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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 golden leader was already closed to a new major breakthrough, or remained stagnant in this protracted warfare in the fighting against AIDS?

To completely overcome AIDS, Ho has to develop an AIDS vaccine, which is exactly his focus of work in the period. Ho said: “Extremely arduous works in the development of AIDS vaccine gave us a great challenge we have never met. We have to wait for a scientific breakthrough, which may be occurred at tomorrow, or many years later.”

Ho’s research team has developed two deoxyribonucleic acid (DNA) vaccines for the prevention of AIDS recently. Phase I clinical trials in human of the two vaccines were started in the United States. However, it will take at least five years before the vaccines introduced into the market. Ho said that his research center has been cooperating with Chinese research institutions, such as Chinese Academy of Medical Sciences. Human trials of AIDS vaccines may be carried out in China in the future.

Ho has traveled between China and the United States many times since the last 20 years. As a scientist, Ho’s activity space is not only limited to the laboratories, but also expanded his AIDS research and prevention & treatment works to all over the world, especially in China.

Ho said that many scientists introduced the cocktail therapy to the serious AIDS epidemic regions like Africa, Thailand and other countries after the invention of the cocktail therapy. “My background naturally leads me to China.” David Ho was born in November 1952, Taichung City, Taiwan Province, then he immigrated to the United States with his family when he was 12-year-old. In his view, to come out from China, then return back to China, it is a very meaningful cycle.

When talking about vaccines, Ho talked off the reel. I was excited when Ho told me that he would introduce the latest progressions for AIDS vaccine research of his team to all the audiences in the conferences. He has started a new journey of human fighting against AIDS after the disputed cocktail therapy has left him away gradually.

“In the next 20 years, you will be 80 years old. Will you still work in the area?” I asked.

“It should be, I am optimistic by nature, otherwise I cannot to do the research work in the AIDS field.” Ho said.

 

Dialogue

Q: How is the status of the research and development in your AIDS vaccine project?

Ho: We have a new HIV prevention project, which is a passive immunization method by using antibodies to block HIV infection. A lot of research works should be developed, in which one study is to promote a proof-of-concept test, aiming to show that this antibody will have better effect pharmacokinetic and pharmacokinetic in its anti-HIV activity.

We have conducted phase I clinical trials in the U.S., and we’ll conduct Phase IIa clinical trials in the U.S. We plan to conduct a pivotal study, a Phase IIb clinical trial, in China in the next two years. There are many reasons to carry out these studies in China, for example, China has a large number of high-risk population; many scientists and research institutions are interested to participate in the studies; Ministry of Science and Technology and Ministry of Health are eagerly to participate in the innovative researches now. Due to it is a very new path, the process is not easy which will probably cost about two years.

Q: Which procedures should be modified after Phase IIb clinical trials enrolled Chinese subjects?

Ho: I hope that China will be included in the study of the next Phase IIb clinical trial. However, it will be very difficult to carry out if there are many operation standards for the study.

I do not think that Western standards are golden standards. However, we should coordinate with each other and establish a mode, which is not only suitable for the Western scientists and Western pharmaceutical companies. If the Chinese scientists want to participate the competition with the world, we should recognize what is the path as a whole.

It is like a time-consuming malathione to carry out Phase IIb trial in China which required the long-term efforts. We will discuss with many relevant officials in China, including the Ministry of Science and Technology, AIDS Fund, and the Ministry of Health. Both the Ministry of Science and Technology and the Ministry of Health have agreed to give us support. In addition, we need to contact with the SFDA, which is the last unit.

Q:  Do you have the shortage of research funds ?

Ho: Yes, very often. Sometimes I feel like running on a treadmill without stop, if I relax in a while, the rotation of the roller will slow down. Due to the current economic situation in the United States makes the Government cuts a large number of research funds, whereas it is better in China. As a foreign scientist, I can’t make a direct application for funding from the Ministry of Science and Technology or the Ministry of Health in China. However, the establishment of a research institute in School of Medicine, Tsinghua University could be a base for funding application. As this study is a multinational trial, we will make full use of the  international funds system to carry out this cooperative research.

Q: There are nearly 1/3 of the researchers from Asia, especially from China, in Aaron Diamond AIDS Research Center. However, more and more Chinese scholars have returned to China to do research, how do you evaluate the overall domestic academic environment?

Ho: The scientists went out from our research center have brought the latest achievements of the AIDS prevention and treatment to all over the world, including China. I am very pleased to see that the responsible scientist of the AIDS research organizations like the Chinese Center for Disease Control and Prevention, Tsinghua University, the University of Hong Kong, and other institutes, are my students.

There are a lot of very good talents in China.  If you visit the laboratories in the Western countries, you will find a lot of Chinese people working there. Many Chinese professionals take the new techniques and new thinking back to China, so the gap between Western scientists and Chinese scientists is narrowing constantly.

