Team:Fudan-CHINA/Human Practices
Human Practices
"Every man is a piece of the continent, a part of the main."
"Technology is only a means,
in itself it is neither good nor evil.
Everything depends upon what man makes of it,
for what purpose it serves him,
under what conditions he places it."
- Karl Theodor Jaspers
iGEMers should never be restricted in laboratory. To solve a real-life problem, STEP was created for cellular immunotherapy. But will it serve people in a responsible way? How can we perfect it by involving the world into our project? What shall we do for the public? Inspired by the idea of opening science, we delivered several lectures to students from kindergarten to college, from Shanghai to Canton. A video, a set of cartoon ‘tuanzi’ and a reportage were created to help the public better understand our project and the true living condition of sci-researchers in China. We contacted experts and stakeholders to help us add social, ethical and juristic considerations to our project. Professionals from synthetic biology, pharmaceutical industry and computer science also put touches into the design and application of STEP.
Synthetic biology has its unique magic: every element works together for one purpose in the system we design, just like an imaginative idea can act as a magnet to draw people together. Involving the public stays on in our mind. In this spirit, we delivered a set of lectures and mini-labs to students of all ages to unlock a world of synthetic biology for juniors. Excitedly, vibrant students from High School Affiliated to Fudan University applauded the idea of synthetic biology and newly established an iGEM team on our instruction. In addition, inspired by the principle of opening science, we interviewed Ms. Shi, a doctoral student in pharmacy, revealing the true living and studying condition of common sci-researchers in China to people outside the industry. Finally, some artwork was created to help explain our STEP system to the public, saturated in the two-way constructing process of humanity and technology.
In our wildest dream of childhood, there always existed a profession named ‘scientist’. But only a few of us hold on to it ultimately. Researchers are always a mystery to the public. In public mind they are a group of people burying themselves in labs and isolated from normal society. Nevertheless, the truth is far from that while the public has started to think differently. Rooted in China, we focus on the topic Society, Research, Researchers to reveal the true living condition of sci-researchers in China today.
1. An image of sci-researchers in China
In our wildest dream of childhood, there always existed a profession named ‘scientist’. But only a few of us hold on to it ultimately. Researchers are always a mystery to the public. In public mind they are a group of people burying themselves in labs and isolated from normal society. Nevertheless, the truth is far from that while the public has started to think differently. Rooted in China, we focus on the topic Society, Research, Researchers to reveal the true living condition of sci-researchers in China today.
In the meeting with Shi, a typical doctoral student of pharmacy, we discover the change of public attitude towards the field of research. What’s their working pattern? How do they step into this field? What do their future look like? Her one-step-at-a-time experience gave the answer.
To propagate synthetic biology and share the fun of iGEM with future synthetic biologists, we organized a series of activities and lectures to students of all ages.
Kindergarten: A mini-lab
For kids in kindergarten, we host a mini-biolab to introduce some basic concepts regarding microorganisms in an interesting way. Moreover, we helped the lovely children cultivate their interest in synthetic biology as well as inform them of the significance of keeping personal hygiene.
PS: Safety is guaranteed during this activity.
Canton primary school: Volunteer teaching
When our team is working as volunteer teacher in rural areas of Canton, we also always bear the responsibility of sharing the idea of iGEM to more people. In Canton, to broaden their horizon to a grander world, our deliver introduced our project and some basic situations of iGEM to hundreds of seated students from primary school and junior high school. Though due to the limit of equipment and knowledge, they could not be iGEMers now, we have planted seeds of synthetic biology in their naïve heart which might grow up to a glorious tree one day in the future.
Senior High School: A newly set-up iGEM team
As for senior high school, we organized some lectures to introduce synthetic biology and our project. Firstly, we held a lecture in High School Affiliated to Fudan University (FDFZ). And this lecture gave us unexpected pleasure.
FDFZ is a well-known high school in Shanghai having a long history. And thanks to the abundant resource of Fudan University, the students of FDFZ can get easy access to top theory and technology in the science field and the atmosphere of exploring is really thick there. Thus, we reached a biology teacher in FDFZ discussing about holding a lecture in FDFZ and the possibility of establishing an iGEM high school team to help them participate in this creative competition. To attract more students to our lecture, we prepared beautiful posters for every classroom and made sufficient plans.
