Table Of ContentINNOVATION IN THE
BIOPHARMACEUTICAL
INDUSTRY
TThhiiss ppaaggee iinntteennttiioonnaallllyy lleefftt bbllaannkk
INNOVATION IN THE
BIOPHARMACEUTICAL
INDUSTRY
EDITORS
RIFAT A. ATUN
Imperial College London, Uk
DESMOND SHERIDAN
Imperial College London, Uk
World Scientific
N E W J E R S E Y • L O N D O N • S I N G A P O R E • B E I J I N G • S H A N G H A I • H O N G K O N G • TA I P E I • C H E N N A I
Published by
World Scientific Publishing Co. Pte. Ltd.
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Library of Congress Cataloging-in-Publication Data
Innovation in the biopharmaceutical industry / edited by Rifat A. Atun and Desmond Sheridan.
p. ; cm.
Includes bibliographical references and index.
ISBN-13: 978-981-270-660-7 (pbk.)
ISBN-10: 981-270-660-7 (pbk.)
1. Pharmaceutical industry--Technological innovations. 2. Pharmaceutical biotechnology. 3.
Biopharmaceuticals. 4. Drug development. I. Atun, Rifat A. II. Sheridan, Desmond J. (Desmond John)
[DNLM: 1. Drug Industry--trends. 2. Delivery of Health Care--trends. 3. Diffusion of Innovation.
4. Health Policy. 5. Technology, Pharmaceutical--trends. QV 736 I58 2007]
RS380.I56 2007
338.4'76151--dc22
2007004943
British Library Cataloguing-in-Publication Data
A catalogue record for this book is available from the British Library.
Copyright © 2007 by World Scientific Publishing Co. Pte. Ltd.
All rights reserved. This book, or parts thereof, may not be reproduced in any form or by any means, electronic or
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Innovation in the Bio.pmd 1 4/13/2007, 9:38 AM
April9,2007 15:24 WSPC/150-IJIM 01_contents
CONTENTS
Acknowledgements vii
Introduction
Innovation inHealthCare:TheEngineofTechnological Advances ix
R.A.AtunandD.Sheridan
Innovation ModelsintheBiopharmaceutical Sector 1
J.Attridge
DevelopmentandInnovation inCardiovascular Medicine 31
D.Sheridan
DevelopmentandInnovation inCancerMedicine 45
K.Sikora
Innovation, PatentsandEconomicGrowth 65
R.A.Atun,I.HarveyandJ.Wild
UptakeandDiffusionofPharmaceutical InnovationsinHealthSystems 85
R.A.Atun,I.Gurol-UrganciandD.Sheridan
Partnership andInnovation intheLifeSciences 109
D.Kleyn,R.KitneyandR.A.Atun
Index 135
v
April9,2007 15:25 WSPC/150-IJIM 02_ack
ACKNOWLEDGEMENTS
This work was supported by Imperial College and by a grant from Pfizer Corp.
Inacknowledging thissupport theauthorsunderstand thattheirresponsibility isto
assist discussion of issues relating to innovation among the academic, healthcare
andgeneralcommunityandthatthisoverridesanyobligationtoanypartywhohas
providedsupportforthework.Webelievewehavecompliedwiththisresponsibility.
Theopinionsexpressedarethoseoftheauthorsandareunderstoodtobesubjectto
normalacademicchallenge anddiscourse.
vii
April9,2007 15:33 WSPC/150-IJIM 03_intro
Introduction
INNOVATIONIN HEALTHCARE:THE ENGINEOF
TECHNOLOGICALADVANCES
RIFATA.ATUN
CentreforHealthManagement,TanakaBusinessSchool
ImperialCollegeLondon,SouthKensingtonCampus
London,SW72AZ,UK
[email protected]
DESMONDSHERIDAN
DepartmentofCardiology
NationalHeartandLungInstitute,ImperialCollegeLondon
andStMary’sHospital,NorfolkPlace,
London,W21PG,UK
[email protected]
Better and equitable health is a global aspiration. Health has become a key issue
in the development of stable global social, political and economic structures and
thecreationofmechanismstoachieveitremainsoneofthegreatestchallenges we
face inthe21st century. Understanding thebreath andcomplexity ofthesolutions
required to improve global health is critical to maintaining substantial progress in
thisendeavour.Greatprogresshasbeenmadeduringthepastcenturyinunderstand-
ingdiseases,developingnewdiagnostictechnologiesandnewmedicines,resulting
inbetterprevention andtreatment ofillness andcontributing tomajoradvances in
longevity in the developed world. Indeed, in the period 1952–1992, over one half
of the gains in health were due to access to better technology and application of
new knowledge. Remaining gains were due to income improvements and better
education (WorldHealthOrganization, 1999). However,inspiteofthesegainsthe
challenges ahead are equally formidable. The emergence of new diseases and the
spreadofdiseaseasadirectresultofhumanactivityorindirectlythroughenviron-
mentalchangearemajornewscientificchallenges.
