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Evaluating the value of 
research-by-consortium 
Mark David Lim, PhD 
September 4, 2014
action 
FasterCures is an “action tank” driven by a singular 
goal – to save lives by speeding up and 
improving the medical research system. 
A center of the Milken Institute, we are a nonprofit 
and nonpartisan organization that works with all the 
sectors of the medical research and development 
ecosystem.
bringing a new discovery from lab to market is a 
long, expensive and risky road
innovation 
Milken Institute partnered with 
Sanofi to host an Innovation 
Retreat in 2011 
Meeting yielded 40+ policy and 
R&D recommendations including: 
• Open innovation and 
cooperation among competitors 
• Collaborating in the 
precompetitive space 
• Defining metrics of success
research-by-consortium 
 Shared scientific challenge 
 Widely-usable tool 
 Virtual team to create / qualify
research-by-consortium 
Academia / 
Clinical 
Patient 
groups 
Government Industry 
Temporary association 
of researchers that share 
resources and effort for 
a common objective. 
Consortia integrate 
multiple types of 
knowledge, data from 
multiple sources, and 
align different interests.
consortiapedia.fastercures.org 
Operational Framework Landscape 
Sci. Trans. Medicine, June 2014 
http://bit.ly/STMConsortia 
• Mission/governance 
• Financing 
• Data-sharing 
• Intellectual property 
• and others… 
Database 
369 consortia 
• Disease focus 
• Types of tools 
• Where and who 
• Why 
Planned release: 
end of 2014 
• Consortium-provided 
content 
• Cross-comparison of 
consortia 
• Point-of-contact
objectives 
• Share findings from analysis of 
the consortia landscape 
• Propose a new framework for 
measuring the value of 
research-by-consortia efforts 
• Have an open dialogue around 
the utility and feasibility of 
measuring consortia value
Metrics 
- collaboration and partnerships 
- framework of consortia 
What is important to you? 
- output, efficiency
Who and what 
Sci. Trans. Medicine, June 2014 
http://bit.ly/STMConsortia
More than half focused on disease/condition 
Sharing comparator arm 
data from clinical trials 
Research assays, 
animal models 
Sci. Trans. Medicine, June 2014 
http://bit.ly/STMConsortia 
Genomic/clinical 
databaseT2D patients 
AgedBrainSYSBIO 
Age-associated 
pathways
Breadth-of-scale: Innovative Medicines Initiative 
€ 14 910 397 
Relative effectiveness 
€ 18 118 249 
Drug kinetics 
€1 952 573 292 
€ 756 906 619 
Infectious diseases - 39% 
€ 213 636 872 
Drug discovery - 11% 
€ 186 102 324 
Brain disorders - 10 % 
€ 118 189 462 
Metabolic disorders - 6% 
€ 116 287 312 
Drug safety - 6% 
€ 76 872 548 
Stem cells - 4% 
€ 74 004 854 
Cancer 
€ 74 345 401 
Data management 4% 
€ 20 462 255 
Drug delivery 
€ 30 531 192 
Sustainable chemistry 
€ 38 994 284 
Education and training 
€ 39 901 138 
Lung diseases 
€ 49 310 000 
Geriatrics 
€ 55 930 954 
Biologicals 
€ 68 069 432 
Inflammatory disorders 
IMI 
funding 
Corporate 
contribution 
IMI Report: May 2014 Highlights
Consortium lifespan: 5 - 6 years 
Inception 
Ramp up 
Mid-stream 
Wind down 
Closure 
| 1 year | 2 - 3 years | 1 year | 
Project launch 
Team culture 
Infrastructure 
Scientific challenge 
Sponsor engagement 
Governance 
Agreements 
Tool concept 
Engaging tool-builders 
Project plan 
Project execution 
Milestones 
Deliverables 
Licensing/IP 
Dissemination Data management 
Licensing/IP 
Dissemination 
Royalties
Evaluations should be simple 
Hub-and-spoke – central source of information 
Innovative Medicines Initiative, Critical Path Initiative, 
Foundation for the National Institutes of Health, 
Health & Environmental Sciences Institute 
Formalized agreements and governance 
transparency 
Established timelines and milestones 
project management
Evaluation = Support 
Inception 
Ramp up 
Mid-stream 
Wind down 
Closure 
| 1 year | 2 - 3 years | 1 year | 
Financial and in-kind commitment 
Monitoring & Evaluation 
Steering 
Committee 
Board of 
Directors
Many formal evaluations 
Steering Committee Board of Directors 
Sponsors Consortium Staff 
Research Team
Many informal evaluations 
Steering Committee Board of Directors 
Sponsors Consortium Staff 
Research Team
How do you evaluate 
consortia?