The outcome is more than fantastic. The number of students that came to our lecture is far over our expectation, and they were all eager to know iGEM and how to take part in it. Thus, we organized two interviews together with a teacher of FDFZ to select suitable students for future competition. In the interview, we asked about lots of things such as their basic knowledge of modern biology, experience in laboratory, the understanding of iGEM and their current ideas. To our surprise, some had attended the John Hopkins Summer Camp and had the experience of PCR, Western Blot and etc. And some had learned pharmacodynamic evaluation, mice emergency immunization, flow cytometry, labeling fluorescent antibody and so on. And their ideas were also innovative concerning Chinese traditional herb, malaria, controlling blood pressure, and regulation of K+. As for the division of labor, they also have their considerations. Some prefer wet laboratory, and others would like to major in modeling or visual designing…… We not only shared basic knowledge of synthetic biology, lab skills and safety rules with them in our mini-class, but also achieved a lot from them- discussing ethic and law issues in regard to advanced technology. What impressed us most is their passion on practice with their own hands. The knowledge they’ve learnt in class inspired fantastic ideas, while we provide a stage to help them realize. Welcome, new iGEMers!
It’s a really successful try, and we did help our next generation not only know about iGEM and synthetic biology but assist them to become one of us, to make them enjoy the interest of it. Now, a promising iGEM team is coming into formation and we will also support them theoretically and practically. The world is changing.
Except this, we were also invited to Shanghai Shixi High School, a famous high school to deliver a lecture named Synthesis + Biology = Synthetic Biology to expand their view.
University: iGEM club
During our summer vacation, we attended a sharing meeting with BIOS (Biology Intensive Orientation Summer) students who were learning basic biological technique to discuss our project and absorb positive opinion to polish our STEP system. Despite their relatively poor experience in research, but their fancy thoughts did inspire us and make our project more charming.
In Fudan University, iGEM exists as a club. In this semester’s giant meeting of all clubs, iGEM has attracted much attention from students of all majors and some showed great interest in iGEM. Through our introduction, they had a deeper understanding of iGEM and synthetic biology and got deeply fascinated by the idea. It’s predictable that next year, there will be more students fond of synthetic biology taking part in iGEM to share the fun.
As a cutting-edge therapy, cellular immunology is really a hot spot. Mostly people only know it by the media, but hardly understand how it works. To make the public get acquaintance with the STEP system and how it comes to our mind, an animated video was created. Producing a video helps us reflect on the whole project design as well as plays an educational role.
2. Future scientists — from kindergarten to college
To propagate synthetic biology and share the fun of iGEM with future synthetic biologists, we organized a series of activities and lectures to students of all ages.
Kindergarten: A mini-lab
For kids in kindergarten, we host a mini-biolab to introduce some basic concepts regarding microorganisms in an interesting way. Moreover, we helped the lovely children cultivate their interest in synthetic biology as well as inform them of the significance of keeping personal hygiene.
PS: Safety is guaranteed during this activity.
As for senior high school, we organized some lectures to introduce synthetic biology and our project. Firstly, we held a lecture in High School Affiliated to Fudan University (FDFZ). And this lecture gave us unexpected pleasure.
FDFZ is a well-known high school in Shanghai having a long history. And thanks to the abundant resource of Fudan University, the students of FDFZ can get easy access to top theory and technology in the science field and the atmosphere of exploring is really thick there. Thus, we reached a biology teacher in FDFZ discussing about holding a lecture in FDFZ and the possibility of establishing an iGEM high school team to help them participate in this creative competition. To attract more students to our lecture, we prepared beautiful posters for every classroom and made sufficient plans.
The outcome is more than fantastic. The number of students that came to our lecture is far over our expectation, and they were all eager to know iGEM and how to take part in it. Thus, we organized two interviews together with a teacher of FDFZ to select suitable students for future competition. In the interview, we asked about lots of things such as their basic knowledge of modern biology, experience in laboratory, the understanding of iGEM and their current ideas. To our surprise, some had attended the John Hopkins Summer Camp and had the experience of PCR, Western Blot and etc. And some had learned pharmacodynamic evaluation, mice emergency immunization, flow cytometry, labeling fluorescent antibody and so on. And their ideas were also innovative concerning Chinese traditional herb, malaria, controlling blood pressure, and regulation of K+. As for the division of labor, they also have their considerations. Some prefer wet laboratory, and others would like to major in modeling or visual designing…… We not only shared basic knowledge of synthetic biology, lab skills and safety rules with them in our mini-class, but also achieved a lot from them- discussing ethic and law issues in regard to advanced technology. What impressed us most is their passion on practice with their own hands. The knowledge they’ve learnt in class inspired fantastic ideas, while we provide a stage to help them realize. Welcome, new iGEMers!
