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UNM College of Pharmacy Radiopharmaceutical Sciences Program

ANS Embedded Topical meeting June 11, 2008. UNM College of Pharmacy Radiopharmaceutical Sciences Program New Mexico Center for Isotopes in Medicine LANL Isotope Production Program UNM Group Members: Jeff Norenberg, PharmD Robert Atcher, PhD, MBA - UNM & LANL.

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UNM College of Pharmacy Radiopharmaceutical Sciences Program

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  1. ANS Embedded Topical meeting June 11, 2008 UNM College of Pharmacy Radiopharmaceutical Sciences Program New Mexico Center for Isotopes in Medicine LANL Isotope Production Program UNM Group Members: Jeff Norenberg, PharmD Robert Atcher, PhD, MBA - UNM & LANL

  2. Manpower Training Needs/Tiered Training Programs: • Based upon NAS and other reports, to assess needs for radiopharmacy, radiochemistry, and biomedical imaging scientists as a variety of training levels. • Discuss potential resources to support a PhD program in appropriate disciplines

  3. Radiochemistry needs by role • Radioisotope Production • Reactor based • Accelerator based • Radiopharmaceutical Production • Commercial Setting • Academic/Hospital Center • Pharma • Radiopharmaceutical Research • Industry • Academic/Government

  4. Radioisotope Production • Reactor based • Commercial entities • Mo-99, Xe-133, I-131, I-125 • Research entities • University • MURR • MITR • TAMU • UCD • National Laboratory • ORNL • INEEL

  5. Radioisotope Production • Accelerator based • Commercial sites • Tl-201, In-111, Ga-67, I-123, Ge-68 • PET radiopharmacy • F-18 • Academic/Hospital Based • F-18, C-11, O-15, N-13 • National Laboratory • High energy, high current accelerators • LANL, BNL • RIA - site TBD

  6. Radiopharmaceutical Production • Commercial setting-”Big RadioPharma” • Perkin Elmer • Lantheus • GE • Siemens • Covidien • Draximage • IBA • Bracco • Nordion

  7. Radiopharmaceutical Production • Commercial - startups • MIP • Cytogen • Trace Sciences • AMIC • Avid Pharmaceuticals • Cyclomedica • North American Scientific • NuView

  8. Radiopharmaceutical Production • Academic or Hospital setting • Routine synthesis • Cyclotron based • Hot box • Custom or Research compounds • Cyclotron based • Custom configured hot box

  9. Radiopharmaceutical Production • Traditional Pharma • Utilize clinically proven radiopharmaceuticals • FDG, FLT, • Custom synthesis of drug candidates • PK/PD studies

  10. Radiopharmaceutical Research • Industry • Market driven • Focus on demand and availability • Waxes and wanes • Academic • Research driven • Utilizes existing or “new” radionuclides • Has been steady till recently • DOE funding • NIH funding

  11. Radiopharmacy Manpower Needs • ~1,000 nuclear pharmacists within the USA • 450 nuclear pharmacies within the USA and growing • Commercial: CH NPS, Covidien, GE, IBA Molecular, PETNet, Triad Isotopes, Independents (UPPI) • Hospital/university-based • Nuclear pharmacy was the first specialty practice area recognized by American Pharmacists Association in 1975 • First specialty recognized through Board Certification by the Board of Pharmaceutical Specialties 1978 • The fastest growing area within nuclear pharmacy practice is in PET • Average starting salary for new graduates >$100,000, parity with hospital and specialty practice settings

  12. Overview of UNM College of PharmacyRadiopharmaceutical Sciences Programs • Education, Research, and Clinical Service • First University-based Radiopharmacy Education and Training Program established in 1972 • First Commercial Nuclear Pharmacy 1973-1992 • DOE ANMI Nuclear Medicine Education Award for Graduate Radiopharmacy Education $300,000 total, 2001-2004 • New Mexico Center for Isotopes in Medicine - UNM-Los Alamos National Laboratory • established 12/2005

  13. Radiopharmaceutical SciencesEducation Program Summary *ASHP accredited in 1982; **Plan I and II programs; ***Distance program w/UAMS

  14. Authorized Nuclear Pharmacist Program • 1972 – Present • 186 Graduates – BS/PharmD + ANP • Professional Radiopharmacists • 10 CFR 35.980 • APhA Syllabus for Nuclear Pharmacist Education and Training • 250 Hours Didactic Education (NRC requires 200) • Physics and Instrumentation • Radiochemistry • Radiation Biology • Radiation Safety • Mathematics • Clinical Clerkships (+50 hours to satisfy NMBOPs, and others) • 500 Hours Structured, Supervised Experiential Training

  15. BPS Board Certification - 1978BCNP n=490

  16. UNM Radiopharmaceutical Sciences Graduate Program • 1986 – Present • MS Pharmaceutical Sciences (Radiopharmacy) • 31 Graduates • Focus on Applied and Translational Research • Pharmaceutical Scientists • Advanced Clinical Practitioners • DOE ANMI NMEA $300,000 2001-2004 • Linked with COP/BSGP PhD programs – 3 graduates

  17. Status of Radiologic Pharmacy Education at Colleges of Pharmacy • 1996 • n=84 • Part of core curriculum 46% • Separate required course 10% • >1 Elective course 46% • Overall 69% of all COPs offer • 31% have zero • Mean 4.5 hours in core curriculum Status of Radiologic Pharmacy Education at Colleges of Pharamcy. Heske SM, Hladik WB, Laven DL, Kavula MP. AJPE 1996;60:152-161.

