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Driving Accelerated Human Clinical Data

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Human clinical data is the critical proof for new medical treatments. The current pharma, venture capital and NIH funding environments make it more important than ever for capital efficient clinical trial design and funding. Here are some best practices in mapping new treatments to clinical applications to accelerate clinical trial data.

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Driving Accelerated Human Clinical Data

  1. 1. Driving AcceleratedClinical Data<br />ZEN CHU<br />Wyss Institute<br />HarvardMedical School<br />Office of Technology Development <br />CIMIT Innovation Grand Rounds<br />Mass General Hospital<br />May 4, 2010<br />© zen@acmedx.com<br />
  2. 2. Best Practices for Med TechAccelerated De-Risking<br />Challenges Today<br />Innovation Landscape & Risks<br />Teams & Conflict of Interest<br />Clinical Innovation Rules & Tradeoffs<br />Panel Discussion<br />Good Business IS Good Medicine<br />© zen@acmedx.com<br />
  3. 3. Challenges In Driving Clinical Data<br />Clinical effectiveness is not enough<br />Pharma & venture funding tight<br />Publications & research polluted with noise<br />High sensitivity to Conflict of Interest<br />FDA reviews more conservative, higher hurdles<br />Payers & Clinicians demand Evidence-Based Data<br />Health reform & Comparative Effectiveness impact today<br />More important than ever to match<br />Focused solution to clinical champions<br />© zen@acmedx.com<br />
  4. 4. Disciplined IntentonRole & Therapy<br />© zen@acmedx.com<br />
  5. 5. Clinical Innovation LandscapeMatch Resources to Opportunity Size <br />Big Opportunities<br />Complex Solutions, <br />Fragmented Services<br />Philanthropy/NIH<br />Basic Research Grants<br />Unknown Mechanisms <br />Large Established<br />Companies <br />Integrate Whole Solutions<br />Humanitarian Exemption,<br />Venture Philantropy<br />Low Capital Required High<br />Venture-Backed<br />Companies<br />Focused Teams to <br />Prioritize & Execute<br />Discrete Product<br />Product-Line Extensions<br />License or Product Acq<br />Royalties<br />$100MM<br />$1B<br /> Market Size of Opportunity<br />© zen@acmedx.com<br />
  6. 6. Segment To FocusPatients, Disease State, Providers<br />Philanthropy/NIH<br />Basic Research Grants<br />Unknown Mechanisms <br />Big Opportunities<br />Complex Solutions, <br />Fragmented Services<br />Unfocused & <br />Requires <br />Segmentation<br />Gates Foundation<br />Ischemic<br />Stroke<br />Cystic Fibrosis<br />Off-Label Uses<br />Low Capital Required High<br />RNAi for AMD<br /> Stem Cells<br />Aortic<br />Abdominal<br />Aneurysm<br />Ortho<br />Lumbar<br />Disc<br />Gastric Bypass<br />$100MM<br />$500MM<br /> Market Size of Opportunity<br />© zen@acmedx.com<br />
  7. 7. Value To Whom?<br />© zen@acmedx.com<br />
  8. 8. Current Healthcare Model Drives Interventions<br />Michael Porter, Tiesberg<br />© zen@acmedx.com<br />
  9. 9. Disease SegmentationMap Unmet Clinical Needs To Development Path<br />Disease Natural History & Diagnostics<br />Comorbidities & Adjacencies<br />Physician Referral Patterns<br />Untreatable Patient Subsegments<br />Humanitarian Exemption<br />Focus Segments on<br />High Impact & High Value<br />© zen@acmedx.com<br />
  10. 10. Market Analysis CriticalEnables Path To Clinical Efficacy<br /> Proven Clinical Adoption Drivers<br />1) Patient pain & outcomes<br />2) Therapeutic procedure time<br />3) System costs over entire disease cycle<br />Comparative Effectiveness <br />Will Impact Prioritization<br />© zen@acmedx.com<br />
  11. 11. Return On Investment Drivers<br />Choose Clinical Endpoints with <br /> Fastest & Highest ROI<br />Hospital stay<br />Re-admission & revision<br />Complications & errors<br />Recurrence<br />Early detection (prevention coming?)<br />Key Players<br />Patients, Payors, Physicians, Hospitals<br />© zen@acmedx.com<br />
