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
#
#/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
*ASHP accredited in 1982; **Plan I and II programs; ***Distance program w/UAMS
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
ASHP-Accredited Programs = 2
 31 Graduates
 SUNY Buffalo School of Pharmacy
 ASHP Accredited
 Advanced Clinical
Practice
 Practice sites
 UNM Radiopharmacy
 VAMC Regional
Medical Center
 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
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.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