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s*****t
发帖数: 247 | 2 听说小硕很难到Scientist,最多Chemist.现申请了一个Sciensit 职位,也拿到了onsite
.我的背景化学+药学(国内,硕士),在国内做过数个ANDA,一个NDA(做到临床),来美国后
又拿了个非化学硕士(主要做分析).此职位主要focus on generic R&D.过来人给说说可
能性怎样? 还是说generic的Scientist比新药研发的Scientist的门槛底很多?
电面的时候问了一些技术方面的细节,我感觉答得不是太好,但好在以前在国内的项目做
得比较踏实,面世我的director还是比较满意.所以拿到了Onsite.但director同时问我
如果降到chemist III 我还接不接受.我说没问题,但同时我也说我现在最需要的是熟悉
他们的环境,相信我很快就能达到Scientist的要求,Director也说他相信这一点.
不知版上有没有在generic里混的大侠?给说说entry level scientist和Chemist III的
薪水如何?如果能拿到scientist,是不是对以后的职业发展会好点?我已经找了大半年了
,对这个机会还是充满 |
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W********t
发帖数: 8514 | 3 Ok, Ok, I have to say somethin on this topic here.
1st, let's use a simple way to picture RA and QA. QA, think about GMP, GLP,
GCP, GTP; RA, think about IND, ANDA, IDE, BLA, 510K
2nd, yes RA/QA get paid well, but this is a small field. |
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j******w
发帖数: 97 | 5 I don't think the article accounts for the generic's market exclusivity and the complications associated with it.
With an FDA approval of a new indication of a off-patent molecule, a 3 year market exclusivity will be granted during which other generics cannot have that indication on their labels. This is not a patent but does offer some protection for the profitability.
ANDA needs to reference a brand name drug and demonstrate substantially equivalent to the brand name. But what if your own prod |
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j******w
发帖数: 97 | 6 Here is my understanding.
There are three drugs.
Drug A, innovator drug, reference drug, the drug to which the generics are
demonstrated to be equivalent and stated in the ANDA as the reference.
Drug B, your drug with a new indication but with the same active ingredient
and probably similar formulation as A.
Drug C, other generics of drug A.
Situations:
1) Drug A is approved for a new indication X through a SNDA
In this case, because drug C has been approved to be equivalent to A, the
indication |
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c*********o
发帖数: 1734 | 7 Contact the recruiter directly.
DUTIES/RESPONSIBILITIES:
Design formulations of solid dosage form and experiments, especially
modified release products.
Manage multiple development projects and develop formulations in a timely
manner.
Write protocols, master manufacturing records, and product development
report.
Support Regulatory Affairs for IND/NDA/ANDA filings.
Provide support to production in process improvement and troubleshooting.
Stays current with recent advances and trends in the drug d |
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L******r
发帖数: 522 | 8 来自主题: Pharmaceutical版 - 国内工作机会 国内一家排名前三名的仿制药API公司希望找一名analytical的director或者manager
。大概要求是这个candidate从对API分析方法的开发到validation都比较熟悉，最好是
在国外医药公司，尤其是仿制药公司有大概5-10年工作经验，熟悉ANDA的准备到递上去
，analytical work发展的全过程。
这是受朋友之托看看有没有合适的人选。如果有意，可以短信给我，简单介绍下自己
背景，我可以提供国内公司的联系方式，你们自己去谈。 |
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t**n
发帖数: 4365 | 9 从orange book上只发现Novast 4个产品，不过看报道其2008年就已经file了15个
ANDA，成功率好像不高啊。
不过，令人惊讶的是，这个公司2005年成立，2008年就有了cGMP厂房，这个速度真是不
一般。。。 |
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b*****y
发帖数: 84 | 10 赞这个主题的信息量。
大鲨鱼能展开说一下３００－４００K的估计吗？
据我所知一个biostudy就二十万左右了。即使雇员工资和仪器厂房都不算的话，原料包
装之类应该也是一笔支出。external regulatory 也要付一些吧。
另外patent cost当然是case by case相差很大。官司一起来怎么说都是以十万来计。
即使不打官司，file Para IV，和patent due diligence也是以万来计的。当然象有些
ANDA patent问题minimal。不过那样的话门槛低了，油水也就少。 |