  12. 12. Analysis Is ParamountEfficacy is NecessaryBut Insufficient ForTranslating to Widespread Practice<br />© zen@acmedx.com<br />
  13. 13. Time & Risks<br />© zen@acmedx.com<br />
  14. 14. Value Inflection PointsTime to Market & FDA Approvalbut alsoTime to First Human Data&Time to Clinical Adoption<br />© zen@acmedx.com<br />
  15. 15. Acquisition/IPO Exit<br /> Reimbursement<br /> Published clinical results<br /> Market Introduction<br /> Salesforce hired<br /> Europe & Japan distribution<br /> FDA Approval <br /> Manufacturing ramp<br /> Human pivotal study<br /> Corporate partnership<br /> First human data<br />First Hiccup & Danger of Momentum Loss<br /> CEO hired<br /> Pilot manufacturing <br /> Patent grant<br /> First FDA meeting<br /> Regulatory opinions<br /> Money raised & team hired<br /> Animal testing<br /> Clinician feedback <br /> Patent disclosure<br /> Prototype/Reduction to Practice<br /> Market Analysis <br />Idea<br />COMPRESS <br />TIME TO MARKET<br />FASTER CURES & ROI<br />Value<br />Time<br />Critical Milestones<br />© zen@acmedx.com<br />Accelerate Clinical ImpactTime is Life<br />
  16. 16. Which Risks to Prioritize?<br />Market Risk<br />Reimbursement<br />Physician & Patient Adoption<br />Packaged Solutions<br />Value<br />Regulatory Risk<br />Safety & Efficacy<br />Management Risk<br />Technology IP Risk<br />Time<br />© zen@acmedx.com<br />
  17. 17. Investor Risk Priorities<br />Market Risk<br />Reimbursement<br />Physician & Patient Adoption<br />Packaged Solutions<br />Largest Risks Must Be Addressed & De-Risked Up Front Before Funding<br />Value<br />Regulatory Risk<br />Safety & Efficacy<br />Investors & Companies Willing to Take These Risks<br />Management Risk<br />Technology IP Risk<br />Time<br />© zen@acmedx.com<br />
  18. 18. Build Team To Execute<br />Market Risk<br />Reimbursement<br />Physician & Patient Adoption<br />Packaged Solutions<br />1) Plan in Reverse<br />2) Team Execution<br />Value<br />Regulatory Risk<br />Safety & Efficacy<br />Management Risk<br />Technology Risk<br />Time<br />© zen@acmedx.com<br />
  19. 19. Teams Drive Data<br />Clinical & Business teams<br />Focus & segment the opportunities<br />Build teams to match opportunity type<br />Complement inventors with team<br />BUILD TEAMS THAT UNDERSTAND <br />THE RISK / EXECUTION TRADEOFFS<br />© zen@acmedx.com<br />
  20. 20. Building Clinical Team WhileNavigating Conflict of Interests<br />Transparency in relationships & publication<br />Equity holders cannot drive clinical data<br />Avoid equity & minimize cash consulting<br />Find & Engage Clinical Champions<br />Match patients to risk/benefit<br />Negotiate IP rights up front<br />CAPITAL EFFICIENT & CREDIBLE DATA<br />© zen@acmedx.com<br />
  21. 21. 7 Rules of Innovation<br />Minimize Time To Demonstration<br />Build Smallest Possible Team<br />Develop Only Bare Minimum<br />Iterate Frequently Before Mfg Controls<br />Never Develop What Can Be Bought<br />Insist on Highest Quality Workmanship<br />Prove One Idea/Variable At A Time<br />EMPHASIS ON SPEED & PROOF<br />© zen@acmedx.com<br />
  22. 22. Clinical Data TradeoffsImpact & Speed versus Cost<br />BALANCE COSTS & RISKS<br />© zen@acmedx.com<br />
  23. 23. Time is Life<br />© zen@acmedx.com<br />
  24. 24. Incremental vs BreakthroughPlenty of Incremental Value, Different Strategy<br />© zen@acmedx.com<br />
  25. 25. Clinical InnovationCritical Success Factors<br />Rigorous Analysis<br />Focused Plan To Early Proof<br />Credible & Creative Team <br />Adapt With New Data<br />Evidence-Based Business<br />Desire to help patients<br />© zen@acmedx.com<br />
  26. 26. Innovation Grand Rounds Panel Discussion:Driving Clinical Proof<br />ZEN CHU<br /> Wyss Institute<br />Harvard Medical School<br />Office of Technology Development<br />HELEN COLQUHOUN, MD<br />Founder & CEO, Pleiad Devices<br />DAVID REED, MD, MBA<br /> Serial Medical Entrepreneur<br />AARON SANDOSKI<br />Managing Director, Norwich Ventures<br />
  27. 27. GOOD BUSINESS ISGOOD MEDICINE<br />Thank You!www.LinkedIn.com/in/zenven<br />© zen@acmedx.com<br />