Transcript to view the file - European Alliance for Medical and Biological

La Raison d’etre pour AIMBE
Raphael C. Lee, MD, ScD, DSc(Hon), FACS
President, AIMBE
Leadership and Advocacy for Medical and Biological Engineering
What is AIMBE?
Provides leadership and advocacy in medical and
biological engineering for the benefit of society.
• Founded in 1991
• 282 Founding Fellows (1992-1993)
• Current membership includes:
• College of Fellows
• Academic Council
• Council of Societies
• Industry Council
• AIMBE Represents – 50,000 Biomedical Engineers
Leadership and Advocacy for Medical and Biological Engineering
What does AIMBE Do?
A vehicle for input of biomedical engineering
expertise into public policy making process:
AIMBE:
• Promotes awareness of medical and biological
engineering as a resource to solve common problems
• Works with lawmakers, government agencies, and
other professional groups to support public policy
impacting research and development
• Promotes the national interest in education, science,
and engineering
Leadership and Advocacy for Medical and Biological Engineering
MBE and the Quality of Life of Americans
Leadership and Advocacy for Medical and Biological Engineering
AIMBE: Fostering Innovation
Collaboration among Industrial, Academic, and
Entrepreneurial members of AIMBE’s Industry Council and
Government guides science and technology translation from
the medical and biological engineering community.
FDA
NIH
Legislative Branch
Executive Branch
CDC
NSF
Leadership and Advocacy for Medical and Biological Engineering
Academia
Timeline
HR 1795 introduced
Passes House
AIMBE Resolution
Passes Senate
NIH Revitalization Bill
1991
Signed into Law
NIH Report: Support for
Bioengineering Research
AIMBE Founded
1992
1993
1994
1995
1996
1997
1998
1999
Legislative Failures
AIMBE & ARRS form
Coalition
2000
Dr. Shu Chien letter in
Science
NDAs Approved by FDA, Drug Patents Granted by USPTO and NIH budget, 1983-2004
250
NIH Budget vs FDA approvals
NDAs Approved
Patents Granted
60
NIH Budget ($x Billions)
50
200
40
150
30
100
20
50
10
0
0
1983-84
1985-86
1987-88
1989-90
1991-92
1993-94
Years
1995-96
1997-98
1999-2000
2001-02
2003-04
Productivity of the Pharmaceutical Industry
NMEs and Biologics Approved
60
R&D Expenditures
Approvals
50
40
40
30
30
20
20
10
10
1995
2000
Sources: FDA/CDER, PhRMA, PricewaterhouseCoopers
Note: R&D spending from non-PhRMA companies not available
Leadership and Advocacy for Medical and Biological Engineering
2005
R&D Spending (US$ Billions)
50
Five Public Policy Issues Affecting
Biomedical Engineering
• Spiraling R&D costs coupled with decreased
productivity
• Demand for safety and post-marketing
surveillance
• Expectation of personalized medicine
• Reimbursement driven by medical and
economic outcomes
• Proliferation and redistribution of healthcare
outcomes information
Leadership and Advocacy for Medical and Biological Engineering
Asia Pacific Rim
Success In Technology Industrialization
• People with strong sense of national purpose
•
•
•
•
Strong investments in education and training
Strategy to move rapidly up value chain
Effective requirements for training and tech transfer
Critical mass in R&D is beginning to be deployed to generate
autonomous sources of innovation & growth
• Government goal is to acquire technological
capabilities both to grow and to maintain national
autonomy.
• Focused, Committed, and Willing to Spend
Modified from C. Dahlman, Georgetown University
Leadership and Advocacy for Medical and Biological Engineering
Why is advocacy important?
Leadership and Advocacy for Medical and Biological Engineering
BME
Why must
INFORMED
scientists be
involved in
legislation ?
Congress
Leadership and Advocacy for Medical and Biological Engineering
Federal Agencies with AIMBE Links
Leadership and Advocacy for Medical and Biological Engineering
MBE’s Impact on the U.S. Economy
• 10.3% growth in net sales in
2008 compared to 5.9%
growth in sales for the rest
of the economy
• 2008: health care and
social assistance industries
increased GDP by 4.6%
• Total GDP attributed to
health care expenditures:
$2.3 trillion (2008)
• MBE-specific exports lead
imports, which increases
national income
Leadership and Advocacy for Medical and Biological Engineering
Grand Challenges for Mankind
from Nobel Laureate Richard Smalley: 1943-2005
Bioengineering related
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
ENERGY
WATER
FOOD
ENVIRONMENT
POVERTY
TERRORISM & WAR
DISEASE
EDUCATION
DEMOCRACY
POPULATION
Leadership and Advocacy for Medical and Biological Engineering
2004
2050
6.5
~ 10
Billion People
Billion People
AIMBE
American Institute for Medical and Biological
Engineering
1701 K St., NW, Suite 510
Washington, DC 20006
Phone: 202-496-9660
Leadership and Advocacy for Medical and Biological Engineering
The Valley Of Death
Existing
Research
Resources
Idea
Valley of
Death
Existing
Commercialization
Resources
Research
Fuzzy Front End
Leadership and Advocacy for Medical and Biological Engineering
From: The PDMA ToolBook 1 for New Product Development
Product Development
Commercialization
Re-engineering Pharmaceutical R&D
“It is not the strongest of the
species that survives, nor the
most intelligent, but the one
most responsive to change.”
Charles Darwin
(1809-1882)
Illustration from The World Is Flat, Thomas L.
Friedman, Farrar, Straus & Giroux, publisher
Leadership and Advocacy for Medical and Biological Engineering
The Cycle of Innovation and
Translational Research
Leadership and Advocacy for Medical and Biological Engineering