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Beschreibung

Can academia save the pharmaceutical industry? The pharmaceutical industry is at a crossroads. The urgent need for novel therapies cannot stem the skyrocketing costs and plummeting productivity plaguing R&D, and many key products are facing patent expiration. Dr. Rathnam Chaguturu presents a case for collaboration between the pharmaceutical industry and academia that could reverse the industry's decline. Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships provides insight into the potential synergy of basing R&D in academia while leaving drug companies to turn hits into marketable products. As Founder and CEO of iDDPartners, focused on pharmaceutical innovation, Founding president of the International Chemical Biology Society, and Senior Director-Discovery Sciences, SRI International, Dr. Chaguturu has assembled a panel of experts from around the world to weigh in on issues that affect the two driving forces in medical advancement. * Gain global perspectives on the benefits and potential issues surrounding collaborative innovation * Discover how industries can come together to prevent another "Pharma Cliff" * Learn how nonprofits are becoming the driving force behind innovation * Read case studies of specific academia-pharma partnerships for real-life examples of successful collaboration * Explore government initiatives that help foster cooperation between industry and academia Dr. Chaguturu's thirty-five years of experience in academia and industry, managing new lead discovery projects and forging collaborative partnerships with academia, disease foundations, nonprofits, and government agencies lend him an informative perspective into the issues facing pharmaceutical progress. In Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships, he and his expert team provide insight into the various nuances of the debate.

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Veröffentlichungsjahr: 2014

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Table of Contents

Wiley Series on Technologies for the Pharmaceutical Industry

Title page

Copyright page

Dedication

Collaborative Drug Discovery Ethos

Foreword

Preface

About the Book

About the Editor

Contributors

Part I: Perspectives on Collaborative Innovation

1: Productive Relationships in Research and Development between Government, Industry, and Universities

Universities, Government, and Industry: Historical Beginnings in Prussia

Refinement and Broad Adoption: the United States

General Principles for Success

Notes

2: Divided We Fall

Challenges

Collaboration Models

Examples of Successful Biomedical Collaborations

Principles of Collaboration

Governance, Administration, and Autonomy

Human Factors

Conclusion

References

3: Innovation: Open Source and Nonprofit Models in Drug Discovery

Why Do People Innovate?

How Do We Encourage Innovation?

Why Is Innovation Important?

Warnings Regarding Innovation in Drug Discovery

Open Source Models

Nonprofit Models

Recommendations

References

4: The Changing Face of Innovation in Drug Discovery

Introduction

Core Objectives of the Drug Discovery Process

Major Innovations in Technology Have Advanced Drug Discovery

An Important Trend: Academic and Pharmaceutical Organizations Are Collaborating in Support of Drug Discovery

Future Perspectives: Where Is Innovation Leading?

References

5: Current Trends in Collaborative Drug Discovery and Strategies to De-Risk Precompetitive Initiatives

Pharmaceutical Industry's Perspective

Academia's Perspective

Open (Collaborative) Innovation: A New Business Model

Drug Discovery through Collaborations

Drug Discovery through Consortia

Drug Discovery through Repurposing Strategies

Probe Discovery in Public Domain

Effective Management of Academia–Pharma Collaborations

Concluding Remarks

References

Notes

6: A Perspective on the Evolution of Collaborative Drug Discovery and Future Challenges

Evolution of Collaborative Drug Discovery

Challenges for Collaborative Drug Discovery

Conclusion

References

Part II: Governmental Initiatives Accelerate Precompetitive Collaboration

7: The Value of University–Industry Partnerships

Guiding Principles for University–Industry Collaborations

The Johnson Continuum

Role of Cocreation: Companies, Government, and Universities

Funding for Collaborations with Academia

New Initiatives to Transform University–Industry Collaborations

Issues Affecting University–Industry Collaborations

Differences between Large- and Small-/Medium-Sized Companies

Large Companies Share Certain Characteristics

Small- and Medium-Sized Enterprises (SMEs) Offer a Contrasting Perspective

The National Academies' University–Industry Demonstration Partnership

Strategies for Building High-Value, High Return U-I Partnerships

Conclusion

Note on this Chapter

Note

References

8: Trends in the Public Sector Adoption of Translational Research Approaches

Steps to Successful Assay Development for HTS

Impact of the NIH Molecular Libraries Assay Development for HTS Initiative

Resourcing the Chemical Optimization of Small Molecule Probes

Using CTSA•IP to Identify and Assemble Translational Project Teams

Concluding Remarks

Notes

References

9: Partnerships for Drug Repositioning: Lessons from the CTSA Pharmaceutical Assets Portal

The CTSA Pharmaceutical Assets Portal

The Pharma Portal Members

Using the Foci-of-Expertise to Identify Potential Collaborators

Partnership for Cures

Material Transfer Agreements for Compound Transfers

Establishing an International Clinical Compound Library at CWHM

Industry Perspective

Conclusions

Acknowledgments

References

10: Development Programs at the U.S. National Cancer Institute: Use of Public–Private Partnerships as a Catalyst to Advance Cancer Therapy

