JULIE NG-A-THAM: So good morning to you all, iGEM participants 2020...
and other attendees.
A warm welcome to you all at this Safe-by- Design website, hosted by the RIVM.
My name is Julie Ng-A-Tham and I will be your moderator today...
and I have two speakers for you lined up.
First of all you can see Sam, Sam Krouwel.
He is our Safe by Design educational specialist and he just waved to you.
And then there is Cécile van der Vlugt.
Cécile will wave to you now.
She is our biotechnology and safety expert.
And then last but not least we also have Sandra Dissel. Sandra, could you also wave?
There she is. She is our technical assistant...
and she will provide you with hand-outs and other things after this seminar.
I would like to start that we all work at the RIVM...
and that's the Dutch National Institute for Public Health and the Environment.
And this institute is very keen on safety.
In fact, it's one of our key issues and key topics.
And we have gained a lot of experience...
and lessons learned...
on how to incorporate safety in all kinds of activities...
and how to assess safety.
So we would like to pass it to you...
and therefore we have designed this webinar.
But now it's up to you...
because you are one of the participants of iGEM...
and as such you are very much anxious...
to begin and start your project...
and to make your dream come true...
on biotechnology and synthetic biology.
Perhaps you have a lot of technical difficulties already...
but we would like to show you that there are also other things to consider...
and that is to include safety into your project.
And as you have probably noticed...
the organization of iGEM is also very keen...
on incorporating safety in the projects.
And therefore I think this webinar will suit you well.
But let's start with a poll...
because we want to know something about your knowledge on Safe-by-Design.
So Sam, could you please...
Yes, there's the first question already.
We would like to know whether it is clear to you what is meant by Safe-by-Design.
Now you can see all the answers. It's a very mixed group.
Some people know quite a lot already...
about Safe-by-Design.
Some others don't agree but neither disagree with that...
and there is a small group...
for whom Safe-by-Design is quite a new topic.
We have another question for you.
Sam, could you pose the next question too?
That's something about your future career.
I consider Safe-by-Design a very useful concept for my future career.
What do you think? So go ahead.
So mostly you agree or somewhat agree with the idea...
that Safe-by-Design can be very useful for your future career.
So let's have a look what Sam can tell us about Safe-by-Design....
why it is important to you and what it does entail.
Sam, could you enlighten us, please?
SAM KROUWEL: Alright, hopefully I can share with you something...
that will expand your understanding of the concept of Safe-by-Design.
Of course today we're talking about the topic of biotechnology...
which is a hugely promising emerging technology.
On the screen you'll see the roadmap of the EBRC that was developed last year.
They tried to distinguish different fields that biotechnology can contribute to...
spanning industrial technology, the energy transition...
environmental challenges, food production of course, health and medicine.
And I can imagine that your projects will fall in one of these categories.
Now this roadmap shows immense promise, immense potential...
for the technology of biotechnology...
but the idea of safety is not really addressed in this roadmap.
And of course there are many potential adverse issues with biotechnology.
I'm sure you are aware of adverse impacts such as the creation of novel pathogens...
that are hazardous to humans or animal health...
the introduction of novel organisms that may disturb ecological balance...
with potentially far-reaching and very unpredictable effects.
And of course a wide range of societal and ethical consequences...
that are difficult to oversee, complex...
and they change how we engage with each other and with the world.
Although you are probably, undoubtedly, aware of these potential adverse impacts...
actually taking them into account throughout your innovation process is a different story...
and hopefully we can help you with that today.
So one of the big difficulties with something like biotechnology...
an emerging technology...
is that it's very difficult to predict where the next breakthrough will occur...
and what that breakthrough will look like.
Now a classic example of this is the discovery of CRISPR-Cas9.
This of course represented a revolution in gene editing...
and a major step in the discovery of this proteine...
was a study that tried to improve yoghurt bacteria's resistence to bacteriophages.
Now the mechanism that these researchers used...
they identified as potentially being very useful in gene editing...
if it could be cross-functionalized across organisms...
but it took another seven years before it actually happened...
and only after that a societal discussion started...
about what the impact of this discovery would be.
Now if these researchers had already foreseen the potential use of this technology...
maybe it would have been nice if we could have already started this discussion.
If we can only start a discussion after something has been introduced...
it's very difficult, especially for outsiders...
to prepare for novel safety issues...
to see ahead and think about how we should prepare...
for the emergence of new technologies.
