At present, there are many institutions engaged in the research and development of new drugs in China, and the number of drug applications is growing rapidly year by year. At the same time, drug manufacturers generally feel that it is difficult to find good varieties with innovation and characteristics. The overall level of domestic drug research and development is not only gratifying but also worrying. There are few innovative drugs and imitated varieties are following up. Thousands of research and development institutions seem to make people feel that there are only dozens of heads, such as edaravone, Lomerizine Hydrochloride, aceglutamide for injection and so on. Academician Qin Boyi has criticized the impetuous phenomenon in the scientific and technological circles on many occasions, and this impetuous phenomenon is also prominent in the field of drug research and development. For example, in many R & D units, comprehensive and systematic project research has been replaced by "hearsay" and opportunistic transplantation; professional drug registration and clinical supervision have become "public relations" with drug administrators and doctors; a complete set of research application materials involving all aspects of drug R & D has become the eight part document that has been repeatedly "cloned"; what do R & D personnel think about The formulation and specification of the drug can not be clearly explained, the proposed drug quality standard can not be reviewed, and the production process can not be repeated. We can imagine the clinical significance of the varieties developed in this way.
1. The lack of excellent R & D technical management talents affects the overall level of domestic drug R & D
There are many factors affecting the level of domestic drug research and development, such as policy environment, market environment, capital investment and so on. However, in terms of specific research institutions, the lack of excellent technical management personnel is one of the direct reasons for the low level of R & D. Due to the lack of high-quality R & D technical directors, the "boss" of some units can only personally determine the "operation" problem, arrange the project, and determine the R & D progress. Many R & D personnel can not well examine and judge whether the project is feasible. In order to complete the "operation" of the boss on time, they often write one set of application materials without understanding. Such drug R & D naturally can not bring up high-quality R & D management personnel, and the lack of high-quality R & D technology management personnel has greatly restricted and hindered the overall level of domestic drug R & D.
2. Responsibilities of drug R & D technical director
A R & D unit or institution with a certain scale usually has a chief technology officer, such as R & D director, chief engineer, chief technology officer or R & D minister. The responsibility of the general director of R & D technology is simply to manage and grasp the whole process of drug R & D technically. Drug research and development is a large system engineering, involving many links and processes, such as project selection and approval, formulation and adjustment of project plan, pilot scale-up of samples, project application, clinical research, solution of technical problems in the production process, and post marketing monitoring of drugs. As the general technical director of a drug R & D unit or institution, he should not only understand the relevant links of drug R & D, but also be able to formulate the management process of the whole R & D process, constantly optimize and upgrade the management process, and handle and coordinate various technical problems in the R & D process at any time.
3. Quality requirements for excellent drug R & D technical management personnel
At present, many R & D technical directors can only organize and carry out the R & D work of generic generic generic generic drugs in a step-by-step manner, whose main role is to upload and release. As an excellent drug R & D technology management talents, they must have high technical quality and management quality at the same time. They should be compound talents who understand pharmaceutical technology, pharmaceutical market, pharmaceutical laws and regulations, clinical and pharmaceutical production, and scientific research management. The "understanding" here is not a simple understanding, but a thorough understanding and control ability. a. In terms of technical quality: be able to master the conventional technology and key points of drug research and development, be clear about the relationship between each link of drug research and development, be able to grasp the main relevant industry policies, industrial policies, especially drug laws and regulations, track the new technology, new products, new processes in the field of drug research and development, and constantly think about their application in the practice of research and development. Be able to grasp the latest changes in the drug market and understand the laws and characteristics of clinical medication. The technical quality of R & D technical management personnel is directly reflected in the quality of project selection and the technical guidance and control ability of the whole process of R & D. b. In terms of management quality: be able to constantly propose and establish R & D objectives, constantly judge which resources (information, technology, talent, equipment, etc.) are needed for R & D, and effectively allocate, use, organize and manage internal and external R & D related technical resources. Therefore, the R & D technical managers should have strong communication and coordination ability, clear and orderly thinking and certain personality charm. The management quality of R & D technical managers is reflected in whether they can formulate clear R & D management process and constantly upgrade the management process, whether they can handle and coordinate various technical problems in the R & D process at any time, and whether they can manage the R & D efficiency of the technical team.
