The New Playbook for Healthcare Innovation CIMIT Innovation Grand Rounds Massachusetts General Hospital ZEN CHU Accelerated Medical Ventures ELAZER EDELMAN, MD, PhD MIT / HST / Harvard Medical School / Highland Capital MICHAEL GREELEY Flybridge Capital Partners MARSHA MOSES, PhD Children's Hospital Boston, Harvard Medical School JOE SMITH, MD, PhD VP, Emerging Technologies, Johnson & Johnson COSAT
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The New Playbook for Healthcare Innovation
CIMIT Innovation Grand RoundsMassachusetts General Hospital
ZEN CHU Accelerated Medical Ventures ELAZER EDELMAN, MD, PhD
MIT / HST / Harvard Medical School / Highland CapitalMICHAEL GREELEY
Flybridge Capital PartnersMARSHA MOSES, PhD
Children's Hospital Boston, Harvard Medical School JOE SMITH, MD, PhD
VP, Emerging Technologies, Johnson & Johnson COSAT
Invention is Spark… butDevelopment Drives New Therapy
Prioritize efforts in the landscape– Approach clinical innovation empirically– Map entire value chain & risks– Match opportunity to funding & team required– Innovation at every level
Tough times require execution discipline– Experimental rigor, same best practices– Adaptation as new data learned
– Current therapies, Physician-adoption hurdles– Untreatable problems & populations, sub-segments– Prevalence vs. incidence & other objective metrics of clinical need– Independent clinical champions
• Stage of Development– Reduced to practice– Prototypes, animal data– Human data– Manufacturing feasibility and economics
• Commercial Potential– Defined product, market size, unambiguous diagnosis– Time to market, regulatory pathway, reimbursement– Interim milestones and risks
• Protection & Competition– Patent & prior art search– Public disclosure, scope of protection, FTO– Natural product line extensions, product/procedure cannibalization
– Consultant opinion, but little FDA feedback – Clinical endpoints and patient recruitment either too slow or not clear– Lack of predictive & robust animal models
• Clinical feedback not complete– Clinical need, economics, practice implications, design prototypes– Solution not matched to expedited proof and approval paths
• Clinical Advisors not matched with staged milestones– Too late to give meaningful feedback on chosen roadmap– Feedback doesn’t impact design modifications – Respected names promoted, but feedback mismatched to stage– Advisors used in early development dropped later for clinical phases
– Actively engage FDA feedback early– Clinical endpoints, clear & quick, for
downstream claims and sales support– Human clinical data ASAP if needed
• File & Source Intellectual Property– Sophisticated mapping & filing of IP
• Choose technology & engineers later– Only after clinical needs, approach,
predicates specified
• Prototypes for quick feedback & testing• Design for manufacturing & scale issues
Right Team, Properly Aligned, Working Quickly
• Rational Portfolio Approach– Products vs. Company analysis– Spin out companies with plan, early data, clinical
plans, rapid funding, ramp team
• Driven by entrepreneurs & VCs– Closely participating VC, early alignment– Large funds avoid EIR costs from mgmnt fees– Deep pockets to fund, build team quickly, but
only when & where appropriate
• Multidimensional MDVC Clinician Advisors– 10+ MDs specific to Project/Company/Domain – Recruit multiple clinical design perspectives – Meaningful early-stage feedback
• Virtual Organizations For Each Project– Anti-Incubator - Not a real estate play!– Co-locate with VCs for ideaflow, alignment– Outsource labs, testing, prototyping, regulatory– No obligation/mis-incentive to create companies
• Center for the Integration of Medicine & Innovative Technology (CIMIT)
• Robert Langer
• Chiefs of Hospital Departments
• Harvard Medical School
• Harvard-MIT Health Science & Technology Faculty & Advisors
• Harvard Business School Faculty
• Partners Healthcare Ventures
• Tech Licensing Offices
• MIT$100K leadership
• MIT Deshpande Center
VCs & CORP DEVELOPMENT• Leading East & West coast med tech VCs• Richard Ferrari, DeNovo Ventures• Richard Foster, McKinsey & Co Healthcare• Med Tech Incubators/Acclerators• Corporate Venturing groups• Entrepreneurs on both coasts• Windhover Publications Editor• MA Governor’s Life Science Initiative
OTHER INSTITUTIONS• Gates Foundation• Milken Foundation & FasterCures• Stanford Biodesign• Stanford Medical School• Biomedical IDEA Competitions• Yale University Medical School Faculty