In Fudan University, iGEM exists as a club. In this semester’s giant meeting of all clubs, iGEM has attracted much attention from students of all majors and some showed great interest in iGEM. Through our introduction, they had a deeper understanding of iGEM and synthetic biology and got deeply fascinated by the idea. It’s predictable that next year, there will be more students fond of synthetic biology taking part in iGEM to share the fun.
3. STEP into Art
Are you attracted by our mascot on the poster? It’s a set of "Tuanzi"（团子）！Really cute , aren’t they? Each represents one of our team member and instructor. Pipette, protein, E.coli, culture medium, camera, computer engineering… As part of our team culture, Tuanzi are our little bonus, for us and for other iGEMers. They were printed on sweaters and key rings, delivered to friends, instructors and others who gave us a hand during our preparation. Also we will bring them to Giant Jamboree. Thanks to them, more and more people come to know our team, realizing that iGEM involves more than wet-lab students. No matter what you are responsible for- human practice, modeling, art design and so on- we wish to express gratitude to every member’s effort in iGEM.
As a cutting-edge therapy, cellular immunology is really a hot spot. Mostly people only know it by the media, but hardly understand how it works. To make the public get acquaintance with the STEP system and how it comes to our mind, an animated video was created. Producing a video helps us reflect on the whole project design as well as plays an educational role.
Watch Project Video
Because I could not stop for death, he kindly stopped for me. The carriage held but just ourselves and immortality.
What’s the connection between porcelain and STEP? We came to a workshop and made a STEP plate with our own hands. As a traditional Chinese art, it contains philosophy from our ancestor. Round and smooth, the porcelain plate serves people as a container, while it would easily hurt us when broken into pieces. Just like our system, it’s never easy to create one and make it serve the public for the right purpose.
When developing a therapeutic project for cancer, it’s not only the technical issues that need to concern about, but also ethical and political issues. Though China have earned a large number of research achievements in the field of cellular immunotherapy, till now, none has been approved or applied in clinical treatment.
The question stays on in our mind- why there is a lack of ethical and political considerations in China, regarding this new therapy? What can we do to make a change? For this purpose, we stepped out of the lab, contacting professionals in the field of ethic and policy, to find out the answer. Also, Dr. Xu, an oncologist of Fudan Univ. Cancer Hospital, explained the approving process of current clinical trial of cellular immunotherapy to us. What’s more, we received a phone call from National Health Commission of the People’s Republic of China, after contacting them by e-mail, which explains the regulations we concerned about.
In our meeting with Dr. Jie Yin(link), an expert in medical ethic, she admitted that the main issue concerned with our project is safety, considering its high cost and risk. Thus the government will give top priority to its approval. For the particularity of cancer patients who are at the end of their life, cellular immunotherapy served as a last resort. Patients flooded into it, striving for a chance to survive. We were reminded that there are certain clinical indications that need to be satisfied before a clinical trial, which made us reflect on a fairer distribution of medical resources.
In China, collective consciousness always plays the leading role on the historical and social stage, covering the light of Spirituality Concern on the value of individual life. Compared with the unprecedented hot market, the lack of ethical consciousness should receive more attention. We called for the existence of humanity in this “technology & market first” society, truly benefiting every single patient.
Just in early October, we received an official phone call from National Health Commission, answering our concerns in the e-mail. Its official firmly declared, till now, no institute or enterprise is permitted to apply a clinical treatment with cellular immunotherapy, while several clinical trials have been approved.
Through our research on policies in the field of cellular immunotherapy in China, we discovered that the attitude of government is quite vague. For years, regulations concerned have swung chaotically from encouraging drug-innovation to strengthening supervision. Yao, an expert in law of health, showed his worries towards the lack of a special committee responsible for cellular immunotherapy. He analyzed the deriving history of regulations concerned, optimistic about its application prospects in China. It would be a good idea to have an outline of the current ethical and political situation in China, he suggested.
