How your CRO can help you attract public research grants for clinical trials
Upcoming SlideShare
Loading in...5
×
 

How your CRO can help you attract public research grants for clinical trials

on

  • 692 views

 

Statistics

Views

Total Views
692
Views on SlideShare
651
Embed Views
41

Actions

Likes
0
Downloads
0
Comments
0

1 Embed 41

http://www.lifescienceopenspace.com 41

Accessibility

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

How your CRO can help you attract public research grants for clinical trials How your CRO can help you attract public research grants for clinical trials Presentation Transcript

  • CLUB MEETING OF THE LIFESCIENCE CLUSTER Krakow, 17 November 2011 HOW YOUR CRO CAN HELP YOU ATTRACT PUBLIC RESEARCH GRANTS FOR CLINICAL TRIALS Knut T Smerud CEO SMERUD CRO Group SMERUD MEDICAL RESEARCH GROUP
  • Presentation Outline
    • Objective
    • Eurostars
      • Introduction
      • Funding criteria
      • Application process
    • Smerud
      • Experience and lessons learned
      • The ideal set-up
      • Writing / partnering services
      • Contact points
    • Questions and back-up slides
    SMERUD MEDICAL RESEARCH GROUP
  • Objectives
    • Aim of presentation
      • To present a new biotech/CRO partnering idea with true risk-sharing
      • To share experiences from successful and non-successful grant applications using EuroStars as the model
    • Target audience
      • Biotech R&D managers, CSOs, CEOs, board members
      • Biotech investors and VC firms
      • Academic (clinical) research units
    SMERUD MEDICAL RESEARCH GROUP
  • Introduction
    • Eureka’s Eurostars Programme is a European Joint Programme dedicated to R&D performing SMEs, co-funded by the European Communities and 33 EUREKA member countries.
    • Eurostars goal is to stimulate research-performing SME’s to lead collaborative research and innovation projects by easing access to support and funding.
    SMERUD MEDICAL RESEARCH GROUP SMERUD MEDICAL RESEARCH GROUP
  • SMERUD MEDICAL RESEARCH GROUP SMERUD MEDICAL RESEARCH GROUP Introduction (2)
    • A Eurostars project can address any technological area, but must have a civilian purpose and be aimed at the development of a new product, process or service
    • A Eurostars project is collaborative, meaning it must involve at least two participants (legal entities) from two different Eurostars member countries
    • The main participant must be an R&D-performing SME from a Eurostars member country
  • SMERUD MEDICAL RESEARCH GROUP SMERUD MEDICAL RESEARCH GROUP Eurostars Funding
    • Eurostars projects are funded primarily through national funding schemes
    • The amount of funding and costs eligible for funding follows national rules and procedures
    • Funding varies between Eurostars member countries; this should be considered when deciding on consortium members
  • SMERUD MEDICAL RESEARCH GROUP SMERUD MEDICAL RESEARCH GROUP Eurostars Application Contents
    • Application Form
      • Project Description
      • Technological Development Envisaged
      • Market Description
      • Cooperation
    • Participants Annual Financial Report / Business Plan
    • Consortium Agreement (Draft)
  • SMERUD MEDICAL RESEARCH GROUP SMERUD MEDICAL RESEARCH GROUP Eurostars Application Process
    • 2 application deadlines per year: March and September
    • If an application is eligible for funding, it is submitted for technical expert review
        • 2 assessors commissioned by EUREKA Secretariat
        • Expert report issued
        • Report reviewed by Independent Evaluation Panel (IEP)
    • Funding decision within 3 months; if successful
        • Contracts are negotiated with national funding body
        • Applicant informed of the date by which the project must commence
  • SMERUD MEDICAL RESEARCH GROUP SMERUD MEDICAL RESEARCH GROUP Smerud’s Eurostars Experience
    • 6 Completed Eurostars Calls (7 th results pending).
    • For the first 3 Eurostars calls no clinical trials were funded; Smerud lobbied for clinical trials to be funded.
    • For calls 4, 5 and 6 Smerud won one Eurostars funding per call. 3 clinical trials have been funded by Eurostars so far (all Smerud submissions).
    • Our Eurostars experience, expertise and lessons learned are why we are the leaders in winning Eurostars funding for clinical trials
  • SMERUD MEDICAL RESEARCH GROUP SMERUD MEDICAL RESEARCH GROUP Eurostars Lessons Learned
    • Simpler than traditional EU grants but still:
      • >200 hours for application preparation
      • Agree crude outline early (2 months before cut-off)
      • Face to Face consortium partner meeting essential
      • Make it clear and simple: Evaluators decide within 2 minutes
    • Strategic choice of partner location
      • Country specific funds vary significantly across Europe
      • Not all local ‘rules’ are transparent
    • CRO’s can act as a partnering vehicle
      • Country-specific location, but avoid obvious constructs
      • Brings in significant drug development knowledge
      • Avoids shareholder dilution for biotech owners .
  • SMERUD MEDICAL RESEARCH GROUP SMERUD MEDICAL RESEARCH GROUP Ideal biotech/CRO R&D consortium Biotech CRO University Clinic Role and Tasks
    • IPR
    • Product Knowledge
    • IMP
    • Technical/Medical Writing
    • Project Management
    • Project Execution
    • Scientific planning and interpretation
    • Clinical expertise
    • Patient recruitment
    Output
    • Advanced product development
    • External financing without dilution
    • Partnering with client
    • Guaranteed later phase contracts
    • Publication
    • External funding for research groups
  • SMERUD MEDICAL RESEARCH GROUP SMERUD MEDICAL RESEARCH GROUP Smerud’s Eurostars Services
    • Smerud can offer the following services :
      • Write and submit a ‘fee for service’ Eurostars application for a client using our Eurostars experience and expertise; the service fee could be off-set against any further contract work for the project.
      • Smerud could become a ‘risk-sharing’ consortium member. The consortium agreement would include clauses relating to Smerud rights to conduct future clinical trials with the product under investigation or buy-out clause if the client wishes to use a different service provider for future development of the product
  • SMERUD MEDICAL RESEARCH GROUP Web www.smerud.com E-mail knut.smerud@smerud.com Phone +47 2327 2000 Mobile +47 9089 2577 Thank you for your attention ! Any questions ?
  • Back-up slides SMERUD MEDICAL RESEARCH GROUP
  • SMERUD MEDICAL RESEARCH GROUP SMERUD MEDICAL RESEARCH GROUP Nine Point Eligibility Check List
    • 1. Does the project proposed meet the criteria set by EUREKA?
    • 2. Is the main participant a research-performing SME (10% of full-time equivalent or 10% of turnover dedicated to R&D activities and established in a Eurostars member country)?
    • 3. Do the SME participants fulfill the European Union-adopted definition of an SME?
        • ≤ 250 employees, annual turnover ≤ EUR 50 million, annual balance sheet total ≤EUR 43 million
        • Development of new product, process or service in any technological sector
        • 4. Are all participants legal entities?
  • SMERUD MEDICAL RESEARCH GROUP SMERUD MEDICAL RESEARCH GROUP Nine Point Eligibility Check List (2)
    • 5. Is at least 50% of the total project costs related to R&D activities carried out by the R&D-performing SME participants? (This percentage can include minor sub-contracting)
          • 6. Is there at least one other participant from another Eurostars member country in the consortium?
    • 7. Is the project consortium well balanced? Is there no participant or country responsible for more than 75% of the project costs?
    • 8. Is the planned duration of the project no more than 36 months?
    • 9. Will clinical trials start within two years of project completion?