WEBVTT 00:00:08.720 --> 00:00:13.240 JULIE NG-A-THAM: So good morning to you all, iGEM participants 2020... 00:00:13.320 --> 00:00:15.120 and other attendees. 00:00:15.200 --> 00:00:22.880 A warm welcome to you all at this Safe-by- Design website, hosted by the RIVM. 00:00:22.960 --> 00:00:27.640 My name is Julie Ng-A-Tham and I will be your moderator today... 00:00:27.720 --> 00:00:30.200 and I have two speakers for you lined up. 00:00:30.280 --> 00:00:34.120 First of all you can see Sam, Sam Krouwel. 00:00:34.200 --> 00:00:39.240 He is our Safe by Design educational specialist and he just waved to you. 00:00:39.320 --> 00:00:41.760 And then there is Cécile van der Vlugt. 00:00:41.840 --> 00:00:44.040 Cécile will wave to you now. 00:00:44.120 --> 00:00:48.480 She is our biotechnology and safety expert. 00:00:48.560 --> 00:00:54.000 And then last but not least we also have Sandra Dissel. Sandra, could you also wave? 00:00:54.080 --> 00:00:57.200 There she is. She is our technical assistant... 00:00:57.280 --> 00:01:02.880 and she will provide you with hand-outs and other things after this seminar. 00:01:04.680 --> 00:01:10.160 I would like to start that we all work at the RIVM... 00:01:10.240 --> 00:01:15.200 and that's the Dutch National Institute for Public Health and the Environment. 00:01:15.280 --> 00:01:21.040 And this institute is very keen on safety. 00:01:21.120 --> 00:01:24.560 In fact, it's one of our key issues and key topics. 00:01:24.640 --> 00:01:27.880 And we have gained a lot of experience... 00:01:27.960 --> 00:01:29.920 and lessons learned... 00:01:30.000 --> 00:01:34.080 on how to incorporate safety in all kinds of activities... 00:01:34.160 --> 00:01:36.720 and how to assess safety. 00:01:36.800 --> 00:01:39.480 So we would like to pass it to you... 00:01:39.560 --> 00:01:44.960 and therefore we have designed this webinar. 00:01:46.880 --> 00:01:49.920 But now it's up to you... 00:01:50.000 --> 00:01:53.400 because you are one of the participants of iGEM... 00:01:53.480 --> 00:01:59.960 and as such you are very much anxious... 00:02:00.040 --> 00:02:02.400 to begin and start your project... 00:02:02.480 --> 00:02:04.600 and to make your dream come true... 00:02:04.680 --> 00:02:08.360 on biotechnology and synthetic biology. 00:02:08.440 --> 00:02:13.560 Perhaps you have a lot of technical difficulties already... 00:02:13.640 --> 00:02:18.280 but we would like to show you that there are also other things to consider... 00:02:18.360 --> 00:02:23.080 and that is to include safety into your project. 00:02:23.160 --> 00:02:25.840 And as you have probably noticed... 00:02:25.920 --> 00:02:29.720 the organization of iGEM is also very keen... 00:02:29.800 --> 00:02:33.720 on incorporating safety in the projects. 00:02:33.800 --> 00:02:39.880 And therefore I think this webinar will suit you well. 00:02:39.960 --> 00:02:43.320 But let's start with a poll... 00:02:43.400 --> 00:02:47.720 because we want to know something about your knowledge on Safe-by-Design. 00:02:47.800 --> 00:02:50.800 So Sam, could you please... 00:02:50.880 --> 00:02:54.120 Yes, there's the first question already. 00:02:54.200 --> 00:03:00.280 We would like to know whether it is clear to you what is meant by Safe-by-Design. 00:03:00.360 --> 00:03:05.480 Now you can see all the answers. It's a very mixed group. 00:03:05.560 --> 00:03:11.440 Some people know quite a lot already... 00:03:11.520 --> 00:03:13.400 about Safe-by-Design. 00:03:13.480 --> 00:03:19.600 Some others don't agree but neither disagree with that... 00:03:19.680 --> 00:03:24.200 and there is a small group... 00:03:24.280 --> 00:03:28.120 for whom Safe-by-Design is quite a new topic. 00:03:28.200 --> 00:03:30.560 We have another question for you. 00:03:30.640 --> 00:03:34.520 Sam, could you pose the next question too? 00:03:37.000 --> 00:03:40.280 That's something about your future career. 00:03:40.360 --> 00:03:46.120 I consider Safe-by-Design a very useful concept for my future career. 00:03:46.200 --> 00:03:49.520 What do you think? So go ahead. 00:03:51.080 --> 00:03:57.800 So mostly you agree or somewhat agree with the idea... 00:03:57.880 --> 00:04:02.400 that Safe-by-Design can be very useful for your future career. 00:04:02.480 --> 00:04:07.720 So let's have a look what Sam can tell us about Safe-by-Design.... 00:04:07.800 --> 00:04:12.000 why it is important to you and what it does entail. 00:04:12.080 --> 00:04:14.720 Sam, could you enlighten us, please? 00:04:14.800 --> 00:04:18.800 SAM KROUWEL: Alright, hopefully I can share with you something... 00:04:18.880 --> 00:04:22.200 that will expand your understanding of the concept of Safe-by-Design. 00:04:22.280 --> 00:04:25.680 Of course today we're talking about the topic of biotechnology... 00:04:25.760 --> 00:04:29.080 which is a hugely promising emerging technology. 00:04:29.160 --> 00:04:34.120 On the screen you'll see the roadmap of the EBRC that was developed last year. 00:04:34.200 --> 00:04:38.400 They tried to distinguish different fields that biotechnology can contribute to... 00:04:38.480 --> 00:04:41.560 spanning industrial technology, the energy transition... 00:04:41.640 --> 00:04:45.600 environmental challenges, food production of course, health and medicine. 00:04:46.040 --> 00:04:51.080 And I can imagine that your projects will fall in one of these categories. 00:04:51.160 --> 00:04:54.800 Now this roadmap shows immense promise, immense potential... 00:04:54.880 --> 00:04:58.280 for the technology of biotechnology... 