Main description:

Sets the stage for a new, improved paradigm in drugdiscovery

Despite spending more than $135 billion annually on R&D, thepharmaceutical industry faces an innovation crisis. Given thecomplexities and the expense of R&D, this book argues that wecan accomplish much more with greater efficiency and lesscost when private and public sectors collaborate, eachfocusing on their core strengths.

Collaborative Innovation in Drug Discovery focuses on theearly stage of drug discovery, the most critical barrier todelivering a steady flow of viable drug candidates into thepipeline. The book assesses the current state of drug discovery inthe pharmaceutical industry, government, non–profit, and academia,identifying the areas where each sector excels and areas where gapsexist. Next, the authors explore ways these sectors can establishmutually beneficial partnerships in order to discover, develop, andbring to market improved, safer drugs to treat human diseases.Topics include:

• Status of healthcare and unmet medical needs


• Biomedical research environment, drug discovery efforts, andmarket risks in industry and academia


• NIH Roadmap and EU–OpenScreen initiatives


• Trends in academia–pharmaceutical partnerships, including casestudies


• Drug repositioning, open source partnerships, and challengesand practices for conducting clinical trials

Editor Rathnam Chaguturu has assembled a panel of expert authorsfrom around the world, representing all the sectors involved indrug discovery. Their contributions are not only based on athorough review of the current literature, but also their ownfirst–hand experience of what works and what doesn t.

Collaborative Innovation in Drug Discovery offerspharmaceutical scientists and managers working in both private andpublic sectors a new, more productive road map to discover drugsthat the world needs.

Back cover:

Sets the stage for a new, improved paradigm in drugdiscovery

Despite spending more than $135 billion annually on R&D, thepharmaceutical industry faces an innovation crisis. Given thecomplexities and the expense of R&D, this book argues that wecan accomplish much more with greater efficiency and lesscost when private and public sectors collaborate, eachfocusing on their core strengths.

Collaborative Innovation in Drug Discovery focuses on theearly stage of drug discovery, the most critical barrier todelivering a steady flow of viable drug candidates into thepipeline. The book assesses the current state of drug discovery inthe pharmaceutical industry, government, non–profit, and academia,identifying the areas where each sector excels and areas where gapsexist. Next, the authors explore ways these sectors can establishmutually beneficial partnerships in order to discover, develop, andbring to market improved, safer drugs to treat human diseases.Topics include:

• Status of healthcare and unmet medical needs


• Biomedical research environment, drug discovery efforts, andmarket risks in industry and academia


• NIH Roadmap and EU–OpenScreen initiatives


• Trends in academia–pharmaceutical partnerships, including casestudies


• Drug repositioning, open source partnerships, and challengesand practices for conducting clinical trials

Editor Rathnam Chaguturu has assembled a panel of expert authorsfrom around the world, representing all the sectors involved indrug discovery. Their contributions are not only based on athorough review of the current literature, but also their ownfirst–hand experience of what works and what doesn t.

Collaborative Innovation in Drug Discovery offerspharmaceutical scientists and managers working in both private andpublic sectors a new, more productive road map to discover drugsthat the world needs.

Contents:

Foreword xv
by Ferid Murad

Preface xix

About the Book xxv

About the Editor xxvii

Contributors xxix

PART I: PERSPECTIVES ON COLLABORATIVE INNOVATION 1
If I have seen further it is by standing on the shoulders ofgiants.
Isaac Newton

1 PRODUCTIVE RELATIONSHIPS IN RESEARCH AND DEVELOPMENT BETWEENGOVERNMENT, INDUSTRY, AND UNIVERSITIES 3
Wyatt R. Hume

2 DIVIDED WE FALL 11
William B. Mattes

3 INNOVATION: OPEN SOURCE AND NONPROFIT MODELS IN DRUG DISCOVERY21
James M. Shaeffer and Sarah MacDonald

4 THE CHANGING FACE OF INNOVATION IN DRUG DISCOVERY 31
Litao Zhang and Carl Decicco

5 CURRENT TRENDS IN COLLABORATIVE DRUG DISCOVERY AND STRATEGIESTO DE–RISK
PRECOMPETITIVE INITIATIVES 57
Anuradha Roy and Rathnam Chaguturu