Just in early October, we received an official phone call from National Health Commission, answering our concerns in the e-mail. Its official firmly declared, till now, no institute or enterprise is permitted to apply a clinical treatment with cellular immunotherapy, while several clinical trials have been approved.
Through our research on policies in the field of cellular immunotherapy in China, we discovered that the attitude of government is quite vague. For years, regulations concerned have swung chaotically from encouraging drug-innovation to strengthening supervision. Yao, an expert in law of health, showed his worries towards the lack of a special committee responsible for cellular immunotherapy. He analyzed the deriving history of regulations concerned, optimistic about its application prospects in China. It would be a good idea to have an outline of the current ethical and political situation in China, he suggested.
In this paper, we discussed current ethical and political problems in the field of cellular immunotherapy, comparing regulations concerned in China with the ones in other developed countries. It is important for people in the field to be aware that only with refined legal system and ethical instructions can this advanced therapy truly work. This kind of insight into thinking about national conditions and the function of interdisciplinary communication was essential to our project design and execution.
Through our Bench-to-Bed approach, we take every effort to make our STEP system perfect and responsible for the world, involving experts in different field into our project. Initially, it was created for cellular immunotherapy. After contacting pathologists and experts from pharmaceutical industry, we paid close attention to cancer treatment. Under the conduction from Prof. Huang and other computational biology experts, we intensify our modeling and develop a distinct and persuasive model on molecular interaction and system output. What’s more, response from ethicists, jurists, hospital administrators and National Health Commission helped us add ethical and juristic considerations to our STEP system, leading to a paper investigating the major interest of cellular immunotherapy in China. An Oncologist responsible for clinical trials of immunotherapy also provided a precious view on our target identification in anti-tumor molecule work. Professionals from Shanghai iDrug Center and pharmaceutical industry proved the application prospects of STEP.
To clarify the integration of our Human Pracitces through every step of our project, an outline flowchart was made. Check it below~
1. Project Design
Dr. Xiaoming Ding
Associate Professor, Department of Microorganism
School of life sciences, Fudan University
What kind of cells should we use in experiment?
The research interest of Prof. Ding is microbial molecular genetics and synthetic biology. In the early stage of our project design, we consulted Prof. Ding about the carriers built by the system. In terms of this direction, he gave us suggestions that the system is more suitable to be built in eukaryotic cells and in this way it is likely to have a higher prospect of success in application. Therefore, we chose 293T and Hela cells to build STEP system.
Prof. Dr. Jiang Zhong
Executive Director of Department of Microbiology and Microbiology Engineering
School of life sciences, Fudan University
Which track should STEP be applied to, therapy or diagnositics?
In the brainstoming stage of our project design, we considered using our core receptor system to detect cancer or thrombotic diseases. Prof. Zhong believed that the current methods for the detection of common diseases were mostly based on colloidal gold test paper. However, for specific diseases such as cancer, blood is usually drawn for blood test. The relevant technology has matured with low detection cost. Such a receptor system may be overqualified if it only aim at detecting the occurrence of a disease. Therefore, he proposed that it would be more promising for us to apply our STEP system into a therapeutic project instead of a diagnostic one.
Prof. Dr. Li Chen
Distinguished Professor of Fudan University
Inventor of first rapid detection kit for salivary-oral pathogens
Former technical supervisor of Japan GC Company
Which cancer would be our target?
After we introduced our project's design and execution, Prof. Chen commended the originality of the idea of our STEP system, and pointed that the the the tools for researching the system can be enriched further. Moreover, he recommended that we could focus on a more specific and clinical situation, which may make it more attractive to those potential investors. Prof. Chen, who has an education background in biology, once worked in pharmaceutical company and now proceeds research for clinical medicine. From his perspective, figuring out a reliable solution to a single problem is more worthy than a hazy answer to a universal question. Thanks for his working experience in medicine industry, we turned our attention to a specific disease, named "Non-Small Cell Lung Cancer", as the concentration of D-Dimer and VEGF in blood has a strong correlation with it.
Dr. Wei Mo
Associate Professor, Department of Biochemistry and Molecular Biology
School of Basic medical sciences, Fudan University
Which molecule to be targeted at?
