Transcript Distribution of PET Pharmaceuticals for Clinical Trials-a

2010 ACRIN Annual Meeting
Distribution of PET
Radiopharmaceuticals for Clinical Trials
– a GE Healthcare Perspective
Ensuring delivery of required dose activity while
acquiring Optimum Images for the Clinical Trials
September 30, 2010
1/
GE /
PET Tracer Coordination
[F-18] labeled
Patient Enrolment
Patient Tracking
Tracer Production
Image Quality
CMC-S
Clinical
Clinical
/Imaging Sites
Robust Image
Quality Control
PET Tracer
Manufacturing
(Synthesis
Platform)
Radiopharmacy
cGMP
2/
GE /
Global Compliance
Mature/Maturing PET Markets
EU
Russia
USA
Brazil
Japan
Korea
China
3/
GE /
PET Tracer Production & Delivery
Contracts
Purchase and shipment
of FASTlab and
dispenser to PET Tracer
Production Site
TT Process
TT Documents
Implementation
including Training
Written & approved
Application of
Out-of-State Permits
Transport Test Protocol
Written & approved
Transport Test
completed
R&D CMC-S &
QA Approval
Tracer
Production &
Delivery to
Clinical Trials
Sites
External IND
Approval
Transfer Copy of
Imaging Sites RAM
License to
Radiopharmacy
Imaging Sites
Ready with engineering
controls to receive
dose
Manufacturing Facility
cGMP Compliance
Readiness
Method of Transport
4/
GE /
PET Tracer Production & Delivery
cGMP / QA
FASTlab
GE135
& GE067
Dispenser
GE135
& GE067
Clinical Materials
For IMPs
Radiopharmacy
FASTlab
GE148
Dispenser
GE148
Hot Cells
Technology Transfer
5/
GE /
Various Site Set-ups Scenarios
Single Site
A
PET Production
Site 3
GE067 & GE148
30 mins
PET
CLIN/IMA
1
4.0 hrs
CLIN/IMA
3
CLIN/IMA
2
CLIN/IMA
1
Multiple Sites
B
PET Production
Site 2
Multiple Sites –
A more complex
combination
C
GE067
CLIN1
GE067
IMA1
4.5 hrs
CLIN2
CLIN3
CLIN4
PET Production
Site 1
IMA2
CLIN/IMA
1
GE135
1.5 hrs
GE148
CLIN5
CLIN/IMA
2
6/
GE /
PET Tracer Distribution for Clinical Trials
Set-up C
Challenges
Most complex Case:
- Dose Capacity at production site
- PET Production Site
- Delivery of requested doses in
distributing multiple tracers to
multiple out-of-state clinical
sites
required volume
- Coordination of multiple doses to
multiple sites in a single day
- Logistics
Goal
- Ensure delivery of required dose
activity while acquire optimum
Images for the Clinical Trials
Accomplishments
- Continuous monitoring to ensure
dose delivery
- Increased reliability of production
with increase rate of dose requests
- Faster recovery from production
challenges
7/
GE /