Present Situation and Thinking of the Evaluation and Management of Biomedical Projects in Shenzhen Industrial Park of Shenzhen-Hong Kong Cooperation Zone

Zhao Xuanhe,Wang Shuling

(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China)

Abstract Objective To put forward some suggestions for the improvement of the evaluation system of Shenzhen Industrial Park of Shenzhen-Hong Kong Innovation Cooperation Zone by studying the scientific research project evaluation and management system of Japan Agency for Medical Research and Development (AMED).Methods Through literature review,lessons were drawn from the review and management policies and methods of biomedical projects implemented by Japan AMED.Then some reference was provided to the review and management of the projects in Shenzhen Industrial Park.Results and Conclusion A basic review framework has been set up in Shenzhen Industrial Park,which consists of scientific research management institution of Shenzhen Industrial Park,Third-Party Review Institution and Science Committee.However,there are three problems in this system:unclear selection criteria of review experts,insufficient supervision and lack of project evaluation standards.These problems can be solved by establishing an expert think tank,setting up graded project supervisors to have the dynamic monitoring,and developing a general evaluation scale for evaluating scientific research projects in Shenzhen Industrial Park.

Keywords: Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone;Japan Agency for Medical Research and Development;biomedicine;review;research project

Shenzhen Industrial Park of Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone (hereinafter referred to as Shenzhen Industrial Park) is the only area in the Guangdong-Hong Kong-Macao Greater Bay Area with the theme of science and technology innovation,which plays an important role in deepening cooperation between Shenzhen and Hong Kong and promoting the two-way fiow of funds.At present,there are 138 officially scientific research projects in Shenzhen Industrial Park.With the increasing number and variety of scientific research projects,Shenzhen Industrial Park needs to build an effective review and supervision system to provide services to these projects.

Taking the biomedical industry as an example,this paper provides reference for further improvement of the review system of scientific research projects in Shenzhen Industrial Park by interpreting the policies of project application,screening,review and supervision,and combining the advanced review and supervision experience in Japan.

1 Overview of application system for existing scientific research projects in Shenzhen Industrial Park

According to the “Several Support Measures for Scientific Research and Innovation in Shenzhen Industrial Park of Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone”[1](hereinafter referred to as “Support Measures”)issued by the People’s Government of Futian District,Shenzhen in 2020,it is known that there are two basic application procedures,namely,the project application and topic selection.

Through these two procedures,the research management organization in Shenzhen Industrial Park will select projects that meet the development support criteria for reasonable allocation of research funds,providing them with various services that are conducive to research.

1.1 Project application and approval mechanism

The project application mechanism gives research institutions or enterprises that meet the requirements a certain degree of freedom.They can determine their own research subjects,and then submit a project application to research management agency.Then they have to wait for experts to review the project.After the project is approved,the research management agency will provide financial support to the project according to its content.The process of project application is shown in Fig.1.

1.2 The project adopting the topic selection mechanism

The topic selection mechanism mainly includes four steps.First is to select the key R&D topics to form a recruitment list,second is to post the list publicly,third is to expose the list to the research institute or enterprise,and fourth is to review and select a reasonable party for the project.

First of all,the scientific research management institution in the industrial park asks enterprises about the key points of scientific and research development.Then it invites experts in relevant fields to sort and refine the information to form the topics of scientific research projects.After that,the key research project topics will be formed into a recruitment list for the public.Scientific research institutions or enterprises will select the topics in the list according to their own situation.Some experts will review the qualifications of the research institutions or enterprises to select the best project recipient.The process of the top selection mechanism is shown in Fig.2.

2 Project review and management procedures in Shenzhen Industrial Park

2.1 Project review and management institutions

In order to support the healthy and efficient operation of scientific research projects in Shenzhen Industrial Park,a scientific research institution was established under the leadership of the Group Office of Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone,which is responsible for the allocation of scientific research funds,the management of scientific research projects,and the provision of various support services for scientific research institutes,enterprises and other organizations.

In order to screen out the best research projects in key fields and improve the efficiency and utilization of research funds,as well as to facilitate the evaluation of research projects in stages and final results,a third-party agency has been introduced to review and manage the projects in the Shenzhen Industrial Park.The third-party agency should have a board of directors to ensure the diversity,internationality and professionalism of the members[1].In addition,a multidisciplinary committee should be established under the board to review and manage the projects within the discipline in a dynamic manner.The chairman of the Disciplinary Committees should be an authoritative professor or technical expert appointed by the third-party agency.The chairman should be responsible for the overall control of research and development (R&D) projects in his respective field.The project review and management procedures in Shenzhen Industrial Park are shown in Fig.3.

