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Teaching Medical
   Technology Innovation
Lessons learned from a new masters program in
            translational medicine


                     Kyle Kurpinski, PhD
 Executive Director, Master of Translational Medicine Program
                     March 21, 2013
            NCIIA Open Minds 2013 conference
                                     Masters of Translational Medicine
                                                    UC Berkeley/UCSF
What “Bench to bedside”
        is “Translational Medicine?”




                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
From Bench to Bedside
         Problem                       Discovery                      Product
                                    (at the lab bench)             (at the bedside)
   cardiovascular disease               Atorvastatin                    Lipitor




                          Research              Translation
                   Synthesizing 20 structurally
                      novel HMGR inhibitors
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Early 1960s
      Plasma cholesterol
      lowered by
                                   As it looked back then
      inhibiting synthesis
      1962
      Triparanol causes
      cataracts in humans


      1982
      Compactin and
      lovastatin*
      development
      suspended due to
      pre-clinical toxicity
      1985
      Atorvastatin
      synthesized
      1992
      Call for a moratorium on
      cholesterol-lowering drugs
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program                 *temporarily
                                                                       UC Berkeley/UCSF
How is translational
                  medicine different?




                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
What do students need to
        know to succeed in this field?




                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Who are the players?

               Research                                  Translation




                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
How do I move a project forward?
                Research                                 Translation


               Do experiments


              Write       Publish
              grants      results




                    Retire



                                                   Image courtesy of The Space Cowboy
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Pre-
                Pre-clinical                     FDA
                                  /Clinical
                prototyping                     review
                                  Studies


    Needs                    Write grants and negotiate contracts                  Start
    finding                                                                      sleeping
      and                                                                        >5 hours
   concept       Establish        Refine                                          a night
                                               Respond          Commercial
    design        Quality         Quality                                          again
                                                to FDA         manufacturing
                  System          System

                Lock down                                       Distribution &
                 your IP         Process                         marketing
                                               Process
                                 develop-
                 Pre-IDE*                     validation       Reimbursement
                                  ment
                 meeting                                           coding

                                  Hire staff and consultants

                                   Years of your life
                                                                           *Investigational
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program           Device Exemption
                                                                       UC Berkeley/UCSF
RockHealth 2011 survey

                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
RockHealth 2011 survey

                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
What do I need to unlearn?
     Research
    fundamental
  problem; multiple
  potential end goals




                     +


                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Translation
 specific end goal; better, cheaper, and/or faster than
                     the competition



                        +
                                                                          $1,000



                        +
                                                                           $700
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
How do we train leaders in
                this field?
               (Besides letting them try and fail
                         repeatedly.)



                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Master of Translational Medicine
     (MTM) Overview


   MTM Mission: To provide
   engineers, clinicians, and life scientists with
   the engineering, business, and biomedical
   training necessary to take new medical
   innovations from initial idea to clinical use.



                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
MTM Program Overview
                                          Bioengineering and Therapeutic
           Bioengineering
                                                      Sciences
        College of Engineering
                                          Schools of Medicine and Pharmacy




       Haas School of Business          Clinical and Translational Science Institute
        School of Public Health                  Entrepreneurship Center
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
MTM Curriculum

 Bioengineering                                              Clinical/Regulatory
  (10 semester                                                (6 semester units)
      units)




    Capstone                                                Business/Leadership
                                                             (8 semester units)
     Project
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
MTM Sample Program
     Fall Semester (UCB)                    Spring Semester (UCB)
                                                                                    Categories
     Fall Quarter (UCSF)       Winter Quarter (UCSF)      Spring Quarter (UCSF)    Business /
   Engineering Leadership I                Engineering Leadership II               Leadership
    Ethics and Social Issues
        in Translational           Principles of Magnetic Resonance Imaging       Bioengineering
            Medicine
        “Translational         Translational Challenges                             Clinical /
   Challenges in Medicine:     in Diagnostics, Devices,
    Anti-Medical School”          and Therapeutics
                                                                                   Regulatory
      Designing Clinical       Health Care Finance and                              Capstone
          Research                   Economics
                                                                                     Project
      Physics of Medical
                                    Clinical Trials            Idea to IPO
           Imaging
                                                                                    Required
    CAPSTONE PROJECT*                         CAPSTONE PROJECT*
                                                                                     Elective
    *Project work continues into summer                 Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Capstone project




           Needs finding                      Lab projects
        • Clinical problem                • Research problem
        • Limited to early                • Early, middle, or
                                            late-stage
          stage
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Capstone project




       Connect students to projects mentored by engineers
                          and clinicians
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Project Example 1:
     “Gauss Surgical”




  Client: Dr. David Rempel     Problem: Monitoring          Solution: Modify existing
         UCB/UCSF            blood loss during surgery     technology to help quantify


