CSRC and ICOS Annual Meeting

October 5-6, 2011

CSRC and ICOS Annual Meeting

October 5-6, 2011

FDA White Oak Facility

The CSRC 2011 Annual Meeting is being held in collaboration with the International CardiOncology Society (ICOS.) For more information on ICOS, please visit their website by clicking here.

October 5, 2011 CSRC Annual Meeting

7:30-8:00      Registration and Continental Breakfast

8:00-8:15

• Welcome and Agenda Overview: Mitchell Krucoff, MD (Duke)
• CSRC: What is CSRC and How Do We Work?: John Finkle, MD (GSK)
• ICOS: Who We Are and What We Do: Daniel Lenihan, MD (Vanderbilt)

8:15-9:15

Reports from the CSRC Committees (Moderators: Paul Kligfield, MD (Cornell) and Theressa Wright, MD (Eli Lilly))

• White Papers: Ignacio Rodriguez, MD (Roche)
• Scientific Oversight Committee: Accomplishments and New Initiatives: Ben Eloff, PhD (FDA)
• ECG Database: Paul Kligfield, MD (Cornell)
• Public Programs Update: Philip Sager, MD (Consultant)

– Thinktank Conclusions and Actions from Meetings

– Future Thinktanks

• CSRC Membership: Expanding to Meet Your Needs: Theressa Wright, MD (Eli Lilly)

9:15-10:00

Plenary Session (Moderators: Mitchell Krucoff, MD (Duke) and Norman Stockbridge, MD, PhD (FDA))

• FDA Set the Stage Talk: Rochelle Fink, PhD
• DIA Priorities for the Future: Paul Pomerantz, MBA
• ACC Priorities and the CSRC: Jack Lewin, MD
• FDA CDER Perspective: Douglas Throckmorton, MD

10:00-10:15  Break

10:15-11:45

Current Safety Issues, Product Development, and Impact on Product Development: How Can We Facilitate Innovation? (Moderator: Rick Turner, PhD (Quintiles))

• Device Development Perspective: Justin Mortara, PhD (Mortara Instrument)
• Pharmaceutical Development Perspective: Rick Sax, MD (Quintiles)
• Alignment of Product Development and Cardiovascular Safety: Matthew Killeen, PhD (Decision Resources, LLC)
• Lessons in Device Innovation: An Academic View: Mitchell Krucoff, MD (Duke)
• FDA Device Viewpoint: Owen Faris, PhD (FDA)
• Panel: All Speakers plus Paul Pomerantz, MBA; Jack Lewin, MD; and Philip Sager, MD

11:45-12:15   Lunch

12:15-1:45

Hot Topics Mini-Symposium I: Innovation in Collecting Safety Data via Novel Randomized Trial Approaches or Other Techniques (Moderators: Cindy Green, PhD (Duke) and Philip Sager, MD (Consultant))

• FDA Viewpoint: Matthew Soukup, PhD (FDA)
• NIH Viewpoint for Innovative Trials: Denise Bonds, MD, MPH (NIH)
• Pharmaceutical Development Perspective: Anders Svensson, MD, PhD (Roche)
• Targeted CV Safety Follow-up: John Finkle, MD (GSK)
• FDA Device Viewpoint: Owen Faris, PhD (FDA)
• Device Development Perspective: Hans-Peter Stoll, MD (Johnson&Johnson)
• Academic Viewpoint: Thomas Suter, MD (Bern University)
• Panel: All Speakers

1:45-2:00     Break

2:00-3:30

Hot Topics Mini-Symposium II: Cardiac Safety and Blood Pressure: Do We Need Thorough BP Studies? If so, for all drugs or only for certain drugs? (Moderators: Norman Stockbridge, MD, PhD (FDA) and Adel Nada, MD (Abbott))

• FDA: What is the Issue?: Robert Fiorentino (FDA)
• Industry View: Robert Blaustein, MD, PhD (Merck)
• Measurement Techniques: Manual vs. Automated: What is the ideal approach?: Jeff Heilbraun, MS (Corelab Partners)
• Statistical View (How to evaluate Blood Pressure Increases by Incorporating the drug’s benefit): Cindy Green, PhD (Duke)
• Practical Aspects of BP Assessment: Larry Satin, MD (Cardiocore)
• Panel: All Speakers plus Eric Michelson, MD

3:30-3:50     Break

3:50- 5:15

CSRC Future Directions 1: Strategic Relationships and Collaboration

Moderators: Ignacio Rodriguez, MD (Roche); John Finkle, MD (GSK)

How are our organizations aligned and how can we more closely collaborate?

