SMERUD Medical Research Group a full-service phase II-IV CRO for ...

Norsk Biotekforum 

Møteplass for klinisk utprøvning 

Seminar # 2/2009: 

CLINICAL TRIAL GRANT 

APPLICATION WRITING 

Oslo, 2. juni 2009 

Møteleder: 

Knut T. Smerud , CEO 

Smerud Medical Research International AS 

SMERUD MEDICAL RESEARCH GROUP 

1

Agenda 

08:30 Enkel bevertning 

09:00 Utfordringer vedrørende offentlig prosjektfinansiering av klinisk utprøvning innen 

Eurostars og 7RP. 

Knut T Smerud, CEO, Smerud Medical Research International AS 

09:40 Erfaringer fra konsortiebygging innen biotech/pharma i klinisk fase. 

10:10 Kaffepause 

Rolf Myrvold, CEO, AlgiPharma AS 

10:25 Søknadsstrategier. 

Knut T Smerud, CEO, Smerud Medical Research International AS 

11:05 Medical Writing as a profession to be utilised in grant applications. 

Steven J Knox, Director Clinical Research, Smerud Medical Research International AS 

11:45 Oppsummering. 

12:00 Avslutning 


2

Utfordringer vedrørende offentlig 

prosjektfinansiering av klinisk utprøvning 

(Eurostars (og 7RP)). 

Knut T Smerud, CEO 



3

Presentation outline 

• Problem statement 

• Eurostars 

• Review of programme 

• Results Call 1 and 2 

• 7th Framework Programme 

• Opportunities (for clinical trials) in July 2009 call 


4

Problem statement 

• Historically, public funding of clinical research 

• is very seldomly involving drug clinical trials 

• in Norway, almost non-existing 

• Framework Programme 

• Specific calls for clinical trials have now been seen 

• Eurostars programme 

• Enthusiasm when launched, as 

• Funding available for projects close(r) to market 

• Enthusiasm changed to 

Dispair (after results of call 1) 

Hope (after results of call 2) 


5

The Eurostars Programme 

The EU-EUREKA joint funding programme 

for R&D-performing SMEs 


6

Background and Purpose 

• Joint initiative of EUREKA and the EC: 

• Funding for market orientated R&D 

• Small and Medium Enterprises (SME) 

• Technology or innovation 

• Improve 

funding for international research projects 

collaboration with the European research community 

• Stimulate economic growth and employment 


7

Central evaluation process 

Next cut-off date 21 September 2009 17:00(CET) 


8

The Eurostars application procedure 

A confirmation of the 

participation to the project 

is asked by sending the 

document signed by fax or 

mail to the Eureka 

Secretariat address within 7 

days following the sending 

date and maximum 7 days 

after the cut off date. 


9

Eurostars Projects : Eligibility 

• Consortium leader is an R&D-performing SME* 

• At least 2 participants from Eurostars countries 

• Project duration is no more than than 36 months 

• Market introduction is foreseen within 2 years after 

project completion 

• The research-performing SMEs undertake minimum 50% 

of total R&D cost 

• Well-balanced partnership, 

with no single country responsible for more than 75% of the 


project costs 

10

The NPC „cover note‟ 


11

Evaluation by the IEP 

• Independent Evaluation Panel : 6 members + 1 chairman 


12

Ranking of applications by the IEP 


13

urostars HLG endorsement of IEP Report 


14

Funding of applications 

Applicants must make immediate contact with their NPC to move 

forward 

> The funding of partners is based on national funding rules 

> The funding of projects is following the ranking list until 

national budget is exhausted 

> For the project to be a valid Eurostars one, all partners must 

be funded 

Ranking Project AT BE CY DE 

… 

… 

58 E!4567 V V 

59 E!4289 V V 

60 E!4978 X V 

61 E!4157 V V 

… 

… 


15

Eurostars is ..claimed to be.. 

..effective because… 

• Predictable procedures 

(effective EUREKA network support and transparency) 

• Short lead-time 

(3 months from cut-off date to funding decision) 

• Funding is assured 

(national commitment) 


16

Results after the first 

Eurostars cut-off 


17

Key facts 

Applications received and validated 215 

Applications eligible 189 

Applications above threshold 133 

Projects financed 84 

Total project cost 

Average project cost 

125 million euro 

1.5 million euro 

Total number of participants 250 

Average number of participants per project 3 

Average number of participating countries per project 2.4 

Average duration in months 29.5 


18

Who participates in these projects 


19

Which countries participate in these projects 


20

hat technologies are involved (based on cost) 


21

Number of projects involving 

clinical trials 

From Call 1 and Call 2 combined..... 