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L******r
发帖数: 522 | 11 我的意思是GDUFA通过以后，FDA开始向generic收钱，每个ANDA成本要增加$300,000-
400,000，不是就是$300,000-400,000。这个数字是这么得出来的：2012年，FDA计划收
$299 M。估计以后大概也差不多。根据过去的数据，一年大概FDA可以批1000个左右，
那么平均下来，再考虑涨点，就是$300,000-400,000。
至于一个不做end-point clinical的generic paragraph IV的成本，这个你去开会，最
常听到的数字是$10 M(所有的，包括打官司费用)。另外一个数字是如果一个drug
sales没有$100 M，去FTF其实是赔钱。但是实际情况还是有起伏的。 |
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s**u
发帖数: 137 | 12 做deal，要卖ANDA。一个国内的公司感兴趣，今天来做due diligence，请了个海归做
他们的顾问。说是前FDAer, 现在是天大的教授。结果问的问题愚蠢至极，很多generic
行业常识的东西都不知道。回来Google一下，发觉此人根本没有OGD的经验，而且简历
上一大堆关于自己上美国名人录的东西。当真劣币驱逐良币。 |
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r*******y
发帖数: 626 | 13 Please see below. I have nothing to do with the company or the recruiter.
We are currently searching for an R&D Principal Scientist -
Pharmacokineticist located in Piscataway, NJ. A short description of the
position is below.
The main responsibilities for this role will be reviewing bio-analytical
method validation reports, reviewing summary basis of approval, prescribing
information and other relevant literature of marketed products to prepare
summaries in support of pharmacokinetic (PK) studie... 阅读全帖 |
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a*****s
发帖数: 375 | 14 土人问一下，新制剂是不是就是换个placebo啊，只要ANDA过了就能生产了？现在这个
waiting list好像要5年。如果国内自己报2，类药很难批吗？ |
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C****3
发帖数: 162 | 15 Asieris Pharmaceuticals hiring a Senior Director / VP, CMC in Shanghai,
level and title can be adapted to the candidate’s experience and
qualification.
This person should have successful track record in supporting pivotal
studies and filed NDA or at least ANDA, and s/he also should have a Ph.D.
degree in Pharmaceutical Science or related area.
You could find more info through http://www.asieris.cn/.
Please contact Rock Yi Senior Consultant, Life Science CGP Life Science 1
DD: +86 21 63335159 | M... 阅读全帖 |
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i*****c
发帖数: 1322 | 16 Due to business expansion, we currently have the following career
opportunity opening in Parsippany, New Jersey.
Project Manager- CMC Drug Regulatory Affairs
ESSENTIAL DUTIES AND RESPONSIBILITIES
The primary duties and responsibilities of this position include the
following. Other duties may be assigned.
• Manage project planning, operation and reporting of assigned
projects.
• Represent company on project meetings with clients.
• Review Chemistry, Manufacturing and C... 阅读全帖 |
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s**********8
发帖数: 25265 | 17 European Medicines Agency
The European Medicines Agency (EMA) is a European agency for the evaluation
of medicinal products. From 1995 to 2004, the European Medicines Agency was
known as European Agency for the Evaluation of Medicinal Products.[1]
Roughly parallel to the U.S. Food and Drug Administration (FDA), but without
FDA-style centralization, the European Medicines Agency was set up in 1995
with funding from the European Union and the pharmaceutical industry, as
well as indirect subsidy fr... 阅读全帖 |
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B*****e
发帖数: 2413 | 23 This is very good. I hope its price can be down a little bit. |
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B*****e
发帖数: 2413 | 24 IPCI has enough cash for burning? |
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g**********1
发帖数: 399 | 25 all five drug are just generic? |
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