Abstract
Introduction
A growing awareness is taking hold across the pharmaceutical industry: what
was once impossible - tailoring treatment to specifi c 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 benefi t 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 effi ciencies,
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, fl uorescence imaging, molecular
diagnostics, gene profi ling, biological signatures, tissue-based diagnostics.
- Pharmaceutical issues: Tailored therapies, disease biology areas, deal
making, innovation, information fl ow 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 benefi t insurers share their
insights on genetic and pharmacogenomic tests, evidence-based review, coding,
and reimbursement issues.
Mentioned in this Spectrum Report
Companies and Organizations
- 454 Life Sciences
- Abbott
- Affymetrix
- Agendia
- Alnylam Pharmaceuticals
- Ambrx
- American College of Obstetricians/Gynecologists
- American Diabetes Association
- American Medical Association
- Amgen
- Arius Research
- Aveo Pharmaceuticals
- Baylor University
- Biosite
- BioVeris
- Blue Cross Blue Shield
- Centers for Disease Control and Prevention
- Chugai
- Daiichi Sankyo
- Eli Lilly and Company
- Enlight Biosciences
- Entelos
- Evaluation of Genomic Applications in Practice and
- Prevention
- Fox Chase Cancer Center
- GE Healthcare
- Genentech
- Genomic Health
- HealthLeaders InterStudy
- Hoffmann-La Roche
- Iris BioTechnologies
- Johnson & Johnson
- Juvenile Diabetes Research Foundation
- Massachusetts General Hospital
- Merck & Co.
- Mirus Bio
- NimbleGen Systems
- Olympus Medical Systems
- Pfi zer
- Piramed
- PureTech Ventures
- Roche Diagnostics
- Roche Group
- Roche Pharmaceuticals
- Sanford University
- Technical University
- Therapeutic Human Polyclonals
- Translational Genomics Research Institute
- University of Michigan
- Ventana Medical Systems
- VisEn Medical
- WellPoint
- WellPoint Health Networks
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