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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. PET Tracer Coordination [ F-18] labeled.

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slide1

2010 ACRIN Annual MeetingDistribution of PET Radiopharmaceuticals for Clinical Trials – a GE Healthcare PerspectiveEnsuring delivery of required dose activity while acquiring Optimum Images for the Clinical TrialsSeptember 30, 2010

pet tracer coordination f 18 labeled
PET Tracer Coordination [F-18] labeled

Patient Enrolment

Patient Tracking

Tracer Production

Image Quality

CMC-S

PET Tracer Manufacturing

(Synthesis Platform)

Radiopharmacy

Clinical

cGMP

Clinical /Imaging Sites

Robust Image Quality Control

GE Healthcare

global compliance mature maturing pet markets
Global Compliance Mature/Maturing PET Markets

EU

Russia

USA

Japan

Korea

Brazil

China

pet tracer production delivery
PET Tracer Production & Delivery

Manufacturing Facility cGMPCompliance Readiness

Purchase and shipment of FASTlab and dispenser to PET Tracer Production Site

Contracts

TT Process

Implementation including Training

TT Documents

Written & approved

R&D CMC-S & QA Approval

Application of

Out-of-State Permits

Tracer Production & Delivery to Clinical Trials Sites

Transport Test Protocol

Written & approved

Transport Test completed

External IND Approval

Transfer Copy of Imaging Sites RAM License to Radiopharmacy

Imaging Sites Ready with engineering controls to receive dose

Method of Transport

pet tracer production delivery1
PET Tracer Production & Delivery

cGMP / QA

FASTlab

GE135

& GE067

Dispenser

GE135

& GE067

Radiopharmacy

Clinical Materials

For IMPs

FASTlab

GE148

Dispenser

GE148

Hot Cells

Technology Transfer

various site set ups scenarios
Various Site Set-ups Scenarios

Single Site

CLIN1

A

PET Production

Site 3

PET

CLIN/IMA

1

GE067 & GE148

IMA1

CLIN2

GE067

30 mins

CLIN3

Multiple Sites

CLIN/IMA

3

CLIN4

PET Production

Site 1

CLIN/IMA

2

PET Production

Site 2

B

GE067

CLIN/IMA

1

IMA2

CLIN5

4.0 hrs

Multiple Sites –

A more complex

combination

CLIN/IMA

1

GE135

4.5 hrs

CLIN/IMA

2

GE148

C

1.5 hrs

slide7

PET Tracer Distribution for Clinical Trials

Set-up C

Challenges

  • Most complex Case:
  • PET Production Site distributing multiple tracers to multiple out-of-state clinical sites
  • Dose Capacity at production site
  • Delivery of requested doses in required volume
  • Coordination of multiple doses to multiple sites in a single day
  • Logistics

Goal

Accomplishments

  • Ensure delivery of required dose
  • activity while acquire optimum
  • Images for the Clinical Trials
  • Continuous monitoring to ensure dose delivery
  • Increased reliability of production with increase rate of dose requests
  • Faster recovery from production challenges