james b. slater, rph, phd
TRANSCRIPT
JAMES B. SLATER, RPH, PHD Director, UCSF Radiopharmaceutical Facility
¨ Purpose
¡ Describe cyclotron services ¡ Develop a communication pathway with
investigators ¨ Objectives
¡ Introduce the cyclotron staff ¡ Mission of the cyclotron laboratory ¡ Current and potential PET drugs available ¡ Process of ordering PET drugs ¡ FDA requirements for human use.
¨ Personnel ¡ James B. Slater, RPh, PhD
ú Chemistry BS 1972 ú Pharmacist RPh 1975 ú Radiopharmacist MS 1977 ú Pharmaceutical Chemistry (radiopharmaceutical) PhD 1982 ú Director, Radiopharmacist/radiochemist UCSF 2006-present
¡ Allan Rosete, PharmD ú Chemical Engineer BS 1991 ú Pharmacist PharmD 2010 ú Radiopharmacist UCSF 2010-present
¡ Salma Jivan BSc Diploma of Technology ú BSc 1979 ú Dipolma of Technology 1981 ú Radiochemist UBC/TRIUMF PET Centre 1981-2012 ú Radiochemist UCSF 2012-present
¡ Cyclotron engineers ú William Mannone ú Jeffrey Krug
¨ Official Name ¡ UCSF Radiopharmaceutical Facility
aka UCSF Cyclotron Laboratory
¨ Classification ¡ UCSF Radiology and Biomedical Imaging Core
services ¡ UCSF Shared Research Facility Level 2 ¡ FDA registered PET drug manufacturer
¨ Mission
¡ Manufacture PET drugs for routine clinical studies ¡ Manufacture PET Drugs for investigational clinical
and animal studies ¡ Provide PET drugs and isotopes for basic science
research ¡ Provide assistance in protocol design using
radiopharmaceuticals and pharmaceuticals
¨ Current PET drugs ¡ Routine clinical
ú FDG ú Ammonia ú NaF
¡ Investigational ú F18 FLT ú F18 FMISO ú F18 SFB ú C11 Methionine ú O15 water ú I124 MIBG
¡ Other cyclotron projects ú Zr-89 labeled antibody PD-1 ú Ga-68 chelates (proposed)
PET DRUG MECHANISM
¨ N13 Ammonia
¨ O15 Water
¨ F18 SFB
¨ Cardiac perfusion
¨ Perfusion
¨ Protein labeling
PET DRUG MECHANISM
¨ F18 FDG
¨ F18 FLT
¨ F18 FMISO
¨ I124 MIBG
¨ C11 Methionine
¨ F18 NaF
¨ Glucose metabolism
¨ Cell division
¨ Hypoxia
¨ Neuroendocrine
¨ Amino acid tracer
¨ Osteogenic activity
PET DRUG MECHANISM
¨ F18 FES
¨ F18, C11 Choline
¨ F18, C11 Acetate
¨ F18 FMT*
¨ Estrogen receptors
¨ Metabolism
¨ Metabolism
¨ Amino acid tracer
PET DRUG MECHANISM
¨ F18 FDOPA*
¨ C11 Raclopride
¨ C11 DASB
¨ C11 MRB
¨ C11 Yohimbine
¨ C11 DTBZ
¨ dopaminergic pathway ¨ D2 receptors
¨ Serotonin transporter
¨ Norepinephrine trans NET
¨ Alpha adrenoceptors
¨ VMAT-2
PET DRUG MECHANISM
¨ C11 Sch23390 ¨ C11 PK11195
¨ C11 PMP ¨ C11 MDL100907 ¨ C11 PIB ¨ F18 FHBG
¨ D1 receptor antagonist ¨ Peripheral benzodiazepine
receptor ¨ Acetyl cholinergic
presynaptic receptors ¨ 5-HT2A antagonist ¨ Beta-amyloid ¨ Reporter probe herpes
simplex
PRECURSOR PURPOSE PRECURSOR DEVELOPMENT
¨ Direct the isotope to a particular site
¨ Eliminate side reactions
¨ In house ¨ Outside GMP
manufacturers
¨ Current PET drug ¡ First time ordering a non-routine PET drug 1 month advanced
notice. ¡ Second time ordering the same non-routine PET drug 48 hour
advanced notice ¨ New PET drug
¡ First time ordering a new PET drug 3-4 months advanced notice ¡ Second time ordering the same non-routine new PET drug 48 hour
advanced notice. ¨ Information on PET Drugs Availability and Pricing
¡ http://www.radiology.ucsf.edu/research/core-services/probes ¡ Click on the 2013 DRUG PRODUCT CATALOG - PDF
¨ Pricing for assistance in proposal preparation is available ¨ It is critical to know about your requests as soon as
possible to provide the best service possible
¨ Critical information ¡ Labeled compound same as an endogenous
compound ¡ Previously used in humans
¨ Procedure for development ¡ Develop procedures and SOPs for manufacturing ¡ Develop procedures and SOPs for quality control ¡ Create batch record ¡ Three consecutive runs need to pass all QC
requirements ¡ Filing IND or RDRC
¨ Quality control requirements ¡ Appearance-visual inspection ¡ Sterility-filter membrane integrity test ¡ Radiochemical identity-HPLC or TLC ¡ Radiochemical purity-HPLC or TLC ¡ Radionuclidic identity-half life calculation ¡ Radionuclidic purity-MCA spectrum ¡ Chemical purity-GC (residual solvents) and/or
HPLC ¡ Bacterial endotoxins test- PTS ¡ Sterility testing-FTM and TSB media
¨ Contact information ¡ E-mail
ú [email protected] ú [email protected] ú [email protected]
¡ Phone numbers ú 415-353-4435 ú 415-353-4476