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    Home > Medical News > Latest Medical News > Li Hao: "Stay" out of the PV life road.

    Li Hao: "Stay" out of the PV life road.

    • Last Update: 2020-07-17
    • Source: Internet
    • Author: User
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    Guide: immersed in the field of PV for more than 20 years, witnessed the development of this industry, his technical life path is simply a living PV development history!----, undressed, funny and pragmatic, saying he was willing to share with young people, and that the humble, affable style was immediately roundedtalked about his career development technology life path, he laughs that it is "getting up" out, immersed in the field of drug safety alert (hereinafter referred to as PV) for more than 20 years, witnessed the development of this industry, his technical life is simply a living PV development historyDr, DrLi Hao, founder and chairman of Detaimai, founder of Teig Aitan, and former Chief Medical Officer of Tyger Pharmaceuticals/01/First Entry, and in 1998, he entered the pharmaceutical industry in the United States, working with many Harvard and other medical students in Abbott", "There is no comparability at all!" "He thought about how he could stand out from many of his famous colleagueshe believes that doing a good job of PV requires more understanding of regulations than medical knowledge, by contrast, Chinese has a strong ability to analyze the logic of regulationsto find a "breakthrough" Li Hao began to study the regulations, the United States, the European Union, all access to the regulations all through, until later around the people encountered regulatory problems, first thought to seek his advice"it's hard to do a good job of drug safety alert (PV) without a good understanding of regulations," he saidto do a good job of PV, first of all to know the specific requirements of the regulations, different national regulations, treatment will be different;/02/The term Pharmacovigilance (PV) from the auxiliary sector to the important sector originated in Europe and has been on the right track of globalization since 1998, when the rules were gradually refined, Li Hao just entered the line to catch up with the process of the formal development of PVat first, European and American pharmaceutical companies have also experienced the current situation of Chinese companiesPV is considered to be a cost department that does not make money and is a subsidiary departmentwants to put products on the market as soon as possible and make more money, and too many adverse reactions don't seem to do much good for selling drugs in short, the clinical sector does not want to see its research results halted because of safety concerns, and the marketing department does not want the sale of listed drugs to be restricted because of the safety risks of the product PV department must be coordinated throughout the company and other departments, and up and down the company leadership communication, to win support in many areas with the development of the industry, in the process of several major new drugs on the market, it is PV played a key role, only to gradually change people's understanding Li Hao tells a classic case of Morphite in Mersadon and Selaxib in Pfizer the two COX-2 selective inhibitors, from clinical and post-market data, were no different, but in the end there were two very different fates - the company was withdrawn five years after the listing due to a serious cardiovascular adverse reaction, which led to huge compensation, and Thereshib is still a best seller "They have only a small difference." "Lee says the key," Pfizer's instructions say, referring to cardiovascular risk "In fact, when The Afxibu was developed in the early stages, some people have raised warnings in this regard, but this issue has not been taken seriously." " when you first find that the drug may have adverse reactions to patients with poor heart function, they should be excluded or warned at the time of clinical trial." " and the instruction manual should be written clearly " At first, pharmaceutical companies thought that too many adverse reactions had been written on the specification, which would affect post-marketing sales but if there is no warning to patients, once similar adverse reactions occur, it is difficult to escape legal liability and the instruction manual clearly tells you of the possible risks, at least not easily ," he added Li Hao also gave an example- of a diabetes drug program the company had basically decided to close the project because of the discovery of the drug that caused platelets to drop This is not acceptable for diabetes medications that require long-term administration when he took over the project, did not rush to give a conclusion, but the relevant examination out to carefully examine the analysis, compare the dose and platelet decline is related, after the decline of the suspension of drugs is rapid lying up, platelet decline of the magnitude is clinical significance, whether there has been bleeding situation .. A round of analysis found that the drug-induced platelet decline and dose of not much, immediately after the suspension of the drug, the decline is only about 10%, up to 15%, and did not appear because of platelet decline caused by bleeding ", "This can go on." ", through various considerations, Li Hao came to a conclusion the final project successfully completed Phase III clinical trials and went public by such a case, we see that PV in the development of new drugs is actually the role of escort, to help the final product market and reduce the risk of products, PV has gradually become a more important sector to guide drug research and development /03/PV is not only an "emergency stop button" "An article last year, which counted how many drugs listed in 15 years were withdrawn for safety reasons what kind of data do you guess? "Sold for a while, Li Hao only told everyone, "12.5%! "If 10,000 projects end up on the market, what are the 12.5 percent of the drugs behind?" However, PV is not just an "emergency stop bond" that allows the drug to be withdrawn or clinically terminated , pv is done and may be "bendover overtaking" Li Hao also told you a classic case: Sigretin of Mershadon and Viglitin of Novartis When sigourin in the Us was approved for listing in the United States, many thought it was the first DPP-4 inhibitor, but Vergretin was the first real one when it was listed in the European Union but why ended up in the United States, where Vergretin was overtaken by Sigretin? Because of the risks that adverse reactions may pose the two drugs were found in the development process to have an effect on kidney function "Simply observation is not possible, and if there is no clinical data to indicate whether the drug is related, when the regulator asks, there is no way to answer, there will