Highlights from ExL Pharma's Site Selection, Activation & Communication


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Highlights from ExL Pharma's Site Selection, Activation & Communication

  1. 1. ExLPharma’s Site Selection, Activation & Communication <br />Washington, D.C.<br />February 1-2, 2010<br />
  2. 2. Site Selection Criteria: Why Making the Right Choice is More Important Today Than Ever Before<br />
  3. 3. Clinical Development Program Background<br />Program/Project and Protocol Timelines<br />Impact to Program/Project Cost and Timelines<br />Marketing Considerations – Opportunities<br />Criteria for Selection<br />Sponsor/CRO Considerations<br />Site/SMO Considerations<br />Academia Considerations<br />Site Selection Criteria Topics<br />
  4. 4. Clinical Development from IND to NDA<br />250 to 500 million USD to complete clinical<br />5 to 7 years timeline for clinical<br />Equates to: <br />35.25 to 71.5 million USD per year to run clinical<br />100K to 200K per day during clinical development<br />Development Key Points<br />
  5. 5. $$- TIME IS MONEY -$$<br />Every day the trial is operating is 100 to 200k USD operational cost.<br />Development Key Points<br />
  6. 6. Marketing Considerations and Opportunities<br />Blockbuster drug can generate 2-5 million USD per day in sales revenue<br />Windows for marketing a drug are dynamic<br />First to market wins market share<br />Claritin OTC versus Zyrtec OTC example<br />Market share decreases dramatically based on tier approval; First in Class, First to Market, 2nd to Market etc. <br />Development Key Points<br />
  7. 7. $$- TIME IS MONEY -$$<br />Delays in Time to Market<br />2 to 5 million per day<br />700 to 1,500 million per year<br />Decreases in market share from 75/80% to 25%<br />Development Key Points<br />
  8. 8. Corporate Fiscal Management<br />Budgets are developed for 3-5 year plans<br />Forecasts are performed yearly and quarterly<br />Development program budgets span across almost a decade<br />Shifting funding from one year or quarter may mean raiding funds for other clinical programs, acquisitions, mergers, bonuses, pay increases, etc.<br />Executive management take very seriously delays that impact corporate investor relations and solvency<br />Development Key Points<br />
  9. 9. Impact of Clinical Development Program Delays <br />Delays impact traditional development models, employees, stakeholders, investors, and the public.<br />Paradigm shifts: Many companies are outsourcing clinical programs to CROs and Clinical Service Providers.<br />Mergers/Acquisitions: Many companies are undergoing mergers to consolidate costs and create synergies.<br />Layoffs: Companies are more often cutting back on employee debt load to conserve finances for development and solvency.<br />Development Key Points<br />
  10. 10. $$- TIME IS MONEY -$$<br />Operational Costs<br />Marketing and Market Opportunity Costs<br />Corporation Cash Flow and Solvency<br />Mergers, Layoffs, and Paradigm Shifts <br />Development Key Points<br />
  11. 11. Clinical Development Program Timelines<br />Clinical endpoints set by FDA, EMEA, and other CAs.<br />Treatment duration defined by endpoints selected.<br />These factors are not dynamic and dictate length of program, project, and protocol duration.<br />Dynamic influencers are study start up, length of recruitment, data cleaning, data analysis, NDA package assembly, and NDA submission.<br />Study start-up and recruitment are low hanging fruit for timeline compression – also areas for dramatic delays.<br />Development Key Points<br />
  12. 12. Timeline Compression or Delay<br />Study Start-up is critical to program timelines.<br />Site Selection.<br />Site budget/contract negotiations.<br />Site approval and activation.<br />First patient in (FPI).<br />Patient recruitment period is critical to timelines.<br />Last patient in (LPI).<br />Last patient out (LPO).<br />Timelines<br />
  13. 13.
