Scientific Program

Wednesday, 30 November


 07:30  Registration 
08:30  Session I: Opening and Keynote Presentations
 

Chairpersons:
Philip Home, UK
Itamer Raz, Israel
Oliver Schnell, Germany

08:30-08:50
Past and Future in Diabetes Drug Development
Alexander Fleming, Kinexum, USA

08:50-09:10
Lessons Learned from a Century of Diabetes Drug Development
Stefano Del Prato, Italy

09:10-09:30
Discussion

09:30  Coffee Break and visit the Exhibition
10:00  Session II: Current Regulatory Trends in Diabetes Drug Development
 

Chairpersons:
Alexander Fleming, Kinexum, USA
Hiddo J. Lambers Heerspink, The Netherlands

10:00-10:20
EMA Perspective
Giuseppe Rosano, Italy

10:20-10:40
FDA Perspective
Alexander Fleming, Kinexum, USA

10:40-11:00
Industry Perspective
James Nolan, InClinica, USA

11:00-11:20
Scientific/Professional Associations Perspective
Paolo Pozzilli, Italy

11:20-11:40
A Novel Modelling and Simulation Approach to Estimate the Efficacy of a Drug 
Hiddo J. Lambers Heerspink, The Netherlands

11:40-12:00
Discussion

 12:00 Lunch Break and visit the exhibition
 13:00  Session III: Design a Clinical Program for Success
  Chairpersons:
Antonio Ceriello, Spain
Anselm GittGermany

13:00-13:20
Can we Reduce Real Time and Costs?
John New, UK

13:20-13:40
Setting the Grounds for Successful Market Access
James Nolan, InClinica, USA

13:40-14:00
Investigator Initiated Trials and the Role of Industry
Markolf Hanefeld, Germany  

14:00-14:20
Real World Evidence (RWE); Big Data
Anselm Gitt, Germany

14:20-14:40
Why are IITs (Investigator Initiated Trials) essential in Drug Evaluation - Panel Discussion
Antonio Ceriello, Spain
Markolf Haneveld, Germany
Ofri Mosenzon, Israel

14:40-15:00
Discussion

 15:00  Coffee Break and visit the Exhibition
 15:30  Session IV: Operational Aspects in Diabetes CT'S
  Chairpersons:
Manu Venkat, Close Concerns, USA
Andreas Pfuetzner, Germany

15:30-15:50
Public Perception of Clinical Trials for Diabetes
Manu Venkat, Close Concerns, USA
Helen Gao, Close Concerns, USA

15:50-16:10
Rule of Thumb for Successful Site Selection
Andreas Pfuetzner, Germany

16:10-16:30
Tools and Best Practices to Help Clinical Sites Optimize Performance and Maintain Compliance with GCP
Thomas Forst, Profil, Germany

16:30-16:50
Study Management - CRO vs In-house
Thomas Forst, Profil, Germany

16:50-17:10
Discussion

 17:15  Welcome Reception in the Exhibition Area

Thursday, 1 December


 07:30 Registration 
 08:00  Session V: Phase 2 / 3 Studies
  Chairpersons:
Eran Leitersdorf, Israel 
Ingrid Gause-Nilsson, AstraZeneca, Sweden

08:00-08:20
Why are Phase 2 Studies so Often Misleading?
Eran Leitersdorf, Israel 

08:20-08:40
Why is it so Difficult to Design a Dose Finding Study?
Roy Eldor, Israel 

08:40-09:00
Geographical Trends
Paolo Pozzilli, Italy

09:00-09:30
Question and Answers

 09:30
 Session VI:  Cardiovascular Outcome Studies Part 1: Relevant Data Collection
  Chairpersons:
Robert Heine, Eli Lilly and Company, USA
David Packham, Melbourne Renal Research Group, Australia

09:30-09:50

Relevant Data Collection in CVOT - Medical Scientific and Clinical Safety Perspective
Ingrid Gause-Nilsson, AstraZeneca, Sweden

09:50-10:10
Will HbA1c remain a valid surrogate endpoint? Implication of recent CVOT results in diabetes
Maximilian von Eynatten, Boehringer Ingelheim, Germany

10:10-10:30
Discussion

 10:30 Coffee Break and visit the Exhibition
 11:00  Session VII: Cardiovascular Outcome Studies Part 2: Design, Interpretation and Translation
  Chairpersons:
John Lachin, USA
Stefano Del Prato, Italy

11:00-11:40
Statistical Considerations in Design and Analysis 
John Lachin, USA

11:40-11:55
The Value of Post Hoc Analyses
Ran Oren, Israel

11:55-12:10
Translating CVOTs into Clinical Practice
Oliver Schnell, Germany

12:10-12:40
Debate: In a Clinical Development Program clinically meaningful Safety Signals can be reliably determined

12:10-12:25

CON - Philip Home, UK
12:25-12:40
PRO - Robert Heine, Eli Lilly and Company, USA

12:40-13:00
Questions and Answers

 13:00
Lunch Break and visit the Exhibition
 14:00 Session VIII: GCP Learning and Best Practice
  Chairpersons:
Eberhard Standl, Germany
Ran Oren, Israel

14:00-14:20
Pharmaceutical Companies Involvement
Eberhard Standl, Germany

14:20-14:40
An Auditor Perspective/Preparing Yourself for a Successful Audit
Gayle van Krevelen, Julius Clinical, The Netherlands

14:40-15:00
Best Practice: Making a Case for a Drug’s Effectiveness and Cost Effectiveness
Amanda Adler, Addenbrooke’s Hospital, Cambridge, UK

15:00-15:30

Discussion

 15:30
Coffee Break, visit the Exhibition and Guided Poster Walk
 16:30  Session IX: Special National Program to Enhance Drug Development
  Chairperson:
Itamar Raz, Israel

16:30-16:50

Special National Program to Enhance Drug Development
Ofri Mosenzon, Israel

16:50-17:10
Panel Discussion
Itamar Raz, Israel, Philip Home, UK, Alexander Fleming, USA, Stefano Del Prato, Italy,  
Oliver Schnell, Germany

17:10    Closing Remarks