00:04:58.360 --> 00:05:03.640 but the idea of safety is not really addressed in this roadmap. 00:05:03.720 --> 00:05:08.080 And of course there are many potential adverse issues with biotechnology. 00:05:08.160 --> 00:05:12.400 I'm sure you are aware of adverse impacts such as the creation of novel pathogens... 00:05:12.480 --> 00:05:16.200 that are hazardous to humans or animal health... 00:05:16.280 --> 00:05:20.000 the introduction of novel organisms that may disturb ecological balance... 00:05:20.080 --> 00:05:23.240 with potentially far-reaching and very unpredictable effects. 00:05:23.320 --> 00:05:26.840 And of course a wide range of societal and ethical consequences... 00:05:26.920 --> 00:05:29.560 that are difficult to oversee, complex... 00:05:29.640 --> 00:05:33.280 and they change how we engage with each other and with the world. 00:05:33.360 --> 00:05:38.280 Although you are probably, undoubtedly, aware of these potential adverse impacts... 00:05:38.360 --> 00:05:43.240 actually taking them into account throughout your innovation process is a different story... 00:05:43.320 --> 00:05:46.000 and hopefully we can help you with that today. 00:05:46.920 --> 00:05:51.120 So one of the big difficulties with something like biotechnology... 00:05:51.200 --> 00:05:52.320 an emerging technology... 00:05:52.400 --> 00:05:55.480 is that it's very difficult to predict where the next breakthrough will occur... 00:05:55.560 --> 00:05:57.440 and what that breakthrough will look like. 00:05:57.520 --> 00:06:01.440 Now a classic example of this is the discovery of CRISPR-Cas9. 00:06:01.520 --> 00:06:05.360 This of course represented a revolution in gene editing... 00:06:05.440 --> 00:06:09.240 and a major step in the discovery of this proteine... 00:06:09.320 --> 00:06:15.440 was a study that tried to improve yoghurt bacteria's resistence to bacteriophages. 00:06:15.520 --> 00:06:19.320 Now the mechanism that these researchers used... 00:06:19.400 --> 00:06:25.000 they identified as potentially being very useful in gene editing... 00:06:25.080 --> 00:06:27.840 if it could be cross-functionalized across organisms... 00:06:27.920 --> 00:06:30.680 but it took another seven years before it actually happened... 00:06:30.760 --> 00:06:33.720 and only after that a societal discussion started... 00:06:33.800 --> 00:06:37.840 about what the impact of this discovery would be. 00:06:37.920 --> 00:06:42.360 Now if these researchers had already foreseen the potential use of this technology... 00:06:42.440 --> 00:06:46.960 maybe it would have been nice if we could have already started this discussion. 00:06:47.040 --> 00:06:49.720 If we can only start a discussion after something has been introduced... 00:06:49.800 --> 00:06:52.720 it's very difficult, especially for outsiders... 00:06:52.800 --> 00:06:54.400 to prepare for novel safety issues... 00:06:54.480 --> 00:06:57.400 to see ahead and think about how we should prepare... 00:06:57.480 --> 00:07:01.160 for the emergence of new technologies. 00:07:01.240 --> 00:07:05.800 Now this example bears similarities to the classical mythological example... 00:07:05.880 --> 00:07:09.400 of Prometheus, a classical Greek myth. 00:07:09.480 --> 00:07:14.200 Prometheus had gifted us humans fire. 00:07:14.280 --> 00:07:17.840 Now fire of course allowed us humans... 00:07:17.920 --> 00:07:21.560 to take control of many things in our environment... 00:07:21.640 --> 00:07:23.840 to change our society for the better... 00:07:23.920 --> 00:07:26.520 but it also gave us a lot of power for the worse. 00:07:26.600 --> 00:07:30.000 And once we were in possession of fire, as the myth goes... 00:07:30.080 --> 00:07:32.880 this door could not be closed again. 00:07:33.880 --> 00:07:37.000 So it's important that, whatever you design... 00:07:37.080 --> 00:07:40.720 you must consider how that design will affect the world. 00:07:40.800 --> 00:07:44.040 And in the case of CRISPR-Cas9 it has much more facilitated... 00:07:44.120 --> 00:07:47.400 the development of do-it-yourself biotechnology. 00:07:47.480 --> 00:07:51.080 For some people this is a democratization of an emerging technology... 00:07:51.160 --> 00:07:52.600 and a very positive thing... 00:07:52.680 --> 00:07:57.240 but at the same time it spreads the access to this technology... 00:07:57.320 --> 00:08:00.720 and it makes it much more difficult to see what's going to happen with it... 00:08:00.800 --> 00:08:04.560 who is going to engage with it and what people are going to do with it. 00:08:04.640 --> 00:08:08.560 So it would have been nice if we could have thought about this beforehand... 00:08:08.640 --> 00:08:11.000 before the door had opened. 00:08:11.960 --> 00:08:15.000 And of course there are always these doom scenarios. 00:08:15.080 --> 00:08:18.280 What would you do if you would learn that the work you're doing... 00:08:18.360 --> 00:08:23.120 the innovation that you're working on, can result in deeply adverse consequences? 00:08:23.200 --> 00:08:25.360 Einstein famously said... 00:08:25.440 --> 00:08:29.040 that if he had known his insights would lead to the creation of a nuclear bomb... 00:08:29.120 --> 00:08:31.680 he would have become a watchmaker. 00:08:31.760 --> 00:08:34.760 A very valid point that is often made in response to this... 00:08:34.840 --> 00:08:36.600 is that he did not know... 00:08:36.680 --> 00:08:38.920 so how could he have taken it into consideration? 00:08:39.360 --> 00:08:43.280 And in part that is true, right? While we can predict and address some of the issues... 