Session 3:

Newer Targets (Part 2)

Chair: Agnes Fogo, USA

08:15 - 08:35

FGF23/FGF receptors/Klotho for calcium and phosphate homeostasis

Makoto Kuro-o, Japan

08:35 - 08:55

Sirtuin-3 for senescence and aging

Ariela Benigni, Italy

08:55 - 09:15

PAI-1 as a molecule regulating vascular regeneration and senescence

Douglas Vaughan, USA

09:15 - 09:25

Discussion

09:25 - 09:55

Coffee Break and Poster Viewing

Session 4:

Collaboration among Academia, Pharma and the Regulator (Part 1)

Chairs: Chih-Wei Yang, Taiwan, Vivekanand Jha, India

09:55 - 10:15

Drug discovery and clinical development: respective role of academia

Toshio Miyata, Japan

10:15 - 10:35

Regulatory Science and global clinical trials: views of a biostatistician

Masahiro Takeuchi, Japan

10:35 - 10:55

Respective roles of academia and industry: messages from pharma

Seigo Izumo, Japan

10:55 - 11:15

Approach to partnership - academia, pharma, and governmental organization: message from Latin America

Ricardo Correa-Rotter, Mexico

11:15 - 11:35

Approach to partnership - academia, pharma, and governmental organization: message from China

Zhi-Hong Liu, China

11:35 - 11:50

Discussion

11:50 - 12:20

Keynote Lecture 2

Chairs: Giuseppe Remuzzi, Italy

50 years of nephrology. Much progress but miles to go before we sleep

Barry M. Brenner, USA

12:20 - 13:35

Potential Industry (Lunch) Symposium 1

Session 5:

Regulatory Science

Chairs: Giuseppe Remuzzi, Italy and Toshio Miyata, Japan

13:35 - 13:55

Presentation from an FDA representative

13:55 - 14:15

Current regulatory issues and strategies by PMDA

Tsuyoshi Ando, Japan

14:15 - 14:35

Regulatory issues and strategies by EMA

Romaldas Maciulaitis, Lithuania

14:35 - 15:05

Keynote Lecture 3

Chairs: Toshio Miyata, Japan

What academicians and pharma are expecting from regulatory authorities and barriers to overcome

Silvio Garattini, Italy

15:05 - 15:25

Panel discussion

Chairs: Giuseppe Remuzzi, Italy and Toshio Miyata, Japan

Discussants: 3 speakers from the regulator

15:25 - 15:45

Coffee Break and Poster Viewing

Session 6:

Clinical Endpoints

Chairs: Dick De Zeeuw, The Netherlands and David G. Warnock, USA

15:45 - 16:05

Kidney volumes and/or GFR in ADPKD trials

Albert Ong, UK

16:05 - 16:25

Specific end points for AKI trials

Raymond Vanholder, Belgium

16:25 - 16:45

Estimated vs measured GFR for disease progression

Piero Ruggenenti, Italy

16:45 - 17:05

Short term changes in multiple on-target and off-target risk markers as a
substitute for hard renal endpoints

Hiddo Lambers Heerspink, The Netherlands

17:05 - 17:20

Discussion

17:20 - 18:20

Potential Industry Symposium 2