In order to become an excellent drug R & D technology management personnel, it is necessary to have a solid and systematic pharmaceutical theoretical basis and rich practical experience in drug R & D. He is good at induction and summary, diligent in thinking and brave in surpassing himself, especially regarding drug research and development as a sacred cause.
(1) We should be good at constantly expanding our professional knowledge and gradually forming a systematic and solid research and development knowledge structure. As mentioned above, drug research and development is a systematic project involving many links such as drug administration laws and regulations, pharmaceutical market, pharmaceutical technology, pharmaceutical production, etc. The laboratory work of chemical drug research and development includes drug synthesis, drug analysis, drug preparation, pharmacology and toxicology. Although many R & D technical managers come from professional and technical personnel, they are often only familiar with individual links or disciplines of drug R & D due to their origins in a specific professional field, and they know little about other related disciplines or fields. This will inevitably lead to some blind spots in technical management, which will affect the overall grasp and overall management of a project, and at the same time, it will make technical personnel feel that they are expert in management.
For example, I majored in pharmaceutical analysis, but I was not familiar with pharmaceutical preparations, pharmaceutical synthesis, pharmacology and toxicology before. In order to be able to manage a project well, start to read relevant professional books, carefully study relevant technical guidelines and pharmaceutical laws and regulations, consult experts, and work with relevant professional and technical personnel to extract technical paths, analyze and summarize key links. After a period of hard study, not only can the project management process be clearly formulated, but also can the technical guidance be given to the personnel in each professional link of the project from the perspective of ideas, so as to improve the recognition of the professional technical personnel, reduce the joints in the project management work, and enhance the pertinence and efficiency of the project technical management work. As a technical manager, learning professional knowledge is not to become an expert in all the disciplines of drug research and development, but to learn from the perspective of grasping and managing the technical links, and to gradually form a solid system of professional knowledge structure through continuous expansion. With the improvement of technology management level, such as drug market information, research and development trends at home and abroad, human resource development and so on have been included in their own learning scope.
(2) Be good at accumulating and summarizing in R & D practice
Drug research and development is a very professional work, whether it is the collection and processing of information, or the sorting of test methods and application data, there are certain rules. The technical management personnel should be good at leading the technical personnel to carry out the accumulation and precipitation of technology while completing the specific R & D work, summarizing and accumulating the good methods, paths and processes formed in the R & D process, distinguishing which are common and which are individual, so as to guide the future R & D practice of the unit, and further accumulating and summarizing in the future practice, That is to say, "from practice to practice".
When being the project leader, first lead the technician to prepare standard test operation procedures (SOP), because this SOP is based on the absorption and digestion of authoritative technical requirements and guidelines such as Pharmacopoeia, technical guidelines of SFDA, expert opinions at drug review meeting, lectures of experts from drug review center, professional books and so on, combined with the test conditions and technical status of the unit It is revised repeatedly and has strong practicability and standardization. It not only greatly improves the work efficiency and quality of the test level, but also greatly standardizes the test operation of technicians and the writing of test records, avoids the confusion of different technicians' one practice in the same test, and reduces the impact on the quality and efficiency of R & D due to the large mobility of technicians 。
In addition to the preparation of test related SOP, the accumulation of this SOP Type has been extended to the links other than the test work, such as the review of application materials, information collection before the approval of generic drugs, on-site assessment, data archiving and management. For example, in the past, the pharmaceutical synthesis technician often took a sample and entrusted the analytical technician to carry out purity determination. There was no batch, number or date for sample handover. The analyst reported the determination results orally. The results often appear that the analyst lost the sample or the synthetic personnel wanted to review the results of the previous determination but could not find it. For this reason, it is required to fill in the form when conducting inter department commissioning test. Gradually, a form developed according to the actual situation gradually covers the basic level of R & D work.
(3) Good at thinking, brave to surpass and innovate
For the person in charge of the professional sub questions, he / she will lead the team to summarize the practical work path on the basis of learning and practice, and prepare the research guiding principles suitable for the specific situation of the unit. For example, after finishing a powder injection, it is required to summarize the general requirements of powder injection prescription and process selection, common problems and solutions, as well as the characteristics and key points of the project. With such continuous accumulation, several projects will feel comfortable.
