, plain text, or comma delimited text (CSV files). Data may also be transferred by hard media, e-mail, normal FTP transfer, or secure FTP transfer.
What volume of blood is recommended to collect for a PGx sample?
6-10ml is recommended. We are able to process samples with as little as 2-3ml.
What is your experience with receiving samples from outside the USA?
Gentris has extensive experience receiving samples from outside the USA. We have supported many complex studies including studies with 125 sites in 26 countries. Our support includes PGx implementation, clinical logistics support, site training, and sample collection/shipping guidelines.
Our primary international courier is World Courier, but we have also worked with FedEx, DHL and UPS. Gentris is well versed in customs specifications for the shipment of samples.
What regulations does Gentris follow?
Gentris processes are compliant with FDA 21 CFR Part 58 guidelines (Good Laboratory Practices).
Are there FDA requirements?
FDA recognizes the importance of pharmacogenomics and encourages its use in drug development. This is reflected in the FDA white paper Stagnation or Innovation? Challenge and Opportunity on the Critical Path to New Medical Products, which identifies pharmacogenomics as a key opportunity for the Critical Path.
Several guidance documents are being developed that provide information on the Agency’s current thinking and the use of pharmacogenomics for regulatory decision making. These guidances are complemented by FDA procedural documents (e.g., MaPPs and SOPPs), which go into more detail for specific regulatory issues.
In addition, the FDA has created a new training program for genomics for review staff, organizes and participates at numerous conferences and workshops and regularly publishes new considerations and findings in the scientific literature. The FDA also engages in several applied research projects to support and promote the translation of pharmacogenomics from basic research, drug discovery and development into clinical practice, focused on ensuring its proper employment to protect public health.