The healthcare sector operates in a uniquely complex social, political and eth-
ical environment. All societies recognise the importance of equity in provision of
ix
April9,2007 15:33 WSPC/150-IJIM 03_intro
x R.A.Atun&D.Sheridan
healthcareandaspiretoachieveitthroughvariousmeans,almostalwaysinvolving
amixofstateandprivatesectorinvolvement.Healthcaresystemsarecharacterised
by involvement of the state to prevent market failure. The extent of this involve-
mentdistinguishesitfromotherformsofconsumption.Theinvolvementofthestate
in health systems varies in different contexts. It may be limited to “stewardship”
ofthesector,withanemphasisonregulation, policydevelopmentandprovisionof
strategicoversight,ormayincludeinvolvementinfinancing,purchasingordelivery
ofhealthcareservices.Involvementinhealthcarefinancingmayincludecollection,
pooling and allocating resources amassed from the citizens or corporations in the
formoftaxes,insuranceordirectpayments.Involvementinservicedeliverymaybe
direct,withownershipandmanagementofhealthcareinstitutionsandemployment
of the staff who work in these. However, involvement in financing and delivery
may be delegated to third parties: public or private “not for profit” or “non-profit
distributing” organisations (such as public insurance agencies, non-governmental
organisations, trusts ormutuals), ortoprivate “for profit” organisations and struc-
tures. However, whatever the mix and the extent of state involvement, all health
systems facethechallenge ofmeeting increasing demands thathave outgrown the
available resources. Understanding thedynamicandcomplexnatureofhealthsys-
tems,andhowregulatoryinterventionshelpachievesystemgoalsandobjectivesis
criticaltodesigning meaningful policies.
Technologicaladvancesanddevelopmentofnewmedicinesareachievedonthe
basisoffundamental research carried outinuniversities andinstitutes ofresearch,
while virtually all end products and medicines are developed and produced by
thepharmaceuticalandrelatedindustries.Theseorganisations operateinmarkedly
differing financial and regulatory environments, but their successful interaction is
criticalforsuccess.Byitsnaturetreatmentofdiseaseinvolvesalteringordisturbing
normalbodyfunctions onatemporary orpermanent basistoachievesomeoverall
benefit in wellbeing or longevity and therefore necessarily involves some element
of risk which is overt and unavoidable. Despite this there appears to be no aspect
ofhumanactivitywhichgenerates amorerisk-averse attitude. Hugeratesofdeath
and disability are blithely accepted and tolerated in exchange for the pleasures of
smoking tobacco and drinking alcohol or the convenience of daily road travel. In
contrast weseemtohavedeludedourselves intoregarding illnessasanunjustified
inconvenienceforwhichwecanexpectriskfreetreatmentasaright.Asaresultthe
healthcare sectoroperates inanenvironment ofintenseanduniqueregulation.
Innovationisattheheartofalladvancesandhasthecapacitytosolveproblems
facing humanity. Societies which have turned away from innovation and techno-
logicaldevelopmenthavefailedintheirabilitytosupporttheirpopulations.Under-
standing the nature of innovation in the life sciences and in particular health care,
April9,2007 15:33 WSPC/150-IJIM 03_intro
InnovationinHealthCare xi
how it operates, what enables and hinders it is therefore of great importance to
meetingthechallenges ahead.
Multiple interacting factors influence the uptake and diffusion of new knowl-
edgeandtechnologies whichareneededtoimprovehealth.Inturn,thedeliveryof
healthcareonaglobalscaledependsoneffectiveandstablepoliticalandeconomic
foundations, which have the capacity to improve and manage disease prevention
andtreatment.
Understanding thenatureofinnovationinthelifesciencesiscriticaltocreating
innovation ecosystems thatcombine anappropriate balance ofincentives, rewards
and regulations that encourage the innovation process but also the uptake and dif-
fusionofinnovations oncethesereachthemarketplace.
Developing suchanunderstanding requires acareful examination ofthenature
ofinnovationinthelifesciences,theinnovationprocessthatspansacademicinstitu-
tions,healthcaresystemsandmultipleindustrialorganisations,andinvolvesawide
rangeofstakeholders, aswellastheinnovation lifecycleinthelifesciences.
Itisalltooeasygiventhecomplexityandscaleofthesechallengestofocusonsin-
gleissuesandpartialsolutionsthathavelittleprospectofachievinglongtermgains
or which may even hinder solutions in other areas. Hence, policy makers should
adopt a holistic approach when developing policies aimed at improving health —
informed bysound understanding ofthe innovation process, knowledge offactors
which encourage or hinder innovation, and awareness of the societal expectations
whichshapethegoalsandobjectivesofhealthsystems.Partialunderstandingofthe
innovationprocess,thefactorswhichinfluencetheuptakeanddiffusionofinnova-
tions,andthegoalsandobjectivesofhealthsystemsmayleadtothedevelopmentof
inappropriate policies and partial regulations which hinder the innovation process
aswellastheuptakeanddiffusion ofinnovations.
This book volume, reprinted from the International Journal of Innovation
Management (Vol. 11, No. 2), brings together a series of papers which address
manyoftheissuesrelatedtoinnovationinthelifesciences.Thepapers,developed
byamultidisciplinarygroupofscholarsandpractitioners,exploreinnovationinthe
lifesciences inaholistic mannerbutviewedthrough avarietyoflenses.
J.Attridgedistinguishestheoryfrompracticeinmanaginginnovation,asabusi-
nessandmanagementstrategyinthelifesciencesandinparticularinthebiopharma
sector. Heexplores how ourunderstanding ofinnovation has evolved from simple
linear“push”and“pull”modelstomorecomplexdynamic,interactiveincremental
onesthatmorerealistically represent whathappens inpractice.
Using real life case histories, D. Sheridan analyses the innovation process in
cardiovascularmedicineandillustrateshowimportantadvanceshaveemerged.His
