The Medical Research Institute where Professor Fei works is an institutional scientific research institution. Regardless of the management model, decision-making process or the subjective initiative of scientific and technical personnel, it must operate according to a set of rigid and unchanging procedures. He has worked in that kind of institution for more than 30 years. , the thinking set has long been formed, and from his perspective, it is impossible to understand the operating mechanism of the Red Star Pharmaceutical Factory Technology Center.
In institutional scientific research institutions, selecting scientific research topics is a sacred and high-end task. General scientific and technical personnel do not have such awareness and sense of smell, nor do they have the power to select topics, so naturally they do not have that kind of motivation.
People who have the power to select scientific research topics are high-ranking technical authorities, because they are usually not on the front line of scientific research. They are generally older, have rigid thinking, slow consciousness, and poor sense of smell. Even if their technical level is not bad, the scientific research topics they propose often lack foresight. It is aimless and self-righteous, so it is difficult to access international cutting-edge technologies, resulting in a considerable part of scientific research work being done in vain.
Professor Fei is considered a relatively enlightened technical authority. Although he is doubtful about Fang Hanmin's statement, he has seen Fang Hanmin's technical achievements with his own eyes and has no doubts about this young man's technical level. As for why Red Star Pharmaceutical Factory chose this patent Of course Lao Fei didn't know that the drug was being copied. It was a decision made by a doctor of pharmaceutical science in the 21st century. Now, the development of generic drugs has been successful. Otherwise, Fang Hanmin would not be confident in looking for clinical trial institutions.
Lao Fei's curiosity brought up this topic, but he knew very well that this was not the purpose of Fang Hanmin coming all the way to find him. Therefore, Lao Fei stopped exploring the past details. He introduced Fang Hanmin to the clinical trial institution. , and plans to take Fang Hanmin to meet with the relevant person in charge of that organization tomorrow.
As agreed in advance, around nine o'clock the next morning, Professor Fei and Fang Hanmin came to Jiuzhou Hospital and met with Vice President Sun, who was in charge of technology.
In Lao Sun's office, after the guests and hosts were seated, Professor Fei briefly introduced the situation of both parties. Later, Fang Hanmin explained the generic drug developed by Hongxing Pharmaceutical Factory and frankly stated the purpose of the clinical trial.
Vice President Sun introduced the specific situation of Jiuzhou Hospital in detail. This is a tertiary A hospital that is particularly good at treating cardiovascular and cerebrovascular diseases. The drug copied by Red Star Pharmaceutical Factory is very effective in treating cardiovascular and cerebrovascular diseases. Vice President Sun Frankly speaking, it is the right place for Jiuzhou Hospital to evaluate the clinical efficacy of this drug.
However, the hospital's hosting of clinical trials requires manpower and material resources, and Vice President Sun hopes that Red Star Pharmaceutical Factory will bear this cost. In addition, in addition to providing certain financial compensation according to regulations for volunteers participating in clinical trials, in order to be safe, he recommended that each volunteer buy a commercial insurance.
Fang Hanmin believes that the conditions proposed by the other party are generally reasonable. The hospital needs to invest extra manpower and spend more energy in management to host clinical trials, so it should be financially compensated.
Although Fang Hanmin has full confidence in the generic drug developed by Hongxing Pharmaceutical Factory, it is a clinical trial after all, and it is understandable to provide certain financial compensation to participating volunteers. However, commercial insurance is a bit redundant.
Fang Hanmin believes that compared with the patent-holding company's drugs of origin, Hongxing Pharmaceutical Factory made some technological innovations when developing this drug, which not only increased the content of the drug's active ingredients, but also further removed the harmful trans- For isomers, using generic drugs for clinical trials has much lower risks than imported drugs. It is really unnecessary to provide insurance for volunteers participating in the trials.
However, Vice President Sun obviously did not want the hospital to take responsibility for any potential risks, and insisted on providing commercial insurance for volunteers. In order to promote cooperation and launch clinical trials as soon as possible, Fang Hanmin no longer argued with him and agreed to Lao Sun's proposal. Opinion.
In the afternoon of the same day, Jiuzhou Hospital drafted a clinical trial cooperation agreement. After Fang Hanmin read it, he felt that the hospital's financial price was relatively high. However, because he came to cooperate with the other party himself and there was no scope to choose from, he took the initiative. The power was in the hands of the other party, and there was little room for bargaining. After weighing it, he decided to accept the other party's conditions.
Before the agreement was signed, Fang Hanmin also made a request. He hoped that while conducting clinical trials, he would also conduct a comparative trial on the efficacy of generic drugs and the same imported drugs from the original patent-holding company.
"Isn't this a bit extraneous?" Lao Sun said reluctantly.
"Isn't it just a comparative test? Dean Sun, this is a piece of cake for you."
"Director Fang, you talk too easily! Clinical trials, human lives are at stake, how can you say it is something that can be done easily?"
"How can a comparative trial of the same drug involve human life? Dean Sun, you are serious!" Because major concessions have been made on the funds involved in the clinical trial, the other party did not even make this small request of his own. Unsatisfied, Fang Hanmin didn't want to compromise anymore.
Just as the cooperation agreement was about to be signed, the two parties reached an impasse on this trivial matter. Professor Fei, who had been sitting nearby drinking tea and rarely interrupting, felt that Vice President Sun was not kind enough. He couldn't help but said: "Old classmate, the so-called Isn't a comparative test comparing the clinical data of generic drugs with the data of imported drugs of the same kind? As a professional hospital for cardiovascular and cerebrovascular diseases, you must have collected the efficacy data of the same imported drugs, and finally compared the two data. Comparative analysis and then issuing an authoritative evaluation are just as easy as Director Fang said!"
