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Highlights from ExL Pharma's 12th Investigator Initiated Trials

  1. 1. Highlights from ExLPharma’s 12th Investigator Initiated Trials<br />September 27-28, 2010<br />Burlingame, CA<br />
  2. 2. A Governance Modelfor Review & Decisions of Investigator- initiated Research<br />
  3. 3. Investigator-initiated Studies<br />Unsolicited<br />Non-Clinical and Clinical<br />Investigator - Driven<br />Typically single center<br />Duration up to two years<br />Scientifically driven<br />Support<br /> drug and /or funding<br />
  4. 4. Building a Committee Charter<br />Scope and Purpose<br />Establish strategic review committee<br />Acquire appropriate membership<br />Define roles and responsibilities<br />Establish meeting logistics<br />Establish operating principles<br />Agree to decisions rights<br />Develop key metrics<br />Measure success<br />
  5. 5. Planning: Develop Strategy<br />Global Strategy Document<br />Provides a disease area with consolidated documentation of scientific areas of focus<br />Includes key regional considerations<br />Identifies areas of research interest for investigator initiated studies to enable: <br />An avenue for investigators worldwide to design and conduct their own research <br />Feasibility of new scientific ideas<br />Discovery of emerging trends and signals<br />Transparency and avoid duplication of studies<br />
  6. 6. Planning: Budget<br />Planning<br />Generate budget and average cost per study<br />Tie to areas of research strategy<br />Forecasting<br />Management of budget<br />
  7. 7. Planning: Operations<br />Identify key stakeholders<br />Internal and external<br />Acquire qualified staff to support programs<br />Establish standard SOPs / guidelines<br />Include timelines<br />Identify training needs<br />Develop standardized tools for investigators<br />Submission /Concept templates <br />
  8. 8. Planning: Operations<br />Technology<br /> Web portal, IT support<br />Document management<br />Establish Metrics to measure progress<br />Performance<br />Compliance<br />Cycle time<br />
  9. 9. Formal Meeting<br /><ul><li>Open session: Scientific and strategic discussion </li></ul>Ensure appropriate committee membership <br />All members have the role of providing meaningful input based on the area of expertise<br /><ul><li>Closed session: Voting / decision</li></ul>Marketing representative is excused from the meeting prior to making decisions<br />Summarization of discussions and final decisions<br />
  10. 10. Review and Decision Process<br /><ul><li>Assessment of research proposal is required to ensure transparency and uniformity
  11. 11. Review of research proposal
  12. 12. Complete and quality proposal
  13. 13. Scientific merit (scientific importance, methodological rigor)
  14. 14. Alignment with therapeutic area strategy
  15. 15. Uniqueness (should not compete or conflict with company research programs
  16. 16. Budget consistent with Fair Market Value</li></li></ul><li>Review and Decision Process<br /><ul><li>Investigator Assessment</li></ul>Capability and feasibility of success<br /><ul><li>Qualified to conduct research and assume responsibilities as sponsor of the study
  17. 17. Experienced
  18. 18. Sufficient resources to conduct the study
  19. 19. Past performance
  20. 20. Feasibility of study timelines
  21. 21. Ability to publish</li></li></ul><li>Communication to Investigators<br />Develop a Communication Plan<br />What do you what to communicate?<br />Request for more information<br />Clarify on request<br />Decision<br />Provide clarity/rationale if the decision is to decline the proposal<br />Who is communicating ?<br />Who is being notified?<br />When does the communication occur?<br />Establish timeline<br />Document decisions<br />
  22. 22. Setting Expectations<br />What you should expect from potential investigators<br />A well written proposal<br />Ability to conduct and complete study<br />Ability to meet study timelines<br />Submission of complete and timely quarterly progress updates<br />To seek expert statistical help in analyzing the data<br />Ability to submit well written abstract and manuscript<br />
