Chapter 1: 醫 學 工 程 概 論

一、簡介What is Biomedical Engineering? 何謂醫學工程 Apply electrical, chemical, optical, mechanical, and other engineering principles to understand, modify or control biological (i.e., human and animal) systems.

What is Clinical Engineering (i.e., Medical Engineering)? 何謂臨床工程Apply within a hospital or clinic.

What is Bioengineering (i.e., Biological Engineering)? 何謂生物工程Defined as a basic research-oriented activity closely related to biotechnology and genetic engineering, that is, the modification of animal or plant cells or parts of cells to improve plants or animals or to develop new microorganisms for beneficial ends.

Examples: Food Industry for improving fermentation. Agriculture for improving crop yields.

Biotechnology means any technique that uses living organisms (or parts of organisms) to make or modify products, to improve plants or animals, or to develop microorganisms for specific use. The development of materials that mimic molecular structures or functions of living systems is included.

「生物科技」是利用生物程序、生物細胞或代謝物質來製造產品及改進人類生活素質的技術，包括製藥、食品、農業、環保及化工等領域。

「生物技術可能會是亞洲國家創造奇蹟

的新契機」

--- 李遠哲,北京大學一百週年校慶演講 (1998)

生物科技與電子科技的異同生物科技產業 電子資訊業

科技技術 高 高智慧財產權IP 重要 重要資金需求 大 大市場導向 全球 全球政府管制 嚴 較鬆產品上市時間 長 短獲利期間 長 短獲利率 很高 高耗能 低 高

生物科技發展的重要里程碑生物科技發展的重要里程碑 19531953 年年 Waston & CrickWaston & Crick 解讀解讀 DNA double DNA double

helixhelix 的結構的結構 ; ; 並於並於 19621962 年獲得諾貝爾獎年獲得諾貝爾獎 19691969 年分離出第一個基因年分離出第一個基因 19901990 年開始年開始 Human Genome Project Human Genome Project

(HGP)(HGP) 19961996 年英國複製羊年英國複製羊 DollyDolly 成功成功 19981998 年年 CeleraCelera 加入加入 HGPHGP 的競賽的競賽 20002000 年 年 Human Genomics Human Genomics 草圖出版草圖出版 ,, 其其中榮陽團隊貢獻第四對染色體之草圖中榮陽團隊貢獻第四對染色體之草圖

生物科技領域

健康食品

動物用添加劑

生技食品

G M O (g ene m od ified org .)

,基因轉殖動物 花卉

藥用植物

,農業 動物生技

生物性觸媒

生物性環境檢測

微生物製劑

生物環保

其他

H ealth ca re m an eg em en t

H IS -h osp ita l in f. sys tem

R IS -rad iolog y

LIS -- lab ora tory

P A C S

E -h ea lth

P re-clin ica l 動物試驗

C lin ica l tria ls 人體試驗

C R O (con tract reserch org .)

D iag n os tics

/醫療 生技服務

醫藥中間體

原料藥

學名藥

新劑型

藥物傳輸系統

,中草藥 科學化中藥

疫苗

( )新藥研發 含孤兒藥

基因治療

,製藥 治療藥物

Lab-on -ch ip

M icroa rrays

(生物晶片 B ioch ip s )

D N A seq u en cin g

G en om ics

Tran scrip tion tom ics

P roteom ics

B io-C om p u ter

生物資訊 B ioin form a tics

(生物晶片 B ioch ip s )(生物資訊 B ioin form a tics )

醫療儀器

血液製劑

醫療材料

檢驗試劑

, ,醫療儀器 材料 試劑

廣義的生物科技

A Robot in every home

小恐龍 Pleo 美國時代雜誌（ Time magazine ） 2006 年最佳創意專題裡，獲選為最有創意的科技玩具。Pleo 全身有三十四個 sensor 裝置，八個電腦晶片 ，相關 IC 也成為台灣廠商新商機

新藥開發過程新藥開發過程 R&D:Drug discovery for 5 among 5000 (3.5 yearR&D:Drug discovery for 5 among 5000 (3.5 year

s):s):

Clinical Trials: Clinical Trials:

Target Identification

Screen Development Screening

Hit Characterization

Target Validation

Lead Optimization

Pre-clinical Trials

efficacy efficacyside effects adverse reaction

time 1 year 2 years 3 years <1 year = 7 years =10 years

people 20-80 100-300 1000-3000pass rate 70% 33% 27% 20% 400 MM

target healthy patient patient

monitoringfor safety

IND Phase I Phase II Phase III NDADrug

on market Phase IV

December 4, 2006 (New York Times)End of Drug Trial Is a Big Loss for Pfizer By ALEX BERENSONThe news came to Pfizer’s chief scientist, Dr. John L. LaMattina, as he was showering at 7 a.m. Saturday: the company’s most promising experimental drug, intended to treat heart disease, actually caused an increase in deaths and heart problems. Eighty-two people had died so far in a clinical trial, versus 51 people in the same trial who had not taken it.

Within hours, Pfizer, the world’s largest drug maker, told more than 100 trial investigators to stop giving patients the drug, called torcetrapib. Shortly after 9 p.m. Saturday, Pfizer announced that it had pulled the plug on the medicine entirely, turning the company’s nearly $1 billion investment in it into a total loss.

SelfCheck Bp

Smart Box

Vital Belt

Elastic resistive transducer

mobile phone

Mobile Wireless Health Care System

開發檢驗試劑/儀器所需步驟Chemistry/Instrumenation Pre-market studies Regulatory filing Post market

Item Search for key componentand methodology

Comparative studiesInterference andPreclinicl trials(3 sites)

CE/FDA applications Follow ups

Time frame

1.5 – 2.5 years 0.5 – 1 years 0.5 - 1.5 years

Cost 0.5 – 2 million 0.5 – 1 million

表四