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

councilscouncilschapterschapters centers of excellencecenters of excellence

Clinical Trials Group

History of Nuclear Medicine

Discovery 1896

Tracers andtherapeutics 1922–today

Instrumentation development 1947–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

Source: IMV

Pro

ced

ure

s in

mil

lio

ns

Total U.S. Nuclear Medicine Procedures

02468

101214161820

1977 1999 2001

Hospital versusNon-

Hospital

Source: IMV

0

2

4

6

8

10

12

14

16

1996 1997 1999 2001 2002 2005

Hospitals

Non-Hospitals

Pro

ced

ure

s in

mil

lio

ns

U.S. Nuclear Medicine Procedure Volume

PAST FUTURE

MolecularMolecular

PET, SPECT, PET, SPECT, MRS, optical, MRS, optical,

contrast-enhanced contrast-enhanced MRI/US/CTMRI/US/CT

FunctionalFunctional

Angiography, Angiography, Doppler US, NM, Doppler US, NM,

MRIMRI

AnatomicAnatomic

Plain films, CT, Plain films, CT, MRI, USMRI, US

The Evolution of Diagnostic Imaging

Positron Emission Tomography

A clinical molecular imaging modality that enables

visualization and quantification of biochemical processes in vivo.

Bio-Tech Systems Radiopharmaceutical Report 2004

0

1

2

3

4

2003 2004 2010

Pro

ced

ure

s in

mil

lio

ns

U.S. PET Procedure Volume

0

500

1000

1500

2000

2001 2002 2003 2005

Source: IMV

U.S. PET Imaging Sites

• PET/CT is improving diagnostic accuracy and optimizing patient care

• Data from concurrent studies are essential for timely diagnosis and management decisions

PET

PET/CT

Hybrid Technology

0

20

40

60

80

100

2001 2002 2003 2004 2005

PET/CT

PET

Source: IMV

Percent of Dedicated PET vs. PET/CT

Scanners in the U.S.

Current Challenges in Current Challenges in Nuclear MedicineNuclear Medicine

Clinical TrialsClinical Trials

ResearchResearchFundingFunding

EconomicsEconomics RRegulatoryegulatory

EducationEducation

• 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

Funding 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

Education 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

• Requirement for uniform imaging protocols in clinical trials–NIH and FDA initiatives

• Increased NRC regulatory burden for use of radioisotopes and accelerators

Regulatory Challenges (cont’d)

• Reimbursement – Avoiding cuts/restoring funding

– Adding new procedures

• “Pay for Performance” – How will nuclear imagers

become stakeholders?

– How will imagers be judged?

• Intellectual Property

Economic 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

Clinical Trial Challenges

• Aggressively working to restore federal funding

• Collaborating with other specialty societies to reduce fragmentation

• Pursuing patient advocacy and education

What SNM Is Doing Today

• 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

What SNM Is Doing Today (cont’d)

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.

PET/CT

SPECT/CT

MR Spectroscopy

Contrast-enhanced

US/Doppler

Existing and Emerging MI Modalities–Vision of Future Patient Care

Bio-active MR contrast agents

Bioluminescence

PET/MRI

Existing and Emerging MI Modalities–Vision of Future Patient Care

• 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

Molecular Imaging: What can it do?

• Improved diagnostic effectiveness

• Prediction of treatment response

• Improved patient outcomes

• Individualized treatment plans

• Identification of appropriate therapies

• Enhancement of resource utilization

Leading to…

• 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

Molecular Imaging: Drug Development

“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.

Challenges and issues:

– Funding for imaging-based research

– Drug discovery and development

– Translation

– Training

– Practice standards

– Reimbursement/Regulatory

SNM: Bringing Molecular Imaging from Bench to Bedside

• 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

Challenges and Issues

• 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

Who will provide the leadership and guidance for the field of molecular imaging and therapy going forward?

SNM

• Refocusing/rebranding SNM

• MI Center of Excellence

• Capital campaign

Positioning SNM as the leader for molecular imaging and therapy

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

SNM Rebranding—2006 and Beyond

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

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

Campaign Leadership and Staff

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

• 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

Industry Donor Categories

•Corporate Circle: $500,000 or more• GE Healthcare

• Siemens Medical Solutions USA

• IBA Molecular

Pledges

•Corporate Visionary: $250,000 - $499,999• Philips

•Corporate Contributor: <$50,000• Flouropharma

•Corporate Friend: $50,000 - $99,999•Molecular Insight

•Corporate Partner: $100,000 - $249,999

• Bristol-Myers Squibb Medical Imaging

• Covidien (formerly Tyco Healthcare/Mallinckrodt)

•MDS Nordion •Cardinal Health