Now this example bears similarities to the classical mythological example...
of Prometheus, a classical Greek myth.
Prometheus had gifted us humans fire.
Now fire of course allowed us humans...
to take control of many things in our environment...
to change our society for the better...
but it also gave us a lot of power for the worse.
And once we were in possession of fire, as the myth goes...
this door could not be closed again.
So it's important that, whatever you design...
you must consider how that design will affect the world.
And in the case of CRISPR-Cas9 it has much more facilitated...
the development of do-it-yourself biotechnology.
For some people this is a democratization of an emerging technology...
and a very positive thing...
but at the same time it spreads the access to this technology...
and it makes it much more difficult to see what's going to happen with it...
who is going to engage with it and what people are going to do with it.
So it would have been nice if we could have thought about this beforehand...
before the door had opened.
And of course there are always these doom scenarios.
What would you do if you would learn that the work you're doing...
the innovation that you're working on, can result in deeply adverse consequences?
Einstein famously said...
that if he had known his insights would lead to the creation of a nuclear bomb...
he would have become a watchmaker.
A very valid point that is often made in response to this...
is that he did not know...
so how could he have taken it into consideration?
And in part that is true, right? While we can predict and address some of the issues...
the pioneering nature of the work means that many uncertainties remain...
about potential consequences of new developments...
so this poses a challenge...
but if Einstein had indeed become a watchmaker we would all be at a loss for it.
We would have missed out on a lot of progress...
so avoiding that challenge is not the issue. We should try and encounter it.
Now a cornerstone idea behind Safe-by-Design...
is represented by the Collingridge dilemma...
and it sort of examplifies this issue that we're talking about.
The Collingridge dilemma shows that as technological innovation progresses...
there's an inverse correlation between the technology's adaptability...
which is shown by the green line.
As technology progresses, adaptability goes down...
and the knowledge of its impacts...
which goes up as technology progresses.
An easy example of this would be found in the car industry.
If you're designing a car you have a conceptual phase...
you work in a 3D program and it changes at the click of a button.
If you move over to the prototyping stage...
if you want to make a change there you'll have to fabricate a new part...
install it, test it. Much more laborious and a bit more expensive...
than working in a 3D program.
But once your innovation is out into the world...
and you discover a safety defect at that point...
you have to issue a very, very expensive recall...
to fix all the individual cars.
At that point it's very difficult, challenging, very expensive...
and there are a lot of incentives against actually adapting those safety issues.
So the more integrated your innovation becomes in society...
the more you can learn about the safety issues...
but the more difficult and expensive it becomes to address them.
So that means that discovering those safety issues in late stages is very undesirable...
but it's precisely with these enriching technologies...
that there's a very high degree of uncertainty.
And that's complicated even further...
by the fact that there's an increasing complexity in the world...
and especially technological innovation is increasingly complex.
We're working with increasingly small mechanisms...
with highly specialized professionals working on very small parts of an innovation process...
that spans the world.
That makes it very difficult to designate someone...
that makes sure that new innovations are developed and introduced safely.
Very often people look to the government for this.
Governments have a very difficult time as an outsider to be on top of the new innovations...
to predict what kind of safety issues will occur.
On the one hand they can be very cautious...
be very restrictive on what kind of new things happen...
but that may hinder new developments.
On the other hand they may provide freedom...
but then they run the risk of unexpectedly introducing high risk situations into the world...
which is something you want to avoid.
So then who keeps an eye on the safety of products...
and the safety of the introduction of those products in society?
Now we have a bit of a daunting mix, right?
We have unpredictable, fast-developing emerging technologies...
where working on improving yoghurt may lead to the next groundbreaking discovery.
It's hard to foresee the impact of those discoveries.
They may lead to a wholly different use of a certain technology.
And these things happen in a very complex system...
where it's very difficult to oversee what's going to happen.
So how do we counter those factors?
Well, this is something that Safe-by-Design hopes to contribute to.
And it hopes to do so to say: We as pioneers, working on this technology...
should all take collective responsibility for the future safety of our work.
And this is what Safe-by-Design helps to do.
By helping you to anticipate on potential problems...
and include a broader context...
and a wide array of stakeholders into your innovation process...
Safe-by-Design provides you a way to learn...
as much about potential adverse consequences as possible...
as early in the innovation chain as possible.
So we're going to try and move that pink line forward as much as we can.
Now in response to the knowledge that you learn...
you can of course adjust your design...
so you can think about building in safety measures...
but also creating a safer environment for the innovation to function in.
