Open 2013: Teaching Medical Technology Innovation: Lessons learned from a new master's program in...
Transcript of Open 2013: Teaching Medical Technology Innovation: Lessons learned from a new master's program in...
Masters of Translational MedicineUC Berkeley/UCSF
Teaching Medical Technology Innovation
Lessons learned from a new masters program in translational medicine
Kyle Kurpinski, PhDExecutive Director, Master of Translational Medicine
Program
March 21, 2013NCIIA Open Minds 2013 conference
Masters of Translational MedicineUC Berkeley/UCSF
“Bench to bedside”
UC Berkeley / UCSF - Master of Translational Medicine Program
What is “Translational Medicine?”
Masters of Translational MedicineUC Berkeley/UCSF
From Bench to BedsideProblem
cardiovascular disease
Discovery(at the lab bench)
Atorvastatin
Product(at the bedside)
Lipitor
Research
Synthesizing 20 structurally novel HMGR inhibitors
Translation
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
As it looked back then
*temporarily
Early 1960sPlasma cholesterol lowered by inhibiting synthesis
1962Triparanol causes cataracts in humans
1982Compactin and lovastatin* development suspended due to pre-clinical toxicity1985Atorvastatin synthesized
1992Call for a moratorium on cholesterol-lowering drugs
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
How is translational medicine different?
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSFUC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
What do students need to know to succeed in this field?
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
Who are the players?
Research Translation
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
How do I move a project forward?
Research Translation
Do experiments
Publish results
Write grants
Retire
Image courtesy of The Space Cowboy
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
Pre-clinical prototyping
Pre-/Clinical Studies
FDA review
Reimbursement coding
Write grants and negotiate contracts
Establish Quality System
Lock down your IP
Hire staff and consultants
Process develop-
ment
Distribution & marketing
Refine Quality System
Process validation
Respond to FDA
Commercial manufacturing
Start sleeping >5 hours a night again
Needs finding
andconcept design
Years of your life
Pre-IDE* meeting
*Investigational Device ExemptionUC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
RockHealth 2011 survey
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
RockHealth 2011 survey
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
What do I need to unlearn?
+
Researchfundamental
problem; multiple potential end
goals
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
Translationspecific end goal; better, cheaper, and/or faster than the competition
+
+
$1,000
$700
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
How do we train leaders in this field?
(Besides letting them try and fail repeatedly.)
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC 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.
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
MTM Program Overview
Haas School of Business
School of Public Health
BioengineeringCollege of Engineering
Bioengineering and Therapeutic SciencesSchools of Medicine and
Pharmacy
Clinical and Translational Science Institute
Entrepreneurship Center
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
Bioengineering (10
semester units)
Business/Leadership (8 semester units)
Clinical/Regulatory (6 semester units)
Capstone
Project
MTM Curriculum
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
MTM Sample ProgramFall Semester (UCB) Spring Semester (UCB)
Fall Quarter (UCSF) Winter Quarter (UCSF) Spring Quarter (UCSF)
Bioengineering
Clinical / Regulatory
Business / Leadership
Capstone Project
Categories
RequiredElective
*Project work continues into summer
Engineering Leadership I Engineering Leadership II
Principles of Magnetic Resonance ImagingEthics and Social Issues
in Translational Medicine
Translational Challenges in Diagnostics, Devices,
and Therapeutics
“Translational Challenges in Medicine:
Anti-Medical School”
Designing Clinical Research
Health Care Finance and Economics
Idea to IPOClinical TrialsPhysics of Medical
Imaging
CAPSTONE PROJECT* CAPSTONE PROJECT*
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
Capstone project
• Clinical problem• Limited to early
stage
• Research problem• Early, middle, or
late-stage
Needs finding Lab projects
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
Capstone project
Connect students to projects mentored by engineers and clinicians
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
Notable achievements– Created and tested initial prototypes– Now operating as a startup company– Recently received two 510(k) clearances from FDA
Client: Dr. David Rempel
UCB/UCSF
Problem: Monitoring blood loss during
surgery
Solution: Modify existing technology to help
quantify
Project Example 1: “Gauss Surgical”
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
Client: Dr. Shyam Patel
NanoNerve, Inc.
Notable achievements– Designed and tested prototypes in a canine duraplasty
model– Assisted with submission of SBIR grant proposal– Multiple publications in progress
Problem: Dura mater repair
Solution: Create a synthetic patch that enhances dural
regeneration
Project Example 2: “NanoNerve”
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
MTM Calendar
CAPSTONE PROJECT
15-20 hours/week Full time (40+ hr/wk)
Vetting
UCB Fall Semester
UCB SpringSemester
UCSF Fall Quarter
UCSF WinterQuarter
UCSF SpringQuarter
Program START
Program END
Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSF
Team-based capstone projectIndividual thesis project
Curriculum includes clinical and business components
Curriculum is predominantly science / engineering
Focus is on basic researchFocus on technology translation
and product development
~2 years
MS MTM
Master of Translational Medicine vs. Master of Science
UC Berkeley / UCSF - Master of Translational Medicine Program
11 months (Aug-Jun)
Masters of Translational MedicineUC Berkeley/UCSF
• New graduate engineers• Engineers with 1-4 years
of industry experience• Late medical school
students and medial professionals
• Wild cards!
Early stage clinicians and engineers
Who are we aiming for?
UC Berkeley / UCSF - Master of Translational Medicine Program
Masters of Translational MedicineUC Berkeley/UCSFUC Berkeley / UCSF - Master of Translational Medicine Program
This is all easier said than done
Donors
Sponsors
Student fees Student aid
Staff
Faculty
Projects
Advertising
Infrastructure
Equipment / supplies
Masters of Translational MedicineUC Berkeley/UCSF
And yet… it’s working!
UC Berkeley / UCSF - Master of Translational Medicine Program
2010-11 2011-12 2012-13 2013-14 2014-15 2015-16 2016-170
5
10
15
20
25
30
35Medical students / MDsNon-CA resident (non-medical)CA resident (non-medical)
Projected
San Francisco VA Medical Center
Children’s Hospital Oakland
Kaiser Permanente Various startup companies
Student population is interdisciplinary and growing
Masters of Translational MedicineUC Berkeley/UCSF
MTM Graduates – 2012
UC Berkeley / UCSF - Master of Translational Medicine Program
9 in industry Abbott Vascular BD Biosciences C1 Consulting
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
Cepheid dQ&A Market Research Hansen Medical
InSite Vision Pocket Gems Siemens
Healthcare
Masters of Translational MedicineUC Berkeley/UCSF
The Master of Translational Medicine Program
Training students how to transform cutting-edge
medical research into better patient care
MTM Executive DirectorKyle Kurpinski, PhD
Visit us on the webbioeng.berkeley.edu/mtm