Third Targeted Radionuclide Therapy (TRT) Conference

Theme:  What is the goal with radionuclide therapies - palliative, curative, or adjuvant treatment?

8:00–8:15 am

Opening Remarks
Vasken Dilsizian, MD (SNMMI President)
Janet Eary, MD (Associate Director CIP, DCTD, NCI)

Session One: Maximizing dose to tumor while sparing normal tissue

8:15–8:35 am

High vs. low LET radionuclides
Joe O’Donoghue, PhD (MSKCC)

8:35–8:55 am

Using imaging to assess the dose effect on tumor and normal tissue 
Sara St. James, PhD (University of California, San Francisco) 

8:55–9:25 am            

Panel discussion: Modeling and Measuring Dose Effects
Moderator: John Sunderland, PhD (U of Iowa)
Speakers: Eric C. Frey, PhD (Johns Hopkins); Anders Josefsson, PhD (Johns Hopkins); Asha Das, MD (Progenics)

Session Two: Current State of the Science:  Maximizing treatment efficacy

9:25–9:50 am            

Normal tissue toxicity – normal tissue limits from low-dose rate radiation effects
Marjan Boerma, PhD (Arkansas)

9:50–10:10 am            

Agent Optimization: ADME, Dose and Decay
Martin Brechbiel, PhD (NIH)

10:10–10:30 am

Landscape Analysis: Summary of Phase 1 Agents
Joseph Osborne, MD (Weill Cornell)

10:30-10:50 am

Break

10:50–11:20 am

Panel discussion: Targeting strategies for radionuclide delivery 
Moderator: Lalitha Shankar, MD, PhD (Nuclear Medicine, CTB, CIP, NCI)
Speakers: Qing Liang, PhD DABR (Actinium Pharmaceuticals); Charles Limoli, PhD (UC Irvine); Michael Schultz, PhD (U of Iowa)

Session Three: Current State of the Art:  Clinical Trials Design

11:20–11:40 am

Safety Considerations and Use of Quantitative Imaging
Neeta Pandit-Taskar, MD (MSKCC)

11:40 am–12:00 pm

Landscape Analysis: Summary of Phase 2 and 3 Agents
Erik Mittra, MD (OHSU)

12:00–1:00 pm

Lunch

1:00–1:20 pm

Clinical Trial Design Strategies: The Australian Experience
Michael Hofman, MD (Peter MacCallum Cancer Center) – by video

1:20–1:40 pm

Clinical Trial Design Strategies: The German Experience
Winfried Brenner, MD (Charité – University Medical Center Berlin, Germany)

1:40–1:50 pm

Clinical Trial Design: FDA Perspective
Sue-Jane Wang PhD (FDA)

1:50–2:20 pm

Panel discussion: Assessing human toxicities – short and long-term
Moderator: Michael McDonald, MD, PhD (CIP, NCI)
Speakers: Frank Lin, MD (NCI); Tom Hope, MD (UCSF); John Buatti, MD (U of Iowa); Tim Akhurst, MD (Peter MacCallum Cancer Center) – by phone

Session Four: Achieving Response: Strategies

2:20–2:40 pm

Where is the gap?  Framing the right question(s)
Janet Eary, MD (Director CIP, NCI)

2:40–3:00 pm

Prioritization of trial objectives: Analysis of treatment failures and conditions that led to Failure
Charles Kunos, MD, PhD (NCI)

3:00–3:20 pm

FDA Perspective: Therapeutic clinical development considerations
Denise Casey, MD (FDA)

FDA Perspective: Diagnostic clinical development considerations
Anthony Fotenos MD (FDA)

3:20–3:40 pm

Industry’s perspective
Maurizio Mariani, MD, PhD (AAA, a Novartis Company)

3:40-4:00 pm

Break

4:00–4:30 pm

Panel discussion: Rationale for combination therapies, sensitization. and normal tissue protection
Moderator: Bhadrasain Vikram, MD (NCI)
Speakers: Richard Wahl, MD (Washington U); Charles Kunos, MD, PhD (Radiation Oncology, CTEP, NCI); Sandy McEwan, MD, PhD (Ipsen)

4:30–5:00 pm

Publication Planning and Meeting Summary
Michael McDonald, MD, PhD (CIP, NCI)
Daniel Lee, MD (Therapy Center of Excellence President, SNMMI)