Overview
• About SNM
• Nuclear medicine today
• Today’s challenges and opportunities
• Changing landscape of imaging and therapy
• Future issues and vision
• Bench to Bedside: A Capital Campaign
SNM
• Founded in 1954
• The largest international scientific
organization dedicated to molecular
imaging and therapy
• A multi-disciplinary organization
– over 16,000 physicians, scientists, pharmacists, and technologists
– industry and other partners interested in the diagnostic, therapeutic,
and investigational uses of molecular imaging and therapy agents,
instrumentation and techniques
chapters
councils
Clinical Trials
Group
centers of excellence
History of Nuclear Medicine
Discovery
1896
Instrumentation
development
1947–today
Tracers and
therapeutics
1922–today
Clinical
application
1972–today
Progression of Nuclear Medicine
2D small region scan–thyroid
2D whole-body scan–bone
3D dynamic scan–heart
3D whole-body fusion scan
Nuclear Medicine Procedures
• 19.7 million nuclear medicine procedures in the
United States (2005)
• 7,205 hospital and non-hospital sites
• Hospital volume unchanged, 2002 – 2005
• Non-hospital volume increased by 22 percent,
2002 – 2005
Source: IMV
Procedures in millions
Total U.S. Nuclear Medicine
Procedures
20
18
16
14
12
10
8
6
4
2
0
1977
1999
Source: IMV
2001
U.S. Nuclear Medicine
Procedure Volume
16
Hospital
versus
NonHospital
Procedures in millions
14
12
10
Hospitals
8
Non-Hospitals
6
4
2
0
1996
1997
1999
2001
2002
2005
Source: IMV
The Evolution of Diagnostic Imaging
PAST
FUTURE
Anatomic
Functional
Molecular
Plain films, CT,
MRI, US
Angiography,
Doppler US, NM,
MRI
PET, SPECT,
MRS, optical,
contrast-enhanced
MRI/US/CT
Positron Emission Tomography
A clinical molecular imaging
modality that enables
visualization and quantification of
biochemical processes in vivo.
U.S. PET Procedure Volume
Procedures in millions
4
3
2
1
0
2003
2004
2010
Bio-Tech Systems Radiopharmaceutical Report 2004
U.S. PET Imaging Sites
2000
1500
1000
500
0
2001 2002 2003
Source: IMV
2005
Hybrid Technology
• PET/CT is improving
PET
diagnostic accuracy and
optimizing patient care
• Data from concurrent studies
are essential for timely
diagnosis and management
decisions
PET/CT
Percent of Dedicated PET vs.
PET/CT
100
Scanners
in the
U.S.
80
60
PET/CT
PET
40
20
0
2001
2002
2003
2004
2005
Source: IMV
Research
Funding
Economics
Regulatory
Current Challenges in
Nuclear Medicine
Education
Clinical Trials
Funding Challenges
• Elimination or stagnation of Federal funding
– Diminished resources for radiotracer and instrumentation research
– Limited funding for development of imaging biomarkers and new
drugs
– Limited availability of isotopes for research
• Competition among too many
professional societies for
corporate support
Education Challenges
• Ensuring practitioners keep abreast of emerging
technologies and cutting-edge research
• Communicating new Maintenance of Certification
requirements
• Reaching out to and educating
other specialists and patients
• Ensuring academic curricula
incorporate new technologies
• Ensuring adequate supply of
new practitioners and researchers
Regulatory Challenges
• Cost of bringing new and orphan drugs to
market, particularly new imaging probes
• Increasing recognition of the importance of
imaging biomarkers in drug development
• Evolving FDA guidelines for
radiopharmaceuticals, biologics
and other agents
Regulatory Challenges (cont’d)
• Requirement for
uniform imaging
protocols in clinical
trials–NIH and
FDA initiatives
• Increased NRC regulatory burden for use of
radioisotopes and accelerators
Economic Challenges
• Reimbursement
– Avoiding cuts/restoring funding
– Adding new procedures
• “Pay for Performance”
– How will nuclear imagers
become stakeholders?
– How will imagers be judged?
