Guide to Business and Regulatory Strategies

Five years after the historic completion of the Human Genome Sequencing Project, personalized nutrition and medicine are fields evolving with an emphasis on discovering and researching biomarkers to aid diagnoses. Specifically, clinical pharmacogenomics, theranostics, and nutrigenomics are all examples of areas where diagnostic have entered the arena of being used in conjunction with drug treatments and nutrition recommendations. The availability of genome sequences and biotechnology developments, such as clinical microarrays during the last year, are driving the development of diagnostics. At the same time, the technology is progressing, regulatory issues have to keep up with the changes. The FDA approval of Affymetrix's AmpliChip at the end of 2004 and beginning of 2005 as a 510K device rather than analyte specific reagents reflects the changing landscape of genetic testing regulation. Therefore, having examples and cases studies of business strategies, business models, regulatory, and reimbursement issues are extremely useful for learning and understanding the commercialization process of diagnostics that are to be used in conjunction with therapeutics.

Report Overview

D&MD's Guide to Business and Regulatory Strategies: Companion Diagnostic Products and Individual Therapies is a unique compilation of historical companion diagnostic products, business models for drug/diagnostic collaborations, education & marketing, intellectual property, regulatory, and reimbursement information for those interested in developing companion diagnostics, as well as stand-alone diagnostics.

This publication answers key questions such as:

> What are the US in vitro diagnostic regulatory guidelines?

> What are the in vitro diagnostic regulatory guidelines outside of the US?

> Why is a diagnostic contract research organization (CRO) useful?

> What are main intellectual property issues to keep in mind?

> What is the difference between an ASR and a 510K?

> How can a company estimate the dollar value a companion diagnostic can add to a therapeutic?

> Why companion diagnostic will not necessarily ruin a therapeutics market?

> How a company can meet both commercial and non-profit goals?

> What does the FDA have to say about pharmacogenomics?

> What are the steps for validating a clinical assay?

Laura Ruth, Ph.D., has been an independent medical, science, and technology writer and consultant. She has provided a wide range of services to education, biotech, journal, and market research clients for the past six years following a nine-year career as a biological chemistry laboratory scientist. Her education, combined with her experiences as a biological chemistry technician at Lawrence Berkeley Laboratories and Syntex, allow her to cover a broad range of science, technology, and policy topics. She has previously authored eleven biotechnology market research reports for Business Communications Company, Inc., Kalorama Information, and Cambridge Healthtech Advisors. Other topics have included gene therapy, protein chips, immunoassays, molecular diagnostics, drugs of abuse diagnostics, and prion diagnostics for applications in industries such as clinical, food, and biodefense. Laura Ruth holds a B.S. in chemistry from MIT and a Ph.D. in biological X-ray crystallography from the University of Pennsylvania.

June 2006, Pages 155, Format PDF
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Price: $895.00 / GBP447.50