  23. 23. Setting Expectations<br />What investigators should expect from you<br />Prompt response to a proposal<br />Thorough scientific review of the proposal<br />Timely decision on acceptance or rejection of proposal<br />Clear rationale regarding rejection<br />Upon study completion, timely and discretionary comments of abstract and manuscript<br />
  24. 24. Elements of Success<br />A well structured operating model that focuses on rigorous scientific review of investigator-initiated proposals will ensure:<br />Program Integrity<br />Transparency of Intent<br />Decisions are based on good science<br />
  25. 25. Elements of Success<br />Build trust and respect<br />Communication should be clear, complete and timely<br />Establish and agree to expectations <br />Effective documentation and tracking will ensure a compliant and efficient program <br />
  26. 26. Bringing MSL Value to Investigator Initiated Trials<br />
  27. 27. Roles and Responsibilities of the MSL<br />Feedback<br /> Presentations<br />Studies <br />Scientific information<br />
  28. 28. Characteristics of the MSL<br />Educational Preparation<br />Experience<br />Competencies<br />
  29. 29. Core Competencies of the MSL<br />Technical expertise<br />Communication<br />Relationship building<br />Team work<br />
  30. 30. Medical Science Liaisons Work Across Multiple Functions <br />Medical Information<br />Commercial Partners<br />Publications<br />MSL<br />Clinical Development<br />Legal<br />
  31. 31. Investigator Initiated Trials (IIT)<br />RESOURCING question:<br />“In relation to other trials in the program, how important is the IIT to the development of drugs?”<br />
  32. 32. In applying overall strategy to a specific product, the questions addressed by the IIT must fit in the LCM plan.<br />Product Specific Strategy<br />Long Term<br />10 year<br />Medium Term<br />3-5 year<br />Explore<br /><ul><li>Consolidate & pursue ongoing indications
  33. 33. Manage Follow on Compounds</li></ul>Maximize Global Value<br />Short Term<br />1 year<br />Extend and Entrench<br /><ul><li>Increase breadth in core business and ongoing indications
  34. 34. Pursue combinations as disease appropriate
  35. 35. Extend IP protection on new therapeutic options
  36. 36. Broad regulatory approval
  37. 37. Expansion </li></ul>Establish<br />Core business <br /><ul><li>Aggressive filing/ launch plans
  38. 38. Broadly explore
  39. 39. Regulatory approvals in key indications</li></li></ul><li>Overall Strategy:Post-Marketing/Medical Affairs Strategic Priorities<br />Treatment Optimization<br />Launch Preparation/Market Entrenchment<br />Positioning<br />Explore Patient Eligibility<br />Signal Seeking<br />
  40. 40. Prioritization of IITs:<br />Trial Priority<br />High<br />Medium<br />Low<br />Resourcing<br />MSL<br />Operations/Contracts<br />Timelines<br />
  41. 41. Methodology for the IIT Program <br />Goals/Objectives<br />IIT Resource Allocation<br />Team review and prioritization<br />
  42. 42. Evaluation of IIT Proposals<br />Three Criteria for Evaluation <br /> Strategy<br /> Design<br /> Site<br />
  43. 43. Strategic Development<br />
  44. 44. Measuring MSL Value <br />Balanced Score Card<br />Strategy Map<br />KPI/KPM <br />Key Performance Indicators<br />Key Performance Measures<br />Total Quality Management <br />
  45. 45. Balanced Score Card<br />R.Kaplan and D.Norton (1992)<br />
  46. 46. Strategy Map<br />R.Kaplan and D.Norton (1996)<br />
  47. 47. Key Performance Indicators/Measures<br />Strategy<br />Objectives<br />SMART format<br />KPIs<br />
  48. 48. KPI/KPM<br />Some examples are:<br />New investigators acquired <br />Analysis of individuals applying to become investigators<br />Status of existing investigators <br />Investigator attrition <br />Project activation, monitoring, and completion<br />
  49. 49. Total Quality Management (TQM)<br />Technology<br />Organization<br />People<br />
  50. 50. Conclusion<br />MSLs are a highly educated group of clinicians/researchers and an important part of the development of new drugs. <br />Evaluation of the value MSLs bring to the IIT program should focus on controllable areas and objectives. <br />
  51. 51. Still have any questions? For additional information on ExLPharma’s Investigator Initiated Trials Conferences, please visit<br />