this is a test

1
?????? ???????????????????

• ?????
• ??????? ??????????
• 2010?6?29?

2
????

• ????
• ?????????????
• ?????

3
??????????

• ???????????,???????????????????,????????,????????,
  ????????????????????,????????????

4
??????? (1)

• ????????????????????????,???????????????????????

????? ??? ????
??? ??? ??? ??? ??? ??? ??? ?? ??? ???
5
??????? (2)

• ????????????,????????,???????

?????(DBPR)??????????,?????????,????????,?????????
???????? (Research Institute)
6
DBPR Development
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
????? ?????
????? ????? (????)
????? (??)
????
???????
??????? ???? / ??
????Outstanding
???????????????????
??????????????????
??????????????????
7
DBPR????
110144
6276
1844
?????????
8
Integrated Drug Discovery Teams
????
??? ?? ??? ?? ??? ???
??????
???? ????/??????
??? ??? ??? ??? ??? ??? ???
??????
??? (???)
????/????
??? ???
????
??? ???
Pharmaceutical Research Development
???
Visiting Professor
9
DBPR Ongoing Drug Discovery Projects

• Anti-Cancer
• Aurora Kinase Inhibitors
• EGFR Kinase Inhibitors
• FLT-3 Kinase Inhibitors
• Anti-Metabolic Disease
• Dipeptidyl Peptidase (DPP-IV) Inhibitors
• Sodium Dependant Glucose Transporter (SGLT2)
  Antagonists
• Glucagon Like Peptide I (GLP-1) Receptor
  Agonists
• Cannabinoid I Receptor (CB-1) Antagonists
• Anti-Infectious Diseases
• Hepatitis C (HCV) NS5A Inhibitors
• Pain Relievers (2010)

10
Meet Medical Challenges

• ????????????????????????????????????
• ?SARS???? ????????????????????????,20????SARS??
  (2004?)
• ????????? ?18???1.5??????????,???????????????????
  ?????,?????????? (2005?)
• ????????????????????????????????????????????,????
  ???????????????? (2006?8???)

11
DBPR from Discovery to Development
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Discovery
Development
??????
DBPR104 DBPR204
???????????
????
??????
? HCV????
????/ Genelabs
BPR000X
????
DBPR303
??????????
DBPR108
????????
???????
????
Leads
12
?????? DBPR104

• ????????????????,?????????????????????????
• ?????2009?12???????????????US FDA?? pre-IND
  meeting
• ???2010??? IND submission (US Taiwan)

13
????????????????????DBPR108???????????(??????1
2.1.2008-6.30.2012)(Total budget
NT1?7?5??,??????)

• ???????? / ????/
• ???? /????/????/
• ???? / ????

14
DBPR108 ????

• DBPR108 DPP-IV???,???????????
• ???????,?????????????????????????????????
• ?? USA/Taiwan IND ,???????????? I ?
• ????,??????????,?????????????????
• ????(??????)??????????????

15
DBPR108 Drug Development Team
Formerly with
Pharmaceutical Development
???
Schering Plough
?????
PK/DM Toxicokinetics
???
BMS
???
Toxicology/Safety Pharmacology
Sepracor
Sanofi-Aventis
???
Clinical Studies
???
Project Management
Merck
Visiting professor
16
DBPR108 Development Project Timeline
?? ??/???? 2009 2009 2010 2010 2011 2011 2012 2012
?? API ??(GMP)
?? CMC profile ??????
?? ???????????(GMP)
?? CMC profile ??????
??????? PK ??(??/??/?)
??????? ???????
??????? ?????????????
??????? CYP isoymes ?????????
??????? ????????????/??/??
??????? ??2??????????
??????? ????????13??????????(TK)
??????? ??4?????????(TK)
??????? ???????????4?????????(TK)
??????? ??????
??????? ??????????????
?????? ???????????(?)
?????? ??????????(??)
?????? ????????????(??)
IND ??????/IND package ??
IND ???IND ?? (US/Taiwan)
IND ???????
YSC 05/25/2010
17
?????????? DBPR(Division of Biotechnology and
Pharmaceutical Research)
???????? IBPR (Institute of Biotechnology and
Pharmaceutical Research)

• As a Division
• ????????????????
• ???????????
• ?????????????????
• ??????????????????(discovery to development)
• ??????
• ???????????????????

• Major Achievement
• ???????????????????
• ??????????????????,?????????
• ??33?????,12???????  (up to date)
• ??225????? (up to date)
• ????????????????????
• ?????????????????????

18
?????

1. ????????,?????????,??????????????
2. ????????????,????????
3. ?????????????????,??????????????????

19
???????
?? Director
????? Scientific Advisory Board
???Associate Director ????? Drug Research
Division
???Associate Director ????? Drug Development
Division

• ?????
• Pre-clinical Development
• - ???????
• - ??????
• non-GLP????
• ??
• ??GLP?????????

• ????
• Pharmaceutical
• Development
• - ??????
• - ?????
• - ??????
• ??/ ????
• ?????
• - ????????

• ??????
• Molecular Pharmacology
• - ????
• - ????

• ????????
• Drug Screening Technology Platform
• - ????????
• - ?????????

• ??????
• Medicinal Chemistry
• - ????
• - ??????

• ????
• Administration Office
• - ???????
• - ???????
• ????????
• ??
• - ???????
• - ??????
• ?????????
• ?????????

Institute of Biotechnology Pharmaceutical
Research (IBPR)
20
??? Vision

• ????
• ????????????(2009??2013?)
• ???????????????????
• ??????????? (2011??2016?)
• ???????,??????????????,?????
• ??
• ??????,??????(Discovery) ???(Development),????????
  ?
• ?????????????????????
• ??
• ????????????
• ?????????????,????????
• ????????????????????
• ??????????CRO?????,??????????
• ??
• ????,?????????????,???????????????,????????????,??
  ???????

21
Acknowledgements

• ???????
• ???????????(NSTP, NSC)
• Dr. Ming-Chu Hsu
• Dr. Chung-Ming Chang
• DBPR RD Teams
• DBPR Administrative Team
• DBPR Adjunct/Visiting Professors
• DBPR Scientific Advisory Board