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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
Agenda

 

Click here to return to the workshop website.

 

Day One: Tuesday, April 13, 2010

Workshop One: Standards for Imaging Endpoints in Clinical Trials

 

 

 

9:00am

Welcome/Introductions

Dwaine Rieves, M.D. (CDER/FDA)

 

 

 

9:05am

CDER Perspective on Imaging

Janet Woodcock, M.D. (CDER/FDA)

 

 

 

9:15am

Workshop Objectives

Orhan Suleiman, M.S., Ph.D., F.A.A.P.M. (CDER/FDA)

Alex Gorovets, M.D. (CDER/FDA)

 

 

 

9:30am

Integrating the Imaging Biomarker Enterprise:

A Roadmap Proposal Developed by Stakeholders

Daniel C. Sullivan, M.D. (RSNA)

 

 

 

9:50am

Facilitating the Use of Imaging Biomarkers in Therapeutic Clinical Trials

Michael Graham, Ph.D., M.D. (SNM)

 

 

 

10:10am

NCI Perspectives on Developing Radiopharmaceuticals and Imaging Biomarkers

James Tatum, M.D. (NCI)

 

 

 

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:

Brian Zimmerman, Ph.D. (NIST)

Paul Christian, C.N.M.T.

(Huntsman Cancer Institute /SNM)

Michael McNitt-Gray, Ph.D., D.A.B.R. (UCLA)

Edward Jackson, Ph.D. (MD Anderson)

Laurence Clarke, Ph.D. (NCI)

Paul Kinahan, Ph.D. (U Washington)

 

 

 

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 ONeal, M.D. (RadPharm)

Lalitha Shankar, M.D., Ph.D. (NIH)

Lawrence Schwartz, M.D. (Columbia University)

Jyoti Zalkikar, Ph.D. (CDER/FDA)

Daniel Rubin, M.D., M.S. (Stanford/ACRIN)

 

 

 

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)

John Sunderland, Ph.D. (U Iowa)

Lori Dodd, Ph.D. (NIAID)

 

 

 

3:00pm

Charge to Breakout Sessions

Wendy Sanhai, Ph.D., M.B.A. (OC/FDA)

 

 

 

3:30pm

Challenges and Approaches to Standardization in Clinical Trials

 

 

 

 

 

Breakout Session 1: Image Acquisition

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)

 

 

 

 

Breakout Session 2: Image Interpretation

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)

 

 

 

 

Breakout Session 3: Management of Imaging Data

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)

 

 

 

 

Day Two: Wednesday, April 14, 2010

8:30am

Presentations by Chairs and Co-chairs/

Summaries of Day One

 

 

 

 

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)

 

Workshop Two: Manufacturing of Positron Emission Tomography (PET) Radiopharmaceutical Products

10:45am

Regulatory Framework for PET Drugs

Eric Duffy, Ph.D. (CDER/FDA)

 

 

 

11:00am

Current Good Manufacturing Practice (CGMP) for PET Drugs: 21 CFR212

Frank Perrella, Ph.D. (CDER/FDA)

 

 

 

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)

 

 

Ravindra Kasliwal, Ph.D. (CDER/FDA)

 

 

 

1:10pm

Considerations for PET Abbreviated New Drug Applications (ANDA)

Martin Shimer, R.Ph. (CDER/FDA)

 

 

 

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)

 

 

 

2:30pm

Standardization: Methods, Analysis, and Reporting from RECIST to PERCIST

Richard Wahl, M.D. (Johns Hopkins)

 

 

 

2:50pm

Panel Discussion: Industry Perspective on PET Drug Manufacturing

Moderator:

Sally Schwarz, M.S. (Washington University)

Panelists:

Steven Zigler, Ph.D. (PETNET)

Jack Coffey, MS, CHP (Cardinal Health)

Richard Frank, M.D., Ph.D. (GE)

Anwer Rizvi (IBA)

John Lister-James, Ph.D. (Avid)

 

 

 

4:00pm

Lessons learned from NCIs FLT F-18 IND and F-18 NaF NDA

Paula Jacobs, Ph.D. (NCI)

 

 

 

4:20pm

Case Studies: Multicenter Clinical Trials

ACRIN (PET Trials)

SNM

Academy of Molecular Imaging (AMI)

 

Mitchell Schnall, M.D., Ph.D

Michael Graham, Ph.D., M.D.

Martin Allen-Auerbach, M.D.

 

 

 

5:20pm

Closing Remarks

Chekesha Clingman, Ph.D. (OC/FDA)