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

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

Radiochemistry needs by role

 Radioisotope Production   Reactor based Accelerator based  Radiopharmaceutical Production    Commercial Setting Academic/Hospital Center Pharma  Radiopharmaceutical Research   Industry Academic/Government

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

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

Radiopharmaceutical Production

 Commercial setting ”Big RadioPharma”          Perkin Elmer Lantheus GE Siemens Covidien Draximage IBA Bracco Nordion

Radiopharmaceutical Production

 Commercial - startups  MIP  Cytogen  Trace Sciences  AMIC  Avid Pharmaceuticals  Cyclomedica  North American Scientific  NuView

Radiopharmaceutical Production

 Academic or Hospital setting  Routine synthesis  Cyclotron based  Hot box  Custom or Research compounds   Cyclotron based Custom configured hot box

Radiopharmaceutical Production

 Traditional Pharma  Utilize clinically proven radiopharmaceuticals  FDG, FLT,  Custom synthesis of drug candidates  PK/PD studies

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

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

Overview of UNM College of Pharmacy Radiopharmaceutical 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

Radiopharmaceutical Sciences Education Program Summary

Date Program

Authorized Nuclear Pharmacist (ANP) 1972 1977 to 1992 Post-graduate Radiopharmacy Residency* 1986 1990 MS Pharmaceutical Sciences ** PhD Biomedical Sciences 2001 2001 7/2004 7/2006 Nuclear Education Online (NEO)*** ANP Authorized Users (Non-Pharmacist)*** Nuclear Pharmacy Technicians*** MD Nuclear Cardiology*** 5/2007 Department of Transportation*** 5/2007 Radiation Safety*** *ASHP accredited in 1982; **Plan I and II programs; ***Distance program w/UAMS

#

186 31 31 3 317 20 >300 157 1817 40

#/yr

5.5

3 1.5

NA 30 2 20 80 500 40

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

BPS Board Certification - 1978 BCNP n=490

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

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.

UNM Radiopharmacy Nuclear 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: [email protected]

 The National Capital Consortium/National Naval and Walter Reed Army Medical Centers  Carol W. Labadie, COL, Pharm.D. (202) 782-6072 E-mail: [email protected]

ACCP-Accredited Programs = 0 Fellowships = 0

UNM MS Pharmaceutical Sciences (Radiopharmaceutical Sciences)

SUGGESTED CURRICULUM 1 PLAN II SUGGESTED CURRICULUM 1 PLAN II Clinical Track 32 Semester hours 1 st 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) 2 nd Year  Clinical Nuclear Medicine (1) Seminar (2) Thesis (3-6) Elective(s) (2-8) Hours 14 Basic Science Track 34 Semester hours 1 st Year             Nuclear Pharmacy Instrumentation (3) Radiopharmacology (3) Health Physics/Radiation Biology (3) Radiopharmaceutical Chemistry (2) Radiopharmaceutics (2) Seminar (2) Elective(s) (2-6) 2 nd 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)

Nuclear Education Online (NEO) www.nuclearonline.org

     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

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

NMCIM Partnerships and



Acknowledgements

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