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Draft Agenda

April 13, 2010 - April 14, 2010
Two Topic Imaging Workshop:
 Day One - Standards for Imaging Endpoints in Clinical Trials
Day Two - Manufacturing of Positron Emission Tomography (PET) Radiopharmaceutical Products

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View Speaker and Panelist Biosketches
April 13, 2010

Day One

Workshop One

 

Standards for Imaging Endpoints in Clinical Trials

8:00 a.m.

Registration and Continental Breakfast

9:00 a.m.

Welcome/Introductions 
Speaker: Dwaine Rieves, M.D. (CDER/FDA)

9:05 a.m.

CDER Perspective on Imaging
Speaker: Janet Woodcock, M.D. (CDER/FDA)

9:15 a.m.

Workshop Objectives 
Speakers: Orhan Suleiman, M.S., Ph.D., F.A.A.P.M. (CDER/FDA), Alex Gorovets, M.D. (CDER/FDA)

9:30 a.m.

Integrating the Imaging Biomarker Enterprise:  A Roadmap Proposal Developed by Stakeholders
Speaker:  Daniel C. Sullivan, M.D. (RSNA)

9:50 a.m.

Facilitating the Use of Imaging Biomarkers in Therapeutic Clinical Trials
Speaker: Michael Graham, Ph.D., M.D. (SNM)

10:10 a.m.

NCI Perspectives on Developing Radiopharmaceuticals and Imaging Biomarkers
Speaker:  James Tatum, M.D. (NCI)

10:30 a.m.

Break

10:45 a.m.  

 

Panel: Standardization and Optimization of Image Acquisition  
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)
Discussion topics:

  • Quality Control Concepts  
  • Equipment  and Software Standardization
  • Phantoms

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m.

 

Panel: Image Interpretation   
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), Jyoti Zalkikar, Ph.D, (CDER/FDA), Daniel Rubin, M.D., M.S. (ACRIN)

  • Independent  Read Design
  • Delineation of sources of variability
  • Potential approaches for resolving variability

2:00 p.m.

 

Panel: Management of Imaging Data
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)
- Acquisition
- Display
-Transmission
- Storage
- Analysis

3:00 p.m.

Charge to Breakout Sessions  
Speaker: Wendy Sanhai, Ph.D., M.B.A. (OC/FDA)

3:15 p.m.

Break

3:30 p.m.

Challenges and approaches to standardization in clinical trials
(questions will be proposed for discussion in each breakout session)

Breakout Session 1:  Image Acquisition
FDA Chair: 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 Chair:  Nicholas Petrick, Ph.D. (CDRH/FDA) and Barbara Stinson, M.D. (CDER)   
Co-chairs: Peter Conti, M.D., Ph.D. (USC) for SNM and Lawrence Schwartz, M.D. (Columbia University) for RSNA

Breakout Session 3:  Management of Imaging Data
FDA Chair: Aldo Badano, Ph.D. (CDRH/FDA)     
Co-chairs: John Hoffman, M.D. (SNM) and  Brad Erickson, M.D., Ph.D. (RSNA)

5:00 p.m.

End of Day 1

April 14, 2010

Day Two


7:30 a.m.

Registration and Continental Breakfast

8:30 a.m.

Presentations by Chairs and Co-chairs/ Summaries of Day 1

10:00 a.m.

Q & A / Transition to Workshop Two: Manufacturing of Positron Emission Tomography (PET) Radiopharmaceutical Products
Speakers: Dwaine Rieves, M.D. (CDER/FDA), Wendy Sanhai, Ph.D., M.B.A. (OC/FDA)

10:30 a.m.

Break

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

10:45 a.m.

Regulatory Framework for PET Drugs
Speaker: Eric Duffy, Ph.D. (CDER/FDA)

11:00 a.m.

Current Good Manufacturing Practice (CGMP) for PET Drugs: 21 CFR212
Speaker: Frank Perrella, Ph.D. (CDER /FDA)

11:30 a.m. – 12:30 p.m.

Lunch

12:30 p.m.

 

Considerations for Chemistry, Manufacturing and Controls (CMC) 

-CMC Requirements for an Investigational New Drug Application (IND)  
Speaker: Eldon Leutzinger, Ph.D. (CDER/FDA)

- Content and format of CMC in a New Drug Application (NDA)
Speaker: Ravindra Kasliwal, Ph.D. (CDER/FDA)

1:10 p.m.

Considerations for PET Abbreviated New Drug Applications (ANDA)
Speaker:  Martin Shimer, R.Ph. (CDER/FDA)

1:30 p.m.

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)

2:15 p.m.

Break

2:30 p.m.

Standardization: Methods, Analysis, and Reporting from RECIST to PERCIST
Speaker: Richard Wahl, M.D. (Johns Hopkins)

2:50 p.m.

 

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

4:00 p.m.

Lessons learned from NCI’s FLT F-18 IND and F-18 NaF NDA
Speaker: Paula Jacobs, Ph.D. (NCI)

4:20 p.m.

 

Case Studies: Multicenter Clinical Trials

ACRIN (PET Trials)
Speaker: Mitchell Schnall, M.D., Ph.D.

- SNM 
Speaker: Michael Graham, Ph.D., M.D. (SNM)

- Academy of Molecular Imaging
Speaker: Martin Allen-Auerback, M.D.

5:20 p.m.

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

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