What do you value? 
Efficiency 
- Convening 
- Executing 
- Managing 
- Concluding 
Output 
- Level of adoption 
- Business strategy alignment 
- Government roles 
- Creating opportunities 
- R&D cost/time/efficiency
Output: eye of the beholder 
Government • public health 
• regulatory science 
• de-risk innovation 
• economic growth 
• state-of-science research guidance documents 
Industry • accelerate pipeline 
• new therapeutic area 
• access resources 
• de-risk innovation 
• access intellectual 
capital 
Academia • access resources 
• opportunities for 
publications 
• training opportunities 
• identify collaborators 
Patient 
organizations 
• accelerate pipelines 
• advance basic 
research 
• de-risk medical 
product development 
Consortium 
researchers 
• simplify day jobs 
• access resources 
• networking 
• training / education
Bibliometrics 
• By the end of 2013, IMI projects had 
delivered over 600 scientific 
publications in over 300 journals 
• The citation index of papers from IMI 
projects is twice the world average, 
and higher than the EU average. 
. 
Data & analysis: Thomson Reuters (Custom Analytics & Engineered Solutions), 2013
Bibliometrics and collaboration 
Pre IMI funding award Post IMI funding award 
Data & analysis: Thomson Reuters (Custom Analytics & Engineered Solutions), 2013
Collaborations – who / what 
Co-authorship – 69% 
Cross-sector collaboration – 42% 
Cross-project collaboration – 37% 
Cross-disease collaboration – 31% 
IMI researcher networks by sector 
Data & analysis: Thomson Reuters (Custom Analytics & Engineered Solutions), 2013
Value of consortia 
How will the output be used? Is consortium on-track? 
 Therapeutic area core strategy vs opportunistic 
 Platform methods / tools clinical trials, personalized medicine, 
data standards / exchange, assays 
 Others? 
Project Name Outcome Output Area 
IMIDIA Smaller clinical trials and Personalized 
medicine; Faster development times, 
Reduced attrition, and Predictive 
models 
Biomarkers and 
personalized medicine; 
Efficacy 
Diabetes 
COMPACT Faster development times, Reduced 
attrition, and Predictive models 
Efficacy Biologicals 
Safe-T Smaller clinical trials and Personalized 
medicine; Faster development times, 
Reduced attrition, and Predictive 
models 
Biomarkers and 
personalized medicine 
Drug Safety 
Examples of IMI consortia
Complexities for evaluation by output 
Not all consortium outputs are publishable – licenses, databases 
Publications are retrospective, rarely primary/secondary deliverable 
Different stakeholders = different expectations on output 
Bias: "Sexiness" of the science 
Virtual collaborations - no dedicated laboratory/workspace 
Semi-committed teams - not their day jobs 
Human capital - turnover, advancement 
Numerous consortia, different operational models 
- cross comparison? 
#
What do you value? 
