Senate Science and Technology Caucus: National Isotope Program

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Senate Science and Technology CaucusNational
Isotope Program
Dr. David J. Hill Chairman ANS Special Isotope
Assurance Committee
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American Nuclear Society

• The American Nuclear Society (ANS) is a
  not-for-profit, international, scientific and
  educational organization composed of
  approximately 10,500 engineers, scientists,
  administrators, and educators representing 1,600
  plus corporations, educational institutions, and
  government agencies
• The ANS serves to develop and safely apply
  nuclear science and technology for public benefit
  through knowledge exchange professional
  development, and enhanced public understanding
• The ANS Special Committee on Isotope Assurance
  was established to develop a Corridor of Action
  to ensure an isotope supply

Members of the ANS Special Committee
on Isotope Assurance (2003-2004) (Parentheses
denote the organization represented by the
individual) David J. Hill, Chair Jeanne K.
Krieger Oak Ridge National Laboratory
Bristol-Myers Squibb Medical Imaging Brad
Patton, Vice Chair Council on Radionuclides
and Oak Ridge National Laboratory
Radiopharmaceuticals CORAR) Leo Bobek James
Muckerheide University of Massachusetts,
Lowell Worcester Polytechnic Institute (ANS
Isotopes and Radiation Division) (ANS Biology
and Medicine Division) Ralph A. Butler Mark J.
Rivard University of Missouri Research
Tufts-New England Medical Center Reactor
Center Edward (Ted) B. Silberstein Marc Garland
University of Cincinnati College of University
of South Carolina Medicine (Society of Nuclear
Medicine)
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Extensive Facilities Needed for Isotope Production
Nuclear reactor or accelerators to produce
isotopes
Isotope enrichment facilities for highly enriched
isotopes for targets
Laboratories for developing radiopharmaceuticals
Hot cells to purify for use
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Historical Government Role

• First radioisotope made available from Oak Ridge
  National Laboratory in 1946
• Isotope research and development is mandated in
  the Atomic Energy Act of 1954
• Majority of large nuclear facilities and nuclear
  and radiochemical expertise reside within DOE and
  its laboratories
• Successful history of major radioisotopes for
  nuclear medicine including (most developed in the
  DOE laboratories)
• Tc-99m, the most important diagnostic
  radioisotope
• Tl-201, the standard for heart scans
• I-131, for thyroid imaging and therapy
• F-18, for PET imaging for cancer and brain
  functions
• Y-90, for cancer therapy
• Ga-67, for tumor imaging

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Development of Radiopharmaceuticals is an 8-10
year Process
Approved for use
Submission, Review and Approval of New Drug
Application to FDA
Set-up and running of FDA approved manufacturing
facility
Phase I, II, and III Clinical Studies
Animal Studies -Proof of principal, toxicity
studies, etc.
Concept to initial chemical development
8-10 years

• Investment - 50-200 million/new
  radiopharmaceutical only two new
  radiopharmaceuticals recently approved

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Summary of Issues Arising From Current Isotope
Situation in the United States

• Dependence on foreign suppliers in situations
  where impacts of supply interruptions are
  unacceptable is not being systematically
  addressed
• Reasonably priced RD isotopes are not available
  due to declining resources and policy changes in
  the DOE Isotope Program
• Elimination of DOE RD funding is impacting
  development of future isotope applications and
  limiting U.S. isotope business development
• Limited national isotope production resources are
  not being coordinated to effectively meet the
  needs of the country
• Lack of infrastructure support for aging
  production facilities and failure to develop
  long-term plans for facility replacement have
  resulted in a loss of capability to produce
  isotopes to a critical level
• Decline in nuclear and radiochemistry education
  is not being addressed to avoid detrimental
  impacts on radioisotope production and
  applications RD

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Recommendations

• Establish a new national isotope policy and
  develop a long-term strategic plan
• Establish a national isotope program organization
  to implement the national isotope policy and
  long-term strategic plan
• Establish an independent scientific advisory
  board for the national isotope program to provide
  oversight and guidance for the program director
• Ensure that the national isotope program office
  is adequately staffed
• Promote technology transfer to the private sector
• Ensure adequate resource allocation to support
  the programs

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Functions of a National Isotope Program