How to Get Ahead with Pharmacogenomics

Published by: Decision Resources

Published: Mar. 19, 2008 - 42 Pages

Table of 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, 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

Abstract

• 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?

• 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.

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