Table of Contents
Chapter 1: Executive Summary 1--1
- Overview 1--1
- Key Pharmacogenomics Players 1--2
- Cost Opportunities 1--4
- Regulatory Impact 1--6
- References 1--8
Chapter 2: Introduction 2--1
- Genetic Distinction and the Impact on Medicine 2--1
- Opportunities and Threats Impacting Companies and Patients 2--3
- Trends in Pharmacogenomics 2--4
- Driving Force for Leading Technologies and Tools 2--5
- References 2--7
Chapter 3: Companies Realizing The Pharmacogenomics Opportunity 3--1
- Market Opportunities 3--1
- Large Pharma 3--1
- Late-stage Compound or Whole Company Acquisition 3--1
- Early-stage Compound Acquisitions 3--1
- Roll Up of Individual Business Units 3--1
- Biotechnology 3--2
- Microarray Chip 3--2
- Services and Diagnostic Kits 3--2
- Platform Technology 3--2
- Bundled Drug and Test 3--2
- Requirements for Market Adoption in the Pharmaceutical Industry 3--3
- Substantiation of Polymorphism to Drug Reaction Relationship 3--3
- Sufficiently Low Cost of SNP Testing 3--3
- Diagnostic Testing Defined in Trial Protocol 3--4
- Reimbursement Coverage for SNP Testing 3--5
- Healthcare and Doctor Acceptance of Diagnostic Testing 3--5
- Mandatory Diagnostic Acceptance for Industry Acceptance 3--6
- Economic Viability of Using Diagnostic in the Drug Sales Model 3--6
- Breakeven Analysis of Diagnostic-Enabled Drug Model 3--7
- Implications for Industry 3--8
- References 3--9
Chapter 4: Industry Forecast 4--1
- Forms of Pharmacogenomics Success 4--1
- Drug Prescriptions Aligned with Patient Needs 4--2
- Drug Distribution Augmentation and Expansion 4--3
- Blockbuster Extension via Price and Volume 4--4
- Key Elements of the Pharmaceutical Value Chain 4--5
- Pharmaceutical and Biotech Companies 4--6
- NCE (New Chemical Entity) Introduction 4--6
- Marketing Strategy and Execution 4--7
- Clinical Trial Management 4--8
- Molecular Diagnostics and Testing 4--9
- Payer-Provider 4--10
- Physicians and Healthcare Delivery 4--11
- Adverse Events and Negligence 4--11
- Negligence and Litigation 4--12
- Relative Cost of Adverse Reactions 4--13
- References 4--14
Chapter 5: Regulatory Update 5--1
- Current Regulatory Process for Drug Development 5--1
- Key Issues Facing Industry 5--4
- Issues Facing the FDA 5--5
- Adequate and Appropriate Informed Consent 5--5
- SNP Data Collection in Clinical Trials 5--6
- Impact to Industry from Pharmacogenomics Regulation 5--6
- Implications for Industry 5--8
- Defend Existing Revenue Streams 5--9
- Ensure that the Basis of Differentiation in Your Diagnostic Tests is Valid
5--9
- Understand Market Opportunities Afforded Players with Drug/Test
Combinations 5--9
- Conclusion 5--9
- References 5--10
Chapter 6: Summary of FDA Guidance for Industry 6--1
- Guidance for Industry1 Pharmacogenomic Data Submissions 6--1
- Introduction 6--1
- Background 6--2
- Submission Policy 6--3
- General Principles 6--3
- Specific Uses of Pharmacogenomic Data in Drug Development and Labeling 6--5
- Benefits of Voluntary Submissions to Sponsors and FDA 6--6
- Submission of Pharmacogenomic Data 6--8
- Submission of Pharmacogenomic Data During the IND Phase 6--8
- Submission of Pharmacogenomic Data to a New NDA, BLA, or Supplement 6--10
- Submission to a Previously Approved NDA or BLA 6--11
- Compliance with 21 CFR Part 58 6--12
- Submission of Voluntary Genomic Data from Application-Independent Research
6--12
- Format and Content of a VGDS 6--12
- Process For Submitting Pharmacogenomic Data 6--14
- Agency Review Of Voluntary Genomic Data Submissions 6--14
- Glossary 6--17
- Appendix A: Submission of Pharmacogenomic (PG) Data to an IND 6--19
- Appendix B: Submission of Pharmacogenomic (PG) Data to a New NDA, BLA, OR
Supplement 6--21
- Appendix C: Submission of Pharmacogenomic (PG) Data to an Approved
- NDA, BLA, OR Supplement 6--23
- Appendix D: Quick Reference on Pharmacogenomic Submissions 6--24
- Appendix E: Voluntary Submission Cover Sheet 6--25
- References 6--26
Chapter 7: Intellectual Property: Compelling Filings By Large And Emerging
Players 7--1
- Overview 7--1
- Strategic Considerations & Implications of Patenting 7--1
- Pay close attention to the specific scope and value of claims and how
those relate to
- your business model and strategic plan. 7--2
- Ensure the IP issued is central to the value for the customer. 7--2
- Use of NIH federal funds in the research of a product. 7--2
- Evaluate your company's freedom to operate. 7--2
- Trade secrets. Internal value: Yes. External value: Sometimes. 7--2
Chapter 8: Survey Results 8--1
- Summary of Market-Based Survey Results 8--1
- Survey Results 8--1
TABLE OF EXHIBITS
- Exhibit 1.1 Cost of Clinical Drug Development 1--4
- Exhibit 1.2 Avoidable Cost of $177.4B of Drug-related Morbidity and
Mortality 1--5
- Exhibit 1.3 Variance Analysis of Increased Cost Originating from
Drug-related Morbidity and Mortality 1--6
- Exhibit 4.1 Percentage Price Premium Consumer is Willing to Pay for
Tailored Drugs 4--5
- Exhibit 4.2 Diagnostics Versus Therapeutic Value Proposition 4--9
- Exhibit 4.3 Molecular and Pharmacogenomics Diagnostics Players 4--10
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