Mo gave us relevant advice when we were choosing small molecules that our receptors can target. We originally had selected VEGF and d-dimer to target cancer, which Prof. Mo thought was feasible. He introduced that the significance of d-dimer in postoperative diagnosis of non-small cell lung cancer had been reported in the literaturE. He also believed that the application of this molecule in tumor targeting and treatment would be a new and meaningful idea by linking two closely related diseases, cardiovascular diseases and tumors, toether.
2. Wet Lab
Prof. Dr. Roman Jerala
Synthetic biologist
Head of Department of Synthetic Biology and Immunology
National Institute of Chemistry
It was a great honor to have a breakfast meeting with Prof. Roman Jerala. As an expert in the field of synthetic biology, he has led the Slovenian team to participate in iGEM for many years and has achieved remarkable results. We talked about our project design and details of protein design in our experiment. He thought that our two-chain system can be improved and simplified into one system. Inspired by this, we evaluated the possibility of a flexible linker and its cutting of another chain. Prof. Roman Jerala provided a unique view for our project which improved the STEP system's protein structures and gene expressions.
Dr. Jiaxue Wu
Principal Investigator, State Key Laboratory of Genetic Engineering
School of life sciences, Fudan University
How to reduce the background noise?
We ran into many problems when testing our STEP system on 293T cells and Hela cells. For example, during the process of testing the activation of the STEP system, we found that the response of the system contained a lot of system noise. Wu, a researcher in the National Key Laboratory of Genetic Engineering who specializes in the field of cells, suggested us to solve the problem of system noise by reducing the transfection concentration of the whole two chains in the system. He thought that we hadn't constructed enough cell membranes which were capable of accommodating the artificial receptors. Moreover, if the number of plasmids transfected into the cell was large enough to express two strands, it was less likely for some of the artificial receptors to be located on the cell membrane. Because of the nuclear localization sequence (NLS) on the transcription factor we had designed, the expression of the downstream gene circuit was directly activated. Therefore, it is possible to solve this problem by reducing the amount of transfection.
Honghai Tang
PhD student in Department od Biostatistics & Computational Biology
School of life sciences, Fudan University
How to gain more protein?
In the process of the KDR purification, we still could not obtain a higher concentration of protein after several attempts. Tang has devoted herself to the study of protein structure for many years and gathered rich experience. He proposed it was inappropriate to simply follow the old protocol, and suggested us to screen out the best conditions for protein expressions by changing the formula of the medium, such as adding glycerin or NaHPO4. His input was integrated in our practice. We successfully obtained more target proteins after changing the temperature of culture, the formulation of culture medium and the concentration of induction.
3. Dry Lab
Prof. Dr. Qiang Huang
Professor, Department of Molecular Biophysics
Engineering Research Center of Gene Technology, Ministry of Education
Fudan University
How to make our model promising enough?
During the process of considering reengineering vegf-scfv to obtain better protein binding capacity, Prof. Huang offered us great help. Based on his knowledge of medical genetics and structural bioinformatics, he guided us in the molecular design of cancer drugs and used computers to carry out theoretical and simulation of biological molecular structure and interaction.
At first, we intended to simulate the receptor movement on the cell membrane to directly study the output level of the STEP system. Afterwards, Prof. Huang pointed that the movement of the receptor on the cell membrane was not completely random, and the differences in different regions on the membrane were not convincing enough. So we turned to the probabilistic model and study the relationship between the parameters of the wet experiment and the model by simulating the motion of the membrane receptor.
Dr. Yi Shi
Associate Professor, Shanghai Center for Systems Biomedicine
Key Laboratory of Systems Biomedicine, Ministry of Education
Shanghai Jiaotong University
How to build up STEP system within the computational power?
To figure out whether the protein ligand we have designed posseses a better combination ability, we came to Shanghai Jiaotong University， where is located the Key Laboratory of Systems Biomedicine established by the Ministry of Education. Expert in Computational Biology and Tumor Genetics ，Shi was strongly interested in our platform. After listening our program introduction, he emphasized the importance of the math modeling in the whole system. “Only the framework with rich logic will possess a better sense of instruction to the wet lab”. Taking Shi’s suggestions, we justified the rationality of simulation by using Rosetta， and, at the same time, considered the spontaneous rotation problem happened on TC\PC chain of cell membrane. Furthermore, he also advised us to compare the STEP system with current CAR-T therapy in the background in order to highlight our originality.
