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this is a test

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Title: 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
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