How to Get Ahead with Pharmacogenomics
Decision Resources
March 19, 2008 42 Pages - SKU: DECR1725823
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Pharmacogenomics (PGx) is an evolutionary-not a revolutionary-process. The "blockbuster" business
model is, of course, still relevant to the pharmaceutical industry, but at the same time, companies must adopt
technologies that will enable them to develop better drugs-value-added drugs that can command the prices
capable of providing an acceptable return on investment for the companies that develop them. Many companies,
pharmaceutical and diagnostic alike, have come to understand that they need to use PGx to their advantage,
a step that requires changing the status quo of drug development to produce targeted medicines together with
diagnostic tests.
Get the Answers You Need to Shape Your Strategy
- The development of targeted medicines and PGx-based testing has been slower than anticipated, and the
promise of PGx is still largely to be realized. Why? What is the key to unlocking the enormous potential
of personalized drug development?
- The industry needs to implement technologies that can be used to produce safer and more efficacious drugs.
What are the challenges associated with embracing the PGx model and the codevelopment of targeted
drugs and their companion diagnostic tests (RxDx codevelopment)? How will PGx improve this
process? Why is collaboration between pharmaceutical and diagnostic companies so important?
- The pharmaceutical, diagnostic, and regulatory communities need to work together effectively to develop
more personalized medicines. What are the bottlenecks delaying these interactions? What still needs to
be done to make this process work better?
- Pharmaceutical companies have come to recognize the current value and future commercial potential of
diagnostics, but they need a path to follow for integrating PGx into drug development. How does a company
begin? What is a reasonable action plan to follow, and why is educating stakeholders so very important?
Scope
- Industry experts: Twelve interviews and/or commentaries from industry leaders who share their
insights and experiences in implementing personalized drug development and PDx testing.
- Targeted drugs and companion diagnostics: "personalized medicine" targets the right patient for
the right medicine; updating drug labels with PGx information; the role of regulators in personalized
medicine; complexities in the underlying biology.
- Building a business case for RxDx codevelopment: a cultural change for the industry; bottlenecks
and stumbling blocks; evolving relationships between big pharma and diagnostics companies; return
on investment; cost-benefit analysis; clinical trial efficiencies, value-added drugs; raising the safety/
efficacy bar.
- Pharmacodiagnostic test development: biomarker discovery and research; CLIA-regulated versus
FDA-approved tests; pricing/reimbursement environment; CPT codes; clinical validity and clinical
utility.
Please note, the PDF e-mail from publisher version of this report is for a global site license.
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- 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 Scientifi c 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
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