• ICOS and the CSRC – Joseph Carver, MD
• ACC and the CSRC – Kathleen Hewitt, MSN
• HESI and the CSRC – Syril Pettit, MEM
• DIA and the CSRC – Paul Pomerantz, MD
• Discussion: 20 min

CSRC Future Directions 2: Open Discussion on Procedures, Priorities, Proposals for Research, White Papers, and Thinktanks

Open Discussion: What additional areas should the CSRC focus on in 2012 that are high impact for Public Health?  How do we measure our impact? Procedures, Priorities and Proposals for Research, White Papers, Think Tanks.

5:15

Adjourn

 6:30- 8:30 PM

• Meet and Greet Reception at the Sheraton Washington North

7:30 – 9:00 PM

• CSRC Executive Committee Meeting
• ICOS Executive Committee Meeting

October 6, 2011 – International CardiOncology Society Annual Meeting

Latest Developments in the Treatment of Cardiac Disease in Cancer Patients

7:30-8:00

Registration & Continental Breakfast

8:00-8:10

The History of the International CardiOncology Society (ICOS):  Carlo Cipolla MD and Daniel Lenihan MD

8:10 – 10:00          What is Cardiotoxicity and How does this impact clinicians and their patients?

• 8:10 Is there such a thing as  late cardiotoxicity-or just poorly recognized cardiac injury?:  Daniela  Cardinale, MD
• 8:30 How can Cardiology help in the development and conduct of a clinical trial for Oncology?: Thomas Suter, MD
• 8:50 New Developments In Echocardiographic Detection: Carol Chen, MD
• 9:10 Anti-angiogenic and anti-VEGF therapy: A Cardiovascular view of the disturbed balance between vascular protection and anti- angiogenesis: Bonnie Ky, MD
• 9:30 FDA perspective:  How does cardiotoxicity impact drug approval?: Patricia Cortazar
• 9:45 Case Presentation: JB Durand, MD
• (Panel members discussion)

Moderators:  Michael Ewer MD, Michael Fisch, MD, Mitchell Krucoff, MD

10:00-10:20  Break

10:20-12:00         Recent Developments in the Overlap of Cardiology and Oncology

• 10:20 High dose chemotherapy and stem cell transplantation:  How do Oncology and Cardiology Interact in these patients?:Fabio Ciceri, MD
• 10:40  Are Cardiologists Responding Appropriately to Oncology Colleagues?: Ron Witteles, MD
• 11:00 QT monitoring during Oncology trials-can we realistically expect to learn anything?: Carlo Cipolla, MD
• 11:20 Harmonizing QT interval requirements for clinical research and cardiac safety worldwide.: Daniel Bloomfield, MD

11:40    Panel Discussion:  All speakers

          Case Presentation (during panel):  Alan Kono, MD

Moderators:  JoAnn Lindenfeld MD, Joanna Bell, MD and Philip Sager MD

12:00-12:40  Lunch

Session 3:  Future for Research in CardiOncology

• 12:40 Can cardiac biomarkers, such as high sensitivity troponin, give us better information for the detection of cardiotoxicity?: Maria Teresa Sandri, MD
• 1:00 Research opportunities that arise in the overlap between Cardiology and Oncology: Giuseppe Curigliano, MD
• 1:20  Can point of care cardiac biomarker testing guide cardiac safety during oncology trials?: Daniel Lenihan, MD
• 1:40 FDA perspective- How do we integrate upcoming research into oncology drug development: Gideon Blumenthal, MD

Moderators: John Finkle MD,  Paige McDonald, MD and Richard Steingart MD

Break:   2:20-2:30

Session 4:    Mechanisms for Cardiac Toxicity and Possible Treatments

• 2:30 Mitochondrial mechanisms and markers of cardiotoxicity: Marco Giorgio, MD
• 2:50 MAO Inhibitors for protection and treatment of cardiotoxicity: Fabio Di Lisa
• 3:10 Does understanding the biology of cardiac injury and repair from cancer therapy lead to new cardiac therapy?: Carrie Geisberg, MD
• 3:30 Early phase trials in Oncology-any concern for CardioVascular toxicity?: Apostolia Tsimberidou, MD
• 3:50 FDA Perspective – Getting to the heart of the matter; parternships for understanding cardiotoxicity: Benjamin Eloff, MD

4:10 Panel Discussion: All speakers; Case Presentations: Charlie Porter, MD

Moderators: Thomas Force MD, Aarif Khakoo MD, and Theressa Wright MD

4:30- 4:50

Next Steps/ Closing Remarks

Joseph Carver, Daniel Lenihan, Carlo Cipolla