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

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


“Bench to bedside”

UC Berkeley / UCSF - Master of Translational Medicine Program

What is “Translational Medicine?”


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



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



How is translational medicine different?


Masters of Translational MedicineUC Berkeley/UCSFUC Berkeley / UCSF - Master of Translational Medicine Program


What do students need to know to succeed in this field?



Who are the players?

Research Translation



How do I move a project forward?

Research Translation

Do experiments

Publish results

Write grants

Retire

Image courtesy of The Space Cowboy



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


RockHealth 2011 survey



RockHealth 2011 survey



What do I need to unlearn?

+

Researchfundamental

problem; multiple potential end

goals



Translationspecific end goal; better, cheaper, and/or faster than the competition

+

+

$1,000

$700



How do we train leaders in this field?

(Besides letting them try and fail repeatedly.)



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.



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



Bioengineering (10

semester units)

Business/Leadership (8 semester units)

Clinical/Regulatory (6 semester units)

Capstone

Project

MTM Curriculum



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*



Capstone project

• Clinical problem• Limited to early

stage

• Research problem• Early, middle, or

late-stage

Needs finding Lab projects



Capstone project

Connect students to projects mentored by engineers and clinicians



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”



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”



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



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


11 months (Aug-Jun)


• 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?


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


And yet… it’s working!


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


MTM Graduates – 2012


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


The Master of Translational Medicine Program

Training students how to transform cutting-edge

medical research into better patient care

MTM Executive DirectorKyle Kurpinski, PhD

[email protected]

Visit us on the webbioeng.berkeley.edu/mtm

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

Documents

mtm sample program

clinical use

project work

capstone project needs

new medical innovations

lab bench

ip process marketing

life scientists