1. ExLPharmas Site Selection, Activation & Communication
Washington, D.C.
February 1-2, 2010

2. Site Selection Criteria: Why Making the Right Choice is More Important Today Than Ever Before

3. Clinical Development Program Background
Program/Project and Protocol Timelines
Impact to Program/Project Cost and Timelines
Marketing Considerations Opportunities
Criteria for Selection
Sponsor/CRO Considerations
Site/SMO Considerations
Academia Considerations
Site Selection Criteria Topics

4. Clinical Development from IND to NDA
250 to 500 million USD to complete clinical
5 to 7 years timeline for clinical
Equates to:
35.25 to 71.5 million USD per year to run clinical
100K to 200K per day during clinical development
Development Key Points

5. $$- TIME IS MONEY -$$
Every day the trial is operating is 100 to 200k USD operational cost.
Development Key Points

6. Marketing Considerations and Opportunities
Blockbuster drug can generate 2-5 million USD per day in sales revenue
Windows for marketing a drug are dynamic
First to market wins market share
Claritin OTC versus Zyrtec OTC example
Market share decreases dramatically based on tier approval; First in Class, First to Market, 2nd to Market etc.
Development Key Points

7. $$- TIME IS MONEY -$$
Delays in Time to Market
2 to 5 million per day
700 to 1,500 million per year
Decreases in market share from 75/80% to 25%
Development Key Points

8. Corporate Fiscal Management
Budgets are developed for 3-5 year plans
Forecasts are performed yearly and quarterly
Development program budgets span across almost a decade
Shifting funding from one year or quarter may mean raiding funds for other clinical programs, acquisitions, mergers, bonuses, pay increases, etc.
Executive management take very seriously delays that impact corporate investor relations and solvency
Development Key Points

9. Impact of Clinical Development Program Delays
Delays impact traditional development models, employees, stakeholders, investors, and the public.
Paradigm shifts: Many companies are outsourcing clinical programs to CROs and Clinical Service Providers.
Mergers/Acquisitions: Many companies are undergoing mergers to consolidate costs and create synergies.
Layoffs: Companies are more often cutting back on employee debt load to conserve finances for development and solvency.
Development Key Points

10. $$- TIME IS MONEY -$$
Operational Costs
Marketing and Market Opportunity Costs
Corporation Cash Flow and Solvency
Mergers, Layoffs, and Paradigm Shifts
Development Key Points

11. Clinical Development Program Timelines
Clinical endpoints set by FDA, EMEA, and other CAs.
Treatment duration defined by endpoints selected.
These factors are not dynamic and dictate length of program, project, and protocol duration.
Dynamic influencers are study start up, length of recruitment, data cleaning, data analysis, NDA package assembly, and NDA submission.
Study start-up and recruitment are low hanging fruit for timeline compression also areas for dramatic delays.
Development Key Points

12. Timeline Compression or Delay
Study Start-up is critical to program timelines.
Site Selection.
Site budget/contract negotiations.
Site approval and activation.
First patient in (FPI).
Patient recruitment period is critical to timelines.
Last patient in (LPI).
Last patient out (LPO).
Timelines

13.

14. Site Selection is critical to timelines
Rapid contract and budget negotiations.
Rapid site IRB approvals.
Rapid site activation.
Hard hitting recruitment.
Rapid FPI
All equate to a shortened program timeline OR
Significant study delays = program delays
Timelines

15. $$- TIME IS MONEY -$$
Shortening study start up by one day
= 100-200K operational costs.
= 2-5 million marketing or sales revenue.
Delays result in similar losses
Timelines = Costs

16. Sites previously used by sponsor speed processes.
Sites that have standardized contracts/budgets.
Eliminates multi-pass review with Legal and Finance.
Accurate program per patient cost projections.
Sites that rapidly negotiate contracts/budgets.
Sites that can use central IRBs or have rapid locals.
Study Site Selection Criteria