be a problem ," Mr Li said at the time, Novartis in the clinical process, did not do a good job of collecting data on drug nephrotoxicity, can not clarify whether it is not leading to a decline in renal function, and Mersadon systematically collected relevant data to prove that sigourin does not exacerbate the decline in renal function, so in the end, Sigretin became the world's largest market first DPP-4 inhibitor this has a profound influence on the market competition pattern of DPP-4 inhibitors in the future "From a PV perspective, we have two purposes, one is to want safer drugs to enter the market, and the other is to help companies design, manage risk, and speed up to market." " Li Hao concluded , in addition, he stressed that adverse reactions are not for all, there are significant individual differences for some innovative companies, there may be only one or two projects on hand, and if the company's lifeline is killed because of PV, it may be broken ", but the early detection of risk seis has been avoidable , " Li Hao pointed out, "as long as the benefits outweigh the risks, it is possible." key is how to screen out high-risk people and reduce risk - something that early PV could help companies design "/04/Return to China's PV with the arrival of PV industry spring, Li Hao also ushered in the rapid development of his career, has served as Kuntai, Abbott Pharmaceuticals, Sanofi Pasteur, Shi Guibao and Amylin and other well-known company headquarters manager to senior medical director early 2013, Li Hao began to return to China to do some consultancy work The and Tiger joint venture was also established in October of that year May of the following year, Li Hao officially returned to China "PV was very lacking, almost blank, before our country entered ICH ," Mr Li said June 1, 2018, China officially became a member of the regulatory member of ICH (International Coordination Committee for the Registration of Human Drugs) means that China's drug regulatory system has truly integrated into the internationally recognized regulatory system over the years, he has also been in the United States with China's drug regulatory department sourcing, communication, so has been very understanding of the situation at home now, he's finally seeing China's PV start he referred to the "60-day clinical trial filing system" for innovative drugs "Everyone said that document 50 is a major benefit to the industry." , yes, but at the same time it also raises higher demands " Li Hao explained: in this system, there are many exchanges, in addition to the declaration of IND, in addition to the request for the most basic information, also stressed the rationality of the experimental program, emphasizing the safety measures for subjects - which repeatedly put forward the requirements of risk-gains assessment and security measures, these requirements not only make a case report, but also the development of security update report, and clearly stated that if overdue, the experiment may be stopped " This actually refers to a new concept, that is, clinical trials should have a risk control plan, there must be a security alert system, but also the Drug Safety Board , " said Li Hao "This is very difficult for domestic enterprises." " Finally, he concluded: "The system raises the threshold significantly and brings out security and risk management." ": "This is the beginning of the development of China's PV /05/China's PV path, however, for China's PV, there is also a big problem: the lack of talent regulations for a long time, resulting in the market for PV does not have the corresponding requirements " regulations are the most important way to promote the market to develop talent ," he said regulations have begun to pay attention to PV, but the training of PV talent is not a one-off " one of the reasons is that the field itself is relatively new " Li Hao said that PV talent on the understanding of regulations, medical judgment of the understanding of the specific implementation of the requirements are not low over the years, he has also been working on doing something for the industry ", "There are several WeChat groups, all of which are over 1,000 people we will discuss some of the specific issues encountered in the work, regulations, the sharing of resources, information, and organize thematic discussions " plus now some meetings of the discussion, training, etc , is now PV is mainly learning position ", but that's not enough PV is not a teaching, requires systematic processes, SOP and so on, has not experienced a complete new drug research and development safety assessment and management projects, it is difficult to understand the requirements of regulations " Li Hao felt that China's PV talent training, there is still a long way to go, and my country's new drug research and development environment to grow together Another reason " is that many companies don't take it seriously ," he pointed out "It's a big challenge for people in the PV industry, " When you don't have enough knowledge to convince the leader, explain the importance of PV, and the leader doesn't pay attention to it, PV is hard to do well ," he said "" the company's management's positioning of PV: whether to support clinical development, post-marketing product maintenance, or just to deal with regulations, which is completely different ," he said this is related to a number of factors, including the product chain " innovative drugs on the demand for PV is higher, because PV can play a role in protecting the possibility of reducing post-market risk, while generic drugs, because there are foreign products listed in the reference, demand will be small " and, "companies need to recognize that PV is not a troublemaker, or even a safety issue, but also a comprehensive consideration of issues including effectiveness, such as 'Viagra' discovery because of the observation of adverse reactions, but from the original hypertension indications to ED treatment." ," he explained when the company can take the harm of drugs to patients as the primary factor, management is directly responsible for, involved in PV work, PV policies, regulations and enforcement can really land from the regulatory level, not only regulations to be in place, more important is the implementation of regulation, regular inspections and non-compliance rectification and penalties " in this way can really help Chinese companies ," he said however, he is confident in the development of China's PV after all, there is European and American experience in - "regulations, internal system formation, etc , can learn from "" THE DEVELOPMENT OF PV IS FIRST OF ALL REGULATIONS IN PLACE, FOLLOWED BY THE COMPANY'S MANAGEMENT'S RISK MANAGEMENT AWARENESS, DOCTORS AND PATIENTS OF POSITIVE FEEDBACK this is to ensure that effective and low-risk drugs serve the public , " he concluded .
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