Or you can think of collaborating with societal actors...
to adjust your innovation to society...
maybe even prepare society for your innovation...
for example by seeking out collaboration with regulators...
to see if you can develop rules and regulations that would guide proper use.
These are all things you can think of...
in response to your increased knowledge about safety impacts.
But of course, not all impacts can be known beforehand.
There's always a degree of uncertainty...
and we should try and see if we can account for that as well.
We can try and design solutions that stay adaptable for as long as possible.
The main thing that you would be able to do...
is to see how we can design something that is easily monitored...
keep check on what is going to happen, what it does, how it interacts with the world...
and try and respond to that.
And even, in extreme cases, you might be able to consider design strategies...
such as flexible design, a more modular design...
that allow you a degree of control on the product you're making...
after it's already been introduced.
Of course it's important to realize that those kinds of design options add complexity...
so that also includes adding uncertainty.
But those kinds of directions of thinking might be helpful in sort of designing for safety.
So Safe-by-Design is a design approach that's characterized...
by a proactive and reflexive attitude towards safety concerns.
It starts at the earliest phases of research and design, development...
and goes all the way to product design but also its societal introduction...
and even thinking ahead towards waste management or recycling of a product.
And it sort of reflects the continuous two-way interaction...
between on the one hand the innovator that's proactive...
thinking about 'How will my innovation impact the world?'...
and the world. 'How does the world impact the thing that I'm designing...
and how should I adjust my design to better suit the environment and the world?'
You can imagine this in practice by looking at innovation progressing in different stages.
We start with a vision, trying to solve a certain problem...
or develop a certain new possibility or technology.
And as we progress through different stages...
we of course are alert for any sort of design elements.
We are part of a biological engineering group...
so we think of how can we design functionalities...
but at the same time you should think about how do we design in safety.
Now while you're doing these things you should continuously be aware...
also of things happening beyond the lab.
So that means the safety, security issues that the introduction of your innovation may pose...
any policy, law or ethical issues that may arise...
with the introduction of your technology...
and also what kind of stakeholders are influenced by that innovation...
and whether they should be included in the development of your technology.
Now this innovation process is visualized as a line...
a linear process, and that's of course not really the case.
A more accurate representation would be innovation shown as a iterative process.
We're still moving through the phases.
You're still starting with an idea and hoping to end up with a product...
but as you're moving through each phase you're looking forward...
trying to imagine already in your first vision, envisioning of a new innovation...
what it would take to produce that innovation for example...
and what kind of issues you may encounter at that stage.
And as you move through each of these stages you look back:
'Have I done everything I can, what kind of new issues should I encounter...
and what can we do to incorporate that into the design?'
A classic example of an innovation that did not follow the procedure...
would be Golden Rice.
Golden Rice was a rice variety...
that aimed to solve the issue of vitamin A deficiency in developing countries.
While the aim was very admirable...
the product really failed because it did not take into account several upstream factors...
such as the fact that this vitamin A deficiency was caused by unvaried diets...
which are a symptom of much larger poverty problems...
and therefore Golden Rice was seen more as a symptomatic treatment...
rather than an actual solution.
And it also didn't sufficiently address several downstream societal symptoms...
such as the fear for corporate control of agricultural stocks...
or the ecological risks of introducing such a rice variety.
It might displace natural rice variations.
So had the researchers looked ahead and looked in a broader context...
they might have gone very differently about presenting or introducing their innovation...
or maybe they wouldn't have gone through with it at all.
So Safe-by-Design allows you as a researcher and also society as a whole...
to adjust the course of innovation while it's still flexible...
and it helps you develop beneficial and safer innovations.
Now I'd like to go back to Julie.
JULIE NG-A-THAM: So Sam provided you with some thoughts...
and dilemmas to address...
and a lot of new things to do.
But perhaps we can help you.
I would like to give Cécile the floor.
Perhaps Cécile can help you with how to incorporate this into your project...
and make it more easy for you. Cécile, the floor is yours.
CÉCILE VAN DER VLUGT: Okay. Thank you, Julie, for this opportunity.
Now dear iGEM'ers, what is your dream project this summer?
To find a solution for the plastic soup in the ocean...
or to design a detection kit for COVID-19...
or do you want to develop a biocontrol agent for a devastating plant disease?
Well, your iGEM project is a big opportunity to explore Safe-by-Design...
while you are developing your own synthetic organism.