00:08:43.360 --> 00:08:46.920 the pioneering nature of the work means that many uncertainties remain... 00:08:47.000 --> 00:08:51.480 about potential consequences of new developments... 00:08:51.560 --> 00:08:53.480 so this poses a challenge... 00:08:53.560 --> 00:08:57.360 but if Einstein had indeed become a watchmaker we would all be at a loss for it. 00:08:57.440 --> 00:08:59.480 We would have missed out on a lot of progress... 00:08:59.560 --> 00:09:03.400 so avoiding that challenge is not the issue. We should try and encounter it. 00:09:04.560 --> 00:09:08.120 Now a cornerstone idea behind Safe-by-Design... 00:09:08.200 --> 00:09:10.040 is represented by the Collingridge dilemma... 00:09:10.120 --> 00:09:14.120 and it sort of examplifies this issue that we're talking about. 00:09:15.000 --> 00:09:19.880 The Collingridge dilemma shows that as technological innovation progresses... 00:09:19.960 --> 00:09:23.560 there's an inverse correlation between the technology's adaptability... 00:09:23.640 --> 00:09:25.920 which is shown by the green line. 00:09:26.000 --> 00:09:28.720 As technology progresses, adaptability goes down... 00:09:28.800 --> 00:09:30.800 and the knowledge of its impacts... 00:09:30.880 --> 00:09:33.960 which goes up as technology progresses. 00:09:34.040 --> 00:09:38.000 An easy example of this would be found in the car industry. 00:09:38.080 --> 00:09:41.240 If you're designing a car you have a conceptual phase... 00:09:41.320 --> 00:09:44.640 you work in a 3D program and it changes at the click of a button. 00:09:45.640 --> 00:09:48.240 If you move over to the prototyping stage... 00:09:48.320 --> 00:09:51.520 if you want to make a change there you'll have to fabricate a new part... 00:09:51.600 --> 00:09:55.560 install it, test it. Much more laborious and a bit more expensive... 00:09:55.640 --> 00:09:57.560 than working in a 3D program. 00:09:57.640 --> 00:10:00.960 But once your innovation is out into the world... 00:10:01.040 --> 00:10:03.720 and you discover a safety defect at that point... 00:10:03.800 --> 00:10:06.600 you have to issue a very, very expensive recall... 00:10:06.680 --> 00:10:09.800 to fix all the individual cars. 00:10:09.880 --> 00:10:12.920 At that point it's very difficult, challenging, very expensive... 00:10:13.000 --> 00:10:17.640 and there are a lot of incentives against actually adapting those safety issues. 00:10:18.440 --> 00:10:21.400 So the more integrated your innovation becomes in society... 00:10:21.480 --> 00:10:23.280 the more you can learn about the safety issues... 00:10:23.360 --> 00:10:27.120 but the more difficult and expensive it becomes to address them. 00:10:27.200 --> 00:10:32.000 So that means that discovering those safety issues in late stages is very undesirable... 00:10:32.080 --> 00:10:34.120 but it's precisely with these enriching technologies... 00:10:34.200 --> 00:10:37.080 that there's a very high degree of uncertainty. 00:10:37.160 --> 00:10:39.360 And that's complicated even further... 00:10:39.440 --> 00:10:41.480 by the fact that there's an increasing complexity in the world... 00:10:41.560 --> 00:10:45.040 and especially technological innovation is increasingly complex. 00:10:45.120 --> 00:10:48.840 We're working with increasingly small mechanisms... 00:10:48.920 --> 00:10:53.160 with highly specialized professionals working on very small parts of an innovation process... 00:10:53.240 --> 00:10:57.120 that spans the world. 00:10:57.200 --> 00:11:00.760 That makes it very difficult to designate someone... 00:11:00.840 --> 00:11:05.120 that makes sure that new innovations are developed and introduced safely. 00:11:05.200 --> 00:11:07.880 Very often people look to the government for this. 00:11:07.960 --> 00:11:13.760 Governments have a very difficult time as an outsider to be on top of the new innovations... 00:11:13.840 --> 00:11:15.960 to predict what kind of safety issues will occur. 00:11:16.040 --> 00:11:19.200 On the one hand they can be very cautious... 00:11:19.280 --> 00:11:21.840 be very restrictive on what kind of new things happen... 00:11:21.920 --> 00:11:23.640 but that may hinder new developments. 00:11:23.720 --> 00:11:26.360 On the other hand they may provide freedom... 00:11:26.440 --> 00:11:30.880 but then they run the risk of unexpectedly introducing high risk situations into the world... 00:11:30.960 --> 00:11:34.280 which is something you want to avoid. 00:11:36.640 --> 00:11:39.120 So then who keeps an eye on the safety of products... 00:11:39.200 --> 00:11:43.440 and the safety of the introduction of those products in society? 00:11:43.520 --> 00:11:45.040 Now we have a bit of a daunting mix, right? 00:11:45.120 --> 00:11:47.800 We have unpredictable, fast-developing emerging technologies... 00:11:47.880 --> 00:11:53.960 where working on improving yoghurt may lead to the next groundbreaking discovery. 00:11:54.040 --> 00:11:56.240 It's hard to foresee the impact of those discoveries. 00:11:56.320 --> 00:11:59.120 They may lead to a wholly different use of a certain technology. 00:12:00.160 --> 00:12:04.080 And these things happen in a very complex system... 00:12:04.160 --> 00:12:07.800 where it's very difficult to oversee what's going to happen. 00:12:07.880 --> 00:12:09.680 So how do we counter those factors? 00:12:09.760 --> 00:12:13.920 Well, this is something that Safe-by-Design hopes to contribute to. 00:12:14.000 --> 00:12:19.040 And it hopes to do so to say: We as pioneers, working on this technology... 