22

O 

Nil 

Zero 


23

Eurostars Call 3 

• Deadline: 24 September 2009 

• Why bother 

• Should any SME invest 250-600 internal hours 

• Consultancy fees of approx. 200‟ – 500‟ NOK 

• Consider carefully, 

or turn attention to other sources... 


24

FP7-Health-2010 

• Assume 30 July 2009 announcement 

• Deadline early-to-mid December 2009 

• Health Call: > 90 mEUR presumably 

• Headline major topics: 

• Biotechnology, generic tools and medical 

technolgies for human health 

• Translating research into human health 

• Optimising delivery of healthcare to European 

citizens 


25

FP7-Health-2010 

Clinical trial opportunities 

• Cell-based immunotherapy 

• Addiction research 

• Infectious diseases: 

• HIV, malaria, TB, neglected inf diseases 

• Cancer 

• Cardiovascular disease 

• Rare diseases 

• Asthma, allergy and autoimmune diseases 


26

Erfaringer fra konsortiebygging 

innen biotech/pharma i klinisk fase. 

Rolf Myrvold, CEO 

AlgiPharma AS 


27

Søknadsstrategier. 


Smerud Medical Research International 

AS 


28


• Decision-making advice 

• Streamlining the proposal writing process 

• Apply for PES 

• The 1-pager proposal 

• Understanding the Eurostars assessment criteria 


29

So.. 

... is Eurostars (or 7FP) something for me 

and my organisation/product, 

..... and will I be able to 

plan and write up a winning proposal 


30

Decision-making advice 

YES, 

YOU CAN! 


31

Streamlining the writing process 

Apply for PES 

Appoint Proposal Writer (PM) 

Write a 1-page proposal 

Circulate for comments 

Consortium meeting 

Budgets 

Implementation 

Impact 

Compile proposal 


32

Project Establishment Support (PES) 

The Research Council of Norway 

• Prepare organisational framework & 

planning related activities for a specific project, including 

• Identification of partners and/or 

• Preparation of plans/grant proposals 

Eurostars 

• Payroll, purchase of services & network measures 

• May not be awarded for more than 12 months 

• Process 

• Proposal reviewed by external experts (2) 

• RC assess the expert reviews and make a ruling 

• If successful, contract is signed defining terms and conditions 


33

The 1-pager proposal 

(applicable to 7FP and ES) 

Structured 

order 

Topic 

Preparation 

order 

1 Work programme and funding scheme 1 

2 Title and acronym 4 

3 Objective of the proposal 5 

4 Background to the proposal 2 

5 Expected results and lead users of the results 3 

6 Phases of work 6 

7 Organisations involved and their roles 7 

8 Expected costs and duration of work 8 


34

Understanding the 

Eurostars Application Assessment 

• Three major dimensions to be assessed 

by 

Independent Evaluation Panel 

• Basic Assessment 

• Technology and Innovation 

• Market and Competitiveness 

• Each dimension can score up to 100 

points 


35

Understanding the Assessment 

Basic Assessment 

• Partnerships and partners 

• Well balanced partnership; 