    Notable achievements
         – Created and tested initial prototypes
         – Now operating as a startup company
         – Recently received two 510(k) clearances from FDA
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Project Example 2:
     “NanoNerve”




  Client: Dr. Shyam Patel    Problem: Dura mater       Solution: Create a synthetic patch
      NanoNerve, Inc.              repair               that enhances dural regeneration


    Notable achievements
         – Designed and tested prototypes in a canine duraplasty model
         – Assisted with submission of SBIR grant proposal
         – Multiple publications in progress
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
MTM Calendar

  Program          UCSF Fall         UCSF Winter      UCSF Spring       Program
   START           Quarter             Quarter         Quarter            END

    Aug    Sep Oct Nov Dec           Jan   Feb Mar Apr May Jun             Jul   Aug


                UCB Fall                    UCB Spring
               Semester                      Semester

                               CAPSTONE PROJECT
                                                               Full time
     Vetting                   15-20 hours/week
                                                             (40+ hr/wk)

                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Master of Translational Medicine vs.
    Master of Science
                   MS                                       MTM
                 ~2 years                            11 months (Aug-Jun)


                                               Focus on technology translation
       Focus is on basic research
                                                 and product development


      Curriculum is predominantly              Curriculum includes clinical and
         science / engineering                      business components


         Individual thesis project              Team-based capstone project

                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
Who are we aiming for?
         Early stage clinicians
            and engineers

    • New graduate engineers
    • Engineers with 1-4 years
      of industry experience
    • Late medical school
      students and medial
      professionals
    • Wild cards!
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
This is all easier said than done




                                                             Equipment /
     Donors                                                          Faculty
                                                              supplies
                                                                     Infrastructure
    Sponsors                                                            Staff
                                                                         Projects
  Student fees                                                     Student aid
                                                              Advertising
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
And yet… it’s working!
   San Francisco VA Medical Center
        Children’s Hospital Oakland
           Kaiser Permanente                         Various startup companies

   Student population is interdisciplinary and growing
   35
             Medical students / MDs
   30
             Non-CA resident (non-medical)
   25        CA resident (non-medical)
   20
   15
   10
    5
    0
          2010-11      2011-12        2012-13   2013-14   2014-15   2015-16   2016-17

                                                            Projected
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
MTM Graduates – 2012
   9 in industry
          Abbott Vascular  Cepheid              InSite Vision
          BD Biosciences  dQ&A Market Research  Pocket Gems
          C1 Consulting    Hansen Medical       Siemens Healthcare
   1 in government
          Singapore Economic Development Board, Biomedical
           Sciences
   2 in medical school
          UC San Diego & UCLA
   1 in a PhD program
          U Penn, Biomedical Imaging
   3 continuing Capstone project work
                                                        Masters of Translational Medicine
UC Berkeley / UCSF - Master of Translational Medicine Program          UC Berkeley/UCSF
The Master of Translational
       Medicine Program
 Training students how to
  transform cutting-edge
medical research into better
        patient care
       Visit us on the web
     bioeng.berkeley.edu/mtm

     MTM Executive Director
        Kyle Kurpinski, PhD
      kkurpins@berkeley.edu
          510-664-4472
                               Masters of Translational Medicine
                                              UC Berkeley/UCSF

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Open 2013: Teaching Medical Technology Innovation: Lessons learned from a new master's program in translational medicine

