H2020 Program Insights

Frank Heemskerk © RIMS May 2014 Tunis
The European R&I program H2020:
"linking Research with Innovation to
create Impact in Society"
Tunis, May 2014

2
Structure:Structure:
- what is H2020?
- how to build a consortium
- successful proposal writing through the eyes of
an evaluator
- what is meant with 'impact'?
- IPR issues in public-private partnerships
- food for thought, Strategic elements for
discussion

3
AboutAboutthe presenterthe presenter……
Academic research (15 yr): Medicine+Biology, PhD
 NL (Utrecht), USA (NIH), FR (Pasteur), BE
 >42 int’l grants, working with industrial partners
Industry experience (17 yr): Biotech/Pharma, Research
Management, contracts, IPR, licensing, partnerships
with academia, merger, multiple private investments
International Research Management: Biotech/Pharma,
2x President EARMA, founder ProTon Europe Assoc
 founder and CEO RIMS bvba: 2002
 Board member/investor of several start-up companies
 Senior Associate European Inst Asian Studies- EIAS
 Consultant& Evaluator EU, CPD Trainer & Coach
 International Cooperation globally (own network of
organizations Latin Am, Africa, SE-Asia, Europe)

4
Knowledge
Strategy building
Experienced management
Research Development
Risk control
Shorter time to market
access to new markets
Innovation
Expert partners
Consortium building
and public funding
Sufficient capacitySufficient private funding
Services
Products
Suppliers
There is more to it than just R&D skills…There is more to it than just R&D skills…
Legal support

5
RIMS can help you to move theRIMS can help you to move the
Research idea all the way to Commercialisation:Research idea all the way to Commercialisation:
1. Analyze and optimize your R&D strategy:
 help to find partners and build international academia/industry
consortia
 manage resources
 get access to international funding sources
2. Research Management & Administration of larger (international/
European) projects:
 structured proposal development (+ help with submission
process )
 negotiations
 implementation and governance(as management partner)
 final reporting
 knowledge transfer
3. Training workshops in International Research Management and
Knowledge Transfer
4. Hands-on Innovation management in start-up phase until Exit
From Laboratory to Market:

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Your partner for Research Management/
Knowledge Transfer on a global level:
- Academic + Industry expertise
- Clients range from SMEs, Research Institutes to big corporations
(Johnson&Johnson, GSK) and governments
- long track record (>42 EU projects, Evaluator for European
Commission)
- A global network of organizations (> 4 000)
- Strategic Partner in Business Development, Sustainable
Development and Capacity Building projects
- advice on public and private Finance, Business Angel Investor
- Managerial hands-on involvement
- Clear focus on Life Sciences-Biotechnologies (Health, Agro,
food) and related ICT fields (e-health, assisted living)
- ‘Bench to Bedside’ / ‘Farm to Fork’ approach
- Long experience with working in non-european contexts.....
RIMS can provide you with valuable assets:RIMS can provide you with valuable assets:

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BackgroundBackground
linking Research to Innovation for Valorisation

8Frank Heemskerk © RIMS May 2014 Tunis
Global Policy Context:

9
Knowledge triangle:Knowledge triangle:
Knowledge for Growth:
Socio-Economic return
Research
Education Innovation
jobs, growthIntellectual
Social
Economical
But HOW?

Project Management and Value chainProject Management and Value chain

11
Why R&D/ Innovation funding?
• Where is the Value in joint R&D projects?
• Innovate products (#, quality, etc) and processes
• Feed pipeline with new/ improve products (students, courses, tools)
• Diversify portfolio (projects), enter new markets, higher visibility
• Why collaborate?:
• Access to new knowledge
• Access to unique infrastructure
• Access to valuable materials, information dbases
• Achieve critical mass (work faster/disseminate wider/ increase visibility)
• Access to new experts (future staff?)
• obtain public funding to lower the risks
InvestInvest
Innovate
Internationalise

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International Challenges:
• Increased need for a multidisciplinary approach to approach
complex problems
• Not all expertise or capacity is available in house to do that alone
• Demand for more exploitation of R&D (towards ‘Knowledge
driven Societies’)
BUT:
• usually no cross border funding from national agencies
• Language differences
• Cultural differences
=> Complexity with Quality => Management issues….
=> Responsible partnering across sectors
WHYWHY InternationalInternational publicpublic fundingfunding??

