After being fired, I became the light of medicine

Chapter 122 There was a problem with the clinical trial of the kidney toxicity clearing dialysis needle! (Subscribe)

In the hearts of all Sichuan people, West China Hospital is the top one.

It is no exaggeration to say that this is the last hope for tens of millions of people in Sichuan Province at a critical moment.

After confirming his identity, Captain Lao Luo respectfully opened the door and allowed Gan Weiguo to enter the Qingshan Pharmaceutical office area.

Zhang Yang was also very surprised by President Gan’s personal visit and hurriedly stood up from his chair to greet him.

Just like what I said just now, West China Hospital is not only famous throughout the country, but it is also the last patron saint of the people of Sichuan Province.

Such a hospital deserves respect.

"President Gan, why did you come here in person? Please take a seat."

Zhang Yang's enthusiastic attitude made Dean Gan feel a little relieved, and he said with a smile:
"Mr. Zhang, I hope my coming here won't disturb you?"

"No, no, you're always welcome."

"Xiao Liu, bring me the tea I just bought. I will personally make a cup for Dean Gan."

As soon as he finished speaking, assistant Xiao Liu hurriedly took out tea from the cupboard. After a while, when the tea was ready, Gan Weiguo picked up the teacup and took a sip:
"Good tea."

Zhang Yang immediately laughed. His tea was just an ordinary tea that cost one or two hundred yuan per pound. It was just drinkable, but not good tea.

However, his smile also dissipated a lot of the strangeness between them.

Seeing this, Gan Weiguo immediately said:

"Mr. Zhang, I actually wanted to visit you in person a long time ago, but I just didn't have the time, so I kept delaying it."

"I hope you don't take it to heart that you, 'Qingshan Afa', entered our group. I really didn't know about it at the time..."

Before he finished speaking, Zhang Yang smiled and waved his hand to interrupt:

"Director Gan, you worry too much. I would have forgotten about it if you hadn't mentioned it. Don't worry, we don't take it to heart at all."

Zhang Yang was speaking from his heart. Not only him, but even Ren Xiaomin, who was involved in the matter, had probably completely forgotten about it.

"That's good."

Gan Weiguo nodded. In his heart, he had always believed that this incident had affected Qingshan Pharmaceutical's attitude towards West China. Now that it had been talked about, it could be considered an end.

After chatting for a few more sentences, he gradually turned the topic to the ultimate purpose of his visit.

"Mr. Zhang, our Qingshan Pharmaceutical has developed excellent drugs in the fields of blood diseases and liver diseases. I wonder if you are interested in the field of kidney diseases?"

Zhang Yang suddenly felt a little strange and asked curiously:
"what happened?"

"Nothing."

Seeing this, Gan Weiguo stopped beating around the bush and tested the issue more directly:

"You should know that there is an organization called the International Society of Nephrology in the world, right? They hold a Kidney Disease Summit every two years. This year, West China Hospital and Peking University Hospital were invited to the summit."

"Because we made a major scientific breakthrough in kidney transplantation last year, the association awarded a recommendation this year, which means we can invite a pharmaceutical company to participate in this Global Kidney Disease Summit."

"I've been thinking about it and I thought of you and Qingshan Pharmaceutical, but I don't know if you are interested in participating."

After he finished speaking, seeing Zhang Yang's expression startled, Gan Weiguo continued:
"Of course, I would like to point out that although your company has not yet developed any drug results in the field of kidney disease, Qingshan Pharmaceutical's current international reputation is enough for us to participate in this summit."

"I was thinking that if you are planning to do some drug research and development in the field of kidney disease in the next few years, this summit would be a good opportunity. At least you can have more exchanges and get to know more foreign kidney disease pharmaceutical companies."

Zhang Yang understood everything at this time, and couldn't help but marvel in his heart. He didn't expect that Dean Gan came here to give him an invitation.