  18. UNM RadiopharmacyNuclear Pharmacy Residency • 1977 – 1992 • 31 Graduates • ASHP Accredited • Advanced Clinical Practice • Practice sites • UNM Radiopharmacy • VAMC Regional Medical Center ASHP-Accredited Programs = 2 • SUNY Buffalo School of Pharmacy • Edward M. Bednarczyk, Pharm.D.
(716) 645-2828
E-mail: eb@buffalo.edu • The National Capital Consortium/National Naval and Walter Reed Army Medical Centers • Carol W. Labadie, COL, Pharm.D.
(202) 782-6072
E-mail: Carol.Labadie@amedd.army.mil ACCP-Accredited Programs = 0 Fellowships = 0

  19. UNM MS Pharmaceutical Sciences (Radiopharmaceutical Sciences) SUGGESTED CURRICULUM1 PLAN II Clinical Track 32 Semester hours 1st Year  • Nuclear Pharmacy Instrumentation (3) • Nuclear Pharmacy Practice I (2) • Radiopharmacology (3) • Seminar (2) • Health Physics/Radiation Biology (3) • Radiopharmacy Management (2) • Radiopharmaceutical Chemistry (2) • Radiopharmaceutics (2) • Elective(s) (0-6)    2nd Year • Clinical Nuclear Medicine (1) • Seminar (2) • Thesis (3-6) • Elective(s) (2-8)  • Hours 14 SUGGESTED CURRICULUM1 PLAN II Basic Science Track 34 Semester hours  1st Year  • Nuclear Pharmacy Instrumentation (3) • Radiopharmacology (3) • Health Physics/Radiation Biology (3) • Radiopharmaceutical Chemistry (2) • Radiopharmaceutics (2) • Seminar (2) • Elective(s) (2-6) 2nd Year • In Vivo/Vitro Radiotracer Procedures (2) • Instrumentation and In Vitro Laboratory (2) • Clinical Nuclear Medicine (1) • Seminar (2) • Thesis (6) • Elective(s) (3-6)

  20. Best Resources for Education Expert Faculty Advantages of Distance Education Anytime Anywhere Any pace Any base Active Learning using Problem-Based Learning (PBL) Consortium UAMS/UNM Authorized Nuclear Pharmacist 2001 Goal 80 Students/Year 317 Graduates 2001-present Authorized Users 75 Students 2001-present Nuclear Pharmacy Technicians ~300 Students 7/2004-present Nuclear Cardiology Physicians 157 Students 7/2006-present DOT Training 1817 Students 6/2007-present Radiation Safety 40 Students 5/2007-present Curriculum Licensed to Universities U of Oklahoma, MUSC Nuclear Education Online (NEO)www.nuclearonline.org

  21. UNM Education & Training Capabilities • NMCIM = UNM + LANL + NMSU • Radiopharmaceuticals • Discovery, Development, and Translation • cGMP Manufacturing and Formulation Support for Clinical Trials • Small-Animal Imaging • NanoSPECT/CT and PET • Image-based Metrology • Los Alamos National Laboratory • Isotope Production Facility • Chemistry Division • Biosciences Division

  22. New Mexico Center for Isotopes in Medicine Scott Burchiel, PhD UNM Assoc VP Research IAS John Pieper, PharmD Dean COP College of Pharmacy, UNM HSC Yubin Miao, PhD, Nalini Shenoy, PhD (Post-doc) Radiopharmaceutical Sciences Laboratory Tamara Anderson, BS (Associate Scientist) Ben Gershman, MS (Imaging Scientist) Jeremy Howard, BS (Sr./Lead BiologyTechnician) Daniel Irwin, BS (Nuclear Medicine Technologist) Tapan Nayak, BPharm, MS (PhD Candidate) Jack Hoppin, PhD et al. - Bioscan, Inc. Melanie Bergeron, MS et al. - GammaMedica Ideas (AMI) UNM Cancer Research Treatment Center Pathology Richard Larson, MD, PhD (LFA-1 NorBIRT) David Brown, PhD (Survival studies) Gloria Semenuk, PhD (Affinity studies) Cell Biology Eric Prossnitz, PhD (Receptor biology) C Revankar, PhD & Daniel Cimino, PhD Center for Molecular High Throughput Screening Larry Sklar, PhD (PI Keck Grant) Bruce Edwards, PhD & Mark Carter, MS Los Alamos National Laboratory Robert Atcher, PhD (Nuclear and Radiochemistry) Jonathon Fitzsimmons, PhD (Post-doc) Eugene Peterson, PhD (Nuclear Chemistry) NIH/NCI Radiation Oncology Branch Martin Brechbiel, PhD (Nuclear and Radiochemistry) Kayhan Garmestani, PhD (Radiochemistry) DOE Isotope Production Program Wolfgang Runde, PhD Research Support (Norenberg) WM Keck Foundation United States Department of Energy, Advanced Nuclear Medicine Initiative DE-FG01-001NE23554 University of New Mexico General Clinical Research Centers DHHS/PHS/NIH/NCRR/GCRC, MO1 RROO997 UNM-LANL Joint Science and Technology Laboratory Initiatives (JSTL) New Mexico Technology Research Collaborative (TRC) UNM CRTC Translational Science Pilot Award Avid Radiopharmaceuticals, Inc. Bioscan, Inc. GammaMedica Ideas (Advanced Molecular Imaging, Inc.) Molecular Insight Pharmaceuticals, Inc. Tyco/Mallinckrodt Healthcare - Covidien NMCIM Partnerships and Acknowledgements

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