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Guide to Business and Regulatory Strategies: Companion Diagnostic Products and Individual Therapies

Drug and Market Development Publishing
June 1, 2006
155 Pages - SKU: DSMD1305173

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Countries covered: United States

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.

Introduction

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?

1 Executive Summary
2 Introduction: Personalized Medicine Perceived Issues; Spear's Seven Pharmacogenomic Myths
3 Intellectual Property Guide: Licensing Issues for Genetic Markers of Disease and Drug Responsiveness; Developing Products For Personalized Medicine: Application of the NIH Research Tools Policy; What is the NIH Research Tools Policy?
4 Regulatory: FDA Perspectives on Pharmacogenetic Testing; FDA GUIDANCE PUBLICATIONS; Clinical Validation
5 Contract Research Organizations: Use of Contract Research Organization (CRO) for Diagnostic Development; Interviews with CROs; Follow-up Interview regarding CE European commercialization with Bill Morton, President, MDCI®
6 Reimbursement: CMS Reimbursement; Private Payer Issues; Local Medicare Coverage; A follow-up interview with David Sholehvar, Director, Strategic Customers for Veridex; BRCA1/2; Chromosomal Banding (Cytogenetics); Exhibit 6.9 depicts that all three of the parts of the process of obtaining local Medicare coverage, scientific literature, regulatory issues, and collaboration between health professionals, and were important for obtaining local Medicare coverage for chromosomal banding. There is a good deal of scientific literature available for Chromosomal Banding (Cytogenetics). Many of the national coverage determination issues surrounding Chromosomal Banding (Cytogenetics) have helped shaped local coverage guidelines. Lastly, the research included collaboration between pathologists and oncologists; Exhibit 6.9 Chromosomal Banding (Cytogenetics) Local Medicare Coverage Process; Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS); Case Study: Genomic Health's OncoDX™ Breast Cancer Assay: Assess Risk, Determine Therapy Benefit, and Maximize Resource Utilization by Ted Snelgrove, Vice President of Marketing:; The Oncotype DX™ Story; Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast Cancer
7 Business Models and Issues: Introduction; Market Incentives and the Business Model for Linked Dx/Rx Products; Companion Diagnostic Commercialization Issues
8 References

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Guide to Business and Regulatory Strategies: Companion Diagnostic Products and Individual Therapies

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