How To Get Ahead With Pharmacogenomics Highlights How Companies Must Adopt Technologies That Will Enable Them To Develop Better Drugs
Research and Markets (http://www.researchandmarkets.com/reports/c88085) has announced the addition of new Decision Resources report “How to Get Ahead with Pharmacogenomics” to their offering.
Introduction
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.
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, Office 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 Efficacy 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 Officer, 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:
Figures:
For more information visit http://www.researchandmarkets.com/reports/c88085