13
AlsoAlso, Europe, Europe can’tcan’t dodo thisthis alonealone eithereither::
•Science is global activity
•Competition is global
•Challenges are common and global
•Problems are increasingly complex/ require complex infrastr.
•Problems in e.g. Africa directly affect Europe too
•Local assets and environments are unique
=>
Need for international cooperation

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Know-How
Components
Materials
Know-How
Components
Materials
PrototypesPrototypes ProductsProducts
Services
Business CasesBusiness CasesDistributeursDistributeurs
MarketMarket
TRL9
TRL6
Innovation
Chain
TRL6
TRL1
UsersUsers
VALUE CHAIN

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Find the Balance:
• When to outsource or subcontract? (no IPR, full cost, full control)
• When to buy-in? (access to IPR, partial costs, but control?)
• When to co-develop/ joint-venture? (shared IPR, shared costs, but marketing
and risks?)
• How to coordinate when playing multiple roles?: strategy + contract
management
• =>What kind of partner are you? e.g. 4 types of SMEs:
R&D performer Co-developer
Subcontractor Late active adopter Front edge early adopter
(Passive user)
R&D level
User involvement

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ProposalProposal writingwriting: issues to: issues to bebe consideredconsidered
1. How might I develop my project ideas into viable
proposals?
2. How do I align my project with donor’s objectives?
3. What do reviewers look for in winning project
proposals?
4. What are key funding do’s and don’ts?
5. How best to protect & commercialize my research
results?
Need for partners, you can’t do this alone: teamwork
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© Fit for Health 2.0, 2014

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Step 1: Register your organization and get a PIC:
17

18
http://ec.europa.eu/research/participants/docs/h2020-funding-guide/index_en.htm
18
Frank Heemskerk © RIMS
May 2014 Tunis

19
PHCPHC--1818
WorkWork
ProgrammeProgramme
20142014--2015:2015:
exampleexample
 'PHC 18 –
2015'
 'Specific
challenge'
 'Scope'
 'Expected
impact'
 'Type of
action'

20
How to proceed?
How to covert an Idea into a Project proposal?
How to build a consortium
Do’s and don’ts?

21
How to prepare a PROPOSAL:
 Take it as a project in itself:
 Scope, tasks/ delegation, time, resources….
 READ the Workprogram, call text, additional documents
 Templates
 Submit ALL elements on time !
 Lobbying:
 use NCP’s, local support
 Follow-up:
 Timing, evaluation, negotiation
 Use your partners, trust your Coordinator! but defend your own
position !
 IPR !!
 Websites, tools
 get professional help.....
21 Frank Heemskerk © RIMS May 2014 Tunis

22
How to start?How to start?
 Define the problem (e.g. medical need)
 Identify the stakeholders (patients, industry, etc)
 Define the requirements (e.g. Drug, quality, state of the
art)
 Define resources needed (costs, people, partners)
 Identity risks (failure, competition,)
 Work to process (what, who, when, how, what if)
 Evaluation, managing and control the structure

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Project aims – Project results
A clear coherence between project aims and
project results is the foundation for describing
the impact
Milestones
It must be clear which results are expected!
Overall Aims Specific Aims Work packages
/ Tasks
Project Results

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Use Methodologies:Use Methodologies:
1. IDEA:
 novelty/challenge, scope/ final objective, develop a summary
2. FIND partners to form a consortium:
 complementarity, divide roles and tasks, fill in gaps, agree on
cooperation mode
3. DEVELOP proposal structure:
 fine tune Objectives, design Workplan with work packages
4. WRITE proposal:
 Positioning, Workplan, Budget, governance, exploitation strategy +
explain how to generate socio-economic Impact
5. EXECUTE and CLOSE project:
 pro-active Management, quality administration, quality and timely
reporting, same for dissemination during project
 proper closure, (sustainable) exploitation of results

Just writing some Objectives is not enough: complexJust writing some Objectives is not enough: complex
projects are based on agreement between the rightprojects are based on agreement between the right
teams ....teams ....

