Policy and Practices

Without effective communication and collaboration between scientists and the general public, all of the efforts we make in the laboratory are potentially useless. In an age where there is so much distrust and misinformation about scientific research, we must double our efforts to educate, collaborate and listen to what the general public has to say about the state of scientific research.

Throughout the policy and practices portion of the iGEM project, we have gained a tremendous about of insight into the public's knowledge and concerns about synthetic biology. We have sought to educate as many people as possible about our project, synthetic biology in general and the amazing potential of re-engineered genetic engineering.

Our policy and practices project is divided into four sections: "Research", "Change", "Outreach", and "Entertainment". In the "Research" and "Change" sections we gathered information and data from the public and from experts in science, medicine and policy analysis so that we could inform ourselves about ALL aspects of our project not just experiments in the lab. Since our project is a health and medicine project, we then took this research and created a policy brief outlining changes that we would like to see in the pharmaceutical and biopharmaceutical industry. This innovative policy brief was then sent to government agencies and some of the most influential people in the world in hopes that they would help us make a lasting change in the world. The "Outreach" and "Entertainment" sections show all of the programs, activities and meet-ups that we have had with various student and public groups.

Research and Change

Our project goal is to prevent tissue damage from chronic inflammation by inhibiting Granzyme B in the extracellular matrix. In order to accomplish this task, we needed A LOT of help and advice. Some of our team members learned a little bit about inflammation in AP or IB biology, but if we wanted to create a project dealing with the harmful effects of inflammation, we needed to ask for more help. We received valuable help from research scientists currently working with Granzyme B, medical doctors who had expertise working with patients with chronic inflammation, and policy analysts who make rules and decisions regarding the safety and viability of synthetic biology projects. Ultimately the information we gathered helped us shape and guide our project. By taking into account the advice from these experts, we have created a possibly feasible project and a functional prototype.

In addition to the advice we received on the background and experimental portion of our project, the policy advice we received from The National Academies of Science, Engineering and Medicine's (Committee on Science, Technology and Law – Forum on Synthetic Biology) helped us create a policy brief that we sent to the US Senate, US House, World Health Organization, Bill and Melinda Gates foundation and Mark Zuckerberg's Silicon Valley Community Foundation. Our innovative policy informed policy makers about the uneven spending discrepancy between R&D and marketing in pharmaceutical companies. Based on our policy research, we offered a potential solution to this problem for policy makers to consider.

Research

We separated our policy and practices research into 4 sections: GzmB, Medical, Policy and Public. Read about each of the sections below to learn about our approach and what we discovered.

GzmB

Dr. Phillip I. Bird, Professor, Department of Biochemistry and Molecular Biology at Monash University

We reached out to Dr. Bird to discuss the effects that inhibiting GzmB in the ECM would have on the human body. He informed us inhibiting GzmB completely would have extremely negative effects. This had a big effect on our project. We needed to figure out a way to only partially inhibit GzmB so that it would maintain normal levels of GzmB. We modeled GzmB concentration vs ACT inhibitor levels and developed a calculator to estimate how much of our inhibitor protein to bring elevated GzmB levels down to normal.(link)

Medical

Dr. Stephanie Hsieh, Medical doctor, formerly from Kaoshiung Medical University Hospital

We interviewed Dr. Hsieh about the different type of inflammation that exist and about her experiences with patients who have had chronic inflammation. Through her we learned that chronic inflammation was a major problem especially for elderly patients. We asked her about the application of our bandage prototype and our cream prototype. She said that she thought both prototype ideas were plausible but would require lots of clinical trials.

Policy

After receiving experimental and application advice from experts, we wanted to investigate the policy roadblocks we would encounter trying to get our project to the actual market. We emailed every member of the The National Academies of Science, Engineering and Medicine's (Committee on Science, Technology and Law – Forum on Synthetic Biology) with a list of 5 questions specifically related to policy issues:

1. What more should the government be doing to encourage the development of synthetic biology and biopharmaceuticals?
2. What are the main obstacles to getting biopharmaceutical treatments to market, and what, if any policy changes should be made to the regulatory environment to get these treatments to market?
3. What, if anything, should the government do to increase the accessibility of biopharmaceutical treatments to the public?
4. To what extent is a supply gap impending for biopharmaceutical treatments? And what, if any steps should governmental, academic and corporate actors take to insure that supply meets demand?
5. Given recent public concerns regarding issues of consuming GMO's, what if any steps should corporations, universities, and governments take to make syn bio treatments more attractive to the public?

We received several responses from the following members:

• Dr. Stephen Hilgartner – Professor of Science and Technology studies at Cornell University
• Dr. Alan Pearson – Head of NHMRC Centre of Research Excellence in Aboriginal Chronic Disease Knowledge Translation and Exchange (CREATE) of the University of Adelaide
• Jordan Paradise J.D. – Schering-Plough Professor of Law at Seton Hall
• Dr. Steven Benner – Distinguished Fellow at Foundation for Applied Molecular Evolution (FAME)
• Dr. Richard Brundage – Professor of Experimental and Clinical Pharmacology at the University of Minnesota

One member, Dr. Sarah R Carter, agreed to have a conference call with us to discuss our project in further detail from a policy stand point. Dr. Carter is a policy analyst for J. Craig Venter Institute and was a former policy analyst for the Obama administration at the White House. We learned that government and FDA involvement in pharmaceuticals was more involved that we had imagined. We also learned that there are very few laws on synthetic biology products and applications.

Click here for our letter to Dr. Carter

Public

Spring Fair Survey Results

We surveyed people about what their views on Synthetic Biology and Genetic Engineering were during our annual School-Sponsored Spring Fair.