Drug Screening Programs at the NCI

The Rapid Access to Intervention Development Program

The Decision Network/Drug Development Group

Natural Products

Cancer Therapy Evaluation Program: Sponsored Clinical Trials

NCI's Experimental Therapeutics Program

Early Discovery

Early Development Resources

Late-Stage Development: The CTEP Clinical Trials Network

Governance

Technology Transfer Mechanisms Utilized by The NExT Program

Discovery to Early-Stage Development: The Chemical Biology Consortium

Mid-Stage Development (Clinical Candidate Prior to Clinical Studies)

Late-Stage Development: The CTEP Clinical Trials Network

The CTEP IP Option: Then and Now

The Collaborative Process: Then and Now

Summary

Case Studies

Acknowledgments

References

11: Nonindustrial Pharmaceutical Research in the BRIC Countries: Lessons for Drug Discovery Partnerships with Academic and Governmental Institutions

BRIC Countries Can Provide a Model for Drug Discovery in Nonindustrial Institutions

Common Drug Development Activities across the BRIC Countries

India

Brazil

China

Russia

Brazil and India Provide Relatively Western Models of Collaboration

Collaboration With China Will Be Driven by the Opportunity to Enter a Major Pharmaceutical Market

Russia Will Remain a Complex Opportunity for Collaboration

Successful Collaborations in BRIC Countries Will Often Be Driven By Relationships with Their Western-Trained Scientists

Leveraging the Experience of Nonindustrial Drug Discovery in the BRIC Countries Will Help Inform Western Strategies

References

12: Death of Drugs and Rebirth of Health Care: Indian Response to Discovery Impasse

Health and Disease

Death of Drugs

Innovation Deficit

Reductionist Drug Discovery to Holistic Medicine Discovery

Indian Perspective

Indian Government Policy

Pharmaceutical Sector Landscape

Situation Analysis

Intellectual Property

New Paradigms

Council for Scientific and Industrial Research

Department of Science and Technology (DST)

Department of Biotechnology (DBT)

Indian Council of Medical Research

AYUSH

Building New Partnerships

Concluding Remarks

Acknowledgments

References

Part III: A Game Changer for Averting Future Pharma Cliff

13: Accelerating Innovation in the Bioscience Revolution

A Great Industry Faces a Painful “Kodak Moment”

The Transformation of a Great Industry

From Ethical Pharm to Animal Pharm

But There Are Other Issues

Myths and Facts about Innovation

Bringing Ethics Back to the Industry

It Does Not Need to Cost Billions

New Models for Innovation

The New Players

The New Collaborative Models

Where Have the Leaders Gone?

Priorities for Restoring Innovation

Note

References

14: Value-Driven Drug Development: Unlocking the Value of Your Pipeline

The Four Imperatives of Value-Driven Drug Development

Concluding Remarks

References

15: Unlocking the Market Potential of Academic Research

Where Does Drug Discovery Fit into the Drug Development Process?

How Does the Drug Discovery Process Work?

Science for Science's Sake and Science for Society's Sake

What Are the Causes of the Gap between Science for Science's Sake and Science for Investment's Sake?

Why Commercialization Is Important

Intellectual Property

Commercializing Nonpatentable Knowledge

Bridging the Gap between Science for Science's Sake and Science for Investment's Sake

Technology Transfer Offices

Have Technical Transfer Offices Fulfilled Their Objectives?

Barriers to Success of Technology Transfer Offices

Venture Capitalists

Nonprofit Organizations

Centers for Therapeutic Innovation (CTI)

Recommendations

Notes

References

16: Collaborative Innovation in Pharmaceutical Industry: Approaches and Requirements

Open Innovation versus Open Access

Open Innovation Models: Key Characteristics and Success Factors

Crowdsourcing Approaches Are Useful to Leverage the Know-How of a Large Group of People to Address Specific Questions

Strategic Alliances

Industry on Campus or Incubator Model

Precompetitive Consortia

Professional Alliance and Collaboration Management

Concluding Remarks

Acknowledgment

References

17: Close Contact: A Colocation Model for Academic–Industrial Partnerships in Drug Discovery

Stakeholders and Their Interests

Relationship Models between Industry and the Academy

Close Contact Case Study: Nordion and University of Ottawa Heart Institute

Research Agreement

Intellectual Property Agreement

Facility Agreement

Benefits of Close Contact

Risks and Challenges of Close Contact

Conclusions

Acknowledgments

18: Success Factors and Obstacles in Academia–Industry Partnerships: A Case Study of a Graduate Program within the Bayer–University of Cologne “Privileged Partnership”

SWOT Analysis of an Industry–Academia Partnership

Bayer–University of Cologne Collaboration

Original Concept and Implementation

Synergies in Graduate Education within the University

Synergies of Industry and Academia in Vocational Field Exploration

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