Efficiency 
- Convening 
- Executing 
- Managing 
- Concluding 
Output 
- Level of adoption 
- Business strategy alignment 
- Government roles 
- Creating opportunities 
- R&D cost/time/efficiency
Evaluating efficiency 
Tracking progress - convene to perform 
Coordinating virtual teams 
• Within work streams 
• Across work streams 
• With governing bodies 
Resolving bottlenecks 
• Maintaining scope 
• Appropriate expertise / resources 
• Communications 
• Conflicts / adaptability 
• Team member turnover
Dynamics of teamwork 
Phase of 
Research 
Stage of 
Team 
Development 
Phase of 
Team 
Adaptation 
Wooten, U. Houston, Science of Team Science conference
Phase of 
Research 
Stage of 
Team 
Development 
Phase of 
Team 
Adaptation 
Development 
- goals, mission 
Conceptualization 
- research question, 
framework 
Implementation 
- launch, conduct 
Translation 
- application 
Wooten, U. Houston, Science of Team Science conference 
Hall et al, Trans Behavioral Med (2012)
Phase of 
Research 
Stage of 
Team 
Development 
Phase of 
Team 
Adaptation 
Assess situation 
- recognition 
Plan formulation 
- goal setting, expectations 
Plan execution 
- monitoring, communication, 
coordination 
Team learning 
- lessons learned 
Wooten, U. Houston, Science of Team Science conference 
Burke et al., J. Applied Psychology (2006)
Phase of 
Research 
Stage of 
Team 
Development 
Phase of 
Team 
Adaptation 
Forming 
- tasks, strategy, team 
Wooten, U. Houston, Science of Team Science conference 
Tuckman & Jensen, Group and Organizational Studies (1977) 
Storming 
- roles and interactions 
Norming 
- rules, roles, expectations 
Performing 
- tasks, implementation 
Adjourning 
- finalizing
Tracking consortium progress via metrics 
Inception 
Ramp up 
Mid-stream 
Wind down 
Closure 
 Collective orientation 
 Interpersonal relations 
 Goal setting 
 Teamwork concept 
 Knowledge 
consideration 
 Role clarification 
 Team subgroups 
 Cohesion / collective efficacy 
 Evolved interpersonal 
relations 
 Maintaining shared vision 
 Problem solving / adaptability 
 Knowledge accommodation 
 Evolved role clarification 
 Autonomy & interdependence 
 Collective knowledge 
transformation 
 Evolved interpersonal relations 
 Defining accomplishments 
 Problem solving 
 Mediated information 
exchange 
 Autonomy & interdependence
Convene Perform Transition 
 Collective orientation 
 Interpersonal relations 
 Goal setting 
 Teamwork concept 
 Knowledge 
consideration 
 Role clarification 
 Team subgroups 
 Cohesion / collective efficacy 
 Evolved interpersonal 
relations 
 Maintaining shared vision 
 Problem solving / adaptability 
 Knowledge accommodation 
 Evolved role clarification 
 Autonomy & interdependence 
 Collective knowledge 
transformation 
 Evolved interpersonal relations 
 Defining accomplishments 
 Problem solving 
 Mediated information 
exchange 
 Autonomy & interdependence 
Which phase?
Convene Integrate Implement 
 Collective orientation 
 Interpersonal relations 
 Goal setting 
 Teamwork concept 
 Knowledge 
consideration 
 Role clarification 
 Team subgroups 
 Cohesion / collective efficacy 
 Evolved interpersonal 
relations 
 Maintaining shared vision 
 Problem solving / adaptability 
 Knowledge accommodation 
 Evolved role clarification 
 Autonomy & interdependence 
 Collective knowledge 
transformation 
 Evolved interpersonal relations 
 Defining accomplishments 
 Problem solving 
 Mediated information 
exchange 
 Autonomy & interdependence 
Leveraging human capital
Periodic survey of team dynamics 
Steering Committee Board of Directors Research Team 
Consortium Staff 
62% 
coherence in mission 
35% 
contribution 
Correctional action: 
- Increased face-to-face interaction 
- Document-sharing technology 
- Conflict resolution
Framework for reports 
Sponsors 
Operational 
efficiency 
Alignment to 
strategy 
Consortium Staff
Metrics = better communication? 
• Output - Did the team deliver? 
• Technical milestones – binary 
• Team dynamics - Could the team have done better? 
• Leverage resources and expertise 
• Adaptability 
Mid-term report overview 
Technical progress: 4 / 5 milestones accomplished 
Stage of team: Perform 
 Team integration across disciplines 
 Document sharing / development 
 Researcher engagement 
 Steering committee alignment 
 Interdependency defined 
 Conflicts resolved
How was output used? 