00:12:19.120 --> 00:12:22.960 should all take collective responsibility for the future safety of our work. 00:12:23.040 --> 00:12:25.800 And this is what Safe-by-Design helps to do. 00:12:25.880 --> 00:12:28.600 By helping you to anticipate on potential problems... 00:12:28.680 --> 00:12:30.160 and include a broader context... 00:12:30.240 --> 00:12:33.360 and a wide array of stakeholders into your innovation process... 00:12:33.440 --> 00:12:35.480 Safe-by-Design provides you a way to learn... 00:12:35.560 --> 00:12:38.440 as much about potential adverse consequences as possible... 00:12:38.520 --> 00:12:41.400 as early in the innovation chain as possible. 00:12:41.480 --> 00:12:46.440 So we're going to try and move that pink line forward as much as we can. 00:12:46.520 --> 00:12:48.320 Now in response to the knowledge that you learn... 00:12:48.400 --> 00:12:51.840 you can of course adjust your design... 00:12:51.920 --> 00:12:55.240 so you can think about building in safety measures... 00:12:55.320 --> 00:12:59.320 but also creating a safer environment for the innovation to function in. 00:12:59.400 --> 00:13:02.040 Or you can think of collaborating with societal actors... 00:13:02.120 --> 00:13:03.720 to adjust your innovation to society... 00:13:03.800 --> 00:13:06.040 maybe even prepare society for your innovation... 00:13:06.120 --> 00:13:09.000 for example by seeking out collaboration with regulators... 00:13:09.080 --> 00:13:13.680 to see if you can develop rules and regulations that would guide proper use. 00:13:13.760 --> 00:13:16.000 These are all things you can think of... 00:13:16.080 --> 00:13:19.520 in response to your increased knowledge about safety impacts. 00:13:20.640 --> 00:13:23.480 But of course, not all impacts can be known beforehand. 00:13:23.560 --> 00:13:25.520 There's always a degree of uncertainty... 00:13:25.600 --> 00:13:29.160 and we should try and see if we can account for that as well. 00:13:29.240 --> 00:13:35.040 We can try and design solutions that stay adaptable for as long as possible. 00:13:35.120 --> 00:13:38.400 The main thing that you would be able to do... 00:13:38.480 --> 00:13:42.320 is to see how we can design something that is easily monitored... 00:13:42.400 --> 00:13:46.120 keep check on what is going to happen, what it does, how it interacts with the world... 00:13:46.200 --> 00:13:48.400 and try and respond to that. 00:13:48.480 --> 00:13:52.400 And even, in extreme cases, you might be able to consider design strategies... 00:13:52.480 --> 00:13:55.320 such as flexible design, a more modular design... 00:13:55.400 --> 00:13:59.040 that allow you a degree of control on the product you're making... 00:13:59.120 --> 00:14:01.240 after it's already been introduced. 00:14:01.320 --> 00:14:05.400 Of course it's important to realize that those kinds of design options add complexity... 00:14:05.480 --> 00:14:08.920 so that also includes adding uncertainty. 00:14:09.000 --> 00:14:13.960 But those kinds of directions of thinking might be helpful in sort of designing for safety. 00:14:15.600 --> 00:14:17.920 So Safe-by-Design is a design approach that's characterized... 00:14:18.000 --> 00:14:22.720 by a proactive and reflexive attitude towards safety concerns. 00:14:22.800 --> 00:14:26.760 It starts at the earliest phases of research and design, development... 00:14:26.840 --> 00:14:29.880 and goes all the way to product design but also its societal introduction... 00:14:29.960 --> 00:14:34.720 and even thinking ahead towards waste management or recycling of a product. 00:14:34.800 --> 00:14:37.480 And it sort of reflects the continuous two-way interaction... 00:14:37.560 --> 00:14:39.920 between on the one hand the innovator that's proactive... 00:14:40.000 --> 00:14:43.240 thinking about 'How will my innovation impact the world?'... 00:14:43.320 --> 00:14:48.000 and the world. 'How does the world impact the thing that I'm designing... 00:14:48.080 --> 00:14:52.720 and how should I adjust my design to better suit the environment and the world?' 00:14:54.600 --> 00:15:00.360 You can imagine this in practice by looking at innovation progressing in different stages. 00:15:00.440 --> 00:15:03.000 We start with a vision, trying to solve a certain problem... 00:15:03.080 --> 00:15:06.880 or develop a certain new possibility or technology. 00:15:06.960 --> 00:15:09.400 And as we progress through different stages... 00:15:09.480 --> 00:15:13.480 we of course are alert for any sort of design elements. 00:15:13.560 --> 00:15:16.720 We are part of a biological engineering group... 00:15:16.800 --> 00:15:19.400 so we think of how can we design functionalities... 00:15:19.480 --> 00:15:23.880 but at the same time you should think about how do we design in safety. 00:15:23.960 --> 00:15:27.320 Now while you're doing these things you should continuously be aware... 00:15:27.400 --> 00:15:30.880 also of things happening beyond the lab. 00:15:30.960 --> 00:15:36.480 So that means the safety, security issues that the introduction of your innovation may pose... 00:15:36.560 --> 00:15:40.600 any policy, law or ethical issues that may arise... 00:15:40.680 --> 00:15:42.760 with the introduction of your technology... 00:15:42.840 --> 00:15:46.720 and also what kind of stakeholders are influenced by that innovation... 00:15:46.800 --> 00:15:50.800 and whether they should be included in the development of your technology. 