Fig.3 Project review and management procedures in Shenzhen Industrial Park

2.2 Review and management framework of the“three-stage” research project

The review process of scientific research projects in Shenzhen Industrial Park is divided into 3 stages.The first stage is project review,in which the person or team in charge of the research project submits the application to the research management organization according to the project selection mechanism or independent application mechanism.Then,the Disciplinary Committee organizes experts to review the qualification of the applicants and determine whether they can carry out the.The second stage is periodic evaluation,which means the Disciplinary Committee organizes peer experts to conduct a comprehensive evaluation of the research project each year.They have the rights to terminate or continue the project based on the evaluation results.Besides,some international peer experts will be introduced to conduct joint evaluation.The third stage is the end-of-project evaluation,in which the Disciplinary Committee hires a professional third-party agency to conduct an evaluation of the results of the project.The frontier research must highlight originality.

2.3 The operation mode of “reflex arc” type review and management

The operation of the review and management system of the research projects in the Shenzhen Industrial Park is similar to the structure of a reflex arc in the nervous system.The scientific research administration as the coordinator is like a receptor,it supervises the third-party agency,the formation and management of Disciplinary Committees by thirdparty agency is similar to the effector.

In this review system,there is not only a forward management system from the coordinating to the execution,but also a reverse feedback system from the execution to the coordinating.In the forward management system,a third-party agency is entrusted by the research administration to review and manage the research projects in the Shenzhen Industrial Park.The third-party agency must set up Disciplinary Committees,which are responsible for the appointment of committee chairpersons.The Disciplinary Committees organize peer review of research projects by experts.In the reverse feedback system,the Disciplinary Committee conducts a comprehensive review based on the research progress report or research results report submitted by the project executor.The relationship between the project review and management system in the Shenzhen Industrial Park is shown in Fig.4.

Fig.4 Project review and management system in Shenzhen Industrial Park

3 Review and management system of biomedical research projects in Japan

In order to improve the integrated R&D environment in the biomedical field,provide more direct services to research projects,and simplify the process of applying for research funding,the Japan Agency for Medical Research and Development(AMED) was established in 2015 by the Office of Health and Medical Policy of the Cabinet Secretariat,the Ministry of Education,Culture,Sports,Science and Technology,the Ministry of Health,Labor and Welfare,the Ministry of Economy,Trade and Industry,and the Ministry of International Affairs and Exchange.AMED is responsible for reviewing,supervising,and providing financial support for research projects in the biomedical field in Japan,as well as facilitating the transformation of research results[2].Generally,the results of the project review are used as the basis for dividing or adjusting the allocation of research funds,which in turn promote the development of the project,thus forming a virtuous circle.The specific relationship between the review and funding of relevant projects in Japan is shown in Fig.5.

Fig.5 Project review and funding relationship diagram

Project review and management has always been placed on a high level of importance by AMED.After years of development and adjustment,it has a complete organizational structure and operating procedures for project review and management now.

3.1 Review and management procedures for biomedical research projects in AMED

3.1.1 Focusing breakthroughs -formulating integrated research themes

AMED classifies research projects within the biomedical field into six integrated themes[3],namely drug R&D,medical device development and healthcare assurance,regenerative medicine/cell/gene therapy,genomic and data research,basic medical research,and seed R&D.

The six integrated research themes are designed to focus resources and efforts on breakthroughs in clinical research and treatment,mainly including scientific research on key diseases such as infectious diseases,cancer,growth and developmental diseases,geriatrics (especially cognitive diseases),psychiatric and neurological diseases,rare diseases,and lifestyle diseases.The contents of AMED’s six integrated research themes are shown in Fig.6.

Fig.6 Contents of AMED’s six integrated research themes

3.1.2 Establishment of a multi-level project leader system

AMED has divided the biomedical field into six integrated programs.To achieve scientific review and management of the programs,three levels of supervision have been established based on the integrated programs[4],namely,program director,program supervisor,and program officer (Fig.7).At each of these three levels,the director should have an excellent academic background,extensive R&D experience,and unique insight into the evaluation and operational management of R&D projects in the research area.The head of each supervisory level has different responsibilities.

Fig.7 The three-level regulatory structure

(1) The project director is responsible for each integrated research theme.His or her main task is to provide expert insight into the project for which he or she is responsible.At the same time,he or she needs to have a comprehensive understanding of the research topics and to coordinate the promotion or collaboration of projects in the focus area.

(2) The project supervisor is required to have a precise and comprehensive understanding of the R&D difficulties and expected results of the specific project he/she is responsible for.Based on the understanding of the project’s R&D objectives,he/she will effectively monitor the operation of the research project.