Change

Creation of a Policy brief to invoke change

Nexavar is an anti-cancer drug developed by Bayer International. As of early 2014, the price of the drug was $65,000.00 USD PER YEAR, per patient (Reference). On December 3rd, 2013, Bayer CEO Marijn Dekkers was quoted at an event saying the following as a response to disputes between Bayer and Indian Government over drug patents and the implementation of the India compulsory license.

"We did not develop this medicine for Indians. We developed it for western patients who can afford it."
- Bayer CEO Marijin Dekkers

We find this attitude from Marijin Dekkers to be absolutely appalling. But we are not naïve enough to think that there aren't more pharmaceutical companies that feel the exact same way. We believe that pharmaceuticals and biopharmaceuticals should be affordable and accessible to anyone who needs treatment. We want to develop an inexpensive, yet viable (from a business perspective) method for the distribution of our treatment. We started to research how pharmaceutical companies spend their money. We discovered that the vast majority of pharmaceutical companies spend more in marketing and advertising than they do in research and development.

Excess spending on marketing and advertising reduces the amount of money that is spent on R&D. This also decreases the availability of new drugs to people who need them. Therefore, our goal is to facilitate biopharmaceutical companies to redistribute money to R&D for life altering diseases instead of overspending on marketing and advertising. Currently the United States has tax incentives for research and development (R&D) for pharmaceutical companies in the U.S. because R&D increases the quality of health care. R&D incentives can encourage the discovery of new drugs and can lower the cost of current pharmaceuticals. These incentives have been successful in supporting pharmaceutical companies' growth. These tax incentives, however, have recently been overused by companies in the “supporting functions” of R&D expenses, namely, marketing and advertising. Hence, the government’s tax credits for developing more effective and efficient drugs is being used beyond its original purpose. To prevent biopharmaceuticals from following this same trend, we propose that there should be clear distinction between incentives for R&D marketing and incentives for actual research. American taxpayer funds should go to promote research that benefits the common good, not additional advertising.

The policy brief that we created was based off of research from our questionnaire from The National Academies of Science, Engineering and Medicine's (Committee on Science, Technology and Law – Forum on Synthetic Biology) in addition to literature research and assistance from our Instructor and debate coach Mr. Richard Brundage.

iGEM Club

By creating the iGEM club, we provided a platform for underclassmen to experience iGEM related activities and develop potential iGEM members to contribute to the formation of our project. Furthermore, we raised awareness during the TAS annual club fair and allow students to join the club. Students in the iGEM club will not only have a chance to input ideas during our planning stage, but also have an opportunity to have a hands on experience of lab work.

Spring Fair

We set up a booth to gain public opinion about synthetic biology and our project through the school’s most renowned social event, the Spring Fair. We created a survey (LINK TO SURVEY) to gain public perception about biopharmaceuticals, GzmB related dieseases and their general knowledge of synthetic biology. The survey results were especially valuable because it helped us in shaping our project.

NYMU Summer Camp

iGEM has always been a way to convene intellectual thinkers and scientific enthusiasts together for an exchange of ideas. Extending our collaboration with NYMU, we continued to work with NYMU by exchanging ideas and assisting one another. On August 15th, the members of NYMU_Taipei held a summer camp to teach out 2016 iGEM team about what it is like to start an iGEM team. They NYMU team members actually contain some of our own TAS students (Huiru, Alvin and Fiona).

Teaching Synthetic Biology to TAS Biology Classes

We were fortunate to have a chance to give an introduction to synthetic biology and the central dogma to an IBHL class of our school. Since genetic engineering is a dynamic method to view biology through the lens of engineering, we are able to teach them about the common methods employed in synthetic biology and spread awareness for synthetic biology.

NCTU Conference

To help us prepare for the Giant Jamboree, we attended the Asia iGEM meet-up conference at NCTU to share and receive valuable feedback from other college and high school level teams. The conference was extremely rewarding because it trained us to think critically and to challenge our own project. We learned a tremendous amount because of the sharing of ideas and collaborative help from all of the teams. This was one of our favorite aspects of the whole iGEM competition so far.

Meet-up with MingDao

After the NCTU conference, on August 27th, we gathered with the Mingdao high school iGEM team that we met from MingDao, Taichung and presented our projects to each other. In addition, we not only had a tour of our lab, but we also examined and determined improvements can be made to enhance the high school iGEM competition.

Science research symposium

We were fortunate to have a chance to give an introduction to synthetic biology and the central dogma to an IBHL class of our school. Since genetic engineering is a dynamic method to view biology through the lens of engineering, we are able to teach them about the common methods employed in synthetic biology and spread awareness for synthetic biology.

Science research speaker series

We invited 5 science researchers to come to our campus to give lectures about their research. This was done to expanding our knowledge about how actual scientific research is done. IN addition, it was great to talk to the speakers about our project and to run our project ideas by them

Teacher Bioethics Panel

We hosted a teacher panel to discuss, debate, and congregate knowledge from different fields including but not limited to philosophy, science, and policy. The teachers engage in a passionate exchange of ideas do discuss questions regarding ethics and the progress of synthetic biology. From this event, we extracted the prime cause for the public to avoid using GMO products and trajectory of scientific research.

Social Media

Entertainment

iGEM is not only about research and hard work in the laboratory. Synthetic biology can be made to be fun as well. Listed below are some of the fun games and activities that we created throughout the year to keep not only the public, but ourselves entertained.

iGem maze

How should we teach kids about the genetic construct? We let kids collect parts in the maze and set them up into specific order and introduced them to the basic component of a construct.

iGem Playlist

Wonder how we keep our strong motivation in the lab? Click on the icon for our “iGEM playlist” on Spotify that we play in our lab!

Phillip’s beat box

During the NCTU Conference, our team member, Phillip also beat-boxed to make NCTU an even more impactful and entertaining experience.