However, this invitation letter is indeed a blessing in disguise. My own "Kidney Toxin Clearing Dialysis Needle" is about to undergo clinical trials. It would be a good idea to take this opportunity to make it public at such an important forum.

Thinking of this, his smile brightened even more:
"President Gan, thank you for remembering Qingshan Pharmaceutical. We do have ideas for developing kidney disease drugs."

"That's perfect!"

Dean Gan's expression suddenly relaxed, and he hurriedly said with a smile:
"Then I will report your names to the association when I get back. You should receive an invitation letter from the association in a few days. You should attend on time then."

"it is good!"

Zhang Yang did not argue with Gan Weiguo, and the result was a happy one for both the host and the guest. After about ten minutes of greetings, Gan Weiguo said goodbye and left.

After watching Gan Weiguo's car drive out of the park, Zhang Yang returned to the office and then carefully read the information about the "Global Kidney Disease Summit" on the Internet.

The level of the summit that Gan Weiguo personally invited must be very high. After learning the details, Zhang Yang became more determined to officially unveil the "Kidney Toxin Clearing Dialysis Needle" at the summit.

Gan Weiguo was very efficient. Within a few days, Zhang Yang received an invitation letter from the International Society of Nephrology, inviting Tsingshan Pharmaceutical to participate in the "Global Nephrology Summit" to be held in Shanghai two months later.

At the same time, Zhang Yang also received a reply from Fang Hanliang.

After several days of consideration, Fang Hanliang has decided to officially join Tsingshan Pharmaceutical, but before that he has to return to the German BI company to handle the resignation procedures and all contract issues.

Zhang Yang was naturally very happy.

Currently, Qingshan Pharmaceutical's main products are all derived from the system output. The only drawback is that the rewards are too random. If it had its own drug research and development team, it could completely supplement the simulator rewards and develop drugs for certain diseases in a targeted manner.

After dealing with these two issues, Zhang Yang immediately shifted his work focus to the "Kidney Toxin Clearing Dialysis Replacement Needle". The current focus of his work is to complete the animal experiments within two months and apply for Phase I clinical trials.

Like various new drugs before, in order to make the research and development process of the "Kidney Toxin Clearing Replacement Injection" look more reasonable and smoother, Zhang Yang provided Wei Tian's team with a semi-finished product with only a 50% effective clearance rate.

He still hopes to improve the product step by step from Phase I clinical trials to Phase III clinical trials as before.

Wei Tian and his team members have also become accustomed to this research and development model in which Zhang Yang proposes a plan and then they improve and perfect it step by step.

but,

Just as Zhang Yang was looking forward to the completion of the animal experiment of the "Kidney Toxin Clearing Dialysis Needle", Wei Tian suddenly broke into the office early in the morning.

He was holding a thick stack of information in his hand, with a stern expression on his face. As soon as he opened his mouth, Zhang Yang was surprised.

"Mr. Zhang, there are serious problems with animal testing. Several experimental animals have died in the past two days."

"Animal death? What happened?"

Zhang Yang quickly took the data from Wei Tian, ​​and after carefully checking it for a few minutes, he immediately understood what went wrong.

Like other innovative drugs, the "Kidney Toxin Clearing Dialysis Needle" needs to complete complete animal experiments before applying for Phase I clinical trials.

Animal experiments are mainly divided into two stages.

The first stage is to verify whether the drug will produce serious side effects after being injected into experimental subjects, such as mice or experimental monkeys. If so, what is the approximate dose that produces strong side effects?

This is to test drug toxicity, in order to provide pharmaceutical companies with sufficient data reference when they actually apply the drug in human trials during Phase I clinical trials.

The second stage is to test the therapeutic effect of the drug, which is professionally called pharmacodynamic trial.

Simply put, Qingshan Pharmaceutical's "dialysis needle" is aimed at patients with uremia. First, mice need to be made to suffer from kidney diseases similar to uremia, and then the "kidney toxicity clearing dialysis needle" is injected into the mice to monitor and analyze the toxicity of the "dialysis needle" in the mice and the drug effects.