00:15:52.040 --> 00:15:55.480 Now this innovation process is visualized as a line... 00:15:55.560 --> 00:15:59.640 a linear process, and that's of course not really the case. 00:15:59.720 --> 00:16:04.360 A more accurate representation would be innovation shown as a iterative process. 00:16:04.440 --> 00:16:05.760 We're still moving through the phases. 00:16:05.840 --> 00:16:08.800 You're still starting with an idea and hoping to end up with a product... 00:16:08.880 --> 00:16:11.720 but as you're moving through each phase you're looking forward... 00:16:11.800 --> 00:16:17.000 trying to imagine already in your first vision, envisioning of a new innovation... 00:16:17.080 --> 00:16:20.440 what it would take to produce that innovation for example... 00:16:20.520 --> 00:16:23.160 and what kind of issues you may encounter at that stage. 00:16:23.640 --> 00:16:26.160 And as you move through each of these stages you look back: 00:16:26.240 --> 00:16:31.760 'Have I done everything I can, what kind of new issues should I encounter... 00:16:31.840 --> 00:16:35.520 and what can we do to incorporate that into the design?' 00:16:35.600 --> 00:16:40.440 A classic example of an innovation that did not follow the procedure... 00:16:40.520 --> 00:16:42.160 would be Golden Rice. 00:16:42.240 --> 00:16:45.080 Golden Rice was a rice variety... 00:16:45.160 --> 00:16:50.600 that aimed to solve the issue of vitamin A deficiency in developing countries. 00:16:50.680 --> 00:16:53.840 While the aim was very admirable... 00:16:53.920 --> 00:16:58.280 the product really failed because it did not take into account several upstream factors... 00:16:58.360 --> 00:17:03.160 such as the fact that this vitamin A deficiency was caused by unvaried diets... 00:17:03.240 --> 00:17:06.160 which are a symptom of much larger poverty problems... 00:17:06.240 --> 00:17:09.680 and therefore Golden Rice was seen more as a symptomatic treatment... 00:17:09.760 --> 00:17:12.360 rather than an actual solution. 00:17:12.440 --> 00:17:16.080 And it also didn't sufficiently address several downstream societal symptoms... 00:17:16.160 --> 00:17:19.720 such as the fear for corporate control of agricultural stocks... 00:17:19.800 --> 00:17:23.640 or the ecological risks of introducing such a rice variety. 00:17:23.720 --> 00:17:27.200 It might displace natural rice variations. 00:17:27.280 --> 00:17:31.960 So had the researchers looked ahead and looked in a broader context... 00:17:32.040 --> 00:17:35.800 they might have gone very differently about presenting or introducing their innovation... 00:17:35.880 --> 00:17:38.560 or maybe they wouldn't have gone through with it at all. 00:17:39.680 --> 00:17:43.280 So Safe-by-Design allows you as a researcher and also society as a whole... 00:17:43.360 --> 00:17:46.160 to adjust the course of innovation while it's still flexible... 00:17:46.240 --> 00:17:50.000 and it helps you develop beneficial and safer innovations. 00:17:50.080 --> 00:17:53.280 Now I'd like to go back to Julie. 00:17:53.360 --> 00:17:56.440 JULIE NG-A-THAM: So Sam provided you with some thoughts... 00:17:56.520 --> 00:18:00.400 and dilemmas to address... 00:18:00.480 --> 00:18:03.360 and a lot of new things to do. 00:18:03.440 --> 00:18:06.600 But perhaps we can help you. 00:18:06.680 --> 00:18:08.760 I would like to give Cécile the floor. 00:18:08.840 --> 00:18:13.360 Perhaps Cécile can help you with how to incorporate this into your project... 00:18:13.440 --> 00:18:17.520 and make it more easy for you. Cécile, the floor is yours. 00:18:17.600 --> 00:18:21.120 CÉCILE VAN DER VLUGT: Okay. Thank you, Julie, for this opportunity. 00:18:21.200 --> 00:18:25.240 Now dear iGEM'ers, what is your dream project this summer? 00:18:25.320 --> 00:18:28.880 To find a solution for the plastic soup in the ocean... 00:18:28.960 --> 00:18:33.280 or to design a detection kit for COVID-19... 00:18:33.360 --> 00:18:38.960 or do you want to develop a biocontrol agent for a devastating plant disease? 00:18:39.040 --> 00:18:43.240 Well, your iGEM project is a big opportunity to explore Safe-by-Design... 00:18:43.320 --> 00:18:46.440 while you are developing your own synthetic organism. 00:18:47.760 --> 00:18:51.440 And how to explore what Safe-by-Design can do for your project? 00:18:51.520 --> 00:18:54.920 How can you make Safe-by-Design alive? 00:18:55.000 --> 00:18:59.160 So let's have a look... 00:18:59.240 --> 00:19:02.800 at the method we are designing for you. 00:19:04.840 --> 00:19:10.240 Yes. That's the method. Safe-by-Design is a simple method, learning by doing. 00:19:10.320 --> 00:19:12.200 You just see three tabs. 00:19:12.280 --> 00:19:16.640 It's challenging because you are asked to think critically. 00:19:16.720 --> 00:19:18.400 It will be an interactive process... 00:19:18.480 --> 00:19:22.320 as you will contact many stakeholders, experts... 00:19:22.400 --> 00:19:26.920 to gain information and have a discussion with your coach. 00:19:27.000 --> 00:19:32.040 We suggest to have a time period of two months... 00:19:32.120 --> 00:19:33.760 along your iGEM project. 00:19:33.840 --> 00:19:35.880 That will be plenty of time... 00:19:35.960 --> 00:19:40.960 but we also see teams working for a bit longer time than the two months. 00:19:41.040 --> 00:19:44.560 So it's up to you how many time you have left for your project... 00:19:44.640 --> 00:19:47.160 but you are still in time at this moment... 00:19:47.240 --> 00:19:51.040 to incorporate the Safe-by-Design method in your project. 00:19:52.720 --> 00:19:57.640 It's important to know that there are two types of actors involved in this method. 