After reading the materials all night, Fan Lunding pretended to be very confident and came to Sinovel Laboratory. Pen @ fun @ pavilion wWw. ｂｉｑUｇE。 ｉｎｆｏ

He was a medicinal chemist and biologist by training, but the more he did, the more aware he was of the challenges he might face, and like all medicinal chemists and biologists face when they first come into contact with a new project, Van Lunding knew that he was going to be confronted with a sea of biological literature and related rationales.

The first thing researchers in any company need to do when they are ready to make a drug is to consult a huge amount of literature.

In the case of Zelicana, researchers would usually fill three rooms with materials, read them all, and make notes.

If you're going to ask your company to spend millions of dollars on a project and expect it to cost hundreds of millions, you'd better be prepared to sell your life.

Don't look at the relaxed performance when talking to Arnold, but Fan Lunding still dared to come to see Yang Rui after staying up all night to make up for it.

"Mr. Yang Rui. Fan Lunding came to Sinovel Labs and greeted the Chinese researchers very politely.

Fan Lunding has read Yang Rui's article, and Fan Lunding has also studied the design of coenzyme Q10 made by Yang Rui.

Although he doesn't want to admit it, Fan Lunding originally joined the industry because of his slightly inferior research talent, not to mention Yang Rui, who is at the top level of the academic world, or an ordinary bull, and Fan Lunding also has to pay attention to the wording.

He didn't want to be caught in the wrong place by Yang Rui, so that he would be ridiculed.

The unfamiliarity with deferiprone is the key flaw that Fan Lunding thinks is the key defect, so after saying hello, Fan Lunding hurriedly said: "I heard that you are not clear about the process of new drug development, I have participated in an immature project before, and I hope to help." ”

"Of course you can help, come in. We need you just right. Yang Rui greeted warmly. What he needs most now is a guide, even if he is blind, as long as he can use crutches to knock out the right way, Yang Rui is very happy.

Van Lunding was a little weak-hearted, and asked a little smugly: "How far have you got?" ”

"We're still synthesizing more active substances. I think it's better to have a few more backups. "Yang Rui has no need to hide it.

Fan Lunding slowly entered the state and said: "That's right, the more active substances, the greater the chance of getting the finished product in the end." ”

Ordinary small companies generally prepare two or three active substances, and their goal is not to make a new drug, but to sell it to a large company after animal experiments or clinical phase I.

Large pharmaceutical companies prepare more than 20 active substances, and companies like Pfizer often prepare more than 50 active substances. The end result, like Pfizer, often has a backup compound and the main compound pass the FDA review together, thus turning one drug into two drugs.

It's a winner-takes-all industry, with most small companies not making it out for 36 months, big pharma companies not always getting their way, and super pharma companies like Pfizer are facing high costs, with an average cost of $700 million per new drug, well above the industry average of $200 million.

Compared with generic drugs, which often only cost a few million yuan, the depth of the bottomless pit of original drugs cannot be measured.

Fan Lunding decided to persuade Yang Rui to do a few more active substances first, then open a few more sets of animal experiments, and then one more set of clinical trials. If there are no results at this point, the average pharmaceutical company is finished.

And the odds of not getting a result are very high.

"The project team I was in used to focus on developing antibiotics, but unfortunately it failed, and if I want to say that I still have the experience, that is, I have to give a relatively generous estimate of the possible problems in the experiment. Van Lundin didn't go on with ferrite, but only talked about his own experience, so as not to show timidity.

Yang Rui agreed: "The generous estimate is very useful. How far have you got?"

Exactly the same problem as Arnold, Van Lunding said: "The second phase of the clinical trial was not successful. ”

"It's a pity. ”

"Related to our initial plan, you know, antibiotics are actually a relatively easy drug to develop, because the effectiveness of the drug can be tested in vitro, so no one expected that the phase II clinical trial would fail. Van Lunding said and introduced some of the situation in the project team.

Yang Rui, Wei Zhenxue and others nodded while listening, this is indeed a rare experience.