In recent years, most of the domestic R & D institutions are engaged in the imitation development of the listed varieties at home and abroad. The saturated and boring market makes some researchers lose interest in the research and development of generic drugs. In fact, it is the simplest variety with national standard, and it is also a sparrow with small size and five internal organs. By dissecting and clarifying a project, we can understand the basic framework of a project. With the basic framework, we will continue to add and enrich the new methods refined in the practice process, and constantly revise and improve the original path. Over time, over time, we will have a thorough understanding of the links in drug research and development, and we will know what are the common technologies in drug research and development, which are individual technologies, which are core technologies and which are key technologies. In a word, one SOP and one technical guideline can form a basic technical realization ability of a unit through continuous accumulation in practice. In the process of summarizing these SOPs and technical guidelines together with technical personnel, the R & D technical director naturally has a strong grasp of specific links and details of drug R & D. When the basic technology realization ability reaches the point of being easy to master, innovation is only a part of the distance.
In addition to summarizing SOP and technical guidelines, in recent years, I have also written a paper to summarize my experience in the work. The papers I have exchanged successively include: "how to carry out technical innovation in new drug R & D enterprises", "new drug R & D after the implementation of" drug registration management measures ", "Knowledge staff management and human resource development of drug R & D enterprises", "how to carry out variety project approval and project management in small and medium-sized pharmaceutical enterprises", "understanding of how to do well in drug registration management", "thinking about how to do well in information management in drug R & D", "construction and R & D of competitive varieties", "new model of R & D management company enterprise research cooperation" And so on.
In recent years, most of the new drugs researched and developed in China belong to the category of generic drugs in essence. Many research and development institutions are engaged in the research and development of "doing work". This kind of research and development makes many research and development personnel become more and more impetuous. Some technical personnel can quickly clone a set of data with the existing template and pay the necessary test samples, which means they have mastered the drug research and development The true meaning of, complacent, do not want to forge ahead. Some R & D personnel, especially R & D management personnel, think that there are few varieties worth doing and capable of doing, and they are pessimistic about the future of drug R & D.
In fact, even if it is to copy and develop drugs with national standards, it is also a highly technical, professional and innovative work. Many varieties need to improve the quality standard due to long time on the market, many varieties need to improve the process due to the low yield of APIs or poor stability of preparations, and some drugs are found to have low bioavailability and high vascular stimulation in the clinical use process. In the dozens of projects I have contacted, almost every project has certain technical challenges. We always actively respond to these challenges and try to think about solutions. This can not only ensure the quality of the project, but also improve their own technical quality and self-confidence. On the contrary, if you encounter problems, you should avoid them, deal with them with a little bit, and hand in the "work" without any understanding. In the end, you can only become "Mr. Nanguo" in the drug research and development army.
Drug R & D technical managers should be good at thinking and dare to surpass. We should keep thinking about the technological opportunities, technological paths and R & D bottlenecks in the new environment and situation, keep pace with the times, and realize transcendence and innovation through continuous thinking and summary. We should constantly think about how to surpass our original knowledge structure, inherent thinking mode, R & D vision, familiar technology and test environment, drive the overall transcendence and innovation of the technical team through self leading transcendence, and then establish new R & D mode, find new varieties of options, and form a more effective organization mode through team transcendence exploration, so on We will find that R & D is no longer boring, no longer inaction, no longer just to "herd sheep". A berberine, many people think there is nothing to do, and through the preparation of masking technology to make good medicine no longer bitter, it will become a popular OTC medicine for children. Innovation is not necessarily to be a kind of new drug, to be good at mining the blank points in the market, to find the problems existing in the clinical use of the listed drugs and the problems existing in the quality of drugs, and then to solve them through technical means, quantitative change will bring about qualitative change, innovation will gradually come true, and small improvements will one day aggregate into large innovation.
As a technical manager, we should also be good at promoting technical innovation through management innovation. For the technical resources of the unit, we should continue to excavate. Through the establishment of good learning organization, dynamic and scientific evaluation mechanism, pleasant and orderly working atmosphere and other management means, we should form an effective incentive and competition mechanism. In the process of organizational transcendence and innovation, we should find the internal shortage of technical resources and actively try to find ways to supplement and allocate them.
