Gold

Overview

As a new therapy project, developing a reliable solution and putting it into practice and making a positive impact on society in a responsible way is what we have long pursued. However, no one can guarantee that our plan is perfect in our research process, which will not only affect the public's interests in a continuous way, but also contribute to the sustainable development of society. Hence, we designed an integrated human practice project to answer the following three questions:

(1) How to make Human Practice consolidate into our cycle of debug and development, improving our iterative and evolutionary process?
(2) How to response the doubt of safety and policy problems, preserves and promotes public confidence to synthetic biology and its applications?
(3) How to establish an effective interaction with the community, stakeholders and society, to reach a consensus and create responsible usage by a virtuous cycle?

In response to the challenges of these three issues and questions, from the beginning, we proposed a set of ideas named CERE cycle (communicating-engagement-reflection-evolution) to guide our integrated human practice. Also, we affiliate the Human practice with entire project closely and actively, for addressing some of the great challenges humanity or our health is facing.

Our Model

As many teams have mentioned and be put into practice, working by the framework of engineering cycles can make human practice effectively contribute to project development and help reflect on many aspects of the entire project. As we will show below, we are trying to put forward a human practice model which is simple and easy to implement in different cultural environments, and we will analyzes in detail how our integrated human practices have a beneficial impact to the entire project, and in interaction with the outside world, Establish an output-input positive and negative feedback mechanism.

Communication

Engagement

Reflection

Evolution

We believe that we should communicate with different people before we start designing the entire project. They may be experts, researchers, potential consumers, manufacturers and stakeholders, even who are interested in our project. The process is called part of early engagement. In our integrated Human Practice, we divided the communication into the following four modules: Interview, Survey, Additional activities and collaboration. It should be noted that these four modules are not isolated, but have intrinsic logical connection: we get expert opinions through interviews; listen to the public's ideas through questionnaires; and draw on experience from R&D industrial practices through additional activities. Finally we exchanged our ideas with peers to boost the improvement of our project.

Evolution

The above comprehensive human practice has a common purpose - to answer the three questions we raised at the outset. We believe that such evolution is not only an internal evolution, but also a process of co-evolution between our team and the community and the public. On the one hand, our impact on the public can create a more friendly atmosphere for the promotion of synthetic biology; on the other hand, the voices of the outside world – from students, seniors, stakeholders, partners, the community and the general public – can give us inspiration. We believe that such interaction and co-evolution are an dynamic integration that takes place throughout the whole cycle of development-and-debug.

Intellectual property and external support

In order to explore how to exploit our project and protect intellectual property, we contacted the University research management office, patent writing and innovative thinking training optional course, Suzhou Borda Biotechnology Co., Ltd. and beyond patent law firm to explore the possibility to obtain a patent and assign it. We also participated in the “Enterprise Patent Infringement and Coping Strategy Seminar” organized by Suzhou Intellectual Property Office.

Safety

Referred to integrated the human practice we have done before, the safety of our team's project has been evaluated from multiple aspects, including laboratory safety, personal protective equipment and measures; biosafety risks and spillover effects, safety management and administration, even possible risks in future applications. In response to these challenges, we have made targeted improvements in our project.

Public policy

We conducted a research on China's bioproducts and biomedicine evaluation and approval policy, and visited the pharmaceutical company, discussing with their manager, and investigating the practical problems faced by these companies in implementing the policy. Moreover, we collected public and clinician’s views on biotherapy. Based on the above conclusions, we reflect on the policy and to table some suggestions.

Click here for details: Policy.