  14. 14. Site Selection is critical to timelines<br />Rapid contract and budget negotiations.<br />Rapid site IRB approvals.<br />Rapid site activation.<br />Hard hitting recruitment. <br />Rapid FPI<br />All equate to a shortened program timeline OR<br />Significant study delays = program delays<br />Timelines<br />
  15. 15. $$- TIME IS MONEY -$$<br />Shortening study start up by one day <br />= 100-200K operational costs.<br />= 2-5 million marketing or sales revenue.<br />Delays result in similar losses<br />Timelines = Costs<br />
  16. 16. Sites previously used by sponsor speed processes. <br />Sites that have standardized contracts/budgets.<br />Eliminates multi-pass review with Legal and Finance.<br />Accurate program per patient cost projections.<br />Sites that rapidly negotiate contracts/budgets.<br />Sites that can use central IRBs or have rapid locals.<br />Study Site Selection Criteria<br />
  17. 17. Sites with that know/experienced with disease indication.<br />Sites that are experienced in clinical research.<br />Sites that are known to be hard hitting recruiters.<br />Sites with internal study marketing personnel.<br />Sites that have large PT DBs.<br />Study Site Selection Criteria<br />
  18. 18. Negotiate MSAs with centers used often – especially acadaemia.<br />Use sites with Hx of rapid negotiations, activation, and FPI, and LPI.<br />Limit number of KOL/academic centers – slow to start and low numbers.<br />Using centers often has benefit of no or short PSV.<br />Sponsor/CRO Considerations<br />
  19. 19. Use sites that are hungry for trials, call often, respond rapidly, provide marketing material.<br />Maintain DB of sites with solid performance metrics, share across TAs, update often.<br />Contract CRAs know the good centers – listen to them.<br />Sponsor/CRO Considerations<br />
  20. 20. Maintain internal performance metrics and hold staff accountable.<br />Have accurate and concise study site marketing materials<br />Hx performance metrics, <br />Breakdown of disease specific Pt DB information, <br />List networks with local referring Docs/practices/centers.<br />Gain exemptions to use central IRBs if using a local.<br />Develop and maintain standardized budgets and contracts.<br />Site/SMO Considerations<br />
  21. 21. Develop and maintain standardized “pull-n-send”regulatory packets for rapid submission.<br />Keep pt DB up to date – build and maintain relationship with clinic and research patients, communicate often via newsletters, mailings, etc.<br />Train or hire marketing coordinator for study promotion.<br />Site/SMO Considerations<br />
  22. 22. Develop and maintain great relationships with Legal, Grants/Contracts, IT, IP, and local IRBs.<br />Work to educate and inform above that centers must have rapid turn around times for Sponsored trials.<br />Obtain local IRB exemptions if at all possible.<br />Academia Considerations<br />
  23. 23. Develop and maintain referral partners within center, town, region, state; communicate often.<br />Be responsive to Sponsor/CROs; return calls and emails immediately, regardless of status changes.<br />Develop execution/action oriented attitude within staff and academic center – must have “can-do” attitude to capture sponsored trials.<br />Put out “fires” immediately – if Sponsor appears frustrated, they are!!<br />Academia Considerations<br />
  24. 24. SITE PERSPECTIVE:An In-depth Look at What Drives Site Decisions and Strategies for Putting Sites in Position for Success<br />
  25. 25. Inaccurate Feasibility Questionnaires<br />Unrealistic enrollment expectations<br />Inaccurate enrollment time lines<br />Research Staff Lacking Training and Experience<br />Inexperienced PIs<br />Not Reading the Protocol in its Entirety <br />Lack of knowing study related procedures<br />Missed details of inclusion and exclusion criteria<br />25<br />Initial Practices that Hamper Site Success<br />
  26. 26. CTA Review<br />Budget Negotiation<br />IRB Submission/Approval<br />ID of Sub-Contracting<br />Required EDC Training<br />Scheduling Conflicts with <br /> Site Initiation Visit<br />26<br />Common Reasons for Delays in Site Activation<br />
  27. 27. 27<br />Factors Most Often Causing Study Delays<br />Source: CenterWatch Survey of Investigative Sites in the U.S.: 2009 (n=950)<br />
  28. 28. 28<br />Faltered Execution at Study Start<br />
  29. 29. Internal Preparation Practices:<br />Unique feasibility assessment<br />PI training/qualification<br />Access to facilities for specific procedures<br />Lasting first impressions for site selection visits<br />Budget development tool<br />Streamlined site activation<br />29<br />Steps to Effectively Prepare for Site Success<br />
  30. 30. 30<br />Achieve Fast Site Activation<br />Improve <br />Efficiency <br />Within <br />Timelines<br />
  31. 31. Time Is of The Essence<br />Budgets & Agreements:<br />Regulatory submissions:<br />Preparing IRB submissions<br />Know what’s required (signatures, ads, etc.)<br />Legal review of agreements/ICF<br />Simultaneous budget negotiation<br />31<br />
  32. 32. Compliance<br />Educate often and be current on new policies for State and National coverage in Clinical Trials<br />Systematic Tracking of Enrollment & Revenue<br />Use study management software to:<br />Track subject enrollment and study visits<br />Better revenue collections<br />Maintain secure subject data<br />Track study milestones and payables<br />32<br />In Addition…<br />
  33. 33. 33<br />Conclusion<br />The Key to Your Success is:<br /><ul><li>Create and utilize tools
  34. 34. Deliver What You Promise
  35. 35. Be prepared and knowledgeable
  36. 36. Leave a good first impression</li></li></ul><li>Still have any questions? For additional information on ExLPharma’s Site Selection, Activation & Communication Conferences, please visit www.exlpharma.com<br />