Chapter 202: No More Compromises
Professor Fei's medical research institute belongs to the scientific research institutions in the system, regardless of the management model, decision-making process or the subjective initiative of scientific and technological personnel, must operate according to a set of rigid and unchanged procedures, he has worked in that kind of unit for more than 30 years, the mindset has long been formed, from his point of view, it is impossible to understand the operation mechanism of the technology center of the Red Star Pharmaceutical Factory.
In the scientific research institutions within the system, the selection of scientific research topics is a sacred and high-end work, and the general scientific and technological personnel have neither the awareness and sense of smell, nor the power to select topics, so they naturally do not have that kind of motivation.
People who have the right to select scientific research topics are high-ranking technical authorities, because they are usually not in the front line of scientific research, they are generally older, rigid thinking, slow consciousness, poor sense of smell, even if the technical level is not bad, the scientific research topics proposed are often lack of forward-looking and pertinent, untargeted, but self-righteous, so it is difficult to get in touch with international cutting-edge technology, resulting in a considerable part of the scientific research work is useless.
Professor Fei is a relatively enlightened technical authority, although he will be skeptical of Fang Hanmin's statement, but after all, he has seen Fang Hanmin's technical achievements with his own eyes, and he is convinced of the young man's technical level, as for why the Red Star Pharmaceutical Factory chose this patented drug for imitation, of course Lao Fei does not know, it is from the decision of a doctor of pharmaceutical science in the 21st century, and now, the development of generic drugs has been successful, otherwise, Fang Hanmin will not be confident to find a clinical trial institution.
Lao Fei's curiosity led to this topic, but he knew very well in his heart that this was not the purpose of Fang Hanmin coming all the way to find him, so Lao Fei no longer explored the details of the past, he introduced the situation of the clinical trial institution to Fang Hanmin, and planned to take Fang Hanmin to meet with the relevant person in charge of that institution tomorrow.
After a prior agreement, at about 9 o'clock in the morning of the next day, Professor Fei and Fang Hanmin came to Kyushu Hospital and met Vice President Sun, who was in charge of technology.
In Lao Sun's office, after the guests and hosts sat down, Professor Fei gave a brief introduction to the situation of both parties, and then Fang Hanmin explained the generic drug developed by Red Star Pharmaceutical Factory and frankly stated the purpose of the clinical trial.
Vice President Sun introduced the specific situation of Kyushu Hospital in detail, this is a tertiary hospital, especially good at treating cardiovascular and cerebrovascular diseases, the drug imitated by Red Star Pharmaceutical Factory is very effective in the treatment of cardiovascular and cerebrovascular diseases.
However, the hospital needs to consume manpower and material resources to host clinical trials, and Vice President Sun hopes that Hongxing Pharmaceutical Factory will bear this cost. In addition, in addition to giving certain financial compensation to volunteers participating in clinical trials, in order to be sure, he suggested that each volunteer should buy a commercial insurance.
Fang Hanmin believes that the conditions proposed by the other party are generally reasonable, and the hospital needs to invest additional manpower and spend more energy on management to host clinical trials, and should be compensated financially.
Although Fang Hanmin is full of confidence in the generic drug developed by Red Star Pharmaceutical Factory, after all, it is a clinical trial, and it is understandable to give some financial compensation to the participating volunteers, but commercial insurance is a bit redundant.
Fang Hanmin believes that compared with the origin drug of the patent-holding company, Red Star Pharmaceutical Factory has innovated in technology when developing this drug, which not only improves the content of the active ingredients of the drug, but also further removes the trans isomers of harmful ingredients, and uses generic drugs for clinical trials, even compared with imported drugs, the risk is reduced a lot, and it is really unnecessary to provide insurance for volunteers participating in the trial.
However, Vice President Sun obviously did not want the hospital to be responsible for any potential risks, and insisted on providing commercial insurance for volunteers.
In the afternoon of the same day, Kyushu Hospital drafted a clinical trial cooperation agreement, Fang Hanmin read it, and felt that the hospital was asking for a relatively high price economically, but because he came to the door to cooperate with the other party, and there was no scope to choose from, the initiative was in the hands of the other party, and there was little room for bargaining, and after weighing it, he decided to accept the other party's conditions.
Before the agreement was signed, Fang Hanmin also put forward a request, he hoped to do a comparative test of the efficacy of the generic drug and the same imported drug of the original patent holding company while doing clinical trials.
"That's a bit of a complication, isn't it?" Lao Sun said reluctantly.
"Isn't it just a comparative test? Dean Sun, this is a matter of effort for you. ”
"Director Fang, you said it too easily! Clinical trials, human life is at stake, how can it be said that it is a matter of effort? ”
"How can a comparative test of the same drug be related to human life? Dean Sun, you're serious! Because major concessions have been made in the various funds involved in clinical trials, and the other party can't even meet his own small requirements, Fang Hanmin doesn't want to compromise anymore.
Seeing that the cooperation agreement was about to be signed, the two sides reached an impasse in this trivial matter, and Professor Fei, who had been sitting next to him drinking tea and rarely interjected, also felt that Vice Dean Sun was not kind enough, and he couldn't help but say: "Old classmate, isn't the so-called comparative test just to compare the clinical data of generic drugs with the data of the same imported drugs?" As a professional hospital for cardiovascular and cerebrovascular diseases, you must have collected the efficacy data of the same imported drugs, and finally compared and analyzed the two data, and then issued an authoritative evaluation. ”
"But ......"