Business strategy 
• Open new therapeutic approaches and research avenues 
• Reduce R&D costs, time to market and development risk 
• Increase the efficacy and/or safety of existing drugs 
Indirect benefits 
• Education and training 
• Spin off companies 
• New partners (patients, foundations, academic, SME) 
• Increased interest in geographic investments 
Others 
• Implementation of standards / best practices / tools into strategy 
• Informing regulatory science (policy / guidelines) 
• Publication output and extent of collaboration 
• Intellectual Property metrics 
IMI Executive Office and other consortia
Design 
• Consortium management 
• Consortium participants 
• Sponsor/stakeholder 
Refine 
• Other consortia – managers/participants 
• Other sponsor within same sector 
Pilot 
• Several consortia 
Optimize 
• Analyze / Evaluate 
• Optimize survey vehicles 
• Re-pilot
? 
Utility 
• Need for these evaluations? 
• Inform best practices? 
• Other non-consortium partnerships? 
Approach 
• Right approach? 
• Aligning consortia with business strategy necessary 
after concept development? 
• Generalizable? 
• Other key elements to measure? 
• Indirect effects? 
• Who/how to pilot? 
Implementation 
• How to measure (surveys, etc)? 
• Who measures?
Seeking insights & expertise 
consortiapedia.fastercures.org 
mlim@fastercures.org

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Evaluating research consortium

  • 1. Evaluating the value of research-by-consortium Mark David Lim, PhD September 4, 2014
  • 2. action FasterCures is an “action tank” driven by a singular goal – to save lives by speeding up and improving the medical research system. A center of the Milken Institute, we are a nonprofit and nonpartisan organization that works with all the sectors of the medical research and development ecosystem.
  • 3. bringing a new discovery from lab to market is a long, expensive and risky road
  • 4. innovation Milken Institute partnered with Sanofi to host an Innovation Retreat in 2011 Meeting yielded 40+ policy and R&D recommendations including: • Open innovation and cooperation among competitors • Collaborating in the precompetitive space • Defining metrics of success
  • 5.
  • 6. research-by-consortium  Shared scientific challenge  Widely-usable tool  Virtual team to create / qualify
  • 7. research-by-consortium Academia / Clinical Patient groups Government Industry Temporary association of researchers that share resources and effort for a common objective. Consortia integrate multiple types of knowledge, data from multiple sources, and align different interests.
  • 8. consortiapedia.fastercures.org Operational Framework Landscape Sci. Trans. Medicine, June 2014 http://bit.ly/STMConsortia • Mission/governance • Financing • Data-sharing • Intellectual property • and others… Database 369 consortia • Disease focus • Types of tools • Where and who • Why Planned release: end of 2014 • Consortium-provided content • Cross-comparison of consortia • Point-of-contact
  • 9. objectives • Share findings from analysis of the consortia landscape • Propose a new framework for measuring the value of research-by-consortia efforts • Have an open dialogue around the utility and feasibility of measuring consortia value
  • 10. Metrics - collaboration and partnerships - framework of consortia What is important to you? - output, efficiency
  • 11. Who and what Sci. Trans. Medicine, June 2014 http://bit.ly/STMConsortia
  • 12. More than half focused on disease/condition Sharing comparator arm data from clinical trials Research assays, animal models Sci. Trans. Medicine, June 2014 http://bit.ly/STMConsortia Genomic/clinical databaseT2D patients AgedBrainSYSBIO Age-associated pathways
  • 13. Breadth-of-scale: Innovative Medicines Initiative € 14 910 397 Relative effectiveness € 18 118 249 Drug kinetics €1 952 573 292 € 756 906 619 Infectious diseases - 39% € 213 636 872 Drug discovery - 11% € 186 102 324 Brain disorders - 10 % € 118 189 462 Metabolic disorders - 6% € 116 287 312 Drug safety - 6% € 76 872 548 Stem cells - 4% € 74 004 854 Cancer € 74 345 401 Data management 4% € 20 462 255 Drug delivery € 30 531 192 Sustainable chemistry € 38 994 284 Education and training € 39 901 138 Lung diseases € 49 310 000 Geriatrics € 55 930 954 Biologicals € 68 069 432 Inflammatory disorders IMI funding Corporate contribution IMI Report: May 2014 Highlights
  • 14. Consortium lifespan: 5 - 6 years Inception Ramp up Mid-stream Wind down Closure | 1 year | 2 - 3 years | 1 year | Project launch Team culture Infrastructure Scientific challenge Sponsor engagement Governance Agreements Tool concept Engaging tool-builders Project plan Project execution Milestones Deliverables Licensing/IP Dissemination Data management Licensing/IP Dissemination Royalties
  • 15. Evaluations should be simple Hub-and-spoke – central source of information Innovative Medicines Initiative, Critical Path Initiative, Foundation for the National Institutes of Health, Health & Environmental Sciences Institute Formalized agreements and governance transparency Established timelines and milestones project management
  • 16. Evaluation = Support Inception Ramp up Mid-stream Wind down Closure | 1 year | 2 - 3 years | 1 year | Financial and in-kind commitment Monitoring & Evaluation Steering Committee Board of Directors
  • 17. Many formal evaluations Steering Committee Board of Directors Sponsors Consortium Staff Research Team
  • 18. Many informal evaluations Steering Committee Board of Directors Sponsors Consortium Staff Research Team
  • 19. How do you evaluate consortia?