17. Sites with that know/experienced with disease indication.
Sites that are experienced in clinical research.
Sites that are known to be hard hitting recruiters.
Sites with internal study marketing personnel.
Sites that have large PT DBs.
Study Site Selection Criteria

18. Negotiate MSAs with centers used often especially acadaemia.
Use sites with Hx of rapid negotiations, activation, and FPI, and LPI.
Limit number of KOL/academic centers slow to start and low numbers.
Using centers often has benefit of no or short PSV.
Sponsor/CRO Considerations

19. Use sites that are hungry for trials, call often, respond rapidly, provide marketing material.
Maintain DB of sites with solid performance metrics, share across TAs, update often.
Contract CRAs know the good centers listen to them.
Sponsor/CRO Considerations

20. Maintain internal performance metrics and hold staff accountable.
Have accurate and concise study site marketing materials
Hx performance metrics,
Breakdown of disease specific Pt DB information,
List networks with local referring Docs/practices/centers.
Gain exemptions to use central IRBs if using a local.
Develop and maintain standardized budgets and contracts.
Site/SMO Considerations

21. Develop and maintain standardized pull-n-sendregulatory packets for rapid submission.
Keep pt DB up to date build and maintain relationship with clinic and research patients, communicate often via newsletters, mailings, etc.
Train or hire marketing coordinator for study promotion.
Site/SMO Considerations

22. Develop and maintain great relationships with Legal, Grants/Contracts, IT, IP, and local IRBs.
Work to educate and inform above that centers must have rapid turn around times for Sponsored trials.
Obtain local IRB exemptions if at all possible.
Academia Considerations

23. Develop and maintain referral partners within center, town, region, state; communicate often.
Be responsive to Sponsor/CROs; return calls and emails immediately, regardless of status changes.
Develop execution/action oriented attitude within staff and academic center must have can-do attitude to capture sponsored trials.
Put out fires immediately if Sponsor appears frustrated, they are!!
Academia Considerations

24. SITE PERSPECTIVE:An In-depth Look at What Drives Site Decisions and Strategies for Putting Sites in Position for Success

25. Inaccurate Feasibility Questionnaires
Unrealistic enrollment expectations
Inaccurate enrollment time lines
Research Staff Lacking Training and Experience
Inexperienced PIs
Not Reading the Protocol in its Entirety
Lack of knowing study related procedures
Missed details of inclusion and exclusion criteria
25
Initial Practices that Hamper Site Success

26. CTA Review
Budget Negotiation
IRB Submission/Approval
ID of Sub-Contracting
Required EDC Training
Scheduling Conflicts with
Site Initiation Visit
26
Common Reasons for Delays in Site Activation

27. 27
Factors Most Often Causing Study Delays
Source: CenterWatch Survey of Investigative Sites in the U.S.: 2009 (n=950)

28. 28
Faltered Execution at Study Start

29. Internal Preparation Practices:
Unique feasibility assessment
PI training/qualification
Access to facilities for specific procedures
Lasting first impressions for site selection visits
Budget development tool
Streamlined site activation
29
Steps to Effectively Prepare for Site Success

30. 30
Achieve Fast Site Activation
Improve
Efficiency
Within
Timelines

31. Time Is of The Essence
Budgets & Agreements:
Regulatory submissions:
Preparing IRB submissions
Know whats required (signatures, ads, etc.)
Legal review of agreements/ICF
Simultaneous budget negotiation
31

32. Compliance
Educate often and be current on new policies for State and National coverage in Clinical Trials
Systematic Tracking of Enrollment & Revenue
Use study management software to:
Track subject enrollment and study visits
Better revenue collections
Maintain secure subject data
Track study milestones and payables
32
In Addition

33. 33
Conclusion
The Key to Your Success is:

• Create and utilize tools
• 34. Deliver What You Promise
• 35. Be prepared and knowledgeable
• 36. Leave a good first impression