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From 2012.igem.org

Stakeholders

For our iGEM project we wanted to know how our project is perceived and what they think the impact could be on society and people’s life when such a system is available. We talked with a wide variety of stakeholders about our project to get a diverse view of how parts of society look to competitions like iGEM and our VLP project.

Companies view

We wanted professional views to investigate how companies respond to our project and the iGEM competition. For this, we first asked a couple of questions to a senior project leader at MSD. MSD (Merck & Co) is a very large company and a world leader in healthcare. They create medicines, vaccines, biological treatments, products and services to provide better healthcare for people and animals. The interviewed senior project leader already knew about the VLP concept and he said the following about our project related to patient treatment:

"This could indeed make big differences."

But he indicated as well that it is very hard to produce a system like this according to the high medical standards with respect to medicine quality. This could give very high production costs so we asked him if the development of our system is financial achievable. To this he responded:

"If it turns out that the combination of delivery and medicine has a superior ability to cure, everything is achievable in the modern world."

Next to opinions about our project we wanted to know how a company like MSD handles with open source competitions like iGEM. MSD does not see iGEM as negative competition because the interests are different. They see iGEM as a positive way for students to express themselves. This is what the senior project leader told us:

"We are always looking for highly educated and interested scientists, and initiatives like iGEM make it possible for students to develop better and profile themselves."

Next to MSD we interviewed someone who graduated at Wageningen University and currently works for another big pharmaceutical company. She had heard of VLPs but not within the concept we use them. We asked her as well if our concept could have a big impact in curing patients, she said:

"Every concept that makes medicine going to a specific place and reduces side effects, is a huge improvement for patients compared to the current available therapies."

With respect to the production costs, she does not see a big issue when these costs are higher than normal.

"The biggest part of the medicine price is the cost of marketing. Next to this, a large amount of the development cost is put into the clinical trials. So larger research costs are to be overcome."

Furthermore, she made two remarks in which she said that big companies like hers, prefer to let academia and small biotech start-ups develop systems/technologies and test these systems/technologies. When a technology seems to be promising after these test phases, a big pharmaceutical company might buy it at a later stage. But there is already some competition concerning VLPs. There are bispecific antibodies and ADCs (antibody-drug conjugates).

"Before the 'Big Pharma' adopts a new technology, this technology should have a significant larger potential (with respect to the patient) than the current alternatives."

About the concept of open-source she said the following:

"Patents are of vital importance to a pharmaceutical company. It offers a company the chance to re-earn the investments during a secure period. With respect to that, open-source is an obstacle because knowledge that is public available cannot be patented anymore."

According to her, companies are more likely to patent a more specific part like a specific receptor or a specific connection mechanism between a VLP and a receptor. But when a new technology that is open-source seems very promising, a big company will not refuse to produce the new technology as long it has its own 'composition of matter' patents.

Institutes and agencies

Besides pharmaceutical companies, we interviewed a programe leader of Vaccine Preventable Diseases at the European Centre for Disease Prevention and Control (ECDC). The ECDCs is there to identify, assess and communicate current and emerging threats to human health posed by infectious diseases. In order to achieve this, the ECDC works in partnership with national health protection bodies across Europe to strengthen and develop continent-wide disease surveillance and early warning systems. By working with experts throughout Europe, ECDC pools Europe's health knowledge to develop authoritative scientific opinions about the risks posed by current and emerging infectious diseases. We asked him what he thought about a standardized platform (our VLP system) related to vaccine development for instance. He replied to this:

" Having in place a system that can rapidly develop a vaccine against unexpected viral agents would be of great importance for public health."

Also, we asked him if our project has the potential for becoming an innovation in disease prevention and control and what his opinion is about this statement.

"A system to standardize the production of new specific vaccines engineering a standard virus-like particle as a carrier would represent a big innovation. This would allow the rapid production of a vaccine against unexpected threats."

With respect to open source he mentioned that this is an important part when a disease or virus is spreading quickly across the globe. Because time is then a limited factor it is so important that corporation takes place.

"Sharing data (and lab specimens) during the avian influenza pandemic posed a series of political challenges but also showed the need for sharing information and lab material in case of world-wide infectious threats."

These are quotes from a different kind of view and show again how important it is to see all the different side views when a total picture and overview of our project will be created. So to take it even broader, we interviewed the NKI (Nederlands Kanker Instituut, Netherlands Cancer Institute). There we spoke to someone who is doing his PhD at the NKI. He never heard of a system such as we presented but he admitted that it sounds very promising when it actually works.

"I think that the concept (as long as it works) could cause a tremendous change. This is because it is very specific and in this way you can deliver large amounts of chemo to specific cells."

"I think that this way of curing is financially achievable for sure. The developing costs are still quite high but there is a very broad range of applications."

Just like all the others before we asked what kind of vision the NKI has on open-source competitions and data. Our PhD told us:

"I am definitely for open-source and the NKI as well. Open-source provides faster innovation and because we all want to cure diseases, this is a good thing."

"The downside of open-source is that the implementation like clinical trials becomes much harder, who is going to pay for something that does not have any profit in return? Another downside is the quality, what happens if someone does not display the results in a fair way?"

With these statements about open-source and clinical trials we went on because if we would finally like to market our VLPs and with it, a novel drug delivery system, it is important to know what is required and what drawbacks come with our project and iGEM in general. We finally interviewed a senior consultant in clinical trial operations to investigate what is possible. The main message was that there is a difference between small biotech companies and big pharmaceutical companies, especially concerning patenting and publishing results and ideas. The open source character of iGEM has some unexpected implications.

“When anything is published without patenting first, there is no money to be earned anymore. Therefore it could slow down the marketing and start of clinical trials for new products.”

So, as soon we make our ideas known to the public by joining iGEM we make it harder to market these great ideas unless we patent first. Besides the open source, we discussed also the benefits and problems of a universal carrier. It indeed might be a standardized tool to make it easier to produce vaccines and deliver medicines, but the regulators such as EMA and FDA will probably still ask for new clinical trials for each new applications.

“If you would like to market your carrier, you should aim at selling the idea to pharmaceutical companies who use it for their own drugs. This would make them responsible for the trials.”

Even though our tool has a large standardized component, it will probably not be standardized enough to bypass at least some of the clinical trials. The cost reduction is thus not in this part of the development of the drugs, but in the design phase. But besides this it was told that still a very large part of the costs are in the marketing aspect. Thus till this far, public and professional opinions. This gives a much better view from outside the university about our iGEM project and the competition itself.