A relatively complete drug clinical specification is the basis of an efficient drug approval system.
In Li Zheng's last life, Hua Guo gradually established drug clinical trial standards in 1999, and the long and inefficient drug approval process was not resolved until Li Zheng left.
"These are 20 drug samples randomly sampled from the market by Xiao Lu from our laboratory. They are common cold medicines and cardiovascular emergency medicines. Our laboratory has conducted preliminary analysis on their components and found a very Interesting things."
"Little Lu, tell the professors." Li Zheng winked at Lu Keke who was behind him.
Lu Keke is not as talented as Meng Jie, nor is he as good as Sun Bin, but he is an expert at analyzing data.
Lu Keke seemed a little nervous. Most of the people in this conference room, he had only seen it on TV or even in textbooks before, he never dreamed that one day, these people would sit together and listen to him speak. .
Li Zheng could clearly hear Lu Keke's rapid breathing and swallowing forcefully. He stood up and patted his subordinate's shoulder, signaling him not to be nervous.
But obviously, Lu Keke was even more nervous.
Don't embarrass Professor Li, don't embarrass Professor Li, Lu Keke repeated in his mind several times before his fast-beating heart calmed down a little.
He distributed the report in his hand to the professors present.
"This is the test report of 20 drug samples, and the clinical trial data of several related drugs that I can find." The sample test report was made by the Ninth Laboratory itself, and the drug clinical trial data is somewhat sensitive. It is not easy for Lu Keke to obtain such a few pieces of data.
The people present were all experts in the industry, and when he glanced at the test report, he understood what Li Zheng meant, and the atmosphere in the conference room suddenly became depressed.
"Professors..."
Lu Keke managed to do a good job of psychological construction and began to speak, but he was interrupted by a furious voice just after he started.
"Bullshit! It's completely bullshit, this is a life-saving medicine! Are they doing this without regret!" Old Yang couldn't help slamming the test report and clinical data on the conference table.
"It's okay to use synthetic vitamins as the main ingredient in cold medicine. What's going on with this heart disease medicine? Can you just eat it without dying? It's a joke about the lives of the common people!" Old Yang flushed with anger.
In the 1980s, when there was no standard for clinical trials of drugs, it was not uncommon for vitamins to be used as cold medicines. As for this heart disease drug, it was claimed to relieve early cardiovascular disease and unclog blood vessels. However, the ninth laboratory detected that its The drug contains trace amounts of iron, which is indeed beneficial to the heart, but the benefit is minimal at all, not to mention the relief of early cardiovascular disease, which is completely messed up.
Talk about ideals first, and then pose problems. This is a skill that is used in negotiation in later generations. It may not be applicable to those who have been "experienced in the market" in later generations, but it is surprisingly easy to use for these scholars who are obsessed with learning. .
Many old professors made the conclusion on the spot that the standard of clinical experiment of this drug must be established as soon as possible.
"Seniors, the specification should be built as soon as possible, but how to build it, how to build it, and how to advance it logically, so as not to cause a backlash, we need to take a long-term plan." Li Zheng said with a smile.
In the half year that Li Zheng left, there has been no breakthrough in the experiment of "infinite organ storage technology". Now that Li Zheng came back, this matter was put on the agenda.
Although the accelerated approval time for erlotinib given by the FDA is 1-3 years, as long as the FDA confirms that erlotinib is clinically effective, the difficulties faced by the Human Genome Project will no longer be difficult.
After the laboratory is built, the Human Genome Project, which is widely participated by various countries and is known to be parallel to the Human Moon Landing Project and the Manhattan Atomic Bomb Project, can be officially launched around the world.
And Li Zheng wants this in between, to drive out the project results of the infinite-time organ storage technology.
"No. 1 and No. 2 are ready to thaw." Li Zheng was wearing a white lab coat. The white mask covered half of his face, revealing only two slightly squinted eyes.
"The equipment is ready."
"The test equipment is ready."
"The computer is ready."
"Okay, one, two, three, thaw!" In the two transparent containers in the laboratory, a lot of white liquid nitrogen gas instantly emerged, and the frost covering the storage organs melted at a speed visible to the naked eye.
"The container is warmed up, and the temperature test is 12 degrees Celsius."
"Temperature test 15 degrees Celsius."
The experimenter reports data every 30 seconds. When the environment in the container reaches the level of the simulated human body, the tester quickly measures the activity of the storage organ.