Haotian Guo
Judge
PhD student in The Center for Research and Interdisplinarity
Leader of 2013 Fudan iGEM Team
How to present the result of our project clearly?
We invited Guo, who has led the Chinese and French teams to participate in iGEM several times and has rich experience in the competition. In his opinion, the basic assumptions of our dry experiment could be refined, so we further considered the reaction mechanism of STEP system completely in the model, and improved the integrity and authenticity of the model.
In addition, he suggested that we should use more intuitive images as a result when introducing projects to the outside world, so that people without professional knowledge can understand meanings. Therefore, while making statistical explanation of the data, we also directly showed the molecular structure diagram to make intuitive comparison.
4. Ethic and Law
Dr. Jie Yin
Associate Professor, School of Philosophy
Fudan University
How ethical issues are involved in cellular immunotherapy?
In China, no medical institution has received clinical application approval for tumor immunotherapy as there exists major ethical issues. As a result, we are very curious about what ethical issues are involved in our research and how to make our research more ethical. Dr. Yin, who graduated from Shanghai medical university, transfer to philosophy after graduation as a clinical undergraduate. She majored in medical philosophy and Kantian philosophy. Her dual degrees in medicine and ethics, therefore, greatly helped us in the field of research ethics and clinical ethics. She highlighted that unlike the embryonic ethical issue facing stem cell therapy, safety is the major ethical controversies facing our STEP system. Tumor immunotherapy is expensive, it can also have serious side effects and fatality.
She stressed that among the four principles of bioethics, the principle of no harm is pivotal. It is crucial for us to consider how the technology and drugs that are still under clinical trials can protect the rights and interests of the subjects. Therefore, we tried to solve the problem of cytokine storm through the cooperation between wet lab and dry lab in subsequent experiments, thereby making our platform more secure.
Dr. Yin also introduced the history, composition and approval process of the Chinese Hospital Ethics Committee to us. When we talk about the current ethical situation in China, we find that the lack of cross-disciplinary talents is one of the major reasons that leads to issues in medical ethics. Humanists show their ignorance of medical knowledge, while physicians lack ethical literacy and critical thinking. While law is the lowest bottom line for developing technology, ethics makes the ever-changing technology responsible for the world.
We take this opportunity to review the purpose, design and execution of our project through an ethical perspective. The STEP system is designed to treat tumor, which is the second leading cause of death in the world; we hope that our system can be good for the world. In the experiments, we think that cell and molecular cloning experiments are not mature enough to reach phase where use of mice is possible as we don't want to hurt innocent mice just to produce good-looking data. We hope that the input of scientific research resources can bring real results.
Medical ethics have been neglected for too long in China. Under the guidance of Dr. Yin, we improved experimental design and execution and wrote a paper on the ethical issues of Chinese tumor immunotherapy, hoping to arouse more ethical awareness of scientific and clinical researchers to make our investigation more responsible for the world.
Jun Yao
Associate Professor, Law school of Fudan University
Expert in Health Regulations
Is there a lack of regulations concerned in China?
Yao was graduated from Shanghai Medical College and later changed his major into law. He has years of experience in dealing with law problems with hospitals, patients and the health administrative department. He was just compiling the book Medical Law when we arrived at his office. After consulting literature, we found that there are still problems about the cellular immunotherapy in China, such as undefined supervisor, ineffective measures of standardization and so on. And that's why we are here to consult him. According to Yao, there is not a single organization that has gained permission for the clinical application of cellular immunotherapy, and all are still at the stage of clinical trial. Therefore, as far as medical organizations are concerned, they are obligated to report their cases to the health administrative department and obtain permission, inform patients of the potential risk and outcome of their experiment without charge. As for China Food and Drug Administration(CFDA)and National Health Commission，they should establish a sound legal system to supervise the whole process from research and development to industrial production and clinical application comprehensively.
In addition, he also called for the emergence of cross-disciplinary talents in medicine and law. Yao made compliments on our attention we had paid to relevant laws and regulations and he answered the questions we were concerned about. He made us realize when we formulated and enforced the laws, we should take the complex commercial benefit and the national overall background into account. We found out the contradiction of innovation and strict control. When China encourages “Mass entrepreneurship and innovation”, the law may not keep pace with the innovation of the new medicines. Therefore, we hope to draw the attention of departments concerned by summarizing these questions and suggestions.
