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Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
Driving Accelerated Human Clinical Data
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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 …

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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  • Timely, current economic crisisImpacts R&D, venture funding, reimbursementFew slides to set stage for panel discussion
  • Timely, current economic crisisImpacts R&D, venture funding, reimbursementFew slides to set stage for panel discussion
  • Framework to Match opportunity to fundingIntend to play where your innovation fits
  • Often allure to view huge opportunitySubsegment to prioritize first clinical footholdFirst clinical studyDrive early approval and adoptionLast IGR, provided techniques for segmenting and prioritizing
  • Timely, current economic crisisImpacts R&D, venture funding, reimbursementFew slides to set stage for panel discussion
  • Timely, current economic crisisImpacts R&D, venture funding, reimbursementFew slides to set stage for panel discussion
  • Timely, current economic crisisImpacts R&D, venture funding, reimbursementFew slides to set stage for panel discussion
  • Typical milestones all the way to patient bedsideTrue translationRequires dedicated team
  • Captures why medical innovation more complexBiggest risks are furthest down path
  • Captures why medical innovation more complexBiggest risks are furthest down path
  • Maximum impact means de-risking just like investors doTeam tuned for the milestonesInnovation at every level of risk
  • Timely, current economic crisisImpacts R&D, venture funding, reimbursementFew slides to set stage for panel discussion
  • Timely, current economic crisisImpacts R&D, venture funding, reimbursementFew slides to set stage for panel discussion
  • Timely, current economic crisisImpacts R&D, venture funding, reimbursementFew slides to set stage for panel discussion
  • Timely, current economic crisisImpacts R&D, venture funding, reimbursementFew slides to set stage for panel discussion
  • MUST ANTICIPATE THESE AND ADDRESS THEMOFTEN PHYSICIAN INNOVATORS MISS THE ECONOMIC FOUNDATIONS FOR WHERE THEIR INVENTION PLAYS
  • Incremental doesn’t mean low value, but often does- Cardiac surgery and interventional cardiology, plenty of examples of wonderfully valuable products improving on prior ideasOne can apply these same metrics to PRODUCT TYPES: IMPLANTABLES, DISPOSABLES, CAPITAL EQUIPMENT
  • Intend where you choose to innovateTakes same empirical approachCrisis requires discipline & creativity
  • Intend where you choose to innovateTakes same empirical approachCrisis requires discipline & creativity
  • Transcript

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

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