(3) The project officer is responsible for supporting the project supervisor in his daily work and assuming the day-to-day management of the project.

The results of basic research are used in clinical studies and practical applications through synergy between the project director,project supervisor and project officer,with consistent regulatory method to facilitate R&D,evaluation,and identification of excellent R&D solutions.

Through collaborative efforts,comprehensive project review research proposals and expert research adjustment recommendations are made based on the use of expertise to grasp the overall situation and challenges within the relevant research area.

3.2 Project review framework of AMED

The project review process of MAED is divided into three main phases[5].The first phase is the selection of project applications and identification of outstanding R&D projects,the second is the phase review of the project R&D status,and the third phase is the review and determination of the final project R&D results.These three review phases can be summarized as prereview,in-process evaluation,and post-evaluation.

3.2.1 Pre-review of scientific research projects

With six comprehensive research themes as the core,some outstanding researchers or teams from Japan or abroad will be attracted by making key research topics,such as the application of induced pluripotent stem cells (iPS cells),regenerative medicine research and application,innovative drug development,and innovative medical device development to the public.The outstanding researchers or teams from Japan and abroad will bid for the project.After the recruitment process,a group of experts will conduct a rigorous review of the project content submitted by the applicant (team) and the applicant’s qualifications,such as whether the R&D objectives are covered in the key research areas,the expected economic benefits,and the innovation of the R&D.

The expert review board is strictly required,and it generally consists of some domestic experts and scholars and international reviewers (internationally known scientists residing outside of Japan).The purpose of introducing international reviewers is to enrich the review perspective of Japanese experts,increase the diversity of experts on the board,and facilitate the identification of outstanding and promising research projects.

The best projects in each priority area are selected through the evaluation of the expert board,and AMED supports research funding based on the evaluation results.

3.2.2 In-process evaluation of scientific research projects

After a scientific research project is formally launched,it needs to be evaluated by experts on a regular basis regarding the progress of the project,its milestones,and the extent to which the actual implementation matches the original plan.The evaluation experts will conduct a comprehensive assessment of the project based on the progress,including the allocation of resources and the adjustment of the research plan during the implementation of the project.In principle,the project research of more than 5 years should be reviewed by experts once every 3 years.Project evaluation is based on a ten-point scale.The experts involved in the review will rate the project against the ten-point scale based on the research and development status.According to the results of the expert review,AMED will determine whether the project can continue to be funded or should be eliminated in a timely manner.The details of the ten-point scale are shown in Table 1.

Table 1 Specific contents of the ten-point scale

3.3 Post-evaluation of scientific research projects

Post-evaluation of scientific research projects is to assess the status of implementation and the results at an appropriate time before the end of the research.The evaluation method is still based on the evaluation of the project by a group of experts using a ten-point scale.

A final evaluation score of 6 and above indicates that the project has been carried out according to the original plan and achieved the expected results.A post-evaluation score of 5 or less indicates that the project does not follow the original plan or fail to achieve the expected results.

AMED can effectively screen out outstanding and excellent research projects in each field through three steps: Pre-review,in-process evaluation,and post-evaluation of scientific research projects,which can improve the success rate and actual output rate of research in the biomedical field in Japan to a certain extent.Besides,it allows AMED to provide targeted funding support services to reduce ineffective investment of research funds.At the same time,AMED can shift the focus of research funding based on the results of post-evaluation.For example,the more output in a certain research area,the more funding will be provided,which will greatly stimulate research enthusiasm.

4 Insights and discussion

At present,the biomedical industry has become one of the key industries to be developed in the new era to promote the progress and development of science and technology.The promotion of biomedical science and technology projects and the transformation of results are not only related to the life and health of the public,but also to the layout of national science and technology.Therefore,it is necessary to build a scientific and accurate research project review and management system to promote the development of pharmaceutical science and technology[6].AMED has allocated a total of nearly 7.5 billion yuan[7]in 2019 to support the key R&D by delineating six comprehensive research projects,setting up scientific and reasonable regulatory levels,and adopting standardized project review criteria to promote the development of the biomedical field in Japan.For Shenzhen Industrial Park,which has over 100 billion dollars assets,its development prospect is unlimited.However,by studying the existing project application system and review management mechanism in Shenzhen Industrial Park,we found that although it has a complete review procedures and operational mechanism,further improvement is needed in some details.By sorting out and refining mode of biomedical project review management implemented by AMED,the following three suggestions are made for further improvement of the review system of research projects in Shenzhen Industrial Park.