26
Exercise:
- Problem to
WHAT
- Problem to
address?
- Scope?
WHAT
- To do?
- Achieve
what?
HOW
- To
implement?
Where
- To act?
When
- timing?
-
sequences?
WHO
- Can do
what?
WHO
- Can use
results?
- How to
create
impact?
5: dissemination,
exploitation,
commercialization
6 Res Management & Admin
1 analyze, map
2 develop
3 test, validate
4 upscale

27
Structure Part B:Structure Part B:
Administrative form templates :
• -a general section where the basic proposal details are filled in by the coordinator
• -a list of declarations
• -participants' and contact persons' data
• -budget breakdown by organization and cost category
• -ethical issues table: http://ec.europa.eu/research/participants/docs/h2020-
funding-guide/cross-cutting-issues/ethics_en.htm
• -call specific questions (if relevant) and gender aspects
Science/Technology part:
fill in core of your proposal (next slide)
Stage
1
Step 3+4: pre-register with PIC and enter organizational/
admin data in online structured templates:
27

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Structure Part B:Structure Part B:
 1: Scientific and/or technical Excellence, related to the topics in the call
 1.1 Objectives
 1.2 Relation to the work programme
 1.3. Concept and approach
 1.4. Ambition
 2: Impact
 2.1 Expected impacts
 2.2 Measures to maximise impact
- a)Dissemination and exploitation of results
- Communication activities
 3:Implementation
 3.1 Work plan – Work Packages, deliverables and milestones
 3.2 Management structure and procedures
 3.3 Consortium as a whole
 3.4 Resources to be committed
 4: Members of the consortium
 4.1 Participants (applicants)
 4.2 Third parties involved in the project (including use of third party resources)
 5: Ethics and Security
 5.1 Ethics
 5.2 Security
Administrative form templates :
Science/Technology part: in Technical ANNEX (download from sys
Stage 1
Stage 2
Step 5: enter organizational/ admin data
in online structured template:
28

29
a few definitions:a few definitions:
A work package is a major sub-division of the proposed
project with a verifiable end-point – normally a
deliverable or a milestone in the overall project.
A deliverable represents a verifiable output of the
project. Normally, each work package will produce
one or more deliverables during its lifetime. Deliverables
are often written reports but can also take another form,
for example the completion of a prototype etc.
Milestones are control points where decisions are
needed with regard to the next stage of the project.
29

30
Expected impacts as listed in the work program
• Contribution towards expected impacts in WP
(European policy, Europe 2020, environment)
 Social impact: data, statistics.
• Steps needed
• why a European (rather than a national or local)
approach?
• account of other national or international
research activities? Relations
• assumptions and external factors
Expected Impact
30

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Basic example Project Management & OrganizationBasic example Project Management & Organization
Project
Advisory
Committee
Project
Board(WP
leaders) (all
partners)
Protocol
development
Team
Working Groups (per
workpackages)
Cooördinator Eur. Commission
31

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 mostly 2 stage submissions: 7 page only in stage 1
 very strict page limits (for sections 1-3)
 template will provide context related help information (no Guide for
Applicants anymore)
 work packages now in Part 3
 new tables for risk and costs
 partner description in Part 4 (with CVs!)
 section on Ethics
 security and gender issues in the Annexes
See H2020 Manual:
 http://ec.europa.eu/research/participants/docs/h2020-funding-
guide/grants/applying-for-funding/submit-proposals_en.htm
The following parts of the proposal do not have page limits:
 the administrative information
 description of the consortium
 the ethics annex including any supporting documents.
New (as compared to FP7):New (as compared to FP7):
32