  • 20. What do you value? Efficiency - Convening - Executing - Managing - Concluding Output - Level of adoption - Business strategy alignment - Government roles - Creating opportunities - R&D cost/time/efficiency
  • 21. Output: eye of the beholder Government • public health • regulatory science • de-risk innovation • economic growth • state-of-science research guidance documents Industry • accelerate pipeline • new therapeutic area • access resources • de-risk innovation • access intellectual capital Academia • access resources • opportunities for publications • training opportunities • identify collaborators Patient organizations • accelerate pipelines • advance basic research • de-risk medical product development Consortium researchers • simplify day jobs • access resources • networking • training / education
  • 22. Bibliometrics • By the end of 2013, IMI projects had delivered over 600 scientific publications in over 300 journals • The citation index of papers from IMI projects is twice the world average, and higher than the EU average. . Data & analysis: Thomson Reuters (Custom Analytics & Engineered Solutions), 2013
  • 23. Bibliometrics and collaboration Pre IMI funding award Post IMI funding award Data & analysis: Thomson Reuters (Custom Analytics & Engineered Solutions), 2013
  • 24. Collaborations – who / what Co-authorship – 69% Cross-sector collaboration – 42% Cross-project collaboration – 37% Cross-disease collaboration – 31% IMI researcher networks by sector Data & analysis: Thomson Reuters (Custom Analytics & Engineered Solutions), 2013
  • 25. Value of consortia How will the output be used? Is consortium on-track?  Therapeutic area core strategy vs opportunistic  Platform methods / tools clinical trials, personalized medicine, data standards / exchange, assays  Others? Project Name Outcome Output Area IMIDIA Smaller clinical trials and Personalized medicine; Faster development times, Reduced attrition, and Predictive models Biomarkers and personalized medicine; Efficacy Diabetes COMPACT Faster development times, Reduced attrition, and Predictive models Efficacy Biologicals Safe-T Smaller clinical trials and Personalized medicine; Faster development times, Reduced attrition, and Predictive models Biomarkers and personalized medicine Drug Safety Examples of IMI consortia
  • 26. Complexities for evaluation by output Not all consortium outputs are publishable – licenses, databases Publications are retrospective, rarely primary/secondary deliverable Different stakeholders = different expectations on output Bias: "Sexiness" of the science Virtual collaborations - no dedicated laboratory/workspace Semi-committed teams - not their day jobs Human capital - turnover, advancement Numerous consortia, different operational models - cross comparison? #
  • 27. What do you value? Efficiency - Convening - Executing - Managing - Concluding Output - Level of adoption - Business strategy alignment - Government roles - Creating opportunities - R&D cost/time/efficiency
  • 28. Evaluating efficiency Tracking progress - convene to perform Coordinating virtual teams • Within work streams • Across work streams • With governing bodies Resolving bottlenecks • Maintaining scope • Appropriate expertise / resources • Communications • Conflicts / adaptability • Team member turnover
  • 29. Dynamics of teamwork Phase of Research Stage of Team Development Phase of Team Adaptation Wooten, U. Houston, Science of Team Science conference
  • 30. Phase of Research Stage of Team Development Phase of Team Adaptation Development - goals, mission Conceptualization - research question, framework Implementation - launch, conduct Translation - application Wooten, U. Houston, Science of Team Science conference Hall et al, Trans Behavioral Med (2012)
  • 31. Phase of Research Stage of Team Development Phase of Team Adaptation Assess situation - recognition Plan formulation - goal setting, expectations Plan execution - monitoring, communication, coordination Team learning - lessons learned Wooten, U. Houston, Science of Team Science conference Burke et al., J. Applied Psychology (2006)
