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

Safe harbor 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.

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.

Success checklist Know your investment opportunities and risks Take a portfolio approach, but manage each grant Seek and secure executive support Align with your research agenda and product strategy Be an open book Use enabling technology

Know your investment opportunities and risks

Take a portfolio approach, but manage each grant

Seek and secure executive support

Align with your research agenda and product strategy

Be an open book

Use enabling technology

Benchmarking Survey IISRA intro Conducted April 2008 with about 50 respondents Further analysis ongoing Only IISRA members polled Represented: Large/small pharmaceutical firms Device Biotech Other

IISRA intro

Conducted April 2008 with about 50 respondents

Further analysis ongoing

Only IISRA members polled

Represented:

Large/small pharmaceutical firms

Device

Biotech

Other

Who’s tasked with managing IIRs? 74% MLSs involved in their research grant program. Dedicate ~30% of their time to this area.

74% MLSs involved in their research grant program.

Dedicate ~30% of their time to this area.

Half of respondents provide support

What percentage of approved projects support IIR… … run by the government? 12.09% … run by private practice researchers not affiliated with any academic center? 16.42% … that are single-center studies? 74.97 % Do you support non-clinical studies? Yes = 76%

… run by the government?

12.09%

… run by private practice researchers not affiliated with any academic center?

16.42%

… that are single-center studies?

74.97 %

Do you support non-clinical studies?

Yes = 76%

Other realities Investigator-initiated research is a major source for INDs with ~1400 new INDs annually, YET… 40% of funded projects never get submitted for publication Almost 30% of your colleagues lack process for managing IIR programs Source: Cutting Edge Research: “Managing Investigator-Initiated Clinical Trials: Structure, Process, and Strategy, 2007; eCliniqua: “IITs – Plentiful but tricky to manage”, 2007

Investigator-initiated research is a major source for INDs with ~1400 new INDs annually, YET…

40% of funded projects never get submitted for publication

Almost 30% of your colleagues lack process for managing IIR programs

Challenges in the middle Growth & Infrastructure

A journey without a destination … Absolutely understand your objectives Know your risks, and manage them Pre/Post Funding – support them differently

Absolutely understand your objectives

Know your risks, and manage them

Pre/Post Funding – support them differently

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, Scoring, Communication Data Collection Data Management Monitoring Reports Payment Biostats Writing Publication

Get the right people on the bus Cultivate an executive champion Early communication with stakeholders Answer “what’s in it for me?” Connect to business & scientific objectives

Cultivate an executive champion

Early communication with stakeholders

Answer “what’s in it for me?”

Connect to business & scientific objectives

Alignment keeps the gears turning Keep your customers in mind Take a lifecycle approach to your IIR program Ask and ask often

Keep your customers in mind

Take a lifecycle approach to your IIR program

Ask and ask often

Transparency will set you free Leave no doubt Communicate with investigators Report, Report, Report Relieve their [sales] burden

Leave no doubt

Communicate with investigators

Report, Report, Report

Relieve their [sales] burden

Find the right tools Don’t re-invent the wheel Understand your process then automate it Become data-driven IISRA

Don’t re-invent the wheel

Understand your process then automate it

Become data-driven

IISRA

Success is never guaranteed Measure everything Communicate across the value chain Don’t be afraid to be a resource and share your expertise

Measure everything

Communicate across the value chain

Don’t be afraid to be a resource and share your expertise

Q & A To schedule a personal demo please visit www.clinipace.com and complete the “request more info” form Chad Ice – [email_address] Daniel Pardi - [email_address]

To schedule a personal demo please visit www.clinipace.com and complete the “request more info” form

Chad Ice – [email_address]

Daniel Pardi - [email_address]