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Published by: Decision Resources
Published: Sep. 24, 2008 - 37 Pages
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
AbstractIntroduction
A growing awareness is taking hold across the pharmaceutical industry: what was once impossible—tailoring
treatment to specific groups of patients rather than to the population as a whole—is becoming possible. What
is needed to integrate a personalized medicine approach into business strategies? We provide perspectives from
pharmaceutical, diagnostic, and managed care executives and create a set of recommendations based on what
experts advise when contemplating the operational shift to the delivery of personalized healthcare.
Get the Answers You Need to Shape Your Strategy
- Lilly has said it needs to transform every part of its operations. How is Lilly working to integrate a
personalized medicine approach into its business strategies? What is entailed in the company’s cultural
and organizational restructuring and its new FIPNet model?
- Roche completed a hostile takeover of Ventana and announced its intention to assume complete control of
Genentech. Why are these two strategic maneuvers so important to Roche and why are they important
to integrating personalized medicine strategies more tightly into the company’s operations? Does
personalized medicine success require that a company consume its diagnostic or targeted therapy
partner outright and own it lock, stock, and barrel?
- The pharmaceutical industry has adopted formularies and benefit plan designs to differentiate drugs. What are
the problems covering and reimbursing genetic testing and pharmacodiagnostic tests? What problems
continue to plague gene-based testing and value-added reimbursement?
Scope
- Business models and strategies: FIPNet, outsourcing, precompetitive collaboration, personalized
medicine, fully integrated pharmaceutical company (FIPCO), virtual companies, nichebusters,
operational efficiencies, cost-cutting, mega-mergers, consolidation, control versus ownership,
decentralized management, hub and spoke business.
- Diagnostic issues: Trends in genetic tests and genetic testing, improving the predictability of
biomarker discovery, standardizing biomarkers, analytic validity, clinical utility, clinical validity,
integrating diagnostic development into clinical development, fluorescence imaging, molecular
diagnostics, gene profiling, biological signatures, tissue-based diagnostics.
- Pharmaceutical issues: Tailored therapies, disease biology areas, deal making, innovation,
information flow and unfettered access to research, nichebusters, patient phenotypes, health
outcomes, value-for-money.
- RxDx partnership issues: Adequate control of intellectual property, structuring the relationship,
structuring the deal, what to look for in a diagnostic partner.
- Managed care issues: Value-added reimbursement, revamping CPT codes, cost-containment,
evidentiary-based review, health policy technology assessments, physician and patient education
strategies, direct-to-consumer marketing.
- Two Spectrum, Personalized Medicine Scorecards: Executive insights from transcripts of Lilly and
Roche company presentations to investors.
- Expert commentaries: Executives from Iris BioTechnologies, Roche, and VisEn Medical share their
insights on genetic tests, targeted therapies, personalized medicine development, transitioning from
research to the clinic, and healthcare coverage and reimbursement.
- Interviews: Senior directors from two health benefit insurers share their insights on genetic and
pharmacogenomic tests, evidence-based review, coding, and reimbursement issues.
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