Scientific Program

Thursday, 16 March


 07:30  Registration 
 08:30  Session I: Welcome and Keynote Presentation
 

Chairperson: Raanan Berger, Israel

08:30-09:00
Novel Immunotherapeutic Combination Clinical Trials
Shilpa Gupta, University of Minnesota, USA

 09:00  Session II: Clinical Trials in Immunology
 
Chairperson: Talia Golan, Israel

09:00-09:30
Basic Translational Introduction: Immunology Perspective
Gal MarkelSheba Medical Center, Israel

09:30-10:00
New Approaches in Immunotherapy Drug Development – Physicians Perspective
Talia Golan
Sheba Medical Center, Israel

10:00-10:30
Immunotherapy Trials in Ovarian Cancer – Challenges and Opportunities that Investigators and Sponsors Need to be Vigilant About
Lucy Gilbert, McGill University, Canada 

 10:30  Coffee Break, Poster Viewing and visit the Exhibition
 11:00  Session III: Companion Diagnosis and Clinical Trials
 
Chairperson: Michele Milella, Italy

11:00-11:30
Evolution of Molecular Diagnostics and Patient Selection Strategies in Haematology Clinical Trials
Robin Foà, Sapienza University, Italy

11:30-12:00
Development of Companion Diagnostic in Solid Tumors: Successes and Failures
Michele Milella, Regina Elena National Cancer Institute, Italy

12:00-12:30
Omics-Based Diagnostics: Just for Discovery or Bedside Tools?
Aldo Scarpa
University of Verona, Italy

 12:30  
12:30-13:00
 Sponsored Symposium supported by 

 Oncology Studies Facilitated by Taking Study Visits to the Patients
 Robin Marcus, Global Care Clinical Trials, USA 

 13:00 Lunch Break, Poster Viewing and visit the Exhibition
 14:00  Session IV: End Point in Oncology
 
Chairperson: Raanan Berger, Israel

14:00-14:30
Receiving Tomorrow’s Medicines Today – The Patient’s Perspective
Matt Ellefson, SURVIVEiT®, USA 
 
14:30-15:00
Survival Time Endpoints in Oncology Trials
Diana GiannarelliRegina Elena National Cancer Institute, Italy
            
15:00-15:30
Keys to a Successful Pivotal Trial Design in Oncology
Andrew Stone, Stone Biostatistics, UK

 15:30  Coffee Break, Poster Viewing and visit the Exhibition
 16:00  Session V: Risk-Based Monitoring and Regulations
 
Chairperson: Aliza Ackerstein, Israel

16:00-16:30
Risk Based Monitoring: Pro and Con
Lihi Bodenuk, Country Study Manager, Roche Pharmaceuticals Israel

16:30-17:00
An Auditor Perspective/Preparing Yourself for a Successful Audit
Gayle van Krevelen, Julius Clinical, Netherlands 

 17:00  Free Paper Presentations
   
Chairperson: Michele Milella, Italy
             
17:00-17:10
Biosimilars Clinical Trials Design and Execution: Challenges from Sponsor Perspective
Laura UllateClinical Operations, Mabxience, Spain

17:10-17:20
Clinical Trials for Cancers of Unknown Primary in the Tumor Profiling and Immunotherapy Era
Hari Deshpande
Medical Oncology, Yale Cancer Center, Yale University, Smilow Cancer Hospital, USA

17:20-17:30
Association between Phase II Trials Design and Successful Subsequent Phase III Trials
Sabrina VariMedical Oncology, Regina Elena National Cancer Institute, Italy

 17:30  Networking Reception in the Exhibition Area

Friday, 17 March 

 08:00 Registration 
 09:00 Session VI: Panel Discussion: Finance & Reimbursement
 
Chairperson: Aliza Ackerstein, Israel
             
09:00-09:30
Financial Aspects of an Oncology Clinical Trial - Sponsor Perspective
Henrik Torp Nielsen, Head of Development Finance, Oncology Region Europe, Novartis, Switzerland

09:30-10:00
Budgeting Clinical Trials in Oncology
Ivana Matic
, Site Ready & Support Lead – Global CollaborationMSD, Austria 

10:00-10:30
Panel Discussion

 10:30  Coffee Break, Poster Viewing and visit the Exhibition
 11:00  Session VII: Personalized Medicine  
 
Chairperson: Raanan Berger, Israel
             
11:00-11:30
Drug Discovery in Translational and Clinical Research Programs of the University of Michigan Comprehensive Cancer Center (UMCCC) & Centers for Discovery of New Medicine & Chemical Genomics
Laurence Baker, University of Michigan Comprehensive Cancer Center, USA 

11:30-12:00
How Realistic is Tissue Biopsy in Clinical Trials – Approach and Implementation
Raanan BergerOncology Institute, Sheba Medical Center, Israel

12:00-12:30
Liquid Biopsy
Giulia Siravegna, Molecular Oncology Lab, Candiolo Cancer Institute, Italy

12:30-13:00
Understanding RECIST
Stephen P. RaskinSheba Medical Center, Israel 

 13:00  Lunch Break, Poster Viewing and visit the Exhibition
 14:00  Session VIII:  Best Practices in Clinical Trials
 
Chairperson: Talia Golan, Israel

14:00-14:30
How to Develop and Obtain Regulatory Approval for an Early Diagnostic Test for Cancer
Lucy Gilbert, McGill University, Canada 

14:30-15:00
Aspects of Monitoring Clinical Trials in the Era of Immunotherapy

Marta Arias-Salgado, MSD, The Netherlands

15:00-15:30
Conducting Cancer Clinical Trials in Brazil & Latin American Countries: Opportunities and Challenges
Andréa Saud Martinez
Atlantis Clinical LLC, USA 

 15:30  Closing Remarks