Not only mice, but also monkeys with uremia, which are closer to the human body, will also undergo the same animal experiments!

The problem this time arises at this step!
Previously, whether it was clinical trials of the hepatotoxic "Afovir" or clinical trials of "hepatocellular carcinogens", patients in the experimental group would take the best current first-line treatment drugs while taking the new drugs.

For example, when testing "Afovir", the experimental group took "Afovir" while taking the best hepatitis B inhibitor "Tenofovir Alafenamide". Similarly, patients with cirrhosis also took "hepatocyte activators" while receiving traditional treatment for cirrhosis.

The purpose is to ensure the safety of the subjects, even if the new drug has no therapeutic effect, the subjects' condition will not be aggravated due to the clinical trial.

And what about this “Kidney Toxin Clearing Dialysis Needle”?

Because it only has a 50% toxin removal effect, and animal experiments cannot allow animals to undergo dialysis, after long-term accumulation of toxins, experimental monkeys suffering from uremia began to die in large numbers in just two weeks.

This is not the most important thing. The most important thing is that Wei Tian realized an extremely serious problem——

If the existing "Kidney Toxin Clearing Dialysis Needle" with a therapeutic clearance rate of only 50% is used clinically in humans, the 50% clearance rate will inevitably cause a large amount of toxins in the human body to be unable to be excreted. Clinical trials lasting one, two, or even three months will definitely cause difficult-to-assess harm to patients, or even death!

Thinking of this, Zhang Yang took a deep breath, looked at Wei Tian seriously, and said:

"How do you plan to deal with this problem in your clinical trial?"

Wei Tian said in a deep voice:
"The method I've come up with is to have the subjects dialyze every two injections. However, even with this method, the toxins in the subjects' bodies will remain above 50% for at least five days a week. It's hard to say whether it will cause harm to the subjects."

"And this frequency is already the limit we can accept! If we go for dialysis after every injection, we simply cannot verify the clinical effect of this drug."

"Moreover, even with this frequency, I am not sure whether the ethics committee will approve our clinical trial. After all, this method poses a great safety hazard to the lives of the subjects."

Zhang Yang nodded.

He remembered that the instructions for the "Kidney Toxin Clearing Dialysis Needle" recommended no more than two injections in a row and that dialysis should be performed no more than once every five days.

This is the case with the complete product, let alone the semi-finished product with a 50% clearance rate!
Thinking of this,

Zhang Yang frowned slightly, but he was not completely without a solution.

The most direct way is to directly use the finished product "Kidney Toxin Clearing Dialysis Needle" with an 80% clearance rate into the Phase I clinical trial. However, in this way, the "clinical product is the finished product" is hard not to be suspicious!
For a moment, Zhang Yang was in a dilemma.

On one hand, there is the safety of the subjects’ lives, and on the other hand, there is Qingshan Pharmaceutical’s biggest secret. It is difficult to make a decision.

"Wei Tian, ​​let's follow the normal animal experiment process first. I'll think about it."

"By the way, we can also ask the Ethics Committee to help evaluate how big the risk is of following your plan of two injections followed by dialysis!"

"it is good!"

Wei Tian also knew the troubles of the clinical trial of the "Kidney Toxin Clearing Dialysis Needle", so he responded and immediately went to deal with the matter.

In the next few days, Zhang Yang kept thinking about this matter, but no matter how hard he thought, he couldn't find a perfect solution.

In desperation, he decided to first increase the effective removal rate of the "Kidney Toxin Clearing Dialysis Needle" to 60%.

The R&D team was very efficient, and with Zhang Yang personally joining in, the clearance rate was increased from 50% to 60% in just one month.