The Chinese government’s investment is growing, which really attracts scientists to come back to China for working, or for the establishment of a cooperative research. Chinese government leadership is also very far-sighted, and they hope that China will become a powerful country in research and development, so that more investments will be made. Certainly, it will need to take sufficient time to change the deep-rooted culture in China.

Q: As a team leader, how do you treat the failures and successes of scientific research?

Ho: If you never fail, you will not be successful; if you do not want to fail, you will be only a mediocrity. This is the prominent in the United States value system, which is different from the oriental culture. Failed and then make correction, the scientific progress is a self-correcting process in a great extent.

我的心啊是一首歌

2012/12/10 – 2:38 下午

月月在少年宫画的画,再放上来,以及一些朋友的评论。

P1040843

我的心啊~是一首歌!看月月的画,就突然想到这句诗

这个真心不错,原以为只会画个简单的吉他了事,没想到还有充满形象力的背景

看孩子的作品次次都是惊喜,好想保护好她独特的观察力,不受外界太过束缚

这个角度是吉他手表演的角度,我们也许应该多从孩子的角度看问题呢

背景敦煌飞天的艺术感染力。

 P1040896

编一个小故事,美工月月后期渲染,一本图形并茂,绘声绘色的儿童读物就诞生了。

CDE的老师们,你们知道企业需要什么指南

2012/12/03 – 3:54 下午

这次在CDE的论坛上,一位来自《医药经理人》杂志的年轻的记者马茗舒当众提了一个问题:

“让我把问题问的更尖锐一些,CDE的老师们,你们知道企业到底需要哪些指南么?”

这个问题问的让我觉得很有共鸣。

_DSC0099

本届论坛大幅压缩了讲者报告的时间,将大多时间留作台上台下互动。图为德盛律师事务所战略顾问、DIA全球主席苏岭博士发问。

两个月前,我和同事小黄在“研发大讲堂”做了一期指南解读。

当时我们做的时候也很没谱,因为,自从CDE2009颁布技术指南以来,翻译转化了许多欧美成熟国家的指南,从选题的角度来看,不具备研发实际经验的采编人员,分不清这些指南的重要性,也无从得知这些指南的适用性以及对业界的指导性。

在各种场合,首次人体试验都被提及,因此,《健康成年志愿者首次临床试验药物最大推荐起始剂量的估算指导原则》今年7月颁布后,我觉得这个指南也许值得解读一下。

当我们找到的鹤群博士看到小黄研读《指南》后制作的采访提纲,他第一个反应是:How did you do that?

我打趣道,对于这份提纲,除了CDE三个英文字母我知道什么意思,其他一句也没看懂。

上海论坛后,程龙部长给本次7位参会的媒体记者写了一封感谢信,

信中提及:药品审评需要公开透明,我们不断地努力着。如果我们不率先对媒体开放,我们所说的开放是难以被证明的。

希望有越来越多年轻的记者像小马和小黄那样,挑战CDE的老师们,也希望有更多CDE的审评员、业内的专家能走进“研发大讲堂”这个栏目。

《验证大脑中的理论假想》

http://web.yyjjb.com:8080/html/2012-11/19/content_180332.htm

采访提纲:

1. 2009年初CDE启动了系统地翻译和转化国外技术指导原则的工作,您认为此次《健康成年志愿者首次临床试验药物最大推荐起始剂量的估算指导原则》出台的意义有哪些?对比欧盟、美国指南其中国的适用性、差异性有哪些?

2.在确定NOAEL时,不同该药物有不同的毒性反应,那么对于候选药,如何判断某种毒性反应具有生物学意义?

3.有些情况下,因受到一些非临床数据的影响,我们不能直接使用NOAEL来计算HED,如有的药物在动物模型身上出现饱和现象时,可暂不出现毒性反应,因此需要使用最低饱和量代替NOAEL,请问除此以外,实际操作中还有哪些类似的情形?

4.指南中提到,对于抗肿瘤药物,有研究显示以体表面积(mg/m2)计算剂量时,导致10%啮齿类动物死亡的剂量(LD10)和非啮齿类动物的MTD均与人体的MTD有很好的相关性。这是否代表所有的抗肿瘤药物均应使用体表面积归一法估算HED?

5.将NOAEL换算成HED时,指南中提到根据体表面积(mg/m2)和根据体重成比例(mg/kg)两种主要的换算方法,研究者在选择时,总体上应把握怎样的基本原则?

6.借助哪些手段能充分证明所选择的为最适合的动物模型?

7.根据以往的经验,您认为在需要增大安全系数的众多情况中,哪些容易为研究者所忽视?

8.什么情况下应考虑计算PAD及其药理学HED?

9.在估算MRSD的整个过程中,体内外数据的收集整理显得异常关键,您认为当中哪些细节值得引起研究者特别留心?

10.您认为,创新药首次人体试验在国内还有哪些方面的环境需要改善?