Scientific Program

Thursday, 16 March

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

Chairperson: Raanan Berger, Israel

Novel Immunotherapeutic Combination Clinical Trials
Shilpa Gupta, University of Minnesota, USA

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

Basic Translational Introduction: Immunology Perspective
Gal MarkelSheba Medical Center, Israel

New Approaches in Immunotherapy Drug Development – Physicians Perspective
Talia Golan
Sheba Medical Center, Israel

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

Evolution of Molecular Diagnostics and Patient Selection Strategies in Haematology Clinical Trials
Robin Foà, Sapienza University, Italy

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

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

 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

Receiving Tomorrow’s Medicines Today – The Patient’s Perspective
Matt Ellefson, SURVIVEiT®, USA 
Survival Time Endpoints in Oncology Trials
Diana GiannarelliRegina Elena National Cancer Institute, Italy
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

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

An Auditor Perspective/Preparing Yourself for a Successful Audit
Gayle van Krevelen, Julius Clinical, Netherlands 

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

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

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
Financial Aspects of an Oncology Clinical Trial - Sponsor Perspective
Henrik Torp Nielsen, Head of Development Finance, Oncology Region Europe, Novartis, Switzerland

Budgeting Clinical Trials in Oncology
Ivana Matic
, Site Ready & Support Lead – Global CollaborationMSD, Austria 

Panel Discussion

 10:30  Coffee Break, Poster Viewing and visit the Exhibition
 11:00  Session VII: Personalized Medicine  
Chairperson: Raanan Berger, Israel
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 

How Realistic is Tissue Biopsy in Clinical Trials – Approach and Implementation
Raanan BergerOncology Institute, Sheba Medical Center, Israel

Liquid Biopsy
Giulia Siravegna, Molecular Oncology Lab, Candiolo Cancer Institute, Italy

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

How to Develop and Obtain Regulatory Approval for an Early Diagnostic Test for Cancer
Lucy Gilbert, McGill University, Canada 

Aspects of Monitoring Clinical Trials in the Era of Immunotherapy

Marta Arias-Salgado, MSD, The Netherlands

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

 15:30  Closing Remarks