比毛毛更可爱的是毛毛的月月

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  • 盘莉: 屌丝中的一位飘过,在上海打拼,必须要有梦想的支撑
  • donglei: 上次见到两个新审评员,一个来自保诺科技,一个来自恒瑞。来自研发单位的也许会多起来。谢谢回复。
  • kevinhh: 深有感触,CDE审评员的药品评审经验是非常丰富的,但是平心而论CDE审评员当中具备企业研发经历的并不多,就跟GMP检查员很少从生产企业出来是一样的。我国应该建立一支审评员和检查员专职队伍,并且应放开渠道从生产企业招人,这才是技术监管的方向。 当然,现在的体制下,编制办给不了那么多的位置...
  • donglei: Brian,今天才看到你的评论呢,谢谢你的关注。
  • 盘莉: 哈哈,圣诞老人给清月准备了什么礼物啊?
  • 红魔: 那天在天桥上碰到清月,长大了喔,妈咪接放学还买好嘢食,哈哈,祝大家都happy啦!!!
  • brian: 毛毛,非常喜欢你从会上发的报道。特别是那篇讲述几名行业人士以及他们的感触,影响特深,过目不忘。将继续关注你的未来大作。

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Greetings from Santa

2012/12/25 – 8:53 上午

 

清月今天一早在被窝里拼命揉眼睛与寒冷斗争,挣扎着起来,发现昨晚放在床头的袜子里有一封圣诞老人给她的信。

在此祝愿大家圣诞快乐,新年进步。

Dear Huang QingYue,

P1050067

I’m the Santa Claus from Finland and I know lots of things about you. 

You are such a sweet, lovely, and well-behaved little girl of Grade 4 in Division 4 at Yucai Primal School, Guangzhou,China.

You are warm-hearted and always ready to offer help to your friends.

I am also very impressed by your paintings.

Hope you will enjoy gifts in your mailbox this year. 

Merry Christmas and Happy New Year.

 

Santa Claus

跨国药厂本土研发合作又下一单

2012/12/10 – 5:11 下午

 

把这条旧闻也放上来,不得不承认,赛诺菲的媒体活动非常多,而且都办的不错。

http://web.yyjjb.com:8080/html/2012-10/15/content_177961.htm

再听李自力博士中文公开演讲

2012/12/10 – 5:06 下午

今年年初写了一篇关于新药审评专家委员会利益冲突的稿子,见链接: http://www.maodl.com/?p=2046

为了了解FDA如何处理利益冲突,我采访了宋华琳教授、前FDA审评官员李宁博士。

据宋教授介绍,在药品审评专家咨询过程中,应尽量避免与企业有利益冲突的专家的使用,但考虑到目前学术界和产业界的紧密联系,如果当专家的专业知识具有无可替代性,而且需要其专业知识的程度超过了其存在的“经济利益”时,可以豁免于因利益冲突而造成的回避。

到底如何豁免呢?我觉得这个问题宏大而又艰深,并且无从得知具体方法。因此,在文章中也点到即止了。

而就在一个月前召开的全国医药经济信息发布会上,在前FDA审评员李自力博士的报告中,我惊喜地听到了FDA对于这一重要细节的处理。

自力博士说:

FDA对任何事没有硬性的规定,而是用非常弹性的管理来限制人的思维和行为。

举一个例子,就是利益冲突。FDA在审评新药时要召开专家审评委员会,这里面大部分人都是在制药业有背景的。这些人拿过药厂的钱,做过药厂的试验。这种现象是必然而且普遍的,在情在理。

所以,专家委员会上,FDA找来的人一定是在行业里非常资深的专家,而越有经验的专家和药厂的联系就越深。

可是,FDA从不硬性规定这种人不能参加新药审评。而是在上会会走一个程序,把所有和药厂有关系的人,拿了谁的钱、拿了多少钱都公布出来,每一个委员会的成员,无论在哪里做事情,只要给药厂做过事情,当过顾问,都要过一个程序。

这个程序并不是评判你的经验资深与否,而是通过公示,通过媒体和公众的压力对一个人的行为进行限制,从而避免利益冲突。

自力博士演讲的全文如下:

http://www.menet.com.cn/Articles/Subject/201211/201211051428392839_82501.html

对于这次公开中文演讲,药审中心的冯毅坐在台下,用他的iPAD做了如下笔录:

