| Personalized medicine is a broad term that covers | | | | study protocol and design is rigorous and difficult, |
| a wide variety of therapeutic approaches which | | | | but rewarding with promising statistically significant |
| include drug/diagnostic combination products arising | | | | and clinically meaningful patient results and |
| from discoveries in areas of pharmacogenomics, | | | | benefits. FDA and global regulatory agencies |
| pharmacogenetics and genetic expression. The | | | | require adherence to quality procedures, |
| largest number of personalized medicine products | | | | processes, data collection, entry, management, |
| available is for oncology. However, personalized | | | | reporting, analysis and regulatory, clinical |
| medicine is already being applied to many other | | | | submission. Data must follow industry and |
| different disease indications. Product development | | | | regulatory standards according to CFR, GCP, GLP, |
| is promising in disease conditions which include | | | | QMP, DMP, QC, SOPs, WIs and otherwise. |
| autism, autoimmune disease, cardiovascular, CNS | | | | As with all emerging science and clinical R&D, |
| disorders, HIV infection, osteoarthritis, | | | | companies participating in a new area of |
| osteoporosis, pain, diabetes, Lupus, Crohn, Renaud | | | | therapeutics face a number of challenging issues, |
| and others. | | | | strategic, logistical, tactical, hypothetical and |
| Personalized medicine, combination products include | | | | theoretical. Pharmaceutical and diagnostic |
| the identification of biomarkers and validation | | | | companies must come together in a rapidly |
| platforms. Validation of new product platforms | | | | changing field of medicine from different |
| and test methods are noted in areas of analytical | | | | segments of the market, traditional and "cutting |
| validation, clinical validation, regulatory validation, | | | | edge" and come to a common understanding and |
| compliance validation, validation of clinical utility, | | | | "working" approach and must interact with each |
| validation of benefit. | | | | other. R&D, product development and regulatory |
| Monitor, manage, QA, QC and review emerging | | | | clinical submission processes and procedures, |
| "cutting edge" data and data concepts. Regulatory | | | | formats and otherwise must be managed by |
| scrutiny promises to be challenging in the | | | | experts, statisticians, data managers, safety and |
| emerging field of personalized medicine. Data and | | | | efficacy review boards and opinion leaders. |
| documentation must be of high quality. Clinical | | | | |