00:19:57.720 --> 00:20:00.040 You as students. 00:20:00.120 --> 00:20:05.480 We suggest to have a selection of four to six students from your team... 00:20:05.560 --> 00:20:07.960 to work on the Safe-by-Design project... 00:20:08.040 --> 00:20:13.720 and it is of an added value if these students have different scientific backgrounds. 00:20:14.800 --> 00:20:19.680 And you are entering the Safe-by-Design method just by learning and doing. 00:20:20.600 --> 00:20:23.600 The second type of actor is a coach. 00:20:23.680 --> 00:20:27.280 That could be your mentor or your supervisor... 00:20:27.360 --> 00:20:32.520 of if they are not available one or two of your team members could also be a coach. 00:20:32.600 --> 00:20:35.600 Because you as a student are a critical thinker... 00:20:35.680 --> 00:20:39.320 and in that you can also take up the role of a coach... 00:20:39.400 --> 00:20:45.200 as you can also question results and keep a close eye on Safe-by-Design aspects. 00:20:47.320 --> 00:20:50.360 So have a look at the first step in the Safe-by-Design method. 00:20:50.440 --> 00:20:54.680 It all starts with your own project idea. 00:20:54.760 --> 00:20:59.160 Have a look at your project idea and think about all kinds of safety issues. 00:20:59.240 --> 00:21:04.520 Biosafety, chemical safety. Do you use any pathogens? 00:21:04.600 --> 00:21:08.440 And think along the whole line of design... 00:21:08.520 --> 00:21:12.840 up to the end use of the final product you wish to design. 00:21:14.080 --> 00:21:18.640 By discussing these different safety issues... 00:21:18.720 --> 00:21:22.080 you get a collective view on this aspect. 00:21:22.160 --> 00:21:26.000 And that will be the start for the coaching session. 00:21:26.080 --> 00:21:31.520 So it's important to document all the aspects you have addressed in your discussion. 00:21:31.600 --> 00:21:38.000 You can make a short proposal or a mindmap, just what is convenient to you. 00:21:40.560 --> 00:21:43.840 To have an idea of the different kinds of safety aspects... 00:21:43.920 --> 00:21:48.320 I would like to have your attention for this project. 00:21:48.400 --> 00:21:53.200 It's a little exercise also for you. A poll question will come up. 00:21:53.280 --> 00:21:58.880 This project was called 'food warden' and was designed to stop food waste... 00:21:58.960 --> 00:22:03.800 especially the food waste in supermarkets from packaged meat. 00:22:03.880 --> 00:22:08.880 Because if the sell-by date was passed then the meat is thrown away... 00:22:08.960 --> 00:22:13.200 without knowing for sure whether the meat was still okay. 00:22:13.280 --> 00:22:17.280 So the students designed a sticker, as you can see in this picture... 00:22:17.360 --> 00:22:20.400 and the sticker was packaged together with the meat. 00:22:20.480 --> 00:22:25.840 It contains GM bacteria and they were released from this inner sticker... 00:22:25.920 --> 00:22:29.600 into the medium which contained nutrients... 00:22:29.680 --> 00:22:34.840 and that activated the metabolism and the genetic circuit. 00:22:34.920 --> 00:22:41.240 Because these GM bacteria were able to smell the rotten meat... 00:22:41.320 --> 00:22:44.320 and upon that smell they colorize. 00:22:44.400 --> 00:22:50.520 So the question is: What kind of safety aspects would you consider for this project? 00:22:50.600 --> 00:22:53.840 And I'm looking now for the poll question... 00:22:53.920 --> 00:22:56.240 that you will see in a second. 00:22:57.920 --> 00:23:02.960 For this poll question I suggested a number of safety aspects. 00:23:03.040 --> 00:23:06.720 And I'd like to ask you to take two or three safety aspects... 00:23:06.800 --> 00:23:10.800 you think are important to consider. 00:23:12.600 --> 00:23:16.440 Food safety is coming up as first. Well yeah, I think that's obvious. 00:23:16.520 --> 00:23:21.040 But then end use and waste disposal is also addressed. 00:23:21.120 --> 00:23:24.600 And I think that's very interesting, that you suggested this to have a look at. 00:23:24.680 --> 00:23:27.280 I mean, for me it's very natural... 00:23:27.360 --> 00:23:32.440 but in another poll we saw that people were very interested to look at lab safety as well. 00:23:32.520 --> 00:23:38.520 But as you understand, using this sticker in the packaged meat... 00:23:38.600 --> 00:23:43.880 and how the public will use that is a very important aspect to address... 00:23:43.960 --> 00:23:48.400 and to think how you could include safety aspects. 00:23:49.320 --> 00:23:52.520 So thank you for your response for that. 00:23:52.600 --> 00:23:55.240 So now let me first address the coach... 00:23:55.320 --> 00:24:00.560 because also as coach you need to know what to do in this method. 00:24:00.640 --> 00:24:05.720 And as I said, you as a student can also act as a coach. 00:24:05.800 --> 00:24:09.120 What we ask from the coach is that they, he or she... 00:24:09.200 --> 00:24:13.320 reads the student's proposal, reflects on the safety issues... 00:24:13.400 --> 00:24:17.240 consider if everything is included from the start to the beginning... 00:24:17.320 --> 00:24:21.560 and additional to that, could you provide some moral and ethical views... 00:24:21.640 --> 00:24:25.360 and think about stakeholders or experts that could be consulted... 00:24:25.440 --> 00:24:29.280 to broaden the view of the students on the project. 00:24:29.360 --> 00:24:34.480 And to get some more idea what is asked for this... 00:24:34.560 --> 00:24:38.840 another iGEM project called 'Gelcatraz'. 