台灣生技的未來==> how about FDA drug-diagnostic codevelop - 生技

※ 引述《echo (KEEP WALKING)》之銘言：

: 不好好為人民的用藥把關，反而為產業界著想，這實非人民之福。
: 扯的遠了~ 台灣生技製藥產業的未來在哪? 在各位的壯志雄心之中。



對不起，小弟打字慢，to put it in English


Why not try recently draft from FDA April 2005

April 8, 2005 FDA published a Drug Diagnostic Co-development Concept Paper


http://www.fda.gov/cder/genomics/pharmacoconceptfn.pdf


Taiwan should put focus on diangostic kits
less effort and capital,easier to success, comparing the biomarkers
discoveries and labeling new drug


For example,
irresa (EGFR-TKI) its responsive mutations (exon 18-21, caltalytic kinase
binding) are recongized and confirmed. Even its resistence mutations are
also reported (NEJM, 2005).

In view of long listed EGFR-TKIs in the phrase II, III, and even downstream
inhibitors in trails and development (JCO, 2005),

there is considerable clinical demand in selecting optial drug for right
patient, i.e. pharmacogenomics or personalized medicine
(molecular typing of cancer as clinical antibiotics sensitivies tests)

Given example of FDA appoved first phamacogenetic diagnostic kits
(Roche and Affymetrix) together with FDA MAQC project schedule (translating
microarray into clinical practice in end of 2007 or early 2008) and
FDA multiplex tests draft (2003 Feb),

pharmacogenomics or personalized medicine (highly racial difference)
is going to realized in the near future.

Comments are welcomed.



Contacts:

Stanley CY Peck, MD (heading for further Ph.D)



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