The improved "Kidney Toxin Clearing Dialysis Needle" significantly prolonged the survival period in animal experiments. Not long after, the Ethics Committee also issued an evaluation report, assessing the improved "Kidney Toxin Clearing Dialysis Needle" as high risk (unknown and unknown risks).

This means that if the "Kidney Toxin Clearing Dialysis Injection" is to undergo clinical trials, just like the last time with "Efovir", many unknown risks must be explained and the subjects must be informed in detail.

However, Zhang Yang knew that the side effects of the "Kidney Toxin Clearing Dialysis Injection" this time were likely to be higher than those of the last "Ekofovir".

Just as Zhang Yang was hesitating whether to apply for Phase I clinical trials, the "Global Nephrology Summit" organized by the "International Society of Nephrology" was quietly approaching.

There was no other way, Zhang Yang had to put aside his hesitation for the time being and come to the Magic City. No matter what, he still had to announce this "Kidney Toxin Clearing Dialysis Needle" to the public first.

August 8st, Grand Hyatt Shanghai.

Located in the Lujiazui Financial and Trade Zone, Grand Hyatt Hotel has a broad view and overlooks the beautiful scenery of the entire city, making it the venue for many important large-scale business conferences.

At 8:30 in the morning, Zhang Yang arrived on time at the "Alice" conference room mentioned in the invitation letter.

At this time, many doctors were already present in the conference hall, and he was soon guided by the on-site staff to the seats for pharmaceutical company representatives on the right side of the conference hall.

As soon as he sat down, he began to observe the doctors who were invited to attend the meeting.

According to the list of participants provided by the organizer, those who can come here today are all top nephrologists from major hospitals around the world.

The two doctors invited to participate were from West China Hospital and Peking University School of Medicine. Others such as the National Hospital of Singapore, Europe and the United States also sent several top doctors to participate in the exchange.

While Zhang Yang was looking at everyone, many doctors also noticed Zhang Yang.

Many doctors started talking about it, especially when they saw Zhang Yang sitting on the seat with the "Qingshan Pharmaceutical" nameplate on it.

"Is this the boss of Qingshan Pharmaceutical? He looks very young."

"That should be correct, but Qingshan Pharmaceutical doesn't seem to have any drugs for kidney disease. Are you here to make yourself known?"

"I don't know. I heard that the organizer didn't invite me. I was recommended by West China Hospital."

The sound of everyone's discussion inevitably fell into Zhang Yang's ears, but he smiled slightly and didn't care.

According to the meeting schedule arranged by the organizer, four top doctors shared some kidney disease treatment plans and the latest surgical cases in the morning.

Reports and discussions on the latest kidney drugs from major pharmaceutical companies will have to wait until the afternoon.

Just as Zhang Yang calmed down and prepared to listen carefully to this high-end academic conference, a familiar figure suddenly appeared in front of Zhang Yang.

He is Gan Weiguo, the president of West China Hospital.

"Mr. Zhang, you're here so early for the 9 o'clock academic meeting?"

"Moreover, the morning discussion session is mainly for academic exchanges among doctors, and pharmaceutical company representatives usually come in the afternoon."

Zhang Yang finally understood why the seats for the pharmaceutical company representatives were empty with only a few people present.

but.

Now that he was here, Zhang Yang was too lazy to leave.

"It's okay. I can also attend the academic conference."

"it is good."

Gan Weiguo smiled slightly, and then thought about the fact that Qingshan Pharmaceutical currently did not have a drug for kidney disease.

Immediately he said:

"Mr. Zhang, please don't feel pressured. The main purpose of coming here this time is to show our faces."

"You can listen to the latest achievements of other pharmaceutical companies at the pharmaceutical company exchange meeting later this afternoon, which may also be helpful for your future research and development of kidney drugs."

Zhang Yang smiled and nodded.

Soon it was 9 o'clock, and the biennial "Global Nephrology Summit" officially kicked off.

……

PS: I failed in the daily 10,000, I am a waste.

(End of this chapter)