• Added value through cooperation 

• Technological capacity of all participants 

• Managerial capacity of all participants 

• Project structure 

• Methodology and planning approach 

• Milestones and deliverables 

• Cost and financing structure 

• Financial commitment of each partner 


36


Technology and Innovation 

• Technological advance 

• Degree of Technological maturity and risk 

• Technological achievements 

• Technological progress for the SME 

• Innovation 

• Degree of Innovation 

• Geographical and sectoral impact 


37


Market and Competitiveness 

• Market and profitability 

• Market size 

• Market access and risk 

• Return on Investment 

• Market potential for SME 

• Time to Market 

• Competitive advantages 

• Strategic importance of project 

• Enhanced capabilities and visibility 


38

Understanding the 

Eurostars assessment criteria 

• Definitions of an ‟Excellent‟ Project per criterium 


39

Well-balanced partnership 

Definition of excellence 

• All partners 

• Possess necessary and complementary key 

qualifications 

• Have strategic and/or commercial interest in the 

results 

• Have a natural company-related and well defined role 

• No overlap of activities 

• Succesful completion requires contribution from all 

• Potential commercial conflicts are dealt with 


40

Added value through co-operation 


• Demonstrates clear sharing of 

• Risks, costs, know-how and benefits 

• Objectives and results give synergy to partnership 

• Participation supports and expands qualifications 

and know-how beyond project results 

• New market 

• New technology 

• New skills 


41

Technological capacity of all partners 


• Each partner 

• Has sufficient, qualified technical personnel 

• Possesses adequate systems and equipment 


42

Managerial capcity of all partners 


• Main partner and PM has 

• Relevant experience, Incl managing multipartner 

projects 

• PM demonstrates 

• Enthusiasm and capability to inspire project staff 

• Ability to communicative convincingly 

• Proposed staff from each partner have adequate 

managerial skills for 

• Implementing project 

• Exploit results 


43

Methodology and planning approach 


• Adoption of problem-solving approach 

• Address key issues 

• Identify and precisely formulate objectives 

• Logical set out of activities 

• Identify resources and costs to each activity 

• Identify assumptions and risks and how to handle 

• Well defined total project organisation 

• In-depth analysis of potential market included 


44

Milestone and deliverables 


• Clearly defined activities 

• milestones 

• deliverables 

• Realistic time schedule vs available resources and 

costs 

• Monitoring indicators identified 

• Quantitative measures 


45

Cost and financing structure 


• Well-structured cost breakdown 

• Sufficient breakdown of financing per party 

• Identify own contributions 

• External support 

• External funding, if any, has been secured 


46

Financial commitment of each partner 


• Each partner has accepted financial commitment 

• Signed by authorised person(s) 

• Each partner clearly demonstrates financial power 

• Own financial contribution of each partner is 

significant 

in relation to overall financial contribution of that 

partner 


47

Degree of technological maturity and risk 


• Central technology in project 

• Potential breakthrough 

• In emerging market 

• High impact on future development of industry 

• Associated technological risk 

• Is high, but 

• Proven track record of expertise within partnership 


48

Technological achievements 


• Project will conribute to important leaps in 

technology itself 

• Technological results represents 

• Fundamentally new solutions 

• Base for new generations of industries 

• Transformation of current infrastructures 

• Technology brings partners 

• In forefront 

• Well beyond state-of-the-art 


49

Degree of innovation 


• Representing a radically new application of 

technology 

• Leads to a product/process/service 

• Superior to alternative solutions 

• Innovation forms a basis for generation of 

new industries 

• Evolves from using the results of R&D at cutting 

edge 

of technology 


50

Geographical and sectoral impact 


• New product is entirely novel at a global level 

• Has the potential to be exploited worldwide 


51

Market size 


• Global market is potentially very large, or 

• Dominating in a global niche market 

• Is a growth market with limited competition 

in the near term 


52

Market access and risk 


• Partners (1 or more) 

• qualified to break into global market 

• Expect to be active globally 

• Proposal has explained 

• Barriers to market 

• Included important customers 

• Reduced time and costs to market 

• Reduced risk for competitors reaching market earlier 


53

Return on investment 


• Relevant market is at a level promising very high 

profitability for each partner 


54

Strategic importance of project 


• Near-term achievements of project will lead to 

• world-class competitive position for ≥1 partner 

• Long-lsting enhancement of competitive position 

• Opening in areas of vital strategic importance 

• Support sales of existing products 

• Creation of new product families/improvements 

To extend total product life-cycle time 


55

Enhanced capabilities and visibility 


• Opens way for good-will and image creation 

• Gives access to networks of importance for growth 

and competitiveness in 

• Commercial 

• Scientific/technological 

• Organisational areas 

• Create strong sustainable competitiveness 

• Cooperation enhances skills and knowledge level 


56

Medical Writing as a profession 

to be utilised in grant applications 

- and why clinical project management experience is essential 

Steven J Knox 

Director Clinical Research 



57


• Aim of presentation 

• Definition of the ‟Medical Writer‟ profession 

• Writing the ‟Impact‟ of the Project 

• Essentials of (Clinical) Development Plans 

• Writing the Implementation Plan 

• Essentials of (Clinical) Project Management 


58

Aims 

• Share experiences to 

• Help researchers/medical directors 

Present their work and idea (project) 