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Evaluation: useful tips and links
Eligible proposals:
- Submitted through the e-system before deadline !!
- Complete (incl. admin part !), readable and printable
Financial capacity: see Financial regulations and follow Rules for Participation
Operational Capacity check:
- CV or profile descript of key persons
- List of max 5 publi’s/products/services
- List of max 5 key projects/activities relevant to the proposed work
- Description of 3rd parties (active working entities that rare not partners: e.g.
hospital pharmacies, provision of access to ICT resources, other facilities)
- Descript of any significant infrastructure, major equipment, etc
- Include a draft Exploitation & Dissemination plan (2nd stage)
- very strict page limits within template: excess pages will be marked with
watermark and will be disregarded by evaluators
See H2020-WP1415 annex B

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Evaluation: the entire process

35
http://ec.europa.eu/research/participants/portal/desktop/en
/experts/index.html
The best training is to
become an expert
Evaluator yourself !
35

36
Why is this so important?

37
EvaluationEvaluation criteria H2020 of EUcriteria H2020 of EU
EXCELLENCE
“relevant to the topics
addressed by the call and
credible approach”
IMPACT
“outputs of the project should
contribute at the European and/or
International level”
IMPLEMENTATION
“Quality and efficiency of the
implementation”
• Soundness of the concept,
including trans-disciplinary
considerations, where
relevant;
• Extent that proposed work is
ambitious, has innovation
potential, and is beyond the
state of the art (e.g. ground-
breaking objectives, novel
concepts and approaches)
• Enhancing innovation capacity
+ new knowledge integration
• Strengthening the
competitiveness and growth of
companies by developing
innovations meeting the needs
of European and global markets
&, if relevant, to deliver these
innovations to their markets
• other environmental and
socially important impacts
• Effectiveness of Exploitation
/Dissemination of Results (incl.
data& IPR management)
• Coherence &effectiveness of
work packages in work plan
• Appropriate allocation of
tasks and resources (budget,
staff, equipment)
• Quality of the consortium as a
whole (including
complementarity, balance)
• Appropriate management
structure and procedures, incl.
risk and innovation management
1 2 3Min threshold: 4/5 Min threshold: 3/5
Evaluation criteria applicable to
Collaborative project proposals,
see H2020_WP1415_annex H

Market
Seed, BA,FFF Local VC Int’l VC IPO
Value
Perceived Risk
Research
Technol-Commercial
Industrialize
Cash needs
Development
Validate Prototypes
Funding
Parallel Product Development
& Transfer at right moment
The Innovation Value chain: Risk perceptionThe Innovation Value chain: Risk perception
and who plays which Role?and who plays which Role?

rest of Society/
Government:
Industry
Academia
Investors
regulatory
ethical
legal
fiscal
infrastructure
education!
Community
involvement
understanding
cooperation
exchange
Understanding
matching
expectations
and in Life Sciences it’s not that simple….

Who gets in first?Who gets in first?

Negotiations !Negotiations !

Academic issues:Academic issues:
•Confidentiality (conferences, students, temp staff,
patenting)
•Protect vs time to publish (permission)
•Material transfer issues
•Lab records (signatures, consistency)
•Quality control issues (originan data, consistency,
security)
•Ethics (access vs privacy, animal and human rights)

43
IPR issues in Collaborative projectsIPR issues in Collaborative projects
Background Knowledge
Foreground Knowledge
Revenue sharing
3rd party licensing
Access rights for
own use
Access rights for
commercial use
IPR: patents, licenses, models, authorship, copyrights, TMs, dbases,
materials, etc (confidentiaity issues, material/ data transfer issues)
Excluded, - list Included, + list

1. Different timelines (days, years)
2. different Expectations (%, €)
3. Lack of insight in business development in academia
4. Insufficient capacity (€, investment) to deliver
5. Organizational capacity (signing contracts, infrastructure)
6. Differences in Management culture and experience
7. Differences in legal and financial context !!
8. Quality Communication!
PLUS: beware of International differences: financial, cultural
and legal frameworks differ !
AcademiaAcademia--Industry Cooperation:Industry Cooperation: otherother
ChallengesChallenges