自力论9大关系

1、美国立法历史和举证责任的变化
2、药物创新不是化合物创新,而是解决未被满足的临床需求
3、澄清IND的“备案”问题
4、内部决策文化、哲学与人
5、临床试验与临床治疗的关系
6、专家意见和循症医学的关系
7、临床试的验数据、结果仅与该制剂连接,不与该化合物和药品标准连接
8、仿制药不存在“优效”
9、审评与标准检验,现场检查的关系

其实FDA是一个非常讲科学的地方,世界上没有什么东西是黑是白,只要能讲出道理就非常好。

我记得很早就写过一篇博客,对于月月,也要处处放置弹簧。

David Ho: Remains Unchanged After 20 Years

2012/12/10 – 4:23 下午

感谢阿斯利康的黄彬组织翻译,感谢姚立新老师提供的帮助。

 

我常常为了展示明天,而忽略了今天——何大一。

 

David Ho, as a professor at Rockefeller University and the founder of the Aaron Diamond AIDS Research Center in the USA, has started a new journey of AIDS vaccine after the disputed cocktail therapy has left him away gradually.

Staff Reporter          Mao Dong-lei          Photoreportage

 

David Ho, professor at Rockefeller University and the founder of the Aaron Diamond AIDS Research Center in the USA, was invited to be one of the honored guest speakers and gave a speech at the 4th China Annual Conference of Drug Information Association (DIA) a few months ago. I contacted the conference organization trying to make a special interview with Professor Ho. As a result, I met the world-famous Chinese scientist David Ho who invented AIDS cocktail therapy at the first time in the VIP room of the Shanghai International Convention Center.

Cocktail therapy: it is only a won battle

On preparation for this interview, I searched all of his reports in Chinese and foreign media over the past two decades, such as RTHK’s TV series “Success Stories“, Time magazine cover story in 1996, CCTV celebrity interview, as well as Phoenix Satellite TV Century Forum, etc.

Ho was regarded as a real hero in retrieving the hopeless situation when human fighting against AIDS by the media in these reports. In addition to the cocktail therapy and AIDS, how can our news report present the readers another aspect of Ho?

When sitting front of me, Ho was sagacious, elegant, and clean, always kept a smile during the whole interview process, as same as seen in the documentary film.  Only his temples are a little more grizzled than a few years ago, as Ho is a nearly 60-year-old, and is still working more than 10 hours each day.

When he saw two accompanying translation experts in the VIP room, Ho said to me: “It’s no problem for me to understand Chinese, you can just ask me questions in Chinese.”

So I asked him the first question: “Professor Ho, how do you think the media reported about you and your achievements, do you think they are the truth?”

Cocktail therapy was successfully developed and used 16 years ago. Ho is one of the scientists in the world who first recognized AIDS is caused by virus, and the AIDS diversity is caused by the replication of the AIDS virus. Based on these knowledge and understanding, Ho and his colleagues were devoting to develop a combination anti-viral therapy, i.e. cocktail therapy. Ho has been going on the forefront of AIDS research for the past 26 years. The AIDS mortality rate has been decreased by 60 percent in the developed countries since the introduction of cocktail therapy, and the international community has taken measures to provide this therapy for the millions of AIDS patients in the developing countries.

Ho was selected as “Person of the Year” in 1996 by the U.S. “Time” magazine, and followed by a variety of honors. Being pushed to the public forefront by these honors, Ho was also placed in a barochamber. A lot of people think that AIDS is overcome with the invention of cocktail therapy, “but in fact, we just win a battle.” Ho said.

By facing the obtained achievements in the past and himself under the media photoflash lamp, Ho said: “Some reports are true, some are from reasonable guess. This is the media, either dwell too much or trying to play down, isn’t it?” He asked me in his reply.

“Although my work has been well-known to the professional field, the praises from “Times“, “Wall Street Journal” and other mainstay media had pushed me to another platform, resulting more public attaining the knowledge of AIDS prevention and treatment. I am grateful for this recognition and the people pay attention to me.”

AIDS vaccine: a breakthrough may be achieved tomorrow or many years later

Several years after obtained the achievements, Ho and his Aaron Diamond AIDS Research Center suffered many frustrations, fallen into the scientific ebb and lack of research direction, which is totally different from the situation when obtained the scientific glory due to cocktail therapy. These challenges made some people concerned about the future of the Aaron Diamond AIDS Research Center: Whether this center and its