Increase likelihood of obtaining funding 

• Cannot work miracles or change science, but 

Ensure reviewers will consider application seriously 

Avoid unneccessary mistakes 

Make writing process more cost-efficient 

• Provide practical writing advice based on 

• NIH website 

• Company experience 


59

What is a medical writer 

• Requires a combination of 

• Technical skills in medical science 

• Rhetorical skills in language arts 

• Common attributes and characteristics 

• Attention to details and deadlines 

• Ability to write accurately 

• Independent with ability to work across teams 

• Excellent communication and logical organisation 

skills 

• Typically freelancer or employed by CRO 


60

Advantages of using medical writers 

• Medical writers can 

• raise the quality of publications 

• accelerate the writing and publication process 

• Medical writers have 

• language and communication skills 

• expertise in presenting data 

• understanding of publication guidelines 

and conventions 


61

Writing the Impact part 

... or making use of your existing state-ofthe-art 

Research Strategy Plan (akas clinical 

development plan) 


62

Research Strategy Plan 

• Organize application for logical flow of ideas & 

actions 

• Everything fits together 

• Nothing is superfluous 

• Nothing is omitted 

• Time table is detailed & realistic 


63


• Specific Aims 

• Background & Significance 

• Preliminary Studies 

• Research Design & Methods 

• 25-page limit – read instructions! 

• Practical limit for ES/7RP (use annex) 

• Formal limit for NIH proposals 


64


• Specific Aims is the MOST important section of RSP 

• Concise, valid, innovative hypothesis 

• Achievable objectives that will provide useful data 

whether outcome is positive or negative 

• Creates focus for entire application 

• 1 page (bullet each aim separately) 


65


• Specific aims define methods 

• Specific aims must be: 

• Tangible 

• Specific 

• Concrete 

• Measurable 

• Realistic 


66


• Specific Aims Pitfalls: 

• Lack of new, original, or innovative idea 

• Fishing expedition 

• Focus on method 

• No relation to future research or public health 

• Not measurable 

• Incremental advance in knowledge 

• Not achievable in time available 


67


• Background Pitfalls: 

• Inappropriate, incomplete, or haphazard use of 

literature 

• Questionable rationale for proposal 

• Uncertainty regarding future direction 

or significance of results (esp if negative) 

• Lack of knowledge of relevant published literature 

(including alternative theories or approaches) 


68


• Preliminary studies underlines intent 

• Establishes feasibility of proposal 

• Demonstrates your qualifications & dedication to 

do the proposed work 

• Shows the hypothesis can be readily & clearly 

tested 

• 5-6 pages 


69


• Preliminary Studies Pitfalls: 

• Lack of general research experience 

• Lack of experience in essential methodology 

• Lack of critical interpretation of preliminary data 

whether performed by you or others 

• Lack of dedication to career in research 

• Preliminary data not published 

lots of abstracts with no articles shows lack of 

productivity & commitment 


70


• Research Design & Methods should be the easiest 

section to write 

• Detailed instructions for what exactly you will do 

• Anticipate problems & include Plan B 

• Logical sequence & timetable 

• Design MUST achieve Specific Aims 

• Show how results will lead to future experiments & 

translation to practice 


71


• Explain in detail for all anticipated results: 

• Analysis 

• Interpretation 

• Dissemination 

• Application to future work 


72


• Research Design & Methods Pitfalls: 

• Diffuse, superficial, unfocused design 

• Methods do not test hypothesis or achieve specific 

aims 

• Unrealistic timetable for methods 

• No difficulties anticipated, 

no solutions proposed for potential problems 

• Inadequate attention to data analysis, 

interpretation, and/or application 


73

Practical writing essentials 

• Use short, concise sentences 

• Make points clearly 

• Use diagrams to illustrate models 

• Use tables to summarize data 

• Never assume reviewers “know what you mean” 

• Never create additional work for the reviewer 


74

• Fully develop study aims 

Summary 

• Contact National Contact Point or NIH to discuss 

aims 

• Review literature related to aims 

• Design study to test & achieve aims 

• Read & follow all instructions 

• Be concise – be complete 

• Seek input early & often 


75

Sources 

http://grants.nih.gov/grants/grant_tips.htm 


76

Writing the Implementation part 

... or making use of your existing state-ofthe-art 

(clinical) project management plan 


77

High Level Project Plans 


78

Clinical Project Management 

• Project team 

• Project definition 

• Detailed project plan 

• Feasibility 

• Enrolment forecast 

• Project financial control 


79

Clinical Project Management team 

Project Manager 

Clinical 

Operations 

Reg Affairs 

PVG & QA 

Med Affairs 

Med Writing 

Biostatistics 

Data 

Management 

Clinical 

Supplies 

& IVRS 

External 

Vendors 

Finance 

Protocol 

CRF 

ICF 

CSR 

Feasibility 

PSV 

Start-up 

Execution 

Closeout 

IMPD Dev 

CA Sub 

Agency ’s 

Labelling 

Protocol 

ICF 

IB 

CSR 

SAE 

IMPD 

Protocol 

CRF 

ICF 

IB 

CSR 

Inc/Exc ’s 

AE/SAEs 

Coding 

Agency Disc. 