And how to explore what Safe-by-Design can do for your project?
How can you make Safe-by-Design alive?
So let's have a look...
at the method we are designing for you.
Yes. That's the method. Safe-by-Design is a simple method, learning by doing.
You just see three tabs.
It's challenging because you are asked to think critically.
It will be an interactive process...
as you will contact many stakeholders, experts...
to gain information and have a discussion with your coach.
We suggest to have a time period of two months...
along your iGEM project.
That will be plenty of time...
but we also see teams working for a bit longer time than the two months.
So it's up to you how many time you have left for your project...
but you are still in time at this moment...
to incorporate the Safe-by-Design method in your project.
It's important to know that there are two types of actors involved in this method.
You as students.
We suggest to have a selection of four to six students from your team...
to work on the Safe-by-Design project...
and it is of an added value if these students have different scientific backgrounds.
And you are entering the Safe-by-Design method just by learning and doing.
The second type of actor is a coach.
That could be your mentor or your supervisor...
of if they are not available one or two of your team members could also be a coach.
Because you as a student are a critical thinker...
and in that you can also take up the role of a coach...
as you can also question results and keep a close eye on Safe-by-Design aspects.
So have a look at the first step in the Safe-by-Design method.
It all starts with your own project idea.
Have a look at your project idea and think about all kinds of safety issues.
Biosafety, chemical safety. Do you use any pathogens?
And think along the whole line of design...
up to the end use of the final product you wish to design.
By discussing these different safety issues...
you get a collective view on this aspect.
And that will be the start for the coaching session.
So it's important to document all the aspects you have addressed in your discussion.
You can make a short proposal or a mindmap, just what is convenient to you.
To have an idea of the different kinds of safety aspects...
I would like to have your attention for this project.
It's a little exercise also for you. A poll question will come up.
This project was called 'food warden' and was designed to stop food waste...
especially the food waste in supermarkets from packaged meat.
Because if the sell-by date was passed then the meat is thrown away...
without knowing for sure whether the meat was still okay.
So the students designed a sticker, as you can see in this picture...
and the sticker was packaged together with the meat.
It contains GM bacteria and they were released from this inner sticker...
into the medium which contained nutrients...
and that activated the metabolism and the genetic circuit.
Because these GM bacteria were able to smell the rotten meat...
and upon that smell they colorize.
So the question is: What kind of safety aspects would you consider for this project?
And I'm looking now for the poll question...
that you will see in a second.
For this poll question I suggested a number of safety aspects.
And I'd like to ask you to take two or three safety aspects...
you think are important to consider.
Food safety is coming up as first. Well yeah, I think that's obvious.
But then end use and waste disposal is also addressed.
And I think that's very interesting, that you suggested this to have a look at.
I mean, for me it's very natural...
but in another poll we saw that people were very interested to look at lab safety as well.
But as you understand, using this sticker in the packaged meat...
and how the public will use that is a very important aspect to address...
and to think how you could include safety aspects.
So thank you for your response for that.
So now let me first address the coach...
because also as coach you need to know what to do in this method.
And as I said, you as a student can also act as a coach.
What we ask from the coach is that they, he or she...
reads the student's proposal, reflects on the safety issues...
consider if everything is included from the start to the beginning...
and additional to that, could you provide some moral and ethical views...
and think about stakeholders or experts that could be consulted...
to broaden the view of the students on the project.
And to get some more idea what is asked for this...
another iGEM project called 'Gelcatraz'.
These students wanted to work with living material...
and they decided to use this biomaterial as part of a bandage to cover wounds.
What you see in this picture is that the GM bacteria are attached to a hydrogel.
Besides that the bacteria are also able to excrete a bacteriocin...
and this bacteriocin could inactivate bacteria causing wound infections.
Now that was the idea.
And I'd like you now to consider also in the next poll:
What are relevant stakeholders and experts to contact...
to broaden your view on what kind of...
What type of information to collect.
Okay.
Well, thank you, excellent.
I'll show you the results. What has been voted?
Relevant stakeholders: health care workers and patients.
Indeed, what I know from this project is...
that that really gave the project a focus on working with a specific type of wounds.
So it's very helpful to address these parties.
I don't see any votes for parties which could help with PR.
But please do consider that...
as these people can reach out to the public, help you with reaching out.
Because if patients need to use this...
you want to know what their points of interest are to work safely.
And also governmental bodies is not clicked...
but this kind of development needs the attention for the GMO assessors...
as well as the medical assessors.