Finally, Yao emphasized, no matter how much benefit were involved, we should always put the right of life in top priority. Behind the laws and regulations, living lives were what our projects were truly facing.
5. Industry and Clinic
Dr. Li Ye
Associate Professor, Microbiology and Biochemical Pharmacy
Fudan University
How is a laboratory project transformed into industrialization?
Prof. Ye has been dedicated to the research of tumor immunotherapy drugs, owning multiple patents, and has been involved in many enterprise technology development projects. We come to Zhangjiang pharmaceutical valley, which is not only the location of the school of pharmacy, but also the base of biomedical science and technology industry gathering a large number of pharmaceutical companies. Ye introduced the current limitations of CAR-T therapy, and proposed that if our cell therapy could be universal, it would greatly reduce the cost of treatment. She made us realize that safety and targeting are two sides of tumor immunotherapy. Therefore, in the later experiment purpose and implementation, we not only improved the work efficiency of STEP system, but also strengthened the attention to security.
In addition, Ye stressed that a new drug cannot be popularized by a single medical or scientific institution and must be industrialized. Therefore, we went to Shanghai Pharmaceutical R&D Collaborative Innovation Center to participate in the Open Day for consultation services on new drug development.
Hui Li
Hospital Administrator
Shanghai Anda Hospital
What kind of role do the hospitals and patients play?
Li’s experience is quite unique. As an expert in medical disputes for decades, he now works on the management in the biggest private hospital of Shanghai after serving the army as a surgeon. Professionally, he analyzed the application prospects of a new medicine from three aspects for us: clinical doctor, hospital management and patient. In terms of our wondering that whether a clinical trial would cause any medical disputes in China, Li admitted that the lack of effective communication between doctors and patients is what to blame for. Clinical trials should never be permitted without informed consent, concerning its high risk. After all, patients are living people, just like us, but not a simple data in the research. With the help of Li, we successfully produce a video which explained our STEP system in plain language for more potential users.
Dr. Litao Xu
Oncologist, Expert in Liver Cancer
Fudan University Cancer Hospital
How does the cellular immunotherapy perform in clinical trials?
Half of our team members are from medical school, and we were lucky enough to have an appointment with Dr. Xu, who is also from Shanghai medical college. He greeted us kindly and gave hearty laughes from time to time. He has rich experience in the treatment of liver cancer. He led the trials of immunotherapy in tumor hospital and handled nearly 60 patients. He showed us the procedures and specifications of clinical trials, and introduced two cases with excellent results.
Previously, we were concerned about the clinical possibilities of the free molecules chosen for the project. In the interview, he affirmed the clinical application value of VEGF as a target in our project, and indicated that in clinical diagnosis, small and medium molecules in blood were often used as diagnostic indicators.
Shanghai Center iDrug Discovery & Development
On Oct.9, 2018, we arrived at the Shanghai Drug Research and Development Collaborative Innovation Center where a open day for advisory services on new drug research and development is held here on Tuesdays on the first week every month. On the open day, diagnosis and consultation on projects are provided freely, which are promoted to develop in the pattern people expected, and it will also bring contacts with the projects’ transformation. The professors from the center and the college of pharmacy gave us professional instructions scientifically and reasonably, as well as reference opinions from the industrialized angle. He commended the integrity of our project and the meaningful directions to wet lab from dry lab. Also, he pointed that the problems of the high prime cost and low safety of the current cell therapy, and wish us to make considerations on the choice of the cell type for transformation.
In iDurg, we gained a more solid understanding of the current situation of Chinese Pharmaceutical Industry. We deeply appreciate this platform , which integrated the resources of high institution, government and enterprises effectively, can bring contacts for our project from lab into the transformation to industry. During the visit, we found that, as for 2016, Anticancer and immune-related drugs took 7 places among the top 10 drugs in the world by retail sales. Thus, we may see that the market size of tumor immunotherapy will be inestimable in the future.
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2005 Songhu Road, Yangpu, Shanghai, China
2005 Songhu Road, Yangpu, Shanghai, China
