How to Get Ahead with Pharmacogenomics

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implicationss
• The Pharmacogenomics Advantage
• The Diagnostic Component
• Expert Commentary -Building a Business Case for RxDx Codevelopment
  • Need for Stakeholder Education
  • Outlook for RxDx Codevelopment
• Expert Commentary -Establishing a Pharmacodiagnostics Model
  • Evolving Pharmaceutical Industry Dynamic
  • PDx Development
  • Steps to Get Ahead
• Expert Commentary -Producing Targeted Drugs: A Cultural Change for Industry
  • Cultural Change
  • Using PGx: Cost and Time Savings
  • Four Changes That Must Be Made
• Expert Commentary-Getting Ahead with Personalized Medicine One Step at a Time
  • A New Era of Drug Development
  • HIV Coreceptor Tropism Test and CCR5 Antagonist Therapy Codevelopment
  • Multiplying Targeted Markets
  • Impact of Pricing/Reimbursement
  • Personalized Medicine
• Expert Commentary -We Have an Obligation to Always Think About Markers
  • New Tools for Decision Making
  • Clinical Development
  • Diagnostic Tests
  • Other Industry Stakeholders
• Expert Commentary -Encouraging Personalized Medicine Without Inhibiting Its Development
  • The Role of Regulators
  • Raising the Effi cacy/Safety Bar: Effect on PGx Uptake
  • Medical Education
  • RxDx Codevelopment
• Expert Interviews: Matters to Be Resolved
  • Clinical Validity and Clinical Utility
  • Cost-Benefi t Analysis
  • Test Codes/Reimbursement
  • Labels: A Clearer Direction for PGx Use
  • CLIA-Regulated vs. PMA-Approved Tests
• Ten-Point Action Plan for Getting Ahead with PGx
• Moving Ahead

Experts Featured:

Mara G. Aspinall, M.B.A., President, Genzyme Genetics; Trustee, Dana-Farber Cancer Institute Michael P. Bates, M.D., Vice President, Clinical Research, Monogram Biosciences, Inc Rolf Ehrnström, M.Sc., Corporate Vice President, Research & Development, Dako A/S Felix W. Frueh, Ph.D., Associate Director for Genomics, Offi ce of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Peter Keeling, M.A., CEO, Diaceutics Klaus Lindpainter, M.D., M.P.H., Head, Roche Genetics, and Director, Roche Center for Medical Genomics Marisa Papaluca, M.D., Deputy Head of Safety and Effi cacy of Medicines, European Medicines Agency Christos J. Petropoulos, Ph.D., Vice President R&D, Virology, and Chief Scientific Officer, Monogram Biosciences, Inc Munir Pirmohamed, Ph.D., Professor of Clinical Pharmacology, the University of Liverpool; Chair, Pharmacogenetics, National Health Service Carol Reed, M.D., Executive Vice President and Chief Medical Offi cer, Clinical Data, Inc

Additional interviews with staff members at the Secretary' s Advisory Committee on Genetics, Health, and Society (SACGHS) and a program leader at a European molecular diagnostics company

Expert Commentaries:

• Building a Business Case for RxDx Codevelopment
• Establishing a Pharmacodiagnostics Model
• Producing Targeted Drugs: A Cultural Change for Industry
• Getting Ahead with Personalized Medicine-One Step at a Time
• We Have an Obligation to Always Think About Markers
• Encouraging Personalized Medicine Without Inhibiting Its Development

Tables:

• 1. Select Targeted Drugs and Their Companion Diagnostics
• 2. Effect of HER2 Testing on the Development of Herceptin
• 3. Drug Marketability and Value: A Larger Share of a More Segmented Market
• 4. Public-Private Consortia
• 5. FDA Publications and Guidance Documents Relating to Pharmacodiagnostics in Drug Development
• 6. PGx Markers: Valid Genomic Biomarkers in the Context of Approved Drug Labels
• 7. Select Biomarker Discovery Companies, Their Technologies, and Pharmaceutical Alliances

Figures:

• 1. Drug Decision Making Based on Pharmacogenomic Testing
• 2. Diagnostic Assay Development in Concert with Drug Development
• 3. Select Therapy Areas: Patient Response Rates to Major Drugs