Pharmacogenomics

Pharmacogenomics

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 of 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.

Diane L. Mauriello, Ph.D., is the President of Dante Resources, Inc. a global clinical research organization specializing in clinical and regulatory submissions with a spotless 17 year track record of successful submissions of without a single refusal to file. Diane has close to 25 years in the medical, science, pharmaceuticals field with deep expertise in developing, filing, servicing clients needs in all areas of regulatory submissions including: medical writing, safety, efficacy, CMC, QC, QA PM, Biometrics, Stats, DM, Programming, consultation provide from IND to NDA/eCTD thorugh Q&A, 4 Month safety Update, AC, Action Letters, Approvals, Labels and PM surveillance.

You can follow Diane, a prolific blogger on her clinical research blog

Article Source: Pharmacogenomics