Concept 

Protocol 

Random. 

DSMC 

CRF 

SAP 

CSR 

Protocol 

CRF 

Mon. Guide 

Data Entry 

Data Rev 

Edit Checks 

Prog. 

Coding 

Protocol 

Packaging 

Labelling 

Distribution 

Destruction 

IVRS 

Other Supp. 

Central Labs 

Safety 

Endpoints 

PK 

DSMC 

Shipping 

Proposal Dev 

Inv. Grants 

Contracts 

Payments 

Forecasts 

Actuals 


80

Project Definition 

• Understand context for the project in overall program 

plan 

• Activities to be performed: 

• IMPD, Investigator Brochure, Protocol & ICF 

• Clinical Trial Applications (CTAs) 

• Site identification, evaluation & selection 

• Study Start-up and execution 

• Clinical Study Report & Publications 

• Key milestones, deliverables and critical path 


81

Project Definition 

• Define 

• The target population 

Treatment naive versus treatment experienced 

Available therapies 

Investigational agents in clinical trials 

• Country Selection to achieve the goals 

Patient access 

Cost of doing business 

Regulatory requirements and start-up timeline 

• Patient split 

Likely distribution of patients across selected countries 


82

Detailed Project Plan 


83

Feasibility 

• Critical in establishing a robust clinical operations plan 

• Patient population 

 

 

 

Standards of care 

• Private versus socialized care provision 

Treatment naive versus treatment experienced 

• Known patients versus new referrals 

• motivation 

Treatment triage 

• Primary care 

• Secondary care and supporting services 

• Country specific factors 

• Competing trials 

• Corporate knowledge 


84

Feasibility 

• Information sources 

• MEDLINE 

• Pubmed 

Site numbers and recruitment periods in papers 

• Press releases from Sponsor websites 

• Clinical speciality treatment guidelines 

• Competent authorities (e.g. EMEA/FDA): 

European pharmaceutical assessment report (EPAR) 

Summary of Product Characteristics (SPC) 

Guidance documents 

Points-to-consider 

Concept papers 


85

Project Financial Control 

• Three main contract types 

• Fee for Service 

• Unitized 

• Hybrid 

• Budgets are based on specific assumptions 

• Breakdown of all tasks included in the contract 

• # Staff/Hours required to complete each task 

• Tasks rolled up into units 

• Units are the currency we „spend‟ when managing the 

project 

• Financial control is the responsibility of the PM 

• Contract compliance 

• Review & approve invoices in your project 

• The PM is responsible for keeping within budget 


86

Project Financial Control 

• „Out of Scope (OOS) Activities 

• Activities not included in the contract 

• Always 

obtain written confirmation of the request 

agree on number of extra hours or running hours 

obtain written agreement on the OOS activity 

• Monitor cumulative OOS activities 

Implementation of Change Order 


87

Summary 




88

Sources and references 

• www.emwa.org 

• http://writedit.files.wordpress.com/2007/02/ 

mlk_nih_grant_proposal_preparation.ppt 

• www.hyperion.ie 


89

Concluding remarks 

• 7RP more likely funder than Eurostars for CTs 

• 7RP only for selected disease areas 

• If your target indication is not among 7RP-2010 

topics, 

start planning Eurostars NOW – before summer 

vacation! 

• Apply for PES grant ASAP 

• Assign (or hire) Project Manager for grant writing 

• Direct on high-level terms, leave details to PM 

• Be prepared for 200 – 600 hours worth of (senior) 

work 

• SMERUD Exploit MEDICAL planning RESEARCH GROUP phase for networking 

90

Kontaktdetaljer 

for 

- consulting 

- partnering, 

- medical writing 

ifm ES/7RP/NIHsøknader 

Web www.smerud.com 

E-mail 

knut.smerud@smerud.com 

Phone +47 2327 2000 

Mobile +47 9089 2577 


91

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