回复croupier的评论:
It is quite difficult to get IPO for biotek company now. If you don't have convincing solid phase II clinical trial data, there is no way you can have IPO. My former company in SH is truly exceptional and involving money games. This is not the first time. There was another drug company in HK went to public in HK and lost all the stock value eventually. But the IPO, they reap about 200 million. Good enough for the game they were playing. They know that game can not be duplicated again in HK, so they moved to oversea. When I have a chance, I will write a book to detail the whole pharmacutical development they are doing to make money without doing phamaceutical. Thank you for your reading and comments.
Thank you very much for your comments. I did manage to go to NIH webisite and found out one hebal mixture for RA. I am not getting into details of our discussion. Basically, my point of view is to understand the herbal mixture completely, namely the composition before moving into the clinical trials. That will be a very prolong and tedious jobs but not difficult. As far as I know, none of the clinical trials on hebal mixture has ted to FDA for clearance of clinical trial from industry (academic research IND is much easier to get FDA clearance). In this context, my concern for NIH clinical supply is the dosage preparation reproducibility and quality control of raw materials and final product. I mentioned in my earlier comment about the bioavailability of herbal medicine. We have to address this issue first before moving into clinical trials. If we cannot work out the formualation to get desired bioavailability, it will be a waste of all the resources to pursue the therapeutic efficacy.
For pharmaceutical development in China, it is chaos right now. We can see a lot of CRO setting up in China now. I am not sure we are thinking of pharmaceutical development. My approach will be to start API business first, to get DMF filing in US and marketing API in US. The next step will be generic drug and then moving into new drug development. The first two steps will build up credibility in front of FDA, establish financial strength, and use our extra resources to develop new therapeutics like herbal mixture or single hebal etc. It is not easy to convince the people in China. All what they are doing there is to seek wealth on a short term basis. Forget about the good drug, all what they are doing is marketing the medicine into hospital or distribtor to make money quickly. I am not sure you can do anything about it. Thank you very much for your comments and continuing reading.
croupier 发表评论于
Running a pharma company from a startup always need a good business plan to begin with, or a "story" to attract investment. The company that you worked for in Shanghai obviously used these IND submissions as a story for IPO to get more money. But down to the R&D ground, the reason for using Chinese herbal is probably nobody in FDA really understands what that is, so it's far easier to get IND done than a new chemical entity of first in class molecule, or a BLA of biologics. IND is just for you to roll out the clinical trial, this is nothing to do with the efficacy of the "drug", all the trials may just fail down the road.
But this is how most of the biotechs work, unfortunately: get one technology/molecule/patent, put some money in, register in FDA for IND, up to Phase II to show its efficacy if yes then out-license to big pharma, most of the company senior people can divest their stock shares to this timepoint and will be able to pack up and leave. This is the typical lifecycle of a startup biotech company.
Sorry for hijacking your conversations. As a Chinese, I am so moved by your talking.
The problem of health care in china is far more complicated than producing effective drugs. That is of course my personal view. The producing of effective drug is perhaps the second step to take after the government (let's live in hope) can sort out the ideological issue on public health. That is, it is the state's responsibility to give its people good health, like most of the European countries and in Australia and New Zealand. I am not sure about American, whether it is via the insurance company or state subsides. The primary role of public hospitals is to cure patients (with the government pays the bills), not the tool for someone (Foreign pharmaceutical companies or the joint-adventures, and various levels of administrations) to squeeze money out of the miserable patients. It comes more direct, as a matter of fact, the majority of the general public can not afford for being sick. This is a systematic problem to be addressed urgently.
About the effectiveness of traditional Chinese medicine, there are two more reasons which may explain why the conclusion drawn from the literature is always negative. For a start, there is an issue how the test of efficiency was run, and whether the same test is really suitable for testing the effective of Chinese medicine, given the mechanisms behind can be quite different. As most people noticed, the Chinese medicine has the focus on curing the root of problem, instead of the symptoms. Thus, the observation time can be a lot longer for testing the Chinese medicine. The other reason is, there is also the slight chance the only paper which had passed the boring peer-review may be the ones only with the negative effects. This selective process in publications is common in other areas of science where the reviewers have certain bias.
By the way, is it the case in American that even the technical solutions are made during the employment time, the individuals can still claim for patents. The company who pays for the time of the employee has not right in this matter? That is interesting.
ironchef2 发表评论于
It is always enlighting and enjoyable to read your articles or notes. I can almost see the sparklings around your head. The NIH trials on herbs is not a single ingradient, but the original formula. See their website:http://nccam.nih.gov/. I read almost every issues of New English Journal of Medicine, Annals of Internal Medicine and JAMA. Occasionally those herbal trials make it to publications. If my memory serves me right, all herbes show no effecacy compared with placebo. I am not sure if you heard of evidence-based medicine. Chinese medicine fails miserably when tested. The only exception is accupuncture and ironically, the best studies on accupucture were from France.
My point is, why waste resources on unproven "medicine"? Do we bear the responsibility to educate general population and Chinese administration to re-direct their resources and improve the nation's heath care?
My other ambition is to drive Amway out of China, sort of. It is ourageous to see Amway selling expensive Magnesium, Selenium etc etc to healthy people without proven benefits. Lots of trials show little benefits and toxicity of supplements. Amway basically is dead in the US and somehow make it big in China, pretty much like your boss, taking advantage of the lack of knowledge or ignorance of Chinese people.
I still believe the future of Chinese medicine relies on the active ingradients it contains. Ephedrine, vincristine were all extracted from plants.
