Chapter 390 I'm too busy to have a video consultation
Soon we arrived at the drug research and development laboratory of the Jin Group in the Magic City.
Under normal circumstances, drug research and development is very difficult, and the process of drug research and development is even more complex.
King's Group's drug research and development, from early stage research and development to drug launch, has to go through many steps and processes that can be arranged from the letter A to H.
A. The first is basic research. This process starts with patients, clinical pathology, and statistical data to find and verify potential targets.
Under normal circumstances, this step would take the developers several years of effort, but here at Tanglou, it can be completed directly.
B. Pharmacology and biomarker development. Including pharmacology and druggability research on targets, and biomarker research related to targets and prognosis.
Tanglou also skipped this step directly. Under normal circumstances, at least tens of millions of dollars would have been invested in the Jinshi Group's laboratory, and it would even take several years to complete.
C. Discovery of lead compounds. Lead compounds are compounds with certain biological activity obtained through various pathways and means. They are usually obtained through in vitro screening and used for further structural modification and optimization.
This step would have cost tens of millions of dollars in the Jin Group's laboratory, and the R&D personnel would still need some luck to discover it. But Tanglou also completed this step in an instant.
D. Optimization of lead compounds, confirmation of preclinical candidate compounds, and preclinical research, production and quality control (CMC) to support the application. In this link, potential drug candidate molecules are screened and systematic pharmacodynamic studies and toxicology studies are conducted.
, it is also necessary to produce samples to support clinical research under quality management (GMP) conditions.
At this step, for the King Group, it is considered very lucky that two or three of the dozens of drug research and development projects can enter this step.
Often, by the time we get to this point, hundreds of millions of R&D expenses have been spent and several years have gone by.
Therefore, for researchers in the pharmaceutical laboratory, a doctoral student's research project in Tanglou completed the compound synthesis of the high blood pressure drug felodipine, and the sample of the small reagent was astonishing to them.
The more I understand how difficult it is to develop new drugs, the more I understand how difficult it is for Tanglou to reach this point.
The head of the new drug research and development laboratory, Dr. Gao Jiangang, greeted Tanglou with great admiration.
"Dr. Tang, did you really spend less than a year developing this sample of felodipine?"
Dr. Gao still asked with some disbelief. Previously, when Tanglou first started cheating reagents from the laboratory, Dr. Gao was very disgusted. He even felt that Kim Yuna must have been stunned by beauty.
However, when he actually saw the demo, he was completely confused.
Just by getting these few reagents from the laboratory, he successfully synthesized the lead compound. Such a smooth and bizarre research and development process was unheard of even in his more than ten years of career.
Therefore, when I saw Tanglou today, Dr. Gao must ask carefully.
"It probably took a few months. To say it was less than a year would be correct."
Tanglou said lightly.
Dr. Gao got the confirmation that looking at the tenement building was like looking at a fairy. This kind of feeling was that in less than a year, the security guard's salary was less than 40,000, and 3,000 a month was less than 40,000.
"He is truly a man favored by the God of Medicine."
Dr. Gao took the lead and led Tang Lou: "Dr. Tang, after you provided the lead compound, we have officially entered clinical research."
That is: E, clinical research. It mainly conducts clinical trials, including phase I, phase II, and phase III clinical trials. The goals of each phase are different and the scale is also different.
Dr. Gao took Tanglou to see the first phase of the Linchuan experiment they had completed.
"Dr. Tang, you see, the first phase of clinical trials is mainly for preliminary clinical pharmacology and human safety evaluation experiments. The laboratory has completed the human body's tolerance and pharmacokinetics of new drugs, providing information for formulating dosing plans.
in accordance with."
"Under your guidance in the early stage, we greatly reduced the range of drug dosage, and quickly obtained the incremental relationship between drug dosage and drug side effects. At the same time, we also clarified the kinetic properties and
The determination of metabolites and the metabolic pathways of drugs in the human body."
"The final result is exactly as you predicted."
Dr. Gao looked at Tanglou in disbelief, his eyes full of admiration.
"After that, we put the felodipine project at the top of all other projects, with the highest priority, and quickly started the second phase of clinical trials."
Dr. Gao continued to show Tanglou the data and various information on their company's phase 2 clinical trials.
Since he had conducted deductions in a systematic laboratory, Tanglou was very clear about this information and knew the correct data.
Therefore, there is no need for Dr. Gao’s detailed explanation at all. Even in some summary statistical results, Tanglou is clearer than Dr. Gao.