"Heart beats, sixty beats per minute, no obvious abnormality."
"Heart beats, seventy-six beats per minute, no obvious abnormality."
"Heart beats, seventy-three beats per minute, no obvious abnormality."
The voice of Sun Bin reporting the data was a little trembling. This was the first big world-class project he participated in. Even if everyone told him that he was about to participate in the greatest biological project in human history, what would happen if " "Unlimited Time Organ Storage Technology" He still has a special "first love complex".
This kind of plot becomes especially obvious when the experimental results are about to be released.
Ten minutes passed.
Half an hour passed.
The heart is beating normally!
The hearts of everyone in the laboratory seemed to be jumping out of their mouths. They dared to swear that their heartbeats were definitely much faster than the heartbeat in the container.
For the next 48 hours, they stared at the data on the computer screen without blinking. Lu Keke's hands quickly danced on the computer keyboard, and beautiful data lines appeared on a screen with his movements.
Forty-eight hours later, until the two hearts stopped beating, their hearts were still moving at a high frequency. Sun Bin clutched his chest, and said blankly, "We... succeeded?"
In the simulated human environment, the maximum storage time of the heart will not exceed forty-eight hours.
Moreover, according to the data collected so far, the effect of storage for half a year on cardiac activity is almost negligible. According to this degree of influence, under the technology of the ninth laboratory, a heart can be stored for as long as 70 years. above.
This cannot be regarded as infinite time storage in strict text description, but in current science, it can already be called that.
A heart can be stored for more than 70 years. According to the current state of visceral donation in the country, Lu Kexue calculated that as long as a heart can be stored for more than 40 years, the needs of patients and the supply of hearts can be balanced.
And the application of this technology is not only the heart, liver, kidney, and even the human brain.
Many biological scientists in the world have proposed human brain transplantation, using human brain transplantation to achieve human immortality. The technology of human brain transplantation has been fully realized in theory, the only two difficulties are the precise brain organ and brain storage technology.
And this infinite time organ storage technology of the ninth laboratory completely solves the latter problem.
"Well, it worked." Li Zheng let out a long breath.
The combination of organ regeneration and organ storage indefinitely will be the epitome of future medical care. In a previous life, because various patents were in the hands of various institutions, even if two technologies were realized, clinical application and joint practice were almost non-existent.
To be honest, while patent rights protect the enthusiasm of researchers, it does hinder the progress of medical science to a certain extent. And in this life, he can probably get rid of this regret.
"Professor, have we really succeeded?" Sun Bin always felt that he was still in a dream.
Li Zheng was dumbfounded.
"Have you finished writing your papers? When the project papers are published, your papers can be published one after another. If you write well, I will recommend them to "Cell" for you."
""Cell"! That "Cell"? "Cell"?!!" Sun Bin opened his mouth wide.
"I... I'll go back and write immediately! Immediately! Immediately!" He jumped up from his seat suddenly, and ran to the lounge next to him, turning his head while running, and said loudly, "Professor, you can talk Do the math! Cell, cell!"
"Science", "Nature" and "Cell" are the top three journals in biology. In the 1980s, Hua Guo published these three journals, and they can count them on one hand.
Before Sun Bin was even surprised, he ran into the lounge and took out his half-written paper, giggling as he wrote, "Cell".
Meng Jie and Lu Keke stood there and hesitated. Although their performance was a little better than Sun Bin, their inner excitement was no less than his. You could tell by their trembling hands.
Li Zheng chuckled lightly, "Go ahead, let them take care of the aftermath for the rest." Li Zheng was referring to the two Huaqing students who helped.
Now the envy and jealousy in their eyes are almost indescribable in words. As expected of the ninth laboratory.
After finishing all the experimental data, Li Zheng called Liu Sizhao and unceremoniously pushed him the work of writing the thesis. Liu Sizhao was able to follow this project from beginning to end, and writing the thesis was not difficult for him.
And Li Zheng was planning to give him a co-first author, so the package was thrown away without any burden.
He himself, on the other hand, wants to set out to promote the establishment of China's drug clinical trial standards.
As he said at the meeting, the specification should be established as soon as possible, but how to build it, how to build it, and how to advance it logically without causing backlash, it needs to be considered in the long run.
In fact, when Li Zheng decided to return to Huajing, he had already thought about this issue. After a year, the plan in his mind became clearer.
Although the drug approval system is related to the biological circle, it is more of a political matter, and political events must be dealt with politically.