My personal bias, the Shanghai work is doomed. I can almost bet it will not produce any drug approved by the FDA to market in the US. If it produces any drug that I can write on my preion, let me know and I send you a gift of your choice within $200. All they are doing is for marketing in China. Everything will sell well with an American flag in China.
yijibang 发表评论于
回复IronChef2的评论:
Thank you very much for your reading and comments. Here are my answers to your questions.
A few random thoughts. I don't see a future for the Chinese herbal medince. All NIH (national institute of health) sponsored clinical trials are negative. Maybe the only way out for Chinese medicine is to identify an active ingradient.
There are several issues to be considered here. All the NIH clinical trials, I believe, is the single molecules derived from herbals. The identification of the active ingredient is not a problem at all and we are doing in China now. The question is whether the single molecule is sufficient to provide the desired efficacy as observed in the Fu Fang (复方). Of course, I do not rule out the possibility to find the efficacy in small molecules. Besides in herbal medicine, when we talked about the single molecule actually is a combination of similar type of compounds (i.e., not a single entity).
I believe the projects you worked in Shanghai was FDA approval for some herbal supplements, but not a "drug".To get FDA approval for a drug, you will need phase 1, 2 and 3 trials with the last 2 clinical and a post market analysis. I think it is a waste of money and resources to spend on herbal medicine with no proven effacacy.
The project is not dietary supplement, it is for therapeutic indications and treatments. For dietary supplement, you don’t have to go through FDA approval process but you do need to have CMC information ready in case that FDA requests the information when an adverse event reported. We all know that the medical response from herbal medicine is slow and this is due to the formulation technology. How many formulation scientists are willing to understand the herbal medicine to increase the bioavailability, none. This is the area we should focus if we really would like herbal medicine to achieve the efficacy as the other drugs.
Another thought, I feel sorry for your boss. She is a loser at least from a personal perspective. Somehow she found her niche to survive in this twisted Chinese society. I think your greatest asset, if you want to contribute to China, probably it is not your skills as a chemist, but the knowledege of American system, either in terms of management or personel evaluation. I think probably you should take a management position in your field instead.
Every company has different goals to accomplish. The reason I decided to join the company is to really pursue the Chinese herbal medicine as they originally promised. Later, I found out all what they are doing was trying to file two USA IND to fulfill the IPO requirement. They had accomplished that. All what they are doing now is just to keep investor happy. The funny thing is they even gave up the herbal medicine and moving into synthetic drugs. There are many returned oversea Chinese companies in China now. The only question I have is how much they had learned from the US companies. Recently C&E News editorial mentioned the rapid pharmaceutical progression in China and hinted that US is currently losing the young talents. We have to ask ourselves, do we really know what we are doing. I always warn myself, I am myself the worst enemy if I don’t know what I don’t know. I am working in this field for almost 30 years and I am still learning things everyday. It never ends. In China, how much time they are willing to spend in update themselves, that is a big question mark.
On a personal level, my dream is to modernize, or westernize if you will, the Chinese health care system. Emergency department need better equipments and training. Pharmaseutical industry needs reform. Chinese medicine need to be excluded from main stream and go to where it belongs, "food category" as in other countries. It is stunning to see a developing country wasting limted resources on unproven "medicine".
At least, I know there are few small private drug companies in China, they are moving very well. They mean to develop good medicine to benefit our beloved people. But the problem is the environment, the sentiment of people surround you. All the people want to make money and make money quickly. They neglect that fact that if you do something right or you have a good product you will make money eventually as well as benefit the people. We need to develop patience, to understand the business, and to change the investment mentality to modernize our pharmaceutical industry. If we don’t, we may be losing the ground to other countries. The API business is a typical example. Most of API used in generic industry today is from India or Europe after they originally imported from China. They bought the API final product from China as raw material and then reprocessed and re-sold to US with a tremendous margin (few cents from China vs.few dollars sold to US). Unfortunately, our government own pharmaceutical companies will not think about any long term project. The private industry like my old company has no idea about how to run the pharmaceutical companies. It is really a very very sad situation there.
Thank you again for your reading and comments.
IronChef2 发表评论于
Still reading on your Shanghai series...
A few random thoughts. I don't see a future for the Chinese herbal medince. All NIH (national institute of health) sponsored clinical trials are negative. Maybe the only way out for Chinese medicine is to identify an active ingradient. I believe the projects you worked in Shanghai was FDA approval for some herbal supplements, but not a "drug".To get FDA approval for a drug, you will need phase 1, 2 and 3 trials with the last 2 clinical and a post market analysis. I think it is a waste of money and resources to spend on herbal medicine with no proven effacacy.
Another thought, I feel sorry for your boss. She is a loser at least from a personal perspective. Somehow she found her niche to survive in this twisted Chinese society. I think your greatest asset, if you want to contribute to China, probably it is not your skills as a chemist, but the knowledege of American system, either in terms of management or personel evaluation. I think probably you should take a management position in your field instead.
On a personal level, my dream is to modernize, or westernize if you will, the Chinese health care system. Emergency department need better equipments and training. Pharmaseutical industry needs reform. Chinese medicine need to be excluded from main stream and go to where it belongs, "food category" as in other countries. It is stunning to see a developing country wasting limted resources on unproven "medicine".
I think your experience exists everywhere, whether in the US, China, or Taiwan. However, we often like to add colorful or racial flavour to it because it involved people of different races. We often refer northern Chinese as "Wai Shen ren" in my hometown, like the Taiwanese people do. However, we never consider that as "racial discrimination" because we are all Chinese.
Immigrants do have lots of inherited disadvantages. However, if you can jump from a low energy level to a higher level, much like an electron does, you will be above all the electrons in the lower levels even though you may be in the lower percentile among your level.
My personal belief is do whatever it takes to achieve personal success. Be aware of the racial issue and always stand up for yourself, just like you did for the second patent without making a big deal of race because this problem exists everywhere.