After a while, Wei Zhenxue asked even more strangely: "You also said just now, the effectiveness of antibiotics does not need to be tested on humans, you can learn in the laboratory, before you do animal experiments, you should know whether it is effective or not, how can it fail in the second phase?"

"We didn't predict that it was a temperature-sensitive compound that would greatly attenuate its potency once a patient had a high fever. Van Lunding shrugged, his face a little embarrassed.

Wei Zhenxue laughed without hesitation.

This is indeed a very stupid way to fail.

Huang Mao said comfortingly: "If you're unlucky, you can't help it." ”

Van Lunding's embarrassment disappeared for a moment, and then he said: "There are too many problems encountered in clinical trials, although I would like to admit that it is a factor of luck, but compared to the successful project team, I think it is our lack of preparation in the early stage." ”

"Oh, what do you mean?"

"The first is that there is no backup compound. "Van Lunding is talking about compounds with the same target but different structures, such as deferoxamine and deferiprone that are in such a relationship, and this hierarchy is more powerful than multiple active substances.

Yang Rui shook his head: "We can't afford it." ”

Van Lunding certainly knew they couldn't afford it, and it wasn't small companies that could afford it.

Van Lunding nodded: "Our project team also wanted to save this money back then to increase the success rate of a compound, I have to say, we were very optimistic about that compound back then, no one thought about it, and eventually encountered a temperature-sensitive situation." ”

"Didn't you do the experiment in advance?" asked Huang Mao.

"The performance of in vitro experiments is not obvious, and the environment in the human body has obviously increased its sensitivity. ”

"It was unexpected. Yang Rui nodded heavily, he was also worried about this kind of thing, or rather, every project director was worried about this kind of unexpected thing, people are not gods, any exploration of new fields, you have to pray for good luck, and when bad luck is riddled with bad luck, everyone has to hit the street.

"Yes, so, if the second phase of the clinical trial was not passed, our project team was disbanded. Van Lunding paused for a moment and said: "In fact, there are many reasons for failure, and the lack of backup drugs is only one of them, and the lack of active substances we prepared in advance is also a big problem." ”

"How many active substances have you synthesized?" Wei Zhenxue naturally followed his words.

"6 kinds. Our project team is not very valued, because it has been reorganized once, and its competitiveness is not as good as other projects, so it is relatively tight, and there are fewer active substances synthesized, resulting in fewer active substances passed by animal experiments, and when it comes to the first phase of clinical trials, there is no choice, and there is a problem in the second phase of clinical trials, and there is no backup, so we can only declare the project a failure...... "Van Lunding told the truth, without a word of falsehood.

There are few active substances synthesized, which is such a drawback. Although the number of active substances in 6 is slightly more than the synthesis of small companies, it is pitiful enough. Normal small pharmaceutical companies don't want to go through phase II or even phase III, and their capital doesn't allow them to invest so much.

Wei Zhenxue's face changed slightly: "You have prepared a total of 6 active substances, all of them?"

Fan Lunding thought that he was scared of Wei Zhenxue, and hurriedly explained: "We have been doing it for nearly a year, and everyone is tired, at that time, our synthesis work was not going well, so in the end, we prepared 6 kinds, if your goal is to make a finished drug for deferiprone products, I think the standard of 6 active substances is not high." ”

"Not high, of course. Wei Zhenxue muttered.

"Huh?" Van Lunding didn't understand too much.

"We've made 12 of them, which is exactly as many as you say. Wei Zhenxue pursed his lips and said, "Yang Rui is still ready to continue to do it." ”

"I agree with you that you must be well prepared. Yang Rui does not understand pharmaceuticals, but he knows the research direction of ferriprone, so it is the most correct choice to make a large number of active substances with the structure of ferriprone and cover them as comprehensively as possible.

Van Lunding prepared a stomach of persuasion, and as soon as he started, he didn't need it...... It is said that his goal has been achieved, but looking at Yang Rui's confident expression and the positive atmosphere in the laboratory, Fan Lunding felt inexplicably sad.

……