Lao Sun still wanted to argue, but Professor Fei waved his hand, "Don't say it, the big things have been decided, just because this small matter hinders the cooperation between the two sides, do you think it's worth it?" ”
Vice Dean Sun was silent for a long time, he could deal with Fang Hanmin, but he had to give Professor Fei's face, because he and Lao Fei were not only classmates, but also the two had an extraordinary personal relationship, "Okay, you can add this article at the end of the agreement." ”......
After implementing the clinical trial cooperation unit, Fang Hanmin said goodbye to Professor Fei, and the two agreed that there would be a period later.
After hurrying back to the unit, Fang Hanmin first assigned a task to Guo Peng, the executive director of the technology center, asking him to hurry up and prepare generic drug preparations for clinical trials in the laboratory as soon as possible according to the formula.
Subsequently, Fang Hanmin urgently convened a factory meeting, and he had to report to the team members on the preparation of the clinical trial, because this involved a large amount of financial investment, and the consent of the majority of the members of the leadership team must be obtained.
At 8:20 a.m. the next day, Fang Hanmin came to the factory conference room in advance, which was a habit he developed every time he held a factory meeting.
Today is rare, before half past eight, including the deputy director of the production plant Lao Wang, all the team members have arrived at the meeting, after everyone took their seats, Fang Hanmin began to introduce the preparation of generic drug clinical trials, the focus is that he went to S City to sign a clinical trial cooperation agreement with Kyushu Hospital.
"I didn't expect that it would cost so much money to do a clinical trial!" After listening to Fang Hanmin's briefing, Deputy Director Zhou, who was in charge of finance, was moved.
The team members cared so much about the capital investment in new products, which was a bit unexpected by Fang Hanmin. It is no wonder that the Red Star Pharmaceutical Factory has been producing APIs, except for the traverser, the people here have never been in contact with new products, let alone know what clinical trials are, Fang Hanmin had to explain to them: "The clinical trials of generic drugs are relatively simple, which is not too expensive, if a new drug is a clinical trial, the investment will be several times or even ten times this!" ”
"I don't know much about clinical trials and don't have the right to make irresponsible remarks about them, but what I don't understand is that Red Star Pharmaceutical Factory imitates products with expired foreign patents, and it is said that this drug was not only sold in China a few years ago, but also has a good curative effect, indicating that foreign companies have already done clinical trials, in this case, why do our generic drugs still need to do clinical trials? Isn't that redundant? "Deputy Director Wang is either absent for some reason, as long as he participates in the team meeting, his speech is always sharp.
In the face of Lao Wang's doubts, Fang Hanmin had to continue to explain, "That's right, since it is a drug that is sold publicly in the pharmaceutical market, the original company must have done clinical trials, otherwise it cannot be marketed." However, it is not without precedent to do clinical trials for generic drugs, and the experts of the Pharmaceutical Administration believe that if there is clinical data, this generic drug will soon occupy the domestic market, and I agree to adopt the experts' advice. In addition, when developing this drug, we made a lot of technical improvements on the basis of the original patent, and I think this drug has better efficacy than the imported drug of the patent holding company, but this needs to be supported by clinical data. ”
Although Fang Hanmin has the least seniority among the members of the leadership team, he has won the trust of the former director by virtue of his true talent and unparalleled contribution to the Red Star Pharmaceutical Factory.
Deputy Director Wang can turn his nose up at Fang Hanmin's qualifications and background, but he can't deny Fang Hanmin's technical level and contributions, in order to vent his grievances and continue to oppose Fang Hanmin at work, Lao Wang can only find awkwardness from other aspects.
"Director Fang's explanation sounds reasonable, but can you tell you how many sales of generic drugs will be sold after they are put on the market without clinical trials? After a clinical trial, how much can this drug increase sales? "Deputy Director Wang has always been in charge of production, never asked about the market situation, in order to make Fang Hanmin unable to come to Taiwan, he suddenly cared about the sales business.
"This ......," Fang Hanmin paused for a moment, sorted out his thoughts and said: "After market research and trend analysis, after the expiration of the patent, in the case of the coexistence of the same generic drug and imported drugs, with its cost advantage, generic drugs can account for up to 40% of the market share, and if there is better clinical data to support it, generic drugs can account for at least 80% or 90% of the market share." It is not difficult to see that it is necessary to conduct clinical trials. ”
Ordinary people are bound to be speechless when faced with this kind of problem, but if they want to embarrass Fang Hanmin, it is not so easy, not to mention that they have researched in advance, Fang Hanmin has long known in his heart, even with his ability to adapt to changes, he can deal with the problem.
While listening to Fang Hanmin's explanation, Lao Wang flipped through the clinical trial cooperation agreement signed by Fang Hanmin and Kyushu Hospital, and suddenly saw that there was a clause in the agreement to purchase commercial insurance for volunteers, which made him find a reason to continue to challenge Fang Hanmin, "Do you sign an agreement with the cooperative unit on behalf of Red Star Pharmaceutical Factory?" As the leader of the unit, this is also too irresponsible! ”
Facing Lao Wang's accusation, Fang Hanmin was puzzled for a while, "Director Wang, what's wrong?" ”
Lao Wang threw the agreement to Fang Hanmin, and said angrily: "Look at it yourself!" For a clinical trial of a generic drug, you are too generous to buy insurance for the volunteers who participated in the trial! ”