6 A PERSPECTIVE ON THE EVOLUTION OF COLLABORATIVE DRUG DISCOVERYAND FUTURE CHALLENGES 75
Christopher A. Lipinski

PART II: GOVERNMENTAL INITIATIVES ACCELERATE PRECOMPETITIVECOLLABORATION 85
Governments will always play a huge part in solving bigproblems. . . .
They also fund basic research, which is a crucial component ofthe innovation that improves life for everyone. BillGates

7 THE VALUE OF UNIVERSITY INDUSTRY PARTNERSHIPS 87
Anthony M. Boccanfuso

8 TRENDS IN THE PUBLIC SECTOR ADOPTION OF TRANSLATIONAL RESEARCHAPPROACHES 99
Mark A. Scheideler

9 PARTNERSHIPS FOR DRUG REPOSITIONING: LESSONS FROM THE CTSAPHARMACEUTICAL ASSETS PORTAL 115
Kate Marusina, Dean J. Welsch, Lynn Rose, Doug Brock, NathanBahr, Aaron M. Cohen, Rafael A. Gacel–Sinclair, Pakou Vang, PeterG. Ruminski, Bruce E. Bloom, Pamela Nagasawa, and Betty P.Guo

10 DEVELOPMENT PROGRAMS AT THE U.S. NATIONAL CANCER INSTITUTE:USE OF PUBLIC PRIVATE PARTNERSHIPS AS A CATALYST TO ADVANCECANCER THERAPY 135
Jason V. Cristofaro

11 NONINDUSTRIAL PHARMACEUTICAL RESEARCH IN THE BRIC COUNTRIES:LESSONS FOR DRUG DISCOVERY PARTNERSHIPS WITH ACADEMIC ANDGOVERNMENTAL INSTITUTIONS 159
John Watson

12 DEATH OF DRUGS AND REBIRTH OF HEALTH CARE: INDIAN RESPONSE TODISCOVERY IMPASSE 173
Bhushan Patwardhan

PART III: A GAME CHANGER FOR AVERTING FUTURE PHARMA CLIFF195
Coming together is a beginning, staying together is progress,and working together is success. Henry Ford

13 ACCELERATING INNOVATION IN THE BIOSCIENCE REVOLUTION197
Bernard H. Munos

14 VALUE–DRIVEN DRUG DEVELOPMENT: UNLOCKING THE VALUE OF YOURPIPELINE 213
Valentina Sartori, Michael Steinmann, Petra Jantzer, andMatthias Evers

15 UNLOCKING THE MARKET POTENTIAL OF ACADEMIC RESEARCH 221
Assem S. el Baghdady and Yasser M.S. el Baghdady

16 COLLABORATIVE INNOVATION IN PHARMACEUTICAL INDUSTRY:APPROACHES AND REQUIREMENTS 255
Monika Lessl and Khusru Asadullah

17 CLOSE CONTACT: A COLOCATION MODEL FORACADEMIC INDUSTRIAL PARTNERSHIPS IN DRUG DISCOVERY 267
Peter A. Covitz and Terrence D. Ruddy

18 SUCCESS FACTORS AND OBSTACLES IN ACADEMIA INDUSTRYPARTNERSHIPS: A CASE STUDY OF A GRADUATE PROGRAM WITHIN THEBAYER UNIVERSITY OF COLOGNE PRIVILEGEDPARTNERSHIP 279
Stefan Herzig, Marion Rozowski, and Ingo Flamme

19 ACADEMIC, COMMERCIAL, AND BIODEFENSE CASE STUDIES FORCOLLABORATIVE DRUG DISCOVERY: POTENTIAL FOR DISRUPTING DRUGDISCOVERY 303
Barry A. Bunin and Sean Ekins

20 ACCESS PLATFORM: A STREAMLINED INTEGRATIVE PARTNERING PROCESSAT SANOFI TO COMMERCIALIZE UNIVERSITY–BASED INTELLECTUAL PROPERTY319
Paul R. Eynott and Carole Fages

21 ENTREPRENEURSHIP: DRUG DISCOVERY INNOVATION AT START–UP ANDMEDIUM–SIZED BIOTECHNOLOGY COMPANIES 341
Allen B. Reitz and Kathleen M. Czupich