00:24:38.920 --> 00:24:43.520 These students wanted to work with living material... 00:24:43.600 --> 00:24:49.800 and they decided to use this biomaterial as part of a bandage to cover wounds. 00:24:49.880 --> 00:24:55.720 What you see in this picture is that the GM bacteria are attached to a hydrogel. 00:24:55.800 --> 00:25:00.760 Besides that the bacteria are also able to excrete a bacteriocin... 00:25:00.840 --> 00:25:08.040 and this bacteriocin could inactivate bacteria causing wound infections. 00:25:08.120 --> 00:25:10.920 Now that was the idea. 00:25:11.000 --> 00:25:15.240 And I'd like you now to consider also in the next poll: 00:25:15.320 --> 00:25:20.760 What are relevant stakeholders and experts to contact... 00:25:20.840 --> 00:25:26.120 to broaden your view on what kind of... 00:25:26.200 --> 00:25:28.960 What type of information to collect. 00:25:33.040 --> 00:25:34.440 Okay. 00:25:35.560 --> 00:25:37.640 Well, thank you, excellent. 00:25:37.720 --> 00:25:41.600 I'll show you the results. What has been voted? 00:25:43.120 --> 00:25:47.320 Relevant stakeholders: health care workers and patients. 00:25:47.400 --> 00:25:50.640 Indeed, what I know from this project is... 00:25:50.720 --> 00:25:57.000 that that really gave the project a focus on working with a specific type of wounds. 00:25:57.080 --> 00:26:00.480 So it's very helpful to address these parties. 00:26:01.480 --> 00:26:06.720 I don't see any votes for parties which could help with PR. 00:26:06.800 --> 00:26:08.240 But please do consider that... 00:26:08.320 --> 00:26:12.320 as these people can reach out to the public, help you with reaching out. 00:26:12.400 --> 00:26:16.040 Because if patients need to use this... 00:26:16.120 --> 00:26:23.120 you want to know what their points of interest are to work safely. 00:26:23.200 --> 00:26:26.040 And also governmental bodies is not clicked... 00:26:26.120 --> 00:26:31.360 but this kind of development needs the attention for the GMO assessors... 00:26:31.440 --> 00:26:33.760 as well as the medical assessors. 00:26:33.840 --> 00:26:35.960 And they look at specific points... 00:26:36.040 --> 00:26:39.960 which you can also consider early in the design phase. 00:26:40.040 --> 00:26:45.560 So these people can also help to address all kinds of safety issues. 00:26:46.920 --> 00:26:50.280 Okay, thank you for your contribution to this. 00:26:50.360 --> 00:26:56.160 And now both parties, students and coach... 00:26:56.240 --> 00:27:00.440 are ready for the next step in the Safe-by-Design method. 00:27:00.520 --> 00:27:03.280 The coaching session. 00:27:03.360 --> 00:27:05.320 In this session you sit together. 00:27:05.400 --> 00:27:07.360 As students you present the project... 00:27:07.440 --> 00:27:11.360 and all the safety aspects you have considered up til now... 00:27:11.440 --> 00:27:14.200 and as coach you reflect on these aspects. 00:27:14.280 --> 00:27:18.280 Together you have a discussion on the whole... 00:27:18.360 --> 00:27:24.760 and what stakeholders could be involved and what experts could be consultated... 00:27:24.840 --> 00:27:28.920 to gain more in-depth information on the project you are working on... 00:27:29.000 --> 00:27:34.360 and also ethical and moral views should be included. 00:27:34.440 --> 00:27:37.200 And after this discussion... 00:27:37.280 --> 00:27:42.080 you as students have the most of the work to do in this Safe-by-Design method... 00:27:42.160 --> 00:27:47.160 because now you have many ideas resulting from the very first step... 00:27:47.240 --> 00:27:51.080 from the coaching session, and now you can think... 00:27:51.160 --> 00:27:56.040 what stakeholders and experts you need to contact for more information... 00:27:56.120 --> 00:28:01.800 and also think how to incorporate these safety aspects in your product design. 00:28:01.880 --> 00:28:06.560 And most importantly, document all these ideas, the interviews... 00:28:06.640 --> 00:28:11.960 results coming up from the discussions, because with that you can later on show... 00:28:12.040 --> 00:28:16.680 how this discussion has affected your design process. 00:28:16.760 --> 00:28:19.880 We suggest to use an infographic for that... 00:28:19.960 --> 00:28:26.240 because that is presenting a very quick overview from the work you have done. 00:28:26.320 --> 00:28:31.760 So as an example, have a look back at the Gelcatraz project. 00:28:32.240 --> 00:28:34.880 This is an example to show... 00:28:34.960 --> 00:28:41.480 what stakeholders they have contacted... 00:28:41.560 --> 00:28:46.840 and also to show what the benefit is from reaching out to stakeholders. 00:28:46.920 --> 00:28:51.520 Because as I said just before, medical professionals suggested... 00:28:51.600 --> 00:28:54.720 to focus on burn wounds and diabetic wounds... 00:28:54.800 --> 00:29:01.120 as these are long-lasting wounds and suffering from infection and pathogenic bacteria. 00:29:01.200 --> 00:29:05.840 So that gave a focus on the type of plaster to be developed... 00:29:05.920 --> 00:29:09.440 and the GM bacteria to be designed. 00:29:09.520 --> 00:29:13.760 And also by contacting professors in biosafety and chemistry... 00:29:13.840 --> 00:29:18.880 for example the use of dextran as a safe matrix was an important decision. 00:29:18.960 --> 00:29:24.080 Because there are also chemical polymers available as a matrix... 00:29:24.160 --> 00:29:29.240 however it turned out that there are also chemicals involved in that process. 