Ομιλία-Παρουσίαση: Etienne Vallée, Europe Radiopharmacy Product Manager, GE Healthcare Τίτλος Ομιλίας: «Trends in PET Radiopharmacy»

1. Confidential. Not to be copied, distributed, or reproduced without prior approval.
Trends in Radiopharmacy
Etienne Vallée
Europe Product Manager Radiopharmacy
October 5, 2018

2. 2
From… …to

3. Or in PET imaging
context:
3
18F
15O
68Ga11C
13N
Water
DOTA-x
PSMA-11
etc.
FES FET
FLT PSMA
NaF DOPA
Vizamyl etc.
NH3
MET ACE
CHO RAC
PIB etc.
18F-FDG
From… …to

4. 4
PET & SPECT 2001-
2016 Sweden
Source: Swedish Radiation Safety Authority (www.ssm.se)
0
50000
100000
150000
MI PROCEDURES
SWEDEN
PET SPECT
0
5000
10000
15000
20000
25000
PET PROCEDURE
GROWTH
0
500
1000
1500
2000
2500
Other PET isotopes
Ga-68 C-11 O-15
Moderate overall growth
Strong PET growth (FDG)
Ga-68 is shooting star

5. PET Radiopharmacy
Dynamics in the market
Consolidations and mergers en masse:

6. Theranostics refers to the use of targeting
molecules labelled either with diagnostic
radionuclides (e.g., positron or gamma
emitters), or with therapeutic radionuclides
(e.g., beta emitters) for diagnosis and therapy of a
particular disease. Therefore, molecular imaging
and diagnosis of the disease can be effectively
followed by personalized treatment utilizing the
same targeting molecules
Diagnostics and Therapy synchronized with same target binding molecule
Let’s talk Theranostics

7. PET Radiopharmacy
1. Diagnostics and Therapy synchronized with
same target binding molecule
NETSPOT and LUTATERA for Neuroendocrine
tumours
*Source: OncoTargets and Therapy 3 October 2017, Yordanova
et. al.
2. Prostate specific membrane antigen (PSMA)*
Let’s talk Theranostics

8. F18
PETTraceTM
Auto Synthesis
FASTlabTM
Cassettes Scanning
DiscoveryTM
Data Analysis, Software
Normal/
Abnormal
by SOT
Interpret Visually Training
Molecular Imaging at GE: Comprehensive PET
imaging
Confidential. Not to be copied, distributed, or reproduced without prior
approval.

9. Cyclotrons
PETtraceTM 800
Distribution / Research
MINItraceTM QILIN
Econo Clinical
GENtrace
Access / In house
10
MeV
7.8
MeV
16.5
MeV
Chemistry
FDG
NaF
FLT
FMISO
FDG
Duo
FASTlabTM 2
Production Platform
TRACERlabTM FX 2
Research Modules
Hot Cells and fume hoods
Shielding and lead
containers
Dispensing systems
Quality Control equipment
Project Management
and Training
QA / GMP
Support
TC-OEM
TRACERcenter portfolio
9

10. TRACERcenter offering
10
• GE cyclotrons
• GE Radiochemistry systems
• Hot Cells - Fume hoods
• Dispensing Systems
• Quality Control
• Radiation Monitoring
• Shielding
QA Program including
documentation and
training:
• Design Review
• QMS
• Facility and Equipment
Qualification
• On site Execution
• Project Management:
o Site Design/Planning
o Site readiness
o Site installations
• Service Support for GE and
3rd party equipment
• Technology Upgrade path
• Education & network
Equipment technology GMP facilitation Overall support

11. Cyclotron Install Base
GE – the world’s largest cyclotron installed base 11
290+ PETtrace
110+ MINItrace
3 GENtrace
>400 GE cyclotrons installed worldwide
>120 in Americas
>130 in APAC, India & China
>140 in EGM/Africa &
Europe
PETtrace
MINItrace
GENtrace
Total PET Cyclotron IB
~1100 Systems
IBA ~225
Siemens
Sumitomo ~180
Other ~80

12. Simplification through automation
125 October 2018Edit Presentation Title in [Insert Tab > Header & Footer]
|
Cyclotron
Engineer /
Operator
Radiochemist
QA Manager /
GMP expert
Today’s PET Radiopharmacy Tomorrow’s PET Radiopharmacy
Nuclear medicine
technologist / Nurse
Automated cyclotron, synthesis,
dispensing workflows
Minimal to zero direct equipment
interaction
Integrated system for digital
traceability and batch release

13. Simplification through automation
135 October 2018
Reduce cost
Reduce complexity
CAPEX
OPEX
Simplified user
interactions
Reduced regulatory
burden/threshold
Make things smaller
Use new technology
Staff costs
Cost of consumables
Integration & automation
Digitalization
Training & support
Use latest technology

14. TRACERcenter VIP provides
1. A complete and minimal configuration (equipment, documentation and services) for GMP-
compliant production of FDG
2. A solution where all steps can be operated by a nuclear medicine technician (not requiring a
radio-chemist or a cyclotron technician/specialist)
3. A solution with 25% lower investment cost
compared to current comparable solutions
4. A solution with 25% lower operating cost
compared to current comparable solutions
Objective with the GENtrace and TRACERcenter VIP
14

15. TRACERcenter VIP – Configuration
A minimum fixed configuration containing all components for FDG
GENtrace Cyclotron
Integrated Hot cell &
Dispensing
FASTlab 2
Chemistry
QC
Rad monitor
Lab
accessories
Services
OPTION
Electronic
Workflow
• GENtrace
self shielded
one 18F-target
system
• Grade D Environment
• Closed aseptic
dispensing system
• Delivery system from
cyclotron
• FASTlab Integration
• FASTlab Multi-
tracer
• Classical
package
meeting either
EU or US
Pharma
• Site planning
• Installation
• Commissioning
• IQ/OQ
• Training
• Data collection
from all parts of
the production line
• Consolidated
batch record
• Ease of use
• Affordable
• Down sizing,
• Ease of use
• Affordable
• Down sizing,
• Ease of use
• Complete
package
• Compliance • Compliance
• Ease of use
Simple upgrade path for other clinical 18F-based tracers,
11C (once available) and research activities
15

16. Conclusion
October 5, 2018Trends in Radiopharmacy 16
• PET is growing, driven by patient aging, increase in
cancer and new tracers.
• The Nuclear Medicine tracers industry is getting mature
with strategic moves
• Theranostics will play a key role in patient management
• PET tracers production and logistic are complex
processes but there is room for simplification
• GE Healthcare provides innovative solutions for in-house
production of PET tracers

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