How to Integrate Personalized Medicine into Business Strategies

Table of Contents

Executive Summary

• Strategic Considerations
• Stakeholder Implications

Introduction

Expert Commentary - Translating Technologies from Preclinical Applications into Clinical Medicine

• The Need to Better Understand Disease Processes
• Improving the Predictability of Biomarker Discovery
• Structuring the DxRx Partnership

Expert Commentary - Integrating Molecular Diagnostics with Personalized Lifestyle Therapies The Multiple Marker Approach

• Integrating Diagnostic Development into Clinical Trials
• The Value-Added Proposition

Lilly Case Study - Developing the Corporate Mind-Set for Personalized Medicine

• Personalized Drug Development
• Prasugrel, an Antiplatelet Drug in Development with Daiichi Sankyo
• Alimta for Mesothelioma and Non-Small-Cell Lung Cancer
• Disease-Modifying Therapies for Alzheimer' s Disease
• Biomarker Study for Xigris
• Cancer AKT1 Biomarker Study
• Molecular Diagnostic and Tailored Therapy Deals
• Integrating a Tailored Medicine Approach into Lilly' s Business Strategies

Roche Case Study - Breaking Down the Barriers

• Personalized Healthcare
• Roche 2015
• What Is Right for the Time
• Moving Away from a Fully Integrated Pharmaceutical Company (FIPCO) Model
• Strengthening the Tie Between Rx and Dx
• Control vs Ownership - Effect on Intellectual Property
• Take-Home Lesson for Other Companies Intending to Work in the Personalized
• Medicine Space

Expert Commentary - Roche Perspectives on How to Integrate Personalized

• Medicine Strategies
• Realistic Expectations and Misperceptions
• Nichebusters - A Fairly New Concept
• Misperceptions
• Integrating Diagnostics into Drug Development
• Stumbling Blocks
• Understanding Cost-Time Expectations
• What to Look for in a Diagnostics Partner
• Resolving Intellectual Property Issues: Who Will Own What?
• Structuring the Relationship
• Structuring the Deal

Genetic Test Coverage and Value-Added Coding

• Types of Genetic Tests
• Need for Coding System Changes

Trends in Genetic Testing and Value-Added Reimbursement

• Revamp Coding and Create Value-Based Reimbursement
• Manage the Cost with Evidence-Based Processes
• Assess Technology to Determine Coverage
• Better Educate - A Genetic Counseling Program

Checklist of Recommendations

Experts

• Finley Austin, Ph.D., Head, U.S. External Research & Innovation Environment, Roche
• Simon Chin, M.B.A., CEO, Iris BioTechnologies
• Kirtland Poss, President and CEO, VisEn Medical Alan B. Rosenberg, M.D., Vice President of Medical Policy, Technology Assessment, and Credentialing Programs, WellPoint

Expert Commentaries

• Translating Technologies from Preclinical Applications into Clinical Medicine
• Integrating Molecular Diagnostics With Personalized Lifestyle Therapies
• Roche Perspectives on How to Integrate Personalized Medicine Strategies

Interviews

• Genetic Test Coverage and Value-Added Coding
• Trends in Genetic Testing and Value-Added Reimbursement

Case Studies

• Lilly - Developing the Corporate Mindset for Personalized Medicine
• Roche - Breaking Down the Barriers

Tables

• 1. Deals to Facilitate Lilly' s Tailored Therapy Strategies
• 2. Roche Deals to Strengthen Its Position in Personalized Medicine Development, 2007-2008

Figures

• 1. Implementing Eli Lilly and Company' s Transformational FIPNet and Personalized Medicine Business Model
• 2. Roche 2015: Strategic Priorities for Innovation and Long-Term Growth

Spectrum, Personalized Medicine Scorecards

• Eli Lilly & Company Executives Speak Out.
• Roche Executives Speak Out