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Two Topic Imaging Workshop: Day One - Standards for Imaging Endpoints
in Clinical Trials Day Two - Manufacturing of Positron
Emission Tomography (PET) Radiopharmaceutical Products April 13, 2010 - April 14, 2010 Click here to return to the
workshop website. |
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Day One: Tuesday, April 13, 2010 Workshop One: Standards for Imaging Endpoints in Clinical Trials |
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9:00am |
Welcome/Introductions |
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9:05am |
CDER Perspective on Imaging |
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9:15am |
Workshop Objectives |
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9:30am |
Integrating the Imaging Biomarker
Enterprise: A Roadmap Proposal Developed by
Stakeholders |
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9:50am |
Facilitating the Use of Imaging Biomarkers
in Therapeutic Clinical Trials |
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10:10am |
NCI Perspectives on Developing
Radiopharmaceuticals and Imaging Biomarkers |
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10:45am |
Panel: Standardization and Optimization of
Image Acquisition Discussion topics: · Quality Control Concepts · Equipment and Software Standardization · Phantoms |
Moderator: Orhan H.
Suleiman, M.S., Ph.D., F.A.A.P.M. (CDER/FDA) Panelists: (Huntsman Cancer Institute /SNM) Michael McNitt-Gray, Ph.D.,
D.A.B.R. (UCLA) |
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1:00pm |
Panel: Image Interpretation Discussion topics: · Independent Read Design · Delineation of sources of variability · Potential approaches for resolving variability |
Moderator: Barbara
Stinson, M.D. (CDER/FDA) Panelists: Michael O’Neal, M.D.
(RadPharm) Lalitha Shankar,
M.D., Ph.D. (NIH) Lawrence Schwartz,
M.D. (Columbia University) |
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2:00pm |
Panel:
Management of Imaging Data Discussion
topics: · Acquisition · Display · Transmission · Storage · Analysis |
Moderator: Alex Gorovets,
M.D. (CDER/FDA) Panelists: Brad Erickson,
M.D., Ph.D. (Mayo Clinic) Eliot Siegel, M.D.
(U Maryland/caBIG) Ted Gastineau
(ICON Medical Imaging) |
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3:00pm |
Charge to Breakout Sessions |
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3:30pm |
Challenges and Approaches to
Standardization in Clinical Trials |
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FDA Chairs: Kyle Myers,
Ph.D. (CDRH/FDA) and Orhan Suleiman, M.S., Ph.D., F.A.A.P.M. (CDER) Co-chairs: Michael
Graham, Ph.D., M.D. (SNM) and Greg Sorensen,
M.D. (RSNA) |
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FDA Chairs: Nicholas
Petrick, Ph.D. (CDRH/FDA) and Barbara Stinson, M.D. (CDER) Co-chairs: Peter Conti, M.D.,
Ph.D. (SNM) and Lawrence
Schwartz, M.D. (RSNA) |
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FDA Chairs: Aldo Badano,
Ph.D. (CDRH/FDA) and
Alex Gorovets, M.D. (CDER) Co-chairs: John Hoffman,
M.D. (SNM) and Brad Erickson,
M.D., Ph.D. (RSNA) |
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Day
Two: Wednesday, April 14, 2010 |
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8:30am |
Presentations by Chairs and Co-chairs/ Summaries of Day One |
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10:00am |
Q & A/Transition to Workshop 2:
Manufacturing of Positron Emission Tomography (PET) Radiopharmaceutical
Products |
Dwaine Rieves,
M.D. (CDER/FDA) Wendy Sanhai,
Ph.D., M.B.A. (OC/FDA) |
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Workshop Two: Manufacturing of
Positron Emission Tomography (PET) Radiopharmaceutical Products |
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10:45am |
Regulatory Framework for PET Drugs |
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11:00am |
Current Good
Manufacturing Practice (CGMP) for PET Drugs: 21 CFR212 |
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12:30pm |
Considerations for Chemistry,
Manufacturing and Controls (CMC) CMC Requirements for an Investigational
New Drug Application (IND) Content and format of CMC in a New Drug
Application (NDA) |
Eldon Leutzinger, Ph.D. (CDER/FDA) |
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1:10pm |
Considerations for PET Abbreviated New
Drug Applications (ANDA) |
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1:30pm |
Panel: FDA Perspective on PET
Radiopharmaceuticals Registration and Manufacturing |
Moderator:
Eric Duffy,
Ph.D. (CDER/FDA) Panelists: Frank
Perrella, Ph.D. (CDER/FDA) Eldon
Leutzinger, Ph.D. (CDER/FDA) Ravindra
Kasliwal, Ph.D. (CDER/FDA) Martin Shimer,
R.Ph. (CDER/FDA) |
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2:30pm |
Standardization: Methods, Analysis, and Reporting
from RECIST to PERCIST |
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2:50pm |
Panel Discussion: Industry Perspective on
PET Drug Manufacturing |
Moderator: Sally Schwarz,
M.S. (Washington University) Panelists: Jack Coffey, MS, CHP (Cardinal Health) |
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4:00pm |
Lessons learned from NCI’s FLT F-18 IND
and F-18 NaF NDA |
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4:20pm |
Case Studies: Multicenter Clinical Trials ACRIN (PET
Trials) SNM Academy of
Molecular Imaging (AMI) |
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5:20pm |
Closing Remarks |
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