2. 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

3. 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

4. councilschapters centers of excellence Clinical Trials Group

5. History of Nuclear Medicine Discovery 1896 Tracers and therapeutics 1922–today Instrumentation development 1947–today Clinical application 1972–today

6. Progression of Nuclear Medicine 2D small region scan–thyroid 2D whole-body scan–bone 3D dynamic scan–heart 3D whole-body fusion scan

7. 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

8. Procedures in millions Total U.S. Nuclear Medicine Procedures

9. Hospital versus Non- Hospital Source: IMV Procedures in millions U.S. Nuclear Medicine Procedure Volume

10. PAST FUTURE Molecular PET, SPECT, MRS, optical, contrast-enhancedMRI/US/CTFunctionalAngiography, Doppler US, NM, MRIAnatomic Plain films, CT, MRI, US The Evolution of Diagnostic Imaging

11. Positron Emission Tomography A clinical molecular imaging modality that enables visualization and quantification of biochemical processes in vivo.

12. Bio-Tech Systems Radiopharmaceutical Report 2004 Procedures in millions U.S. PET Procedure Volume

13. Source: IMV U.S. PET Imaging Sites

14. 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

15. Source: IMV Percent of Dedicated PET vs. PET/CT Scanners in the U.S.

16. Current Challenges in Nuclear Medicine Clinical Trials ResearchFunding Economics R egulatory Education

17. 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

18. 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

19. 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

20. 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)

21. 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

22. 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

23. Aggressively working to restore federal funding Collaborating with other specialty societies to reduce fragmentation Pursuing patient advocacy and education What SNM Is Doing Today

24. 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)

25. 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)

26. 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)

27. 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.

28. 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.

29. PET/CT SPECT/CT MR Spectroscopy Contrast- enhanced US/Doppler Existing and Emerging MI Modalities– Vision of Future Patient Care

30. Bio-active MR contrast agents Bioluminescence PET/MRI Existing and Emerging MI Modalities– Vision of Future Patient Care

31. 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?

32. 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?

33. Improved diagnostic effectiveness Prediction of treatment response Improved patient outcomes Individualized treatment plans Identification of appropriate therapies Enhancement of resource utilization Leading to…

34. 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

35. “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.

36. 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

37. 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

38. 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

39. 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

40. 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

41. 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

42. Refocusing/rebranding SNM MI Center of Excellence Capital campaign Positioning SNM as the leader for molecular imaging and therapy

43. 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

44. 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

45. 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

46. 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

47. 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

48. 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

49. 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

50. Educate and promote collaboration with referring physicians and patient groups Create outreach programs for: – referring physicians – patient groups – federal agencies – regulators – general public

51. 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

52. 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

53. 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

54. 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

55. 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

56. 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

57. 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 NordionCardinal Health