(4) Good at communication, communication and cooperation
Technical management is at the connection of technology and management. In front of the administrative director, the technical director is the technical personnel, and in front of the technical personnel is the management personnel. Therefore, it is very important for senior R & D managers to have a certain communication ability. They should be willing to spend time communicating and constantly ponder over the art and methods of communication. The communication with the leader in charge can understand the intention of the leader well, and help the "boss" to make scientific decision and management at the same time. The good communication with the technical personnel can not only make the project plan well implemented, but also fully mobilize the enthusiasm and creativity of the technical personnel. At the same time, it is conducive to grasp the R & D quality and summarize valuable experience from the R & D practice. Communication with customers can make the research and development in the laboratory closer to the market and production reality.
In addition to internal vertical communication, we should also strengthen exchanges and cooperation with other R & D peers at home and abroad. Technology can learn from each other, skills can learn from each other, ideas can inspire each other, and hardware can share with each other. Building a car behind closed doors can only lead to closure and backwardness. We should be good at correcting ourselves, improving ourselves, enriching and developing ourselves in mutual communication and cooperation. To this end, I actively participated in some forums and conferences on drug research and development, and launched the "freehand sketch forum" in October 2004. The purpose is to exchange experience with more drug research and development personnel, use this exchange platform to collect the practical path of drug research and development, systematically summarize the technology and management experience of domestic drug research and development, and form a truly practical drug research and development The system enables drug R & D personnel, especially technical management personnel, to improve and develop together in mutual communication. Real drug research and development is forward-looking and avant-garde. Through continuous three-dimensional multi-directional communication, we need to maintain a high degree of sensitivity to new resources of drug research and development, and constantly seek new combinations of these new resources, thus characteristic varieties may be born.
(5) Love drug research and development, and take drug research and development as their sacred cause
Drug research and development for many people is a profession, a job. Some R & D personnel engaged in drug research and development, especially generic drug research and development, lack confidence in the future of drug research and development, are bored with the process of drug research and development, are troubled by the confusion of drug research and development, and are confused about their future career development. I've had this idea myself. However, with the deepening understanding of research and development, I gradually feel that no matter how the world changes, the pursuit of health is an eternal topic for human beings, and new drug research and development will never stop. Although the rate of discovery of new compounds has slowed down in the past two decades, new R & D resources are also emerging. For example, through DDS (drug delivery system), there are many new drugs on the market every year, while old drugs, new drugs, compound drugs, combination drugs and so on are still promising. Biotechnological drugs, especially Chinese herbal medicine, have immeasurable development space. The resources of drug research and development are not exhausted, and will never be exhausted. What will be exhausted is the resources of generic drugs that are easy to be "cloned" without protection. The era of profiteering and speculation in drug research and development is becoming history. Therefore, in the case of profound changes in domestic drug R & D policies, market and technical environment compared with those of the previous years, we should abandon the inertial thinking, remove the illusion of speculation, no longer be a member of the "herd", return to the original track of drug R & D, take the road of sustainable development and innovation, and drug R & D will have great achievements. At present, many GMP pharmaceutical factories in China usually only accept some short-term generic drugs due to temporary financial difficulties. With the end of the life cycle of these short-term drugs, many people in the industry predict that after two or three years, the technical market of drugs will be revitalized, and the varieties favored by the market will be characteristic ones. Therefore, as long as it is truly in line with the market needs, clinical needs, and has certain technological innovation or characteristics of drug research and development can not only survive, but also usher in lasting development.
Build up the confidence of drug research and development, accumulate, surpass and innovate constantly, and be good at communication, communication and cooperation, we will find that drug research and development can bring happiness, enrichment, upward impulse, growth power and competition confidence to ourselves. I used to shout out the slogan "I am happy to work, I work hard" in the R & D team led by myself. It is such a slogan that makes me "happy to progress" in drug R & D in recent years. When drug R & D is carried out with a positive attitude, it will gradually love drug R & D, and the heart will be from the original only concerned about a technology, a set of information, to the hope to master the whole process of drug R & D, and gradually expand to the desire to grasp the pulse of drug R & D at home and around the world. Only responding to drug approval can never be an excellent talent. Only when we really regard drug research and development as a career, can we reach a higher level of quality as a technical manager.
In short, to become an excellent R & D technical management personnel, we must love the drug R & D work, have solid basic professional knowledge, be good at learning new knowledge, be good at accumulation and summary, be good at thinking and surpassing, and be good at communication and exchange. We need to build up a solid foundation and work hard to achieve the level of drawing lessons from one instance and drawing lessons from another, comprehending, comprehending, comprehending, and being able to deal with problems in the management of R & D technology.