22 CHEMICAL CONSULTING 355
Lester A. Mitscher

PART IV: NONPROFITS DRIVE BENCH–TO–BEDSIDE INNOVATION367
Can t afford to innovate? Open up! HenryChesbrough

23 OPEN SOURCE DRUG DISCOVERY FOR NEGLECTED DISEASES 369
Tonny Johnson and Sanchayita Kar

24 THE MYELIN REPAIR FOUNDATION ACCELERATED RESEARCHCOLLABORATIONTM MODEL: INNOVATIVE DISRUPTION IN BIOMEDICAL RESEARCH385
Gali Hagel

25 FROM CATALYSIS TO MASS ACTION: THE EVOLUTION OF CHDIFOUNDATION, A DRUG–DEVELOPMENT ORGANIZATION DEVOTED TOHUNTINGTON S DISEASE 411
Allan J. Tobin

26 LESSONS FROM THE PAST AS A MEANS TO THE FUTURE: INSTITUTPASTEUR AS A MODEL STRATEGY 437
Spencer L. Shorte

27 SEEDING OPEN INNOVATION DRUG DISCOVERY AND TRANSLATIONALCOLLABORATIONS TO LEVERAGE GOVERNMENT FUNDING: A CASE STUDY OFSTRATEGIC PARTNERSHIP BETWEEN SANFORD–BURNHAM AND MAYO CLINIC451
Thomas D.Y. Chung, Sundeep Khosla, Andrew D. Badley, and MichaelR. Jackson

PART V: ACADEMIC SCREENING CENTERS COME OF AGE 487
Open access high–throughput drug discovery in the public domainis a Mount Everest in the making. Rathnam Chaguturu

28 FINDING THE MIDDLE GROUND: DRUG DISCOVERY TECHNOLOGY IN THEERA OF ACADEMIC SCREENING CENTERS 489
Nathan S. Blow

29 OPEN INNOVATION–BASED DRUG DISCOVERY IN EUROPE: SOME EXAMPLESOF NATIONAL AND TRANSNATIONAL EUROPEAN INITIATIVES INTEGRATINGCHEMISTRY, BIOLOGY, AND TECHNOLOGY PLATFORMS 499
Philip Gribbon

30 IN SICKNESS AND IN HEALTH: A SHOTGUN MARRIAGE THAT ISFLOURISHING 517
Horst Flotow and Alex Matter

31 A FLEXIBLE MODEL FOR COMPOUND MANAGEMENT FACILITIES TOSTIMULATE COLLABORATIONS IN THE LIFE SCIENCES 533
David Camp

PART VI: INTELLECTUAL PROPERTY AND TECHNOLOGY TRANSFER563
Everything that can be invented has been invented. Charles Duell

32 SUCCESSFUL TECHNOLOGY TRANSFER: LESSONS FROM THETRANSLATIONAL MEDICINE RESEARCH COLLABORATION 565
Assem S. el Baghdady

33 CHALLENGES AND OPPORTUNITIES IN COMMERCIALIZING ACADEMIC DRUGDISCOVERIES 577
Christopher Paschall

34 THE PIVOTAL ROLE OF THE ACADEMIC ENTREPRENEUR AND THEENTREPRENEURIAL UNIVERSITY IN GLOBAL LIFE SCIENCES 609
Donna Marie De Carolis

PART VII: THE FINAL FRONTIER 621
No one can whistle a symphony; it takes a whole orchestra toplay it.
Halford E. Luccock

35 THE CORE MODEL: DRUG DISCOVERY AND DEVELOPMENT VIA EFFECTIVETRANSLATIONAL SCIENCE AND PUBLIC PRIVATE COLLABORATION623
Ibis Sánchez–Serrano

36 USING MARKET–DRIVEN COLLABORATION TO ACCELERATE INNOVATION INBIOMEDICINE 653
Elizabeth Iorns

37 THE COST OF TAKING EYES OFF THE TRUE END USER: FOCUS ONPATIENT NEEDS AND OUTCOMES 663
Deborah E. Collyar

38 TO LEASH OR UNLEASH THE POWER OF PUBLIC PRIVATECOLLABORATION: IN HEALTH AND DISEASE 679
Hakim Djaballah

Index 687