4.1 Further refining the selection principles of project evaluation experts and setting up an expert think tank

Project review experts are strategically important in the process of research project review,and their professionalism,work experience,and technical skills have a significant impact on the project review[8].At present,the selection of project review experts in Shenzhen Industrial Park is mainly the responsibility of the Disciplinary Committee under the thirdparty agency,which invites academic professors and industry chief technology officers from different fields.The qualification requirements are only generally stipulated that they should be experts in the front line of research.Obviously,such requirements are not clear and detailed enough to support the future goals of Shenzhen Industrial Park,an international research center.

Shenzhen Industrial Park should further refine the selection principles of experts involved in project review.Besides,an expert think tank around the new industries should be established[9].

The future goal of Shenzhen Industrial Park is to become an innovation breakthrough for Shenzhen-Hong Kong cooperation zone,which should become the national R&D center and a leading international innovation region.Therefore,the expert think tank in the Industry Park should be built based on this situation.In addition to the professional competence and previous R&D experience of the relevant experts,the diversity of the think tank should also be emphasized.The diversity of the think tank means that these experts should have multi-disciplinary,multiidentity backgrounds and multi-genders.The multidisciplinary means not only inviting experts in the new industries that the park focuses on developing,but also absorbing outstanding people from other fields to form a composite expert talent pool.Multi-identity backgrounds means that the experts should come from different countries and regions.In addition to the experts from mainland China,Hong Kong,Macao and Taiwan,overseas experts and scholars who are leading in the international arena should also be invited.The multi-gender composition means that we should pay attention to the gender ratio of men and women in the think tank.

The construction of a diversity of expert think tanks can broaden the perspective of scientific research project review.Experts and scholars with different backgrounds will also evaluate scientific research projects from different perspectives,which can improve the quality of scientific research project evaluation.

4.2 Setting up graded project supervision commissioner and implementing dynamic monitoring

In the periodic review mechanism of Shenzhen Industrial Park,the Disciplinary Committee organizes experts to review the research progress reports or phase research reports submitted by the R&D team every year.The content of the expert review is passively provided by the research team rather than actively obtained,so this passive review mechanism cannot achieve real-time monitoring and dynamic control of the research project.Since the review committee is unable to determine the authenticity of the relevant information submitted by the research team,it can lead to biased review results.It is suggested that a dynamic monitoring process should be introduced in the review of scientific research projects,and a hierarchical project supervisor should be appointed to achieve a real-time grasp of the R&D projects[10].

The real-time supervision of research projects can be divided into three levels.The first level should be the chairman of each discipline committee who can achieve overall control of all research projects.The second level should be the project inspector,responsible for real-time R&D dynamic understanding of specific projects to confirm whether there are deviations or changes in the actual R&D plans.The third level should be the project monitoring secretary,who is responsible for coordinating the work of the project monitor and providing services to the R&D team of the research project.These people should be dispatched by the scientific research management institution of Shenzhen Industrial Park.The dynamic supervision level of scientific research projects is shown in Fig.8.

Fig.8 Dynamic supervision level of scientific research projects

4.3 Developing an evaluation scale for the review of scientific research projects in Shenzhen Industrial Park

According to the “Support Measures”,it can be understood that no evaluation criteria have been developed for the review of projects in Shenzhen Industrial Park.But reasonable project review criteria and corresponding review methods play an important role in the process of project review.Shenzhen Industrial Park can refer to AMED’s evaluation methods and standards to develop project evaluation standards applicable to it.

By constructing scientific and appropriate evaluation criteria,standardizing the evaluation behavior of experts,simplifying the steps of expert evaluation,and providing a clear judgment basis for the evaluation of the project,we can ultimately improve the accuracy of the evaluation results of research projects,thus supporting the management and services of the research management institutions in the Shenzhen Industrial Park[10,11].

5 Conclusion

Dozens of scientific research projects in different fields are already being carried out in Shenzhen Industrial Park.Meanwhile,many more projects are under negotiation.With the continuous improvement of the construction of Shenzhen Industrial Park,more research projects will come in the future.Therefore,Shenzhen Industrial Park needs to quickly establish an effective supervision and review system for scientific research projects.Besides,it should clarify the review procedures of scientific research projects to ensure that the review is simple,effective,fair and open.At present,Shenzhen Industrial Park has formed a project application procedure and a basic review management system,but the existing system has shortcomings in the review such as unclear principles for selecting experts and insufficient supervision.Therefore,in the process of improving the future regulatory system,we should set up an expert think tank to provide services for the project review.In addition,a threelevel supervision system should be set up to grasp the dynamics of research and development of the projects in real time.By constantly improving the above two regulatory systems of Shenzhen Industrial Park,we can make up for its deficiencies in a short time.