• Intellectual Property
Clinical Trial Challenges
• Need to prove clinical utility of imaging and
therapy agents
– Framework
– Funding of clinical trials
– More clinical trials for new agents
– More use of nuclear medicine in
existing trials
• Develop data to support regulatory change to
facilitate imaging biomarker proof-of-principle
studies
What SNM Is Doing Today
• Aggressively working to restore federal
funding
• Collaborating with other specialty societies
to reduce fragmentation
• Pursuing patient
advocacy and education
What SNM Is Doing Today (cont’d)
• Introducing new physician education
programs
– Life-long self-assessment programs,
including CT and PET/CT cases
– Programs to help physicians meet
MOC requirements
– Curriculum for nuclear medicine training,
including CT and molecular imaging
(3-year residency)
What SNM Is Doing Today (cont’d)
• Increasing referring physician outreach
• Creating a central repository of information for:
– Medical community
– Patients and the public
• Publishing cutting edge
research articles and
abstracts in journals and
at meetings
What SNM Is Doing Today (cont’d)
• Promoting novel research through pilot grants
• Attracting talented students through fellowships
• Managing a clinical trials program
• Enhancing patient care and quality of services through:
–
Practice guidelines
–
Laboratory accreditation guideline
• Collaborating with other societies on
Pay for Performance and practice
standards
Molecular Imaging: What is it?
Molecular imaging is the visualization,
characterization, and measurement of
biological processes at the molecular and
cellular levels in humans and other living
systems.
– Molecular imaging typically includes two- or three-
dimensional imaging as well as quantification over time.
– The techniques used include radiotracer imaging/nuclear
medicine, MRI, MRS, optical imaging, ultrasound and
others.
Molecular Imaging Agents
Molecular imaging agents are probes used to
visualize, characterize, and measure biological
processes in living systems.
-Both endogenous molecules
and exogenous probes can
be molecular imaging agents.
Existing and Emerging MI Modalities–
Vision of Future Patient Care
MR Spectroscopy
PET/CT
SPECT/CT
Contrastenhanced
US/Doppler
Existing and Emerging MI Modalities–
Vision of Future Patient Care
Bioluminescence
PET/MRI
Bio-active MR
contrast agents
Molecular Imaging: What can it do?
• Assess the biological nature of disease early and
throughout its evolution
• Facilitate drug discovery and development
• Provide biological information for developing and
assessing innovative therapies
• Predict, monitor, and measure
treatment response
• Support clinical trials as
imaging biomarkers
Molecular Imaging: What can it do?
• Study in vivo molecular biology and guide individualized
patient care
• Facilitate the understanding of
the molecular basis of disease
• Enhance drug development
through the use of molecular
imaging in clinical trials
Leading to…
• Improved diagnostic
effectiveness
• Prediction of treatment
response
• Improved patient outcomes
• Individualized treatment plans
• Identification of appropriate therapies
• Enhancement of resource utilization
Molecular Imaging: Drug Development
• In vivo biological characterization
• Pharmacokinetics measurements
• Imaging biomarkers in clinical trials
• Determination of treatment effect
• Improve drug development
successes
• Discovery of novel diagnostic
imaging agents
“Targeted Imaging”
Drive Towards Personalized Medicine
• Streamlining drug discovery: finding the right
drug against the right target to treat the right
disease in the right patient.
• For targeted imaging: finding the right molecular
probe for the right target to monitor the right
disease in the right patient.
SNM: Bringing Molecular Imaging
from Bench to Bedside
Challenges and issues:
– Funding for imaging-based
research
– Drug discovery and
development
– Translation
– Training
– Practice standards
– Reimbursement/Regulatory
Challenges and Issues
• Increase success rate for new pharmaceutical
targets
• Define and promote molecular imaging in drug
development
• Introduce novel diagnostic
molecular imaging agents
• Facilitate the use of molecular
therapies such as
Radioimmunotherapy
Challenges and Issues
• Few new tracers
• No methodologies to validate
and standardize quantitation
• No standardized protocols for
cooperative clinical trials
• Lack of integration with other
imaging methodologies
• Absence of health technology assessment
Challenges and Issues
• Need for regulatory change to reduce
requirements for proof of principle studies
• Need to define correlative outcomes required for
imaging biomarkers
• Decreased funding for research
on molecular probe development
and instrumentation improvements
Challenges and Issues
• Ensuring imaging practitioner of the future is well
prepared to adopt new technologies
• Meeting multidisciplinary educational needs
• Raising awareness of applications and benefits
of molecular imaging
• Molecular imaging is not a medical specialty
Who will provide the leadership and guidance for the
field of molecular imaging and therapy going forward?