00:29:30.400 --> 00:29:34.560 So along with a number of other stakeholders... 00:29:34.640 --> 00:29:39.640 this contact really shaped also the project of this team. 00:29:39.720 --> 00:29:43.760 And I show you here just a concept infographic. 00:29:43.840 --> 00:29:47.920 You don't need to read this or to copy this. This is just an illustration. 00:29:48.000 --> 00:29:53.600 What this team has done is finding a pictogram for every safety aspect... 00:29:55.280 --> 00:29:58.440 put it in this infographic with some additional text... 00:29:58.520 --> 00:30:01.880 on the stakeholders and experts they contacted... 00:30:01.960 --> 00:30:05.360 and what that gave as an output. 00:30:06.560 --> 00:30:12.840 And also this concept infographic is useful for the second coaching session. 00:30:12.920 --> 00:30:17.920 Because in that session, as the final step of your Safe-by-Design method... 00:30:18.000 --> 00:30:20.600 you sit together again with your coach... 00:30:20.680 --> 00:30:27.200 and you reflect on Safe-by-Design aspects investigated thus far. 00:30:27.280 --> 00:30:30.480 Maybe there are still unaddressed safety aspects... 00:30:30.560 --> 00:30:33.360 difficult to address... 00:30:33.440 --> 00:30:38.840 because some aspects could be conflicting in product design. 00:30:38.920 --> 00:30:43.200 And how is the translation of Safe-by-Design done in the product design? 00:30:43.280 --> 00:30:49.400 Because is it doable due to the time and money constraints, for example? 00:30:49.480 --> 00:30:53.080 Your project is only lasting for a couple of months. 00:30:53.160 --> 00:30:56.680 You cannot do everything so you have to make choices. 00:30:56.760 --> 00:31:00.680 And what is the impact of Safe-by-Design on your project? 00:31:00.760 --> 00:31:05.960 Because as I already said, you can have conflicting safety issues... 00:31:06.040 --> 00:31:10.080 and what kind of choices you should make then? 00:31:10.160 --> 00:31:12.520 So use this discussion with your coach... 00:31:12.600 --> 00:31:15.560 to get some in-depth insight in your choices... 00:31:15.640 --> 00:31:20.240 and also document that in an infographic. 00:31:20.320 --> 00:31:25.680 Because with that you are in the final step of the Safe-by-Design method. 00:31:25.760 --> 00:31:28.080 Some finishing touches I have for you. 00:31:28.160 --> 00:31:34.280 Decide on the final Safe-by-Design aspects to integrate in your product design... 00:31:34.360 --> 00:31:36.800 and also finalize this infographic. 00:31:36.880 --> 00:31:39.760 And this infographic is not just for fun. 00:31:39.840 --> 00:31:44.320 It can help you to inform the public... 00:31:44.400 --> 00:31:51.200 on how you have thought and designed on your synthetic organism. 00:31:51.280 --> 00:31:56.280 Maybe if your project is succesful, you can reach out to your manufacturer... 00:31:56.360 --> 00:32:01.600 on what you have done and already included in your project. 00:32:01.680 --> 00:32:07.440 But I think the most obvious reason to make such an infographic... 00:32:07.520 --> 00:32:11.720 is also to show it to the judges in the iGEM Jamboree... 00:32:11.800 --> 00:32:13.880 as they will also have a look at this... 00:32:13.960 --> 00:32:17.880 and understand what you have done for working safe... 00:32:17.960 --> 00:32:22.800 and practising safety and finalizing a safe product. 00:32:23.360 --> 00:32:30.000 So with this I come to the end of explaining the process. 00:32:30.080 --> 00:32:32.880 If you have followed this process you nailed it. 00:32:32.960 --> 00:32:38.600 You incorporated Safe-by-Design in your iGEM project. 00:32:38.680 --> 00:32:45.720 And I think if you look back and look that you started with your own project idea... 00:32:45.800 --> 00:32:50.920 faced many safety issues and found solutions for yourself... 00:32:51.000 --> 00:32:53.240 then you have learned Safe-by-Design by doing... 00:32:53.320 --> 00:32:58.760 and making a very complicated process as you have seen in the introduction of Sam... 00:32:58.840 --> 00:33:02.520 you have made this complicated process doable. 00:33:02.600 --> 00:33:06.440 So I wish you a wonderful time and very much success in iGEM... 00:33:06.520 --> 00:33:09.360 and I give the word back to Julie. 00:33:10.560 --> 00:33:15.680 JULIE NG-A-THAM: So we come to the end of our webinar. 00:33:17.040 --> 00:33:19.760 The method Cécile illustrated... 00:33:19.840 --> 00:33:23.520 we could not do that without the help of all the previous iGEM teams... 00:33:23.600 --> 00:33:27.920 so I would like to thank all the iGEM teams for their efforts... 00:33:28.000 --> 00:33:33.000 but also the Ministry of Infrastructure and Water Management... 00:33:33.080 --> 00:33:37.280 because they have sponsored us during our work to do this. 00:33:39.160 --> 00:33:41.440 But now it's up to you. 00:33:41.520 --> 00:33:46.760 You are part of the community of young synthetic biology researchers... 00:33:46.840 --> 00:33:51.560 and as such you have a responsibility regarding safety... 00:33:51.640 --> 00:33:53.880 and Safe-by-Design. 00:33:53.960 --> 00:34:00.360 And let's face it, it is quite a difficult task, but try to enjoy the ride... 00:34:00.440 --> 00:34:04.280 because it can be very promising... 00:34:04.360 --> 00:34:09.400 and also pretty satisfying... 00:34:09.480 --> 00:34:15.240 when you can contribute your experiences to the iGEM community. 00:34:16.080 --> 00:34:22.240 So go out and try to make this world more safe and more sustainable... 00:34:22.320 --> 00:34:25.800 and, in the end, a better place. Thank you very much.