行业故事:山水有相逢

入得谷来,祸福自求。
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Jun
Posts: 26025
Joined: 2003-12-15 11:43

行业故事:山水有相逢

Post by Jun » 2020-09-18 8:47

话说年初疫情正闹的时候,我跟一家 consulting 公司签了合同,他们主要是做帮药厂递新药申请的工作,我就帮他们写写和修改文档啥的。

今天老总来找我接一个新项目,我说大佬啊,最近我真的忙到四脚朝天,只剩下吃饭睡觉的工夫,没时间接新项目哎。他说工作量很少的啦,背景材料都有了,你修改下就好了嘛,而且都是下个月要做。我看公司名是神经系统药,个人比较有兴趣,就接了。

然后他就把药名发给我了。哇!吓一跳!这个妹妹我认识! :rabbit001: (就算没读过红楼梦也看过电视剧。)

大约七年前,我刚脱离体制跑出来临时工的干活,被一个老同事拉进某IND研发项目,就是这个药!!! 当时它在另一家小公司手中——这家小公司本身也很有趣,老板是在其它行业发财了之后半路出家买下了这个药打算开发一下。后来他们钱不够做临床的,就把它转手倒卖给另一家公司。当时我觉得数据麻麻,估计成功率不高,也许过两年就自然死亡了。

没想到还没死!这家药厂在外国做了一个临床,数据怎么样我不知道,但是显然没彻底失败,现在又杀回了美国重新开启临床试验。兜兜转转又落到了我的手中 ... :f20: 真的好神奇哦。
There was nothing to warn anyone about. The world went on, even as it fell apart, changed irrevocably, became something strange and different. --- "Acceptance" in The Southern Reach Trilogy by Jeff VanderMeer

Knowing
Posts: 32824
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Re: 行业故事:山水有相逢

Post by Knowing » 2020-09-18 8:57

什么是IND?
所以这个药还在做?
Nevertheless, she persisted.

Jun
Posts: 26025
Joined: 2003-12-15 11:43

Re: 行业故事:山水有相逢

Post by Jun » 2020-09-18 9:30

这个药还在做,而且原公司的主要俩人也参与进去,还在那里搞,没放弃。 :mrgreen:

IND就是递交一个申请,让FDA审查一下,允许药厂在美国做临床试验。如果药太危险,FDA就不让你在人身上试验。
There was nothing to warn anyone about. The world went on, even as it fell apart, changed irrevocably, became something strange and different. --- "Acceptance" in The Southern Reach Trilogy by Jeff VanderMeer

Knowing
Posts: 32824
Joined: 2003-11-22 20:37

Re: 行业故事:山水有相逢

Post by Knowing » 2020-09-18 9:44

好执着!
Nevertheless, she persisted.

Jun
Posts: 26025
Joined: 2003-12-15 11:43

Re: 行业故事:山水有相逢

Post by Jun » 2020-09-18 10:16

那时候网上开会技术还没那么厉害,总裁把整个 team (没几个人)拉到北加州的一个旅馆里赶工一星期。旅馆隔壁就是个小机场,脑海里还能浮现早上阳光反射在小飞机机翼上的景象。
There was nothing to warn anyone about. The world went on, even as it fell apart, changed irrevocably, became something strange and different. --- "Acceptance" in The Southern Reach Trilogy by Jeff VanderMeer

tiffany
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Joined: 2003-11-22 20:59

Re: 行业故事:山水有相逢

Post by tiffany » 2020-09-18 13:38

Investigational new drug 就,动物实验做得差不多了,要在活人身上实验了,跟FDA递的申请
有酒有酒 闲饮东窗

笑嘻嘻
Posts: 21737
Joined: 2003-11-22 18:00

Re: 行业故事:山水有相逢

Post by 笑嘻嘻 » 2020-09-18 14:13

💊生何处不相逢。
云浆未饮结成冰

Jun
Posts: 26025
Joined: 2003-12-15 11:43

Re: 行业故事:山水有相逢

Post by Jun » 2020-09-18 14:28

笑嘻嘻 wrote:
2020-09-18 14:13
💊生何处不相逢。
:laughting015: :laughting015:

对就是白博说的那个,把动物毒性试验拿出来看看,给活人吃是不是值得。
There was nothing to warn anyone about. The world went on, even as it fell apart, changed irrevocably, became something strange and different. --- "Acceptance" in The Southern Reach Trilogy by Jeff VanderMeer

Jun
Posts: 26025
Joined: 2003-12-15 11:43

Re: 行业故事:山水有相逢

Post by Jun » 2020-09-18 14:41

我考虑了一下这件事,感想是,制药行业真的不是一个 efficient market,算不上优胜劣汰,最好的药必然脱颖而出,无效的药也不会浪费大家的资源。当然也不是完全 inefficient,但经常成功的决定因素不一定是药物本身的 merit。就连如此 scientific 的行业,数据挂帅,都不是真正的 meritocracy ,复杂模糊的其它领域就更别提了。
There was nothing to warn anyone about. The world went on, even as it fell apart, changed irrevocably, became something strange and different. --- "Acceptance" in The Southern Reach Trilogy by Jeff VanderMeer

Jun
Posts: 26025
Joined: 2003-12-15 11:43

Re: 行业故事:山水有相逢

Post by Jun » 2020-09-23 9:47

今天细看了一下前因后果,惊奇地发现我之前想错了!并不是前一家公司把分子转手倒卖给后一家公司,而是前一家公司没钱了,老头不知在哪儿搭上一个硅谷的家伙,集资了不少钱。然后把公司名字改了,后来又上市了!哇好厉害哦。两个医学和制药的局外人,一头扎在这场长期赌博中,这是什么精神?!
There was nothing to warn anyone about. The world went on, even as it fell apart, changed irrevocably, became something strange and different. --- "Acceptance" in The Southern Reach Trilogy by Jeff VanderMeer

Knowing
Posts: 32824
Joined: 2003-11-22 20:37

Re: 行业故事:山水有相逢

Post by Knowing » 2020-09-23 9:48

执着!科研需要这样的冤大头。
Nevertheless, she persisted.

lucoco
Posts: 508
Joined: 2006-02-05 1:21

Re: 行业故事:山水有相逢

Post by lucoco » 2020-09-23 10:24

Jun wrote:
2020-09-23 9:47
今天细看了一下前因后果,惊奇地发现我之前想错了!并不是前一家公司把分子转手倒卖给后一家公司,而是前一家公司没钱了,老头不知在哪儿搭上一个硅谷的家伙,集资了不少钱。然后把公司名字改了,后来又上市了!哇好厉害哦。两个医学和制药的局外人,一头扎在这场长期赌博中,这是什么精神?!
很常见,新药研发早期都是这么跌宕起伏的。最近刚刚碰到一例,还涉及到第三方的技术转让和债务,搞了一个月才算理清了。。。
一个人的性格决定他的命运。

Jun
Posts: 26025
Joined: 2003-12-15 11:43

Re: 行业故事:山水有相逢

Post by Jun » 2020-09-23 10:52

这药根本没有 patent period,所以才没人要。
There was nothing to warn anyone about. The world went on, even as it fell apart, changed irrevocably, became something strange and different. --- "Acceptance" in The Southern Reach Trilogy by Jeff VanderMeer

dropby
Posts: 10284
Joined: 2003-11-24 12:23

Re: 行业故事:山水有相逢

Post by dropby » 2020-09-23 10:52

觉得你们这行好有趣啊。

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