  • 32. Phase of Research Stage of Team Development Phase of Team Adaptation Forming - tasks, strategy, team Wooten, U. Houston, Science of Team Science conference Tuckman & Jensen, Group and Organizational Studies (1977) Storming - roles and interactions Norming - rules, roles, expectations Performing - tasks, implementation Adjourning - finalizing
  • 33. Tracking consortium progress via metrics Inception Ramp up Mid-stream Wind down Closure  Collective orientation  Interpersonal relations  Goal setting  Teamwork concept  Knowledge consideration  Role clarification  Team subgroups  Cohesion / collective efficacy  Evolved interpersonal relations  Maintaining shared vision  Problem solving / adaptability  Knowledge accommodation  Evolved role clarification  Autonomy & interdependence  Collective knowledge transformation  Evolved interpersonal relations  Defining accomplishments  Problem solving  Mediated information exchange  Autonomy & interdependence
  • 34. Convene Perform Transition  Collective orientation  Interpersonal relations  Goal setting  Teamwork concept  Knowledge consideration  Role clarification  Team subgroups  Cohesion / collective efficacy  Evolved interpersonal relations  Maintaining shared vision  Problem solving / adaptability  Knowledge accommodation  Evolved role clarification  Autonomy & interdependence  Collective knowledge transformation  Evolved interpersonal relations  Defining accomplishments  Problem solving  Mediated information exchange  Autonomy & interdependence Which phase?
  • 35. Convene Integrate Implement  Collective orientation  Interpersonal relations  Goal setting  Teamwork concept  Knowledge consideration  Role clarification  Team subgroups  Cohesion / collective efficacy  Evolved interpersonal relations  Maintaining shared vision  Problem solving / adaptability  Knowledge accommodation  Evolved role clarification  Autonomy & interdependence  Collective knowledge transformation  Evolved interpersonal relations  Defining accomplishments  Problem solving  Mediated information exchange  Autonomy & interdependence Leveraging human capital
  • 36. Periodic survey of team dynamics Steering Committee Board of Directors Research Team Consortium Staff 62% coherence in mission 35% contribution Correctional action: - Increased face-to-face interaction - Document-sharing technology - Conflict resolution
  • 37. Framework for reports Sponsors Operational efficiency Alignment to strategy Consortium Staff
  • 38. Metrics = better communication? • Output - Did the team deliver? • Technical milestones – binary • Team dynamics - Could the team have done better? • Leverage resources and expertise • Adaptability Mid-term report overview Technical progress: 4 / 5 milestones accomplished Stage of team: Perform  Team integration across disciplines  Document sharing / development  Researcher engagement  Steering committee alignment  Interdependency defined  Conflicts resolved
  • 39. How was output used? Business strategy • Open new therapeutic approaches and research avenues • Reduce R&D costs, time to market and development risk • Increase the efficacy and/or safety of existing drugs Indirect benefits • Education and training • Spin off companies • New partners (patients, foundations, academic, SME) • Increased interest in geographic investments Others • Implementation of standards / best practices / tools into strategy • Informing regulatory science (policy / guidelines) • Publication output and extent of collaboration • Intellectual Property metrics IMI Executive Office and other consortia
  • 40. Design • Consortium management • Consortium participants • Sponsor/stakeholder Refine • Other consortia – managers/participants • Other sponsor within same sector Pilot • Several consortia Optimize • Analyze / Evaluate • Optimize survey vehicles • Re-pilot
  • 41. ? Utility • Need for these evaluations? • Inform best practices? • Other non-consortium partnerships? Approach • Right approach? • Aligning consortia with business strategy necessary after concept development? • Generalizable? • Other key elements to measure? • Indirect effects? • Who/how to pilot? Implementation • How to measure (surveys, etc)? • Who measures?
  • 42. Seeking insights & expertise consortiapedia.fastercures.org mlim@fastercures.org

Hinweis der Redaktion

  1. We cannot get to solutions until we break out of the siloes we’re in.
  2. Temporary partnerships.