After all, Dr. Gao relied entirely on the laboratory staff to compile and compile experimental data and obtain the final results.
Tanglou is the standard answer for direct reading. There will always be some deviations in the artificial statistics of the laboratory.
"Dr. Tang, the phase II clinical trial is the preliminary evaluation stage of the therapeutic effect. Its purpose is to initially evaluate the therapeutic effect and safety of the drug on patients with target indications. This step also requires determining the research design and dosing of the phase III clinical trial.
Dosage plan. This time, I invite you to come here because I want to work together to formulate the plan for this phase three trial."
"Here is my preliminary plan and data support, please take a look first."
Dr. Gao himself is very knowledgeable in statistics and data processing. After all, his second major is mathematics, especially statistics.
Seeing Dr. Gao's data and plan, Tang Lou was also very impressed. Dr. Gao's plan was very close to the standard answer.
Tanglou looked at it and said with great appreciation: "Dr. Gao's skills are indeed profound. This plan is basically feasible. So, give me a day tomorrow and I will give you my suggestions."
"certainly."
Dr. Gao was very much looking forward to returning and arranged a special office for the tenement building.
In the laboratory, other colleagues are also very curious and looking forward to whether Dr. Tang has real talent and knowledge despite his reputation.
After spending a day in seclusion, studying the experimental data, and proposing a three-phase plan, just listening to it made the laboratory staff excited. If they could really draw a conclusion, then Dr. Tang would really make them worship him.
The next day, the tenement building was in the office. Of course, it was just to deceive others. After all, it would be too scary to give the answer at a glance.
Moreover, Tanglou thought about it and decided to use this day to conduct a remote consultation with the Second Hospital of Harbin Medical University.
After all, Professor Liu invited him so sincerely, and it would be too disrespectful to not even participate in the consultation.
In order not to affect the tenement building, Dr. Gao arranged the largest and quietest room in the tenement building. Of course, it also has various supporting facilities and there is no shortage of remote systems.
Tanglou put away a pile of information and wrote out the dosage plan for the third phase and the clinical trial plan for the third phase.
First, several sets of data from Dr. Gao were revised, and then a randomized blind selection method was used to control clinical trials, and placebos and already-marketed drugs were added as controls.
Soon, a rigorous, scientific and detailed plan was completed.
After doing all this, Tanglou looked at the time and saw that it was time for the consultation at the Second Hospital of Harbin Medical University.
And, at this moment, in the consultation room of the Second Hospital of Harbin Medical University, a team of experts also broke out.
"Doctor Tang, is he reliable? He didn't agree to come for consultation today. Where is he?"
"Dr. Tang didn't get on that plane at all. I waited at the airport for a long time and didn't arrive, and I couldn't get through the call."
Doctor Chen's face was full of grievances, but he was a little happy in his heart. If Tanglou really didn't come, Yishu would still be his.
Professor Liu was a little surprised that Dr. Tang actually escaped from the battlefield.
Just when he was depressed, his cell phone rang. It was Tanglou's number, and Professor Liu immediately answered the call.
"Professor Liu, I'm sorry, I'm in the same situation as you were at Union Hospital. I also have an emergency here. I was supposed to go to the Second Hospital of Harbin Medical University this morning, but I was captured by Manager Jin of the Jin Group and taken back to the Magic City.
, the guidance laboratory is carrying out the plan for the third phase of the Linchuan experiment. Therefore, today we can only participate in the consultation through remote video."
Professor Liu also didn't expect that Dr. Tang would be so difficult to deal with.
Moreover, he actually led the research and development of a new drug and even conducted phase III clinical trials?
What a magical operation this is.
Professor Liu smiled bitterly: "Okay, then I'll arrange the remote video."
After Professor Liu hung up the phone and said that Tanglou wanted to participate in the consultation via remote video, everyone in the expert team exploded.
"Isn't this too arrogant? No one will come, just a video consultation?"
"It's just that they don't take us seriously."
"Only one would believe that a young doctor like him can lead the research and development of new drugs and enter phase III clinical trials."
"Is it possible that you are not confident about participating in a second heart transplant, so you simply don't dare to come over and find an excuse to shirk it during the consultation?"
"It's very possible. After all, the difficulty and complexity of ordinary heart transplantation and secondary heart transplantation are very different."
"Oh, he slipped up at the critical moment. I really thought highly of him before."
Chapter completed!