Thursday, May 27, 2010

Personalized Medicine on the Horizon

Personalized medicine is a broad term that covers a wide variety of therapeutic approaches which include drug/diagnostic combination products arising from discoveries in areas of pharmacogenomics, pharmacogenetics and genetic expression. The largest number of personalized medicine products available is for oncology. However, personalized medicine is already being applied to many other different disease indications. Product development is promising in disease conditions which include autism, autoimmune disease, cardiovascular, CNS disorders, HIV infection, osteoarthritis, osteoporosis, pain, diabetes, Lupus, Crohn, Renaud and others.

Personalized medicine, combination products include the identification of biomarkers and validation platforms. Validation new product platforms and test methods are noted in areas of analytical validation, clinical validation, regulatory validation, compliance validation, validation of clinical utility, validation of benefit.

Monitor, manage, QA, QC and review emerging "cutting edge" data and data concepts. Regulatory scrutiny promises to be challenging in the emerging field of personalized medicine. Data and documentation must be of high quality. Clinical study protocol and design is rigorous and difficult, but rewarding with promising statistically significant and clinically meaningful patient results and benefits. FDA and global regulatory agencies require adherence to quality procedures, processes, data collection, entry, management, reporting, analysis and regulatory, clinical submission. Data must follow industry and regulatory standards according to CFR, GCP, GLP, QMP, DMP, QC, SOPs, WIs and otherwise.

As with all emerging science and clinical R&D, companies participating in a new area of therapeutics face a number of challenging issues, strategic, logistical, tactical, hypothetical and theoretical. Pharmaceutical and diagnostic companies must come together in a rapidly changing field of medicine from different segments of the market, traditional and "cutting edge" and come to a common understanding and "working" approach and must interact with each other. R&D, product development and regulatory clinical submission processes and procedures, formats and otherwise must be managed by experts, statisticians, data managers, safety and efficacy review boards and opinion leaders. Seek experts, contact,

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