TcLand Expression is the founder and member of EPEMED (European Personalized Medicine association: www.epemed.org). EPEMED is a European, not for profit organization bringing together global forces in personalized medicine and aims to provide a platform for the harmonization of personalized medicine development and implementation across Europe, focusing on the crucial role of diagnostics, to make personalized medicine a reality.
TcLand Expression is also member of PMC (American Personalized Medicine Coalition: www.personalizedmedicinecoalition.org).
The objective of Personalized Medicine is to achieve optimum medical outcomes in the management of a patient’s disease by using molecular analysis. Molecular analysis, and particularly genomic information, is the cornerstone of any personalized medicine approach. Molecular analysis is carried out by using in vitro devices and instruments (IVD), or through a laboratory designed test performed in a central laboratory.
Personalized medicine promises to introduce a new standard of healthcare, and to address many issues faced by patients and physicians, and notably by:
- Detecting disease at an earlier stage, when it is easier to treat effectively
- Enabling the selection of optimal therapy and reducing “trial and error” prescribing
- Reducing adverse drug reactions
- Increasing patient compliance with therapy
- Shifting the emphasis in medicine from reaction to prevention
- Focusing on patient education emphasizing proactive care, prevention, and targeted therapies
- Reducing the overall cost of healthcare
Source = PowerPoint presentation “Personalized Medicine; regulatory perspective” by Dr. Andy Kessler (1958 -) Author and Hedge Fund Manager
Companion Diagnostics is integral to the part of personalized medicine that allows MD to determine patients’ potential responses to drug treatment. Diagnostic tests are developed together with drugs for particular populations. By testing for specific genetic variations related to certain biomarkers, health professionals can customize their treatments to achieve the best possible therapeutic results and avoid unnecessary treatments.
Source = PowerPoint presentation “FDA’s Approach to Regulation of In Vitro Diagnostic” by Elizabeth Mansfield, PhD (OIVD/CDRH/FDA Tests)
Drug-device co-development process : key steps during development: Of particular note are the label considerations based on the status of the marker used for stratification. Clinical validation of the marker has a direct influence on the clinical utility and therefore on the label of the co-developed product.
Figure from a concept paper reflecting preliminary Agency thoughts on how to prospectively co-develop a drug or biological therapy (drugs) and device test in a scientifically robust and efficient way. Source = FDA Preliminary Concept Paper: Drug-Diagnostic Co-Development