Get a grip on your grants Best practices in managing your investigator-initiated research program Chad Ice, Senior Directo...
Safe harbor <ul><li>The material presented within this webcast are the personal opinions of the presenters and do not nece...
Success checklist <ul><li>Know your investment opportunities and risks </li></ul><ul><li>Take a portfolio approach, but ma...
Benchmarking Survey  <ul><li>IISRA intro </li></ul><ul><li>Conducted April 2008 with about 50 respondents </li></ul><ul><l...
Who’s tasked with managing IIRs? <ul><li>74%  MLSs involved in their research grant program. </li></ul><ul><ul><li>Dedicat...
Half of respondents provide support
What percentage of approved projects support IIR… <ul><li>… run by the government? </li></ul><ul><ul><li>12.09% </li></ul>...
Other realities  <ul><li>Investigator-initiated research is a major source for INDs with ~1400 new INDs annually, YET… </l...
Challenges in the middle Growth & Infrastructure
A journey without a destination … <ul><li>Absolutely understand your objectives </li></ul><ul><li>Know your risks, and man...
Maximize your returns and minimize your risks
Manage both sides
Technology is always an enabler Integrated Grants Management and Research Platform Investment Criteria, Review Process, Sc...
Get the right people on the bus <ul><li>Cultivate an executive champion </li></ul><ul><li>Early communication with stakeho...
Alignment keeps the gears turning <ul><li>Keep your customers in mind </li></ul><ul><li>Take a lifecycle approach to your ...
Transparency will set you free <ul><li>Leave no doubt </li></ul><ul><li>Communicate with investigators </li></ul><ul><li>R...
Find the right tools <ul><li>Don’t re-invent the wheel </li></ul><ul><li>Understand your process then automate it </li></u...
Success is never guaranteed <ul><li>Measure everything </li></ul><ul><li>Communicate across the value chain </li></ul><ul>...
Q & A <ul><li>To schedule a personal demo please visit  www.clinipace.com  and complete the “request more info” form </li>...
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Get a Grip on Your Grants: Six best practices in managing your investigator-initiated research program

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In this FREE 45 minute webcast held on June 26th, 2008, we discuss the opportunities and challenges of starting and managing an investigator-initiated research program.

In addition, we shared best practices on how to ensure executive-level buy-in, alignment with research initiatives and product strategy, grant promotion and evaluation, tackling transparency in an age of increasing regulatory oversight, and selecting and implementing the right tracking and management system to ensure success.

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Get a Grip on Your Grants: Six best practices in managing your investigator-initiated research program

  1. 1. Get a grip on your grants Best practices in managing your investigator-initiated research program Chad Ice, Senior Director, Clinical Development at Inspire Pharmaceuticals Daniel Pardi, Senior Manager, Medical Affairs at Jazz Pharmaceuticals Chris Porter, COO at Clinipace
  2. 2. Safe harbor <ul><li>The material presented within this webcast are the personal opinions of the presenters and do not necessarily represent the views or policies of Jazz or Inspire Pharmaceuticals. </li></ul>
  3. 3. Success checklist <ul><li>Know your investment opportunities and risks </li></ul><ul><li>Take a portfolio approach, but manage each grant </li></ul><ul><li>Seek and secure executive support </li></ul><ul><li>Align with your research agenda and product strategy </li></ul><ul><li>Be an open book </li></ul><ul><li>Use enabling technology </li></ul>
  4. 4. Benchmarking Survey <ul><li>IISRA intro </li></ul><ul><li>Conducted April 2008 with about 50 respondents </li></ul><ul><li>Further analysis ongoing </li></ul><ul><li>Only IISRA members polled </li></ul><ul><li>Represented: </li></ul><ul><ul><li>Large/small pharmaceutical firms </li></ul></ul><ul><ul><li>Device </li></ul></ul><ul><ul><li>Biotech </li></ul></ul><ul><ul><li>Other </li></ul></ul>
  5. 5. Who’s tasked with managing IIRs? <ul><li>74% MLSs involved in their research grant program. </li></ul><ul><ul><li>Dedicate ~30% of their time to this area. </li></ul></ul>
  6. 6. Half of respondents provide support
  7. 7. What percentage of approved projects support IIR… <ul><li>… run by the government? </li></ul><ul><ul><li>12.09% </li></ul></ul><ul><li>… run by private practice researchers not affiliated with any academic center? </li></ul><ul><ul><li>16.42% </li></ul></ul><ul><li>… that are single-center studies? </li></ul><ul><ul><li>74.97 % </li></ul></ul><ul><li>Do you support non-clinical studies? </li></ul><ul><ul><li>Yes = 76% </li></ul></ul>
  8. 8. Other realities <ul><li>Investigator-initiated research is a major source for INDs with ~1400 new INDs annually, YET… </li></ul><ul><ul><li>40% of funded projects never get submitted for publication </li></ul></ul><ul><ul><li>Almost 30% of your colleagues lack process for managing IIR programs </li></ul></ul>Source: Cutting Edge Research: “Managing Investigator-Initiated Clinical Trials: Structure, Process, and Strategy, 2007; eCliniqua: “IITs – Plentiful but tricky to manage”, 2007
  9. 9. Challenges in the middle Growth & Infrastructure
  10. 10. A journey without a destination … <ul><li>Absolutely understand your objectives </li></ul><ul><li>Know your risks, and manage them </li></ul><ul><li>Pre/Post Funding – support them differently </li></ul>
  11. 11. Maximize your returns and minimize your risks
  12. 12. Manage both sides
  13. 13. Technology is always an enabler Integrated Grants Management and Research Platform Investment Criteria, Review Process, Scoring, Communication Data Collection Data Management Monitoring Reports Payment Biostats Writing Publication
  14. 14. Get the right people on the bus <ul><li>Cultivate an executive champion </li></ul><ul><li>Early communication with stakeholders </li></ul><ul><li>Answer “what’s in it for me?” </li></ul><ul><li>Connect to business & scientific objectives </li></ul>
  15. 15. Alignment keeps the gears turning <ul><li>Keep your customers in mind </li></ul><ul><li>Take a lifecycle approach to your IIR program </li></ul><ul><li>Ask and ask often </li></ul>
  16. 16. Transparency will set you free <ul><li>Leave no doubt </li></ul><ul><li>Communicate with investigators </li></ul><ul><li>Report, Report, Report </li></ul><ul><li>Relieve their [sales] burden </li></ul>
  17. 17. Find the right tools <ul><li>Don’t re-invent the wheel </li></ul><ul><li>Understand your process then automate it </li></ul><ul><li>Become data-driven </li></ul><ul><li>IISRA </li></ul>
  18. 18. Success is never guaranteed <ul><li>Measure everything </li></ul><ul><li>Communicate across the value chain </li></ul><ul><li>Don’t be afraid to be a resource and share your expertise </li></ul>
  19. 19. Q & A <ul><li>To schedule a personal demo please visit www.clinipace.com and complete the “request more info” form </li></ul><ul><li>Chad Ice – [email_address] </li></ul><ul><li>Daniel Pardi - [email_address] </li></ul>

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