And they look at specific points...
which you can also consider early in the design phase.
So these people can also help to address all kinds of safety issues.
Okay, thank you for your contribution to this.
And now both parties, students and coach...
are ready for the next step in the Safe-by-Design method.
The coaching session.
In this session you sit together.
As students you present the project...
and all the safety aspects you have considered up til now...
and as coach you reflect on these aspects.
Together you have a discussion on the whole...
and what stakeholders could be involved and what experts could be consultated...
to gain more in-depth information on the project you are working on...
and also ethical and moral views should be included.
And after this discussion...
you as students have the most of the work to do in this Safe-by-Design method...
because now you have many ideas resulting from the very first step...
from the coaching session, and now you can think...
what stakeholders and experts you need to contact for more information...
and also think how to incorporate these safety aspects in your product design.
And most importantly, document all these ideas, the interviews...
results coming up from the discussions, because with that you can later on show...
how this discussion has affected your design process.
We suggest to use an infographic for that...
because that is presenting a very quick overview from the work you have done.
So as an example, have a look back at the Gelcatraz project.
This is an example to show...
what stakeholders they have contacted...
and also to show what the benefit is from reaching out to stakeholders.
Because as I said just before, medical professionals suggested...
to focus on burn wounds and diabetic wounds...
as these are long-lasting wounds and suffering from infection and pathogenic bacteria.
So that gave a focus on the type of plaster to be developed...
and the GM bacteria to be designed.
And also by contacting professors in biosafety and chemistry...
for example the use of dextran as a safe matrix was an important decision.
Because there are also chemical polymers available as a matrix...
however it turned out that there are also chemicals involved in that process.
So along with a number of other stakeholders...
this contact really shaped also the project of this team.
And I show you here just a concept infographic.
You don't need to read this or to copy this. This is just an illustration.
What this team has done is finding a pictogram for every safety aspect...
put it in this infographic with some additional text...
on the stakeholders and experts they contacted...
and what that gave as an output.
And also this concept infographic is useful for the second coaching session.
Because in that session, as the final step of your Safe-by-Design method...
you sit together again with your coach...
and you reflect on Safe-by-Design aspects investigated thus far.
Maybe there are still unaddressed safety aspects...
difficult to address...
because some aspects could be conflicting in product design.
And how is the translation of Safe-by-Design done in the product design?
Because is it doable due to the time and money constraints, for example?
Your project is only lasting for a couple of months.
You cannot do everything so you have to make choices.
And what is the impact of Safe-by-Design on your project?
Because as I already said, you can have conflicting safety issues...
and what kind of choices you should make then?
So use this discussion with your coach...
to get some in-depth insight in your choices...
and also document that in an infographic.
Because with that you are in the final step of the Safe-by-Design method.
Some finishing touches I have for you.
Decide on the final Safe-by-Design aspects to integrate in your product design...
and also finalize this infographic.
And this infographic is not just for fun.
It can help you to inform the public...
on how you have thought and designed on your synthetic organism.
Maybe if your project is succesful, you can reach out to your manufacturer...
on what you have done and already included in your project.
But I think the most obvious reason to make such an infographic...
is also to show it to the judges in the iGEM Jamboree...
as they will also have a look at this...
and understand what you have done for working safe...
and practising safety and finalizing a safe product.
So with this I come to the end of explaining the process.
If you have followed this process you nailed it.
You incorporated Safe-by-Design in your iGEM project.
And I think if you look back and look that you started with your own project idea...
faced many safety issues and found solutions for yourself...
then you have learned Safe-by-Design by doing...
and making a very complicated process as you have seen in the introduction of Sam...
you have made this complicated process doable.
So I wish you a wonderful time and very much success in iGEM...
and I give the word back to Julie.
JULIE NG-A-THAM: So we come to the end of our webinar.
The method Cécile illustrated...
we could not do that without the help of all the previous iGEM teams...
so I would like to thank all the iGEM teams for their efforts...
but also the Ministry of Infrastructure and Water Management...
because they have sponsored us during our work to do this.
But now it's up to you.
You are part of the community of young synthetic biology researchers...
and as such you have a responsibility regarding safety...
and Safe-by-Design.
And let's face it, it is quite a difficult task, but try to enjoy the ride...
because it can be very promising...
and also pretty satisfying...
when you can contribute your experiences to the iGEM community.
So go out and try to make this world more safe and more sustainable...
and, in the end, a better place. Thank you very much.