SNM
•
Basic scientists conducting multi-modality research
•
Clinicians and technologists practicing molecular imaging and therapy;
conducting supporting clinic
•
Health policy infrastructure addressing regulatory, funding, and
outreach activities
•
Educational offerings and knowledge base that cross the
interdisciplinary boundaries
Positioning SNM as the leader for
molecular imaging and therapy
• Refocusing/rebranding SNM
• MI Center of Excellence
• Capital campaign
SNM Rebranding—2006 and Beyond
Core Purpose: To improve health care by
advancing molecular imaging and therapy
Vision: SNM will be the leader in advancing
and unifying molecular imaging and therapy
MI Center of Excellence Leadership
• Martin Pomper, MD, PhD - President
• Henry Van Brocklin, PhD – Vice-President
• Carolyn Anderson, PhD – Secretary/Treasurer
Staff
•
•
Marybeth Howlett, MEM – Director, MI Center of Excellence
Zachary Hochstetler – MI Center of Excellence Coordinator
Bench to Bedside:
A Molecular Imaging Campaign
• Translate Molecular Imaging to Clinical Practice
• Fundraising Goal: $5 million
• Components:
– Advocacy
– Education of referring physicians and patients
– Training
– Supporting translational research
Vision of the Campaign
• Recognizes expanding role of molecular imaging in patient
care
• Builds on SNM’s unique role in medical community
• Highlights importance of molecular imaging in drug discovery
and development
• Ensures imaging practitioners and technologists are well
prepared to adopt and use this technology
• Ensures medical community is well informed and partnerships
are formed outside imaging field
Goals of the
Molecular Imaging Campaign
• Provide indispensable resources for education,
knowledge exchange, training and networking
• Advocate for molecular imaging and therapy
• Educate and promote collaboration with referring
physicians and patient groups
• Support innovations in translational research
• Position molecular medicine as an essential tool in
providing the highest standards of patient care around
the world
Provide indispensable resources for education,
knowledge exchange, training and networking
• Be a central repository for molecular imaging
• Create and award grants and fellowships
• Develop training curriculum for residents, fellows and
technologist students
• Conduct workshops to attract and meet diversified
needs of molecular imaging practitioners
• Implement continuing educational programs and
web-based training
Advocate for molecular imaging and therapy
• Proactively lobby for reimbursement and
research funding
• Strengthen relationships with federal agencies
and Congress
• Educate community on benefits of molecular
imaging and emerging technologies
Educate and promote collaboration with
referring physicians and patient groups
Create outreach programs for:
– referring physicians
– patient groups
– federal agencies
– regulators
– general public
Support innovations in translational research
• Develop standardized imaging protocols and outcome
measures
• Define the role of biomarkers in clinical trials
• Investigate the implications of molecular imaging in
diagnosis and the prediction and monitoring of treatment
response
• Develop a technology assessment mechanism
• Provide new grant funding opportunities
• Assure the viability of MI through the development of
techniques that meet a clinical need and that are
reimbursable
Position SNM as the professional society
promoting the highest standards of molecular
imaging and therapy around the world
• Develop major media marketing plan to influence the
introduction and acceptance of molecular imaging and
therapy technology and benefits
• Develop an integrated strategic marketing plan to
position SNM as the recognized leader
• Increase membership by molecular imaging
professionals outside of nuclear medicine
How to Support the Campaign
• Corporate donations and pledges
• Individual gifts and pledges
• Collaboration in task forces, summits
• Feedback and ideas
• Involvement through MI Center of Excellence,
Web site, list-serve
Campaign Leadership and Staff
Co-chairs of the campaign:
Peter S. Conti, M.D., Ph.D.; SNM Past President
Michael D. Devous, Sr., Ph.D.; ERF Past President
Hadi Moufarrej; GE Healthcare
SNM Campaign staff:
Virginia Pappas; Chief Executive Officer
Theresa Pinkham; Director, Development
Renee Bergen; Program Manager, Development
Marybeth Howlett; Director, MI Center of Excellence
Financial Support
• Corporate pledges over five years or less –
Campaign Staff Theresa Pinkham
• Individual gifts and pledges –
Campaign Staff Theresa Pinkham
• Donor recognition began in 2006
Industry Donor Categories
• Corporate Circle:
$500,000 or more
• Corporate Visionary:
$250,000 - $499,999
• Corporate Partner:
$100,000 - $249,999
• Corporate Friend:
$50,000 - $99,999
• Corporate Contributor:
<$50,000
Pledges
•Corporate Circle: $500,000 or more
• GE Healthcare
• Bristol-Myers Squibb Medical Imaging
• Siemens Medical Solutions USA
• Covidien (formerly Tyco Healthcare/Mallinckrodt)
• IBA Molecular
•Corporate Visionary: $250,000 - $499,999
• Philips
•MDS Nordion
•Cardinal Health
•Corporate Partner: $100,000 - $249,999
•Corporate Friend: $50,000 - $99,999
•Molecular Insight
•Corporate Contributor: <$50,000
• Flouropharma