Sharing/Transfering Knowledge in a Responsible manner
- share IP under Open Innovation contract
- share risk according to role
- share revenues through milestone payment
see: Responsible Partnering Guidelines (see links on EUA,
EARMA, EIRMA, ASPT-ProTon-Europe websites)
intellectual capital
profit
image/goodwill
ExamplesExamples ofof goodgood practisepractise::

46
Examples and casesExamples and cases

Case 1: Key role of Dissemination in Creating a new
Market & Impact
intellectual capital
market
profit

Main objectivesMain objectives
 To develop a novel concept of compact, high efficiency and cost-effective
waste treatment plant for water recycling in textile finishing.
 The idea builds on the application and further development of the know-how,
developed by the European Space Agency, on membrane bioreactors for
100% water recycling in micro-ecological space-life support systems.
Collective Research Example: SPACE2TEXCollective Research Example: SPACE2TEX

 Expected economic benefits
 Water and energy savings,
 Water treatment cost savings,
 Sludge recovery costs
 Main strategic & social benefits
 Opening a new market for MB technology in textile waste
water recycling, worth 165 M€/year in the medium term in
Europe Improve the QUALITY OF LIFE AND HEALTH for
the European citizens,
 Improve COMPETITIVENESS of the textile finishing and
hence creating new employment opportunities for estimated
12.400 people by 2010,
 ENERGY SAVING from warm water and reduction of
estimated 700 thousands of tons CO2.

Publicationsopen
WWW-server
RTD performers
Industrial Associations
Associated Companies
Dissemination to
Third Party; Scientific community
open
WWW-server
Reporting
Workshops
Conferences
SME Core Group

Example 2:Example 2:
Thematic international Cluster:
translational research to market

 Small M Curie Chair project:
 Top female specialist USA => Central European country
 Idea => Chair at University + research program on HIV vaccine
(Nanomedicine)
 VALUE coming out:
 Develop a Clinical trials vaccine cluster: building up specific
expertise
 Develop larger international Consortium to do world class R&D and
attract more public funded € projects
 Center of Excellence that is unique for Central-East Europe
 High level training events in specialist areas
 Now a spin-off company (jobs)
 + leverage for investment (private €)
International Thematic Cluster on NanoMedicine:International Thematic Cluster on NanoMedicine:

Cluster Strategic Product Development Plan:Cluster Strategic Product Development Plan:
© VTC ImmuneTherapy cluster
Transfer to othersTransfer to others
New ideas pipelineNew ideas pipeline
Build prototypesBuild prototypes
Test with patients: safety+efficacyTest with patients: safety+efficacy
Example:Example:

Example 3:
- new research => public €
- improved efficiency and organization
- bigger capacity that can be re-utilized for
other products
- enhance product pipeline
- company growth => jobs and private €

55
VersatileVersatile R&D environments:R&D environments:
Res
R&D
Platform
Know how
Dev
High-end Services
Products
Key end user
to validate
clients
A
A
A
A
A
I
I
I to validate
A

56
PhenotypicPhenotypic
DatabaseDatabase
GenotypicGenotypic
DatabaseDatabase
Understanding HIV Drug resistance is the key
to designing new drugs:
UHTSUHTS
PhenotypingPhenotyping
Treatment
monitoring
tools
New Drugs
BioinformaticsBioinformatics
GenomicsGenomics
Drug
Targets
Pharmacogenomics enginePharmacogenomics engine
DrugDrug
Discovery & DevelopmentDiscovery & Development
PlatformsPlatforms

Create leverage (industry case):
 Idea for proprietary HIV assay => patent + specific know how +
unique proprietary dbase
1. Enables faster drug discovery progam (core) => attract investment 1
for drug development (Tibotec)
2. Enables Spin-off company for diagnostics=> short term revenue
stream (Virco)
3. Enables to attract investment 2 for capacity development =>
result: Real GROWTH
• Tibotec (started 1994) - Virco (started 1995)
• 1998: 28 people
• 2002: 250 people and acquired by Johnson& Johnson (500 M€)
• 2010: 670 people and 2 drugs on the market (blockbuster...)
Company example 4: Flemish region of Belgium

