University of New Mexico College of PharmacyUniversity of New Mexico College of PharmacyRadiopharmaceutical Sciences ProgramRadiopharmaceutical Sciences Program

New Mexico Center for Isotopes in MedicineNew Mexico Center for Isotopes in MedicineLos Alamos National Laboratory Isotope Production Los Alamos National Laboratory Isotope Production

ProgramProgram

UNM Group Members: UNM Group Members: Jeff Norenberg, PharmDJeff Norenberg, PharmD

Robert Atcher, PhD, MBA - UNM & LANLRobert Atcher, PhD, MBA - UNM & LANL

ANS Embedded Topical meetingANS Embedded Topical meetingJune 11, 2008June 11, 2008

Manpower Training Needs/Tiered Training Programs:Based upon National Academy of Sciences Panel

report from Fall 2007 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 ProductionReactor basedAccelerator based

Radiopharmaceutical ProductionCommercial SettingAcademic/Hospital CenterPharma

Radiopharmaceutical Research IndustryAcademic/Government

Radioisotope ProductionReactor based

Commercial entities Mo-99, Xe-133, I-131, I-125

Research entities University

Missouri Univ. Research Reactor Massachusetts Institute of Technology Reactor Texas A&M University Univ. of California-Davis

National Laboratory Oak Ridge National Lab Idaho National Engineering and Environmental Laboratory

Radioisotope ProductionAccelerator 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, Brookhaven National Lab Rare Isotope Accelerator - site To Be Determined

Radiopharmaceutical Production

Commercial setting-”Big RadioPharma”Perkin ElmerLantheusGESiemensCovidienDraximage IBABraccoNordion

Radiopharmaceutical Production

Commercial - startupsMolecular Insight PharmaceuticalCytogenTrace SciencesAMICAvid PharmaceuticalsCyclomedicaNorth American ScientificNuView

Radiopharmaceutical Production

Academic or Hospital settingRoutine synthesis

Cyclotron based Hot box

Custom or Research compounds Cyclotron based Custom configured hot box

Radiopharmaceutical Production

Traditional PharmaUtilize clinically proven radiopharmaceuticals

FDG, FLT, FMISO

Custom synthesis of drug candidates Pharmacokinetic/PharmacoDynamic studies

Radiopharmaceutical Research

IndustryMarket drivenFocus on demand and availabilityWaxes and wanes

AcademicResearch drivenUtilizes existing or “new” radionuclidesHas been steady till recently

Dept. of Energy funding NIH funding

Radiopharmacy Manpower Needs~1,000 nuclear pharmacists within the USA450 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 PharmacyRadiopharmaceutical Sciences Programs

Education, Research, and Clinical ServiceFirst University-based Radiopharmacy Education and

Training Program established in 1972First Commercial Nuclear Pharmacy 1973-1992DOE ANMI Nuclear Medicine Education Award for Graduate

Radiopharmacy Education $300,000 total, 2001-2004New Mexico Center for Isotopes in Medicine - UNM-Los

Alamos National Laboratoryestablished 12/2005

*ASHP accredited in 1982; **Plan I and II programs; ***Distance program w/UAMS

Date Program # #/yr

1972 Authorized Nuclear Pharmacist (ANP) 186 5.5

1977 to 1992 Post-graduate Radiopharmacy Residency* 31 3

1986 MS Pharmaceutical Sciences ** 31 1.5

1990 PhD Biomedical Sciences 3 NA

2001 Nuclear Education Online (NEO)*** ANP 317 30

2001 Authorized Users (Non-Pharmacist)*** 20 2

7/2004 Nuclear Pharmacy Technicians*** >300 20

7/2006 MD Nuclear Cardiology*** 157 80

5/2007 Department of Transportation*** 1817 500

5/2007 Radiation Safety*** 40 40

Authorized Nuclear Pharmacist Program1972 – Present186 Graduates – BS/PharmD + ANPProfessional Radiopharmacists

10 CFR 35.980APhA Syllabus for Nuclear Pharmacist Education and

Training250 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 - 1978BCNP n=490

UNM Radiopharmaceutical Sciences Graduate Program

1986 – PresentMS Pharmaceutical Sciences (Radiopharmacy)31 GraduatesFocus on Applied and Translational ResearchPharmaceutical ScientistsAdvanced Clinical PractitionersDOE ANMI NMEA $300,000 2001-2004Linked with COP/BSGP PhD programs – 3

graduates

Status of Radiologic Pharmacy Education at Colleges of Pharamcy. Heske SM, Hladik WB, Laven DL, Kavula MP. AJPE 1996;60:152-161.

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

UNM RadiopharmacyNuclear Pharmacy Residency1977 – 199231 GraduatesAmerican Society of

Hospital Pharmacy Accredited

Advanced Clinical Practice

Practice sitesUNM RadiopharmacyVA Medical Ctr Regional

Medical Center

ASHP-Accredited Programs = 2SUNY Buffalo School of Pharmacy

Edward M. Bednarczyk, Pharm.D.(716) 645-2828E-mail: eb@buffalo.edu

The National Capital Consortium/National Naval and Walter Reed Army Medical Centers Carol W. Labadie, COL, Pharm.D.

(202) 782-6072E-mail: Carol.Labadie@amedd.army.mil

ACCP-Accredited Programs = 0

Fellowships = 0

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)

Nuclear Education Online (NEO)www.nuclearonline.orgBest Resources for EducationExpert FacultyAdvantages 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

New Mexico Center for Isotopes in Medicine = UNM & LANL & New Mexico State Univ.

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• Bioscience Division

NMCIM Partnerships and AcknowledgementsNew Mexico Center for Isotopes in MedicineScott Burchiel, PhD UNM Assoc VP Research IASJohn Pieper, PharmD Dean COPCollege of Pharmacy, UNM HSCYubin Miao, PhD, Nalini Shenoy, PhD (Post-doc)Radiopharmaceutical Sciences LaboratoryTamara 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 CenterPathologyRichard Larson, MD, PhD (LFA-1 NorBIRT)David Brown, PhD (Survival studies)Gloria Semenuk, PhD (Affinity studies)Cell BiologyEric Prossnitz, PhD (Receptor biology)C Revankar, PhD & Daniel Cimino, PhDCenter for Molecular High Throughput ScreeningLarry Sklar, PhD (PI Keck Grant)Bruce Edwards, PhD & Mark Carter, MS

Los Alamos National LaboratoryRobert Atcher, PhD, MBA (Nuclear and Radiochemistry)Jonathon Fitzsimmons, PhD (Post-doc)Eugene Peterson, PhD (Nuclear Chemistry)NIH/NCI Radiation Oncology BranchMartin Brechbiel, PhD (Nuclear and Radiochemistry)Kayhan Garmestani, PhD (Radiochemistry)DOE Isotope Production ProgramWolfgang Runde, PhDResearch Support (Norenberg)WM Keck FoundationUnited States DOE, Advanced Nuclear Medicine Initiative

DE-FG01-001NE23554UNM General Clinical Research Centers

DHHS/PHS/NIH/NCRR/GCRC, MO1 RROO997UNM-LANL Joint Science and Technology Laboratory

Initiatives (JSTL)New Mexico Technology Research CollaborativeUNM CRTC Translational Science Pilot AwardAvid Radiopharmaceuticals, Inc.Bioscan, Inc.GammaMedica Ideas (Advanced Molecular Imaging, Inc.)Molecular Insight Pharmaceuticals, Inc.Tyco/Mallinckrodt Healthcare - Covidien