FDA-Duke Global Regulatory Pre-Workshop
White Flint Amphitheater
Date: Tuesday, May 7, 2019
8:00 – 8:30 AM
Registration/Continental Breakfast
8:30 – 8:35 am
Session I: International Regulators’ Forum
| Agnes Chan | Singapore HSA |
| Larissa Higgins | EMA Representative |
| Jaigi Mathai | Health Canada |
| Jan Mueller-Berghaus | Germany PEI |
| Sumimasa Nagai | Japan PMDA |
| Kelly Norsworthy | US FDA |
| Ho Jung Oh | Korea MFDS |
| Anuradha Poonepalli | Singapore HSA |
| S. Eswara Reddy | India CDSCO |
| Arun Singhal | Government of India |
| Joohee Sul | US FDA |
| Reiko Yanagihara | Japan PMDA |
| Hong Zhang | China NMPA |
| Ming Zhou | China NMPA |
10:05 – 10:30 am
Break
Session II: Academic Investigators’ Perspectives
Panelists
| Xiaoyuan Chen | Tsinghua University |
| Thomas Gross | National Cancer Institute |
| Abiola Ibraheem | University of Chicago |
| University of Chicago | |
| Jun Ren | China Capital Medical University |
| Martin Stockler | The University of Sydney |
11:45 – 12:45 pm
Lunch
Session III: Oncology Drug Development and Approval in China
Panelists
| Tao Fu | Zai Laboratory |
| Xiaoyuan Chen | Tsinghua University |
| Frank Jiang | CStone |
| Jian Peng | Shenogen Pharma Group |
| Dan Zhang | Fountain Medicine |
2:05 – 2:25 pm
Break
2:25 – 3:45 pm
Moderator
Joseph Arena, Pfizer
Session IV: Industry’s View on Global Drug Development
Panelists
| Jonathan Cheng | Merck |
| Chitkala Kalidas | Bayer |
| Geoff Kim | AstraZeneca |
| Rominder Singh | Pfizer |
| Craig Tendler | Janssen |
3:45 – 4:45 pm
Moderator
Kate Rawson, Prevision Policy
Session V: What Media Say about Global Drug Development
Panelists
| Joshua Berlin | Biocentury |
| Nielsen Hobbs | The Pink Sheet |
| Sarah Karlin-Smith | Politico |
| Steve Usdin | Biocentury |
| Craig Tendler | Janssen |