  • 1. Teaching Medical Technology Innovation Lessons learned from a new masters program in translational medicine Kyle Kurpinski, PhD Executive Director, Master of Translational Medicine Program March 21, 2013 NCIIA Open Minds 2013 conference Masters of Translational Medicine UC Berkeley/UCSF
  • 2. What “Bench to bedside” is “Translational Medicine?” Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 3. From Bench to Bedside Problem Discovery Product (at the lab bench) (at the bedside) cardiovascular disease Atorvastatin Lipitor Research Translation Synthesizing 20 structurally novel HMGR inhibitors Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 4. Early 1960s Plasma cholesterol lowered by As it looked back then inhibiting synthesis 1962 Triparanol causes cataracts in humans 1982 Compactin and lovastatin* development suspended due to pre-clinical toxicity 1985 Atorvastatin synthesized 1992 Call for a moratorium on cholesterol-lowering drugs Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program *temporarily UC Berkeley/UCSF
  • 5. How is translational medicine different? Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 6. Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 7. What do students need to know to succeed in this field? Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 8. Who are the players? Research Translation Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 9. How do I move a project forward? Research Translation Do experiments Write Publish grants results Retire Image courtesy of The Space Cowboy Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 10. Pre- Pre-clinical FDA /Clinical prototyping review Studies Needs Write grants and negotiate contracts Start finding sleeping and >5 hours concept Establish Refine a night Respond Commercial design Quality Quality again to FDA manufacturing System System Lock down Distribution & your IP Process marketing Process develop- Pre-IDE* validation Reimbursement ment meeting coding Hire staff and consultants Years of your life *Investigational Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program Device Exemption UC Berkeley/UCSF
  • 11. RockHealth 2011 survey Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 12. RockHealth 2011 survey Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 13. What do I need to unlearn? Research fundamental problem; multiple potential end goals + Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 14. Translation specific end goal; better, cheaper, and/or faster than the competition + $1,000 + $700 Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 15. How do we train leaders in this field? (Besides letting them try and fail repeatedly.) Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 16. Master of Translational Medicine (MTM) Overview MTM Mission: To provide engineers, clinicians, and life scientists with the engineering, business, and biomedical training necessary to take new medical innovations from initial idea to clinical use. Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 17. MTM Program Overview Bioengineering and Therapeutic Bioengineering Sciences College of Engineering Schools of Medicine and Pharmacy Haas School of Business Clinical and Translational Science Institute School of Public Health Entrepreneurship Center Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 18. MTM Curriculum Bioengineering Clinical/Regulatory (10 semester (6 semester units) units) Capstone Business/Leadership (8 semester units) Project Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 19. MTM Sample Program Fall Semester (UCB) Spring Semester (UCB) Categories Fall Quarter (UCSF) Winter Quarter (UCSF) Spring Quarter (UCSF) Business / Engineering Leadership I Engineering Leadership II Leadership Ethics and Social Issues in Translational Principles of Magnetic Resonance Imaging Bioengineering Medicine “Translational Translational Challenges Clinical / Challenges in Medicine: in Diagnostics, Devices, Anti-Medical School” and Therapeutics Regulatory Designing Clinical Health Care Finance and Capstone Research Economics Project Physics of Medical Clinical Trials Idea to IPO Imaging Required CAPSTONE PROJECT* CAPSTONE PROJECT* Elective *Project work continues into summer Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 20. Capstone project Needs finding Lab projects • Clinical problem • Research problem • Limited to early • Early, middle, or late-stage stage Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 21. Capstone project Connect students to projects mentored by engineers and clinicians Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 22. Project Example 1: “Gauss Surgical” Client: Dr. David Rempel Problem: Monitoring Solution: Modify existing UCB/UCSF blood loss during surgery technology to help quantify Notable achievements – Created and tested initial prototypes – Now operating as a startup company – Recently received two 510(k) clearances from FDA Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 23. Project Example 2: “NanoNerve” Client: Dr. Shyam Patel Problem: Dura mater Solution: Create a synthetic patch NanoNerve, Inc. repair that enhances dural regeneration Notable achievements – Designed and tested prototypes in a canine duraplasty model – Assisted with submission of SBIR grant proposal – Multiple publications in progress Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 24. MTM Calendar Program UCSF Fall UCSF Winter UCSF Spring Program START Quarter Quarter Quarter END Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug UCB Fall UCB Spring Semester Semester CAPSTONE PROJECT Full time Vetting 15-20 hours/week (40+ hr/wk) Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 25. Master of Translational Medicine vs. Master of Science MS MTM ~2 years 11 months (Aug-Jun) Focus on technology translation Focus is on basic research and product development Curriculum is predominantly Curriculum includes clinical and science / engineering business components Individual thesis project Team-based capstone project Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 26. Who are we aiming for? Early stage clinicians and engineers • New graduate engineers • Engineers with 1-4 years of industry experience • Late medical school students and medial professionals • Wild cards! Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 27. This is all easier said than done Equipment / Donors Faculty supplies Infrastructure Sponsors Staff Projects Student fees Student aid Advertising Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 28. And yet… it’s working! San Francisco VA Medical Center Children’s Hospital Oakland Kaiser Permanente Various startup companies Student population is interdisciplinary and growing 35 Medical students / MDs 30 Non-CA resident (non-medical) 25 CA resident (non-medical) 20 15 10 5 0 2010-11 2011-12 2012-13 2013-14 2014-15 2015-16 2016-17 Projected Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 29. MTM Graduates – 2012 9 in industry  Abbott Vascular  Cepheid  InSite Vision  BD Biosciences  dQ&A Market Research  Pocket Gems  C1 Consulting  Hansen Medical  Siemens Healthcare 1 in government  Singapore Economic Development Board, Biomedical Sciences 2 in medical school  UC San Diego & UCLA 1 in a PhD program  U Penn, Biomedical Imaging 3 continuing Capstone project work Masters of Translational Medicine UC Berkeley / UCSF - Master of Translational Medicine Program UC Berkeley/UCSF
  • 30. The Master of Translational Medicine Program Training students how to transform cutting-edge medical research into better patient care Visit us on the web bioeng.berkeley.edu/mtm MTM Executive Director Kyle Kurpinski, PhD kkurpins@berkeley.edu 510-664-4472 Masters of Translational Medicine UC Berkeley/UCSF

Notas do Editor

  1. HMGR inhibitors based on fungal metabolites