"But......"
Lao Sun still wanted to defend, but Professor Fei waved his hand, "Stop talking, the big things have been decided. Do you think it's worth it just because of this small matter to hinder the cooperation between the two parties?"
Vice President Sun was silent for a long time. He could argue with Fang Hanmin, but he had to give Professor Fei face because he and Lao Fei were not only classmates, but also had an extraordinary personal relationship. "Okay, you can add this at the end of the agreement. One piece."...
After confirming the clinical trial cooperation unit, Fang Hanmin said goodbye to Professor Fei, and the two agreed to meet again later.
After hurried back to the unit, Fang Hanmin first assigned a task to Guo Peng, executive director of the technology center, asking him to seize the time and prepare generic drug preparations for clinical trials in the laboratory as soon as possible according to the formula.
Subsequently, Fang Hanmin held an emergency factory affairs meeting. He wanted to report to the team members on the preparations for the clinical trial, because it involved a large capital investment and had to be approved by the majority of the leadership team.
At 8:20 a.m. the next day, Fang Hanmin came to the factory meeting room early. This was a habit he developed every time he held a factory affairs meeting.
It was a rare day today. Before 8:30, all the team members, including Wang, the deputy director of the production factory, arrived at the meeting one after another. After everyone took their seats, Fang Hanmin began to introduce the preparations for clinical trials of generic drugs. The focus was on his visit to S City and Jiuzhou Hospital. Signed a clinical trial cooperation agreement.
"I didn't expect that it would cost so much money to conduct a clinical trial!" After listening to Fang Hanmin's introduction, Deputy Director Zhou, who was in charge of finance, felt inspired.
The fact that the team members care so much about investing in new products is a bit beyond Fang Hanmin's expectation. It’s no wonder that Red Star Pharmaceutical Factory has always produced APIs. Except for the time travellers, everyone here has never been exposed to new products, and they don’t know what clinical trials are. Fang Hanmin had to explain to them: “Clinical trials of generic drugs are relatively simple. It doesn’t cost much, but if you do a clinical trial on a brand new innovative drug, the investment will be several times or even ten times that!”
"I don't know much about clinical trials and have no right to make irresponsible remarks about them, but what I don't understand is that Hongxing Pharmaceutical Co., Ltd. is copying a product whose foreign patent has expired. It is said that this drug was not only sold in China a few years ago, but also has excellent efficacy. Very good, it shows that foreign companies have already done clinical trials. If this is the case, why do our generic drugs still need to do clinical trials? Is this unnecessary?" Deputy Director Wang is either absent with excuses, as long as he attends team meetings, his speech is always sharp .
Faced with Lao Wang's doubts, Fang Hanmin had to continue to explain, "Yes, since it is a drug sold publicly in the pharmaceutical market, the original company must have done clinical trials, otherwise it would not be allowed to go on the market. However, it is not necessary to conduct clinical trials for generic drugs. It’s not without precedent. Experts from the Medical Administration believe that if there are clinical data, this generic drug will soon occupy the domestic market. I agree to adopt the experts’ suggestions. In addition, when developing this drug, we based on the original patent A lot of technical improvements have been made. Compared with imported drugs from patent-holding companies, I think this drug has better efficacy, but this needs to be supported by clinical data."
Deputy Director Wang could find no fault with this explanation. Although Fang Hanmin was the least senior among the members of the leadership team, he won the trust of his predecessor based solely on his true talents and knowledge and his unparalleled contribution to Red Star Pharmaceutical Factory. The trust of the factory director.
Deputy Factory Director Wang could dismiss Fang Hanmin's qualifications and background, but he could not deny Fang Hanmin's technical level and contribution. In order to vent his grievances and continue to oppose Fang Hanmin at work, Lao Wang could only start from Finding awkwardness in other aspects.
"Director Fang's explanation sounds reasonable, but can you tell everyone how much sales of generic drugs will be after they are put on the market without clinical trials? How much sales will this drug increase after clinical trials are conducted?" Deputy Wang The factory director had always been in charge of production and never asked about the market situation. In order to prevent Fang Hanmin from coming to Taiwan, he suddenly became concerned about the sales business.
"This..." Fang Hanmin paused for a moment, collected his thoughts and then said: "After market research and trend analysis, after the patent expires, when the same generic drugs and imported drugs coexist, by virtue of their cost Advantages, generic drugs can account for up to 40% of the market share. If supported by clinical data with better efficacy, generic drugs can account for at least 80% to 90% of the market share. It is not difficult to see from this that the development of Clinical trials are necessary."
Most people would be speechless when faced with this kind of question, but it is not that easy to embarrass Fang Hanmin. Not to mention having conducted research in advance, Fang Hanmin already knew it. Even with his adaptability, he could Able to deal with problems.
While listening to Fang Hanmin's explanation, Lao Wang flipped through the clinical trial cooperation agreement signed by Fang Hanmin and Jiuzhou Hospital. Suddenly he saw that the agreement included a clause on purchasing commercial insurance for volunteers. This gave him another reason to continue to attack Fang Hanmin, "You Are you just going to sign an agreement with the cooperative unit on behalf of Red Star Pharmaceutical Factory? As the leader of the unit, this is too irresponsible!"
Faced with Lao Wang's accusation, Fang Hanmin was confused for a moment, "Director Wang, what's wrong?"
Lao Wang threw the agreement to Fang Hanmin and said angrily: "See for yourself! For a clinical trial of generic drugs, you are too generous to buy insurance for the volunteers participating in the trial!"
