Open 2013: The Challenges of Simplifying and Packaging Creative Engineering ...
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