How to Succeed In Personalized Medicine by Using Tools and Technologies Which Companies and Technologies are Pro fiting From a Favorable Regulatory Environment

Published by: Drug and Market Development Publishing

Published: Jan. 1, 2006 - 113 Pages

Table of Contents

Chapter 1: Executive Summary

Overview

Key Pharmacogenomics Players

Cost Opportunities

Regulatory Impact

References

Chapter 2: Introduction

Genetic Distinction and the Impact on Medicine

Opportunities and Threats Impacting Companies and Patients

Trends in Pharmacogenomics

Driving Force for Leading Technologies and Tools

References

Chapter 3: Companies Realizing The Pharmacogenomics Opportunity

Market Opportunities

Large Pharma

Late-stage Compound or Whole Company Acquisition

Early-stage Compound Acquisitions

Roll Up of Individual Business Units

Biotechnology

Microarray Chip

Services and Diagnostic Kits

Platform Technology

Bundled Drug and Test

Requirements for Market Adoption in the Pharmaceutical Industry

Substantiation of Polymorphism to Drug Reaction Relationship

Sufficiently Low Cost of SNP Testing

Diagnostic Testing Defined in Trial Protocol

Reimbursement Coverage for SNP Testing

Healthcare and Doctor Acceptance of Diagnostic Testing

Mandatory Diagnostic Acceptance for Industry Acceptance

Economic Viability of Using Diagnostic in the Drug Sales Model

Breakeven Analysis of Diagnostic-Enabled Drug Model

Implications for Industry

References

Chapter 4: Industry Forecast

Forms of Pharmacogenomics Success

Drug Prescriptions Aligned with Patient Needs

Drug Distribution Augmentation and Expansion

Blockbuster Extension via Price and Volume

Key Elements of the Pharmaceutical Value Chain

Pharmaceutical and Biotech Companies

NCE (New Chemical Entity) Introduction

Marketing Strategy and Execution

Clinical Trial Management

Molecular Diagnostics and Testing

Payer-Provider

Physicians and Healthcare Delivery

Adverse Events and Negligence

Negligence and Litigation

Relative Cost of Adverse Reactions

References

Chapter 5: Regulatory Update

Current Regulatory Process for Drug Development

Key Issues Facing Industry

Issues Facing the FDA

Adequate and Appropriate Informed Consent

SNP Data Collection in Clinical Trials

Impact to Industry from Pharmacogenomics Regulation

Implications for Industry

Defend Existing Revenue Streams

Ensure that the Basis of Differentiation in Your Diagnostic Tests is Valid

Understand Market Opportunities Afforded Players with Drug/Test Combinations

Conclusion

References

Chapter 6: Summary of FDA Guidance for Industry

Guidance for Industry1 Pharmacogenomic Data Submissions

Introduction

Background

Submission Policy

General Principles

Specifc Uses of Pharmacogenomic Data in Drug Development and Labeling

Benefts of Voluntary Submissions to Sponsors and FDA

Submission of Pharmacogenomic Data

Submission of Pharmacogenomic Data During the IND Phase

Submission of Pharmacogenomic Data to a New NDA, BLA, or Supplement

Submission to a Previously Approved NDA or BLA

Compliance with 21 CFR Part 58

Submission of Voluntary Genomic Data from Application-Independent Research

Format and Content of a VGDS

Process For Submitting Pharmacogenomic Data

Agency Review Of Voluntary Genomic Data Submissions

Glossary

Appendix A: Submission of Pharmacogenomic (PG) Data to an IND

Appendix B: Submission of Pharmacogenomic (PG) Data to a New

NDA, BLA, OR Supplement

Appendix C: Submission of Pharmacogenomic (PG) Data to an Approved

NDA, BLA, OR Supplement

Appendix D: Quick Reference on Pharmacogenomic Submissions

Appendix E: Voluntary Submission Cover Sheet

References

Chapter 7: Intellectual Property: Compelling Filings By Large And Emerging Players

Overview

Strategic Considerations & Implications of Patenting

Pay close attention to the specific scope and value of claims and how those relate to

your business model and strategic plan.

Ensure the IP issued is central to the value for the customer.

Use of NIH federal funds in the research of a product.

Evaluate your company’s freedom to operate.

Trade secrets. Internal value: Yes. External value: Sometimes.

Chapter 8: Survey Results

Summary of Market-Based Survey Results

Survey Results

TABLE OF EXHIBITS

Exhibit 1.1 Cost of Clinical Drug Development

Exhibit 1.2 Avoidable Cost of $177.4B of Drug-related Morbidity and Mortality

Exhibit 1.3 Variance Analysis of Increased Cost Originating from Drug-related Morbidity and Mortality

Exhibit 4.1 Percentage Price Premium Consumer is Willing to Pay for Tailored Drugs

Exhibit 4.2 Diagnostics Versus Therapeutic Value Proposition

Exhibit 4.3 Molecular and Pharmacogenomics Diagnostics Players

Abstract

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