Case 4: Clinical Studies in Africa:
invest in infrastructure and people to create Impact
issue: no infrastructure to support studies + therapy
compliance in long term: key role for NGO
- roads, sewer
- schools, childcare
- training/professional education
- medical supply
people
image/goodwill
planet profit

59
Successful industry partnerships are based on:
 A) complementary R&D capacity
 B) track record w/ external funding (public and/or
private)
 C) track record w/ industry- academia cooperation
 D) familiarity w/ IPR _ Finance management
See: “Responsible Partnering Guidelines” handbook:
http://www.eua.be/eua-work-and-policy-area/research-and-
innovation/Responsible-Partnering-Initiative.aspx

1. Focus NOT only on Tech Transfer and short term returns (# of
licenses transferred, milestone and royalty payments received, etc)
2. Do Focus on VALUE building for multiple stakeholders (who are the
potential beneficiaries around the University? How can there be a socio-
economic return for the University?)
socio-economic IMPACT elsewhere
3. Make optimal use of the assets and resources of partners in local
and global networks and work through consorti
4. If you Focus on joint provision of solutions (not on products) with
the right Business Model, plenty of revenue/ funding can follow !
ConclusionsConclusions -- Recommendations:Recommendations:

Sust Devlpmt is about building socio-economic value for the
Community that can become financially self-supporting:
intangibles and to manage them not as cost elements, but as
investments in PPP
- Social capital (People, Knowledge, Skills, Health, Qual. Life)
- Intellectual capital (Profit, Research, IP => Innovation of
product/service portfolio)
- Goodwill (People => Profit, Growth, new Markets)
- Environmental capital (Planet, waste as resource)
nb: these are interconnected !
FoodFood forfor thoughtthought::

62
Food for thought, elements for discussion

Right timing for innovation....Right timing for innovation....

Know-How
Components
Materials
Know-How
Components
Materials
PrototypesPrototypes ProductsProducts
Services
Business CasesBusiness CasesDistributeursDistributeurs
MarketMarket
TRL9
TRL6
Innovation
Chain
TRL6
TRL1
UsersUsers
VALUE CHAIN
SOCIAL + INTELLECTUAL
goodwill + ENVIRONMENT+

66
How toHow to start developing a balancedstart developing a balanced
Business Plan?Business Plan?
 Define the problem (e.g. medical need + target market niche)
and WHO is the (paying) customer
 Identify the stakeholders (patients, industry, regulatory, etc)
 Define the requirements (e.g. drug, quality, state of the art)
 Define Business Model
 Define resources needed (costs, people, partners), especially
the skill set of the core team
 Work the process (what, who, when, how, what if)
 Identify and evaluate risks (technical failure, cash flow,
competition, slow adoption, etc)
 managing culture, control levels and risk management, the
governance structure, advisors and innovation for growth

67
Project
Leader
Technical
Expert
Consultant
Security
Expert
Union
Rep
Communication
Expert
Project
Leader
Assistant
project
leader
ICT
expert
Expert
logistics
Project: City Development
Poor Scientist
Management PitfallsManagement Pitfalls

68
Leadership: essential, but not sufficient...Leadership: essential, but not sufficient...
“And stop telling me
everyone has his own way of
doing things !”

69
Soft Skills:
- Networking !
- Teamwork
- Presentation skills !
- Empathy
- negotiation skills
Hard Skills:
- scientific/technical knowledge across
disciplines
- Project management
- Time management
- Budgeting

70
Communication PitfallsCommunication Pitfalls
Culture
Poor project
definition Poor
Communication
No ownership
No champion
Poor planning
Not aligned with
organization
Insufficient
resourcesInappropriate
structure
lack of control
Organisation
People

71
“International/public entrepreneurship in a complex network
environment: you need professionals to enable the different players to
act together”
LLearn to listen to each other and cooperateearn to listen to each other and cooperate

Research & Innovation
Management Services bvba
Dr Frank Heemskerk
E= Frank.Heemskerk@telenet.be
Tel.: +32 16